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Tapering lupus drugs in stable patients: Large study outlines risks, benefits
The question looms large for patients with stable systemic lupus erythematosus (SLE): to taper or not to taper corticosteroids or immunosuppressive therapy? For patients and the physicians treating them, the evidence points in both directions. Flares are exacerbated by tapering, but simultaneously organ damage is tempered. Where is the balance? What competing factors together inform decision-making?
A recent multinational, observational cohort study conducted by Jiacai Cho, MBBS, of National University Hospital, Singapore, and colleagues, and published in The Lancet Rheumatology concluded that, given the odds of excess flares associated with tapering of corticosteroids and immunosuppressive therapy in patients with stable SLE, drug tapering warrants careful consideration of risks and benefits and is best reserved for those in complete clinical and serological remission with stable disease for at least 6 months. However, in an accompanying editorial, Yann Nguyen, MD, MPH, and Nathalie Costedoat-Chalumeau, MD, PhD, of the National Referral Center for Rare Autoimmune and Systemic Diseases at Cochin Hospital, Paris, and the Center for Research in Epidemiology and Statistics at Paris City University, argued for tipping the scale back from some of those expressed cautions.
In interviews, experts in the field expressed both strong appreciation for the cohort study and, like the editorialists, cognizance of its limitations.
Dr. Cho and colleagues recruited 3,002 adult patients with SLE (92.2% female, median age 39.5 years), from 25 sites across 13 Asia-Pacific countries. They were receiving routine clinical care and had achieved stable disease in at least one of two or more visits. Stable disease was defined by meeting criteria for Lupus Low Disease Activity State (LLDAS; SLE Disease Activity Index 2000 [SLEDAI-2K] score ≤ 4, Physician Global Assessment [PGA] ≤ 1, and prednisolone ≤ 7.5 mg/day), the 2021 DORIS definition of remission (clinical SLEDAI-2K score 0, PGA score < 0.5, and prednisolone dose ≤ 5 mg/day), or DORIS complete remission on therapy (SLEDAI-2K score 0, PGA score < 0.5, and prednisolone dose ≤ 5 mg/day). Any decrease in dose of corticosteroids or immunosuppressive therapy (mycophenolate mofetil, calcineurin inhibitors, azathioprine, leflunomide, or methotrexate) defined tapering. The investigators compared the odds of disease flares (SELENA-SLEDAI Flare Index) at the visit following tapering among those with tapering versus those who had continued the same drug doses.
Higher odds of flare with tapering
Tapering, compared with continuing with the same dose, was clearly associated with higher odds of flare at the next visit (11.4% with continuing vs. 17.0% with tapering; odds ratio, 1.24; 95% confidence interval, 1.10-1.39; P = .0005). Flares among patients who tapered were also slightly more often severe than with continuing the same dose (21.5% of flares vs. 19.7%). The level of remission at the time of tapering also mattered. Of 2,095 continuous tapering attempts, 860 (41.1%) were initiated in LLDAS, 596 (28.4%) in remission, and 639 (30.5%) in complete remission. Tapering when in LLDAS or remission, compared with complete remission, was associated with a higher likelihood of flare by 1 year (LLDAS: OR, 1.37; 95% CI, 1.03-1.81; P = .029; and remission: OR, 1.45; 95% CI, 1.08-1.94; P = .013). Time to first flare followed the same pattern. Also, sustained LLDAS, remission, or complete remission for at least 6 months just before the time of taper was associated with lower odds of flare at next visit and flares in 1 year, and longer time to flare.
Take baseline disease status, hydroxychloroquine’s effect into account
Dr. Nguyen and Dr. Costedoat-Chalumeau underscored several factors that may soften the risk for flares seen with tapering. They pointed to higher baseline doses of prednisone and immunosuppressants (and thus likely more severe disease that is more likely to flare) in the patients with tapering. Also, the SELENA-SLEDAI Flare Index used in the study classifies some clinically insignificant flares as mild to moderate and ignores the benefit of tapering. (It classifies patients as having a severe flare even when starting a new immunosuppressant prescription, such as azathioprine, methotrexate, or both, in an effort to reduce corticosteroid use.) They wrote that the study did not assess the rate of clinically meaningful flares (“essentially renal flares”), nor did it highlight that the “tiny” increase in absolute risk of severe flares (from 2.2% to 3.7%) could be further contextualized by the offset of the smaller, unmeasured rate of clinically significant flares and the “extremely relevant” risk of concomitant damage from prolonged treatment.
Dr. Nguyen and Dr. Costedoat-Chalumeau urged hydroxychloroquine use for all patients unless clearly contraindicated. In their own research, they have detailed hydroxychloroquine benefits in reducing not only flare risk, but also comorbidities, damage, and mortality. In the current study, the prevalence of hydroxychloroquine use in all the patient visits was only 63.3%. “We can assume that if more patients had been treated with hydroxychloroquine, both the number of flares and the difference between the two strategies would have been lower,” they wrote. They cited findings from a study of patients in remission for 2 years or longer in the Toronto Lupus Cohort in which a gradual taper of corticosteroids over 1 year was safe and feasible and resulted in less damage accrual at 24 months than not tapering. Optimizing tapering can minimize flare risk, they concluded.
Tapering SLE medications always involves some chance of flare and has to be considered a calculated risk, Sasha Bernatsky, MD, the James McGill professor of medicine in the division of rheumatology at McGill University, Montreal, said in an interview. “Long-term prednisone is not good for patients. I have heard it called ‘the miracle drug from hell’ – meaning that, yes, it controls disease, but at a cost of long-term complications. So we must be conscientious about tapering prednisone.” She observed that in the short-term, there may not be a huge risk to keeping a patient on an antimalarial and counseling patients to stay on it because their risk of flare is higher if they taper. Rheumatologists usually agree, however, that after 10 years or more, there is a real chance of retinal toxicity. “In our Montreal cohort, the risk of retinal toxicity was 5% after an average of 12.8 years of antimalarial use. My concern is that if a patient develops SLE in their 20s, how do we decide if we should keep them on an antimalarial for the next 60 or 70 years? If we keep them on the drug from age 25 to 45, and they then get retinal toxicity, they would essentially never be able to be on the drug again. So I do try to keep patients on the lowest dose of an antimalarial that is possible.”
Dr. Bernatsky pointed out further, “We think about tapering other immunosuppressants (such as methotrexate or mycophenolate or azathioprine) quite differently than prednisone tapering. We take our time a bit more, since many patients will tolerate being on standard doses of these drugs fairly well. If or when we do consider tapering these drugs, both our intuition and the literature suggests that someone with worse baseline disease activity or severity, who has needed a lot of steroids and multiple combinations of drugs to control disease, has a higher chance of flaring than someone with milder disease. As the editorial points out, lupus physicians (and their patients) need to think carefully about the patient’s risk profile, and be sure to tailor follow-up based on flare risk.”
Frank discussions with patients about the risks of tapering are needed, she said. “On one hand, there is consensus about how some aspects of lupus should be managed (for example, aggressive treatment of severe nephritis), but on the other hand, when it comes to long-term management and especially discussing tapering, we must have good discussions with patients. When a patient asks if they can taper a drug – many just lower or stop their drugs without asking – I am as honest as I can be, but ultimately have to admit any taper could be associated with a flare. It’s helpful to have actual figures to discuss with patients.”
No surprises
“This is an interesting study, which did not produce any surprises,” Dafna D. Gladman, MD, professor of medicine at University of Toronto and senior scientist at the university’s Schroeder Arthritis Institute, said when asked to comment. “We already knew from previous studies that abrupt withdrawal is not a good idea, and that if you taper when a patient is under conditions of remission, the rate of flare is actually lower than the usual rate of flare that occurs in people who continue on these medications. But the major limitation is that they did not specifically look at those who we would taper in clinical practice. In addition, they do not specify that the patients had to be on low-dose glucocorticoids before tapering, and they combined both immunosuppressive and steroids. It is not clear from the study what the excess flare rate was, or whether the flares were mild or severe. Most flares in patients with SLE are mild, consisting of skin and joint manifestations, while only a few patients have flares in kidney or neurologic manifestations.”
Dr. Gladman described her approach to tapering: “We aim for our patients to be taking no more than 5 mg of prednisone and to be in at least clinical remission with a SLEDAI-2K of 0 for at least 2 years before we would taper to glucocorticoids withdrawal. We always withdraw glucocorticoids first and immunosuppressives later, and keep patients on antimalarials the longest, unless there are specific side effects to the immunosuppressive or antimalarials which require their cessation earlier.”
Uncertainty persists
Other SLE experts weighing in confirmed the view that future research should aim to achieve clarity about the relative risks and benefits of tapering SLE drug regimens to maintain disease remission while minimizing potential for organ damage.
“Steroids are our friend and our enemy,” Joan T. Merrill, MD, professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “If a person with lupus is in a lot of trouble, corticosteroids are almost universally a good option to get them out. But for too many decades, for too many patients, despite all the improvements we have made in better understanding the disease and developing some promising new treatments, we have yet to shed the inexorable toxicity in multiple organs of steroid dependence.” She continued, “Corticosteroids, even at low dose, may have broad-spectrum effects. But, in fact, so do many of the more ‘targeted’ agents. If all patients were lined up at the beginning of a study while being given azathioprine or a calcineurin inhibitor or belimumab at a stable, tolerable dose, you might see the same data if you tapered that agent down. What we really need is improved individualized guidance about when and how fast to remove immune modulators from stable patients with lupus without disturbing the balance that had been achieved in such a quiescent patient.”
That enduring uncertainty was echoed by Daniel J. Wallace, MD, professor of medicine at Cedars-Sinai Medical Center, Los Angeles: “The take-home message from this interesting paper,” he commented, “is that current lupus biomarkers are not adequate. They do not guide the practitioner well enough, so that all too often medication regimens are tapered even though the risks are not really well known. Also, there is evidence in the literature that fibrosis and ‘damage’ progress even if acute phase reactants such as sedimentation rate, [C-reactive protein], complement 3 and 4, and anti-dsDNA are normal. We don’t have a good metric to detect them.”
Dr. Cho and colleagues’ study was funded by AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck Serono, GlaxoSmithKline, and UCB. Dr. Gladman disclosed consulting and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB.
The question looms large for patients with stable systemic lupus erythematosus (SLE): to taper or not to taper corticosteroids or immunosuppressive therapy? For patients and the physicians treating them, the evidence points in both directions. Flares are exacerbated by tapering, but simultaneously organ damage is tempered. Where is the balance? What competing factors together inform decision-making?
A recent multinational, observational cohort study conducted by Jiacai Cho, MBBS, of National University Hospital, Singapore, and colleagues, and published in The Lancet Rheumatology concluded that, given the odds of excess flares associated with tapering of corticosteroids and immunosuppressive therapy in patients with stable SLE, drug tapering warrants careful consideration of risks and benefits and is best reserved for those in complete clinical and serological remission with stable disease for at least 6 months. However, in an accompanying editorial, Yann Nguyen, MD, MPH, and Nathalie Costedoat-Chalumeau, MD, PhD, of the National Referral Center for Rare Autoimmune and Systemic Diseases at Cochin Hospital, Paris, and the Center for Research in Epidemiology and Statistics at Paris City University, argued for tipping the scale back from some of those expressed cautions.
In interviews, experts in the field expressed both strong appreciation for the cohort study and, like the editorialists, cognizance of its limitations.
Dr. Cho and colleagues recruited 3,002 adult patients with SLE (92.2% female, median age 39.5 years), from 25 sites across 13 Asia-Pacific countries. They were receiving routine clinical care and had achieved stable disease in at least one of two or more visits. Stable disease was defined by meeting criteria for Lupus Low Disease Activity State (LLDAS; SLE Disease Activity Index 2000 [SLEDAI-2K] score ≤ 4, Physician Global Assessment [PGA] ≤ 1, and prednisolone ≤ 7.5 mg/day), the 2021 DORIS definition of remission (clinical SLEDAI-2K score 0, PGA score < 0.5, and prednisolone dose ≤ 5 mg/day), or DORIS complete remission on therapy (SLEDAI-2K score 0, PGA score < 0.5, and prednisolone dose ≤ 5 mg/day). Any decrease in dose of corticosteroids or immunosuppressive therapy (mycophenolate mofetil, calcineurin inhibitors, azathioprine, leflunomide, or methotrexate) defined tapering. The investigators compared the odds of disease flares (SELENA-SLEDAI Flare Index) at the visit following tapering among those with tapering versus those who had continued the same drug doses.
Higher odds of flare with tapering
Tapering, compared with continuing with the same dose, was clearly associated with higher odds of flare at the next visit (11.4% with continuing vs. 17.0% with tapering; odds ratio, 1.24; 95% confidence interval, 1.10-1.39; P = .0005). Flares among patients who tapered were also slightly more often severe than with continuing the same dose (21.5% of flares vs. 19.7%). The level of remission at the time of tapering also mattered. Of 2,095 continuous tapering attempts, 860 (41.1%) were initiated in LLDAS, 596 (28.4%) in remission, and 639 (30.5%) in complete remission. Tapering when in LLDAS or remission, compared with complete remission, was associated with a higher likelihood of flare by 1 year (LLDAS: OR, 1.37; 95% CI, 1.03-1.81; P = .029; and remission: OR, 1.45; 95% CI, 1.08-1.94; P = .013). Time to first flare followed the same pattern. Also, sustained LLDAS, remission, or complete remission for at least 6 months just before the time of taper was associated with lower odds of flare at next visit and flares in 1 year, and longer time to flare.
Take baseline disease status, hydroxychloroquine’s effect into account
Dr. Nguyen and Dr. Costedoat-Chalumeau underscored several factors that may soften the risk for flares seen with tapering. They pointed to higher baseline doses of prednisone and immunosuppressants (and thus likely more severe disease that is more likely to flare) in the patients with tapering. Also, the SELENA-SLEDAI Flare Index used in the study classifies some clinically insignificant flares as mild to moderate and ignores the benefit of tapering. (It classifies patients as having a severe flare even when starting a new immunosuppressant prescription, such as azathioprine, methotrexate, or both, in an effort to reduce corticosteroid use.) They wrote that the study did not assess the rate of clinically meaningful flares (“essentially renal flares”), nor did it highlight that the “tiny” increase in absolute risk of severe flares (from 2.2% to 3.7%) could be further contextualized by the offset of the smaller, unmeasured rate of clinically significant flares and the “extremely relevant” risk of concomitant damage from prolonged treatment.
Dr. Nguyen and Dr. Costedoat-Chalumeau urged hydroxychloroquine use for all patients unless clearly contraindicated. In their own research, they have detailed hydroxychloroquine benefits in reducing not only flare risk, but also comorbidities, damage, and mortality. In the current study, the prevalence of hydroxychloroquine use in all the patient visits was only 63.3%. “We can assume that if more patients had been treated with hydroxychloroquine, both the number of flares and the difference between the two strategies would have been lower,” they wrote. They cited findings from a study of patients in remission for 2 years or longer in the Toronto Lupus Cohort in which a gradual taper of corticosteroids over 1 year was safe and feasible and resulted in less damage accrual at 24 months than not tapering. Optimizing tapering can minimize flare risk, they concluded.
Tapering SLE medications always involves some chance of flare and has to be considered a calculated risk, Sasha Bernatsky, MD, the James McGill professor of medicine in the division of rheumatology at McGill University, Montreal, said in an interview. “Long-term prednisone is not good for patients. I have heard it called ‘the miracle drug from hell’ – meaning that, yes, it controls disease, but at a cost of long-term complications. So we must be conscientious about tapering prednisone.” She observed that in the short-term, there may not be a huge risk to keeping a patient on an antimalarial and counseling patients to stay on it because their risk of flare is higher if they taper. Rheumatologists usually agree, however, that after 10 years or more, there is a real chance of retinal toxicity. “In our Montreal cohort, the risk of retinal toxicity was 5% after an average of 12.8 years of antimalarial use. My concern is that if a patient develops SLE in their 20s, how do we decide if we should keep them on an antimalarial for the next 60 or 70 years? If we keep them on the drug from age 25 to 45, and they then get retinal toxicity, they would essentially never be able to be on the drug again. So I do try to keep patients on the lowest dose of an antimalarial that is possible.”
Dr. Bernatsky pointed out further, “We think about tapering other immunosuppressants (such as methotrexate or mycophenolate or azathioprine) quite differently than prednisone tapering. We take our time a bit more, since many patients will tolerate being on standard doses of these drugs fairly well. If or when we do consider tapering these drugs, both our intuition and the literature suggests that someone with worse baseline disease activity or severity, who has needed a lot of steroids and multiple combinations of drugs to control disease, has a higher chance of flaring than someone with milder disease. As the editorial points out, lupus physicians (and their patients) need to think carefully about the patient’s risk profile, and be sure to tailor follow-up based on flare risk.”
Frank discussions with patients about the risks of tapering are needed, she said. “On one hand, there is consensus about how some aspects of lupus should be managed (for example, aggressive treatment of severe nephritis), but on the other hand, when it comes to long-term management and especially discussing tapering, we must have good discussions with patients. When a patient asks if they can taper a drug – many just lower or stop their drugs without asking – I am as honest as I can be, but ultimately have to admit any taper could be associated with a flare. It’s helpful to have actual figures to discuss with patients.”
No surprises
“This is an interesting study, which did not produce any surprises,” Dafna D. Gladman, MD, professor of medicine at University of Toronto and senior scientist at the university’s Schroeder Arthritis Institute, said when asked to comment. “We already knew from previous studies that abrupt withdrawal is not a good idea, and that if you taper when a patient is under conditions of remission, the rate of flare is actually lower than the usual rate of flare that occurs in people who continue on these medications. But the major limitation is that they did not specifically look at those who we would taper in clinical practice. In addition, they do not specify that the patients had to be on low-dose glucocorticoids before tapering, and they combined both immunosuppressive and steroids. It is not clear from the study what the excess flare rate was, or whether the flares were mild or severe. Most flares in patients with SLE are mild, consisting of skin and joint manifestations, while only a few patients have flares in kidney or neurologic manifestations.”
Dr. Gladman described her approach to tapering: “We aim for our patients to be taking no more than 5 mg of prednisone and to be in at least clinical remission with a SLEDAI-2K of 0 for at least 2 years before we would taper to glucocorticoids withdrawal. We always withdraw glucocorticoids first and immunosuppressives later, and keep patients on antimalarials the longest, unless there are specific side effects to the immunosuppressive or antimalarials which require their cessation earlier.”
Uncertainty persists
Other SLE experts weighing in confirmed the view that future research should aim to achieve clarity about the relative risks and benefits of tapering SLE drug regimens to maintain disease remission while minimizing potential for organ damage.
“Steroids are our friend and our enemy,” Joan T. Merrill, MD, professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “If a person with lupus is in a lot of trouble, corticosteroids are almost universally a good option to get them out. But for too many decades, for too many patients, despite all the improvements we have made in better understanding the disease and developing some promising new treatments, we have yet to shed the inexorable toxicity in multiple organs of steroid dependence.” She continued, “Corticosteroids, even at low dose, may have broad-spectrum effects. But, in fact, so do many of the more ‘targeted’ agents. If all patients were lined up at the beginning of a study while being given azathioprine or a calcineurin inhibitor or belimumab at a stable, tolerable dose, you might see the same data if you tapered that agent down. What we really need is improved individualized guidance about when and how fast to remove immune modulators from stable patients with lupus without disturbing the balance that had been achieved in such a quiescent patient.”
That enduring uncertainty was echoed by Daniel J. Wallace, MD, professor of medicine at Cedars-Sinai Medical Center, Los Angeles: “The take-home message from this interesting paper,” he commented, “is that current lupus biomarkers are not adequate. They do not guide the practitioner well enough, so that all too often medication regimens are tapered even though the risks are not really well known. Also, there is evidence in the literature that fibrosis and ‘damage’ progress even if acute phase reactants such as sedimentation rate, [C-reactive protein], complement 3 and 4, and anti-dsDNA are normal. We don’t have a good metric to detect them.”
Dr. Cho and colleagues’ study was funded by AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck Serono, GlaxoSmithKline, and UCB. Dr. Gladman disclosed consulting and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB.
The question looms large for patients with stable systemic lupus erythematosus (SLE): to taper or not to taper corticosteroids or immunosuppressive therapy? For patients and the physicians treating them, the evidence points in both directions. Flares are exacerbated by tapering, but simultaneously organ damage is tempered. Where is the balance? What competing factors together inform decision-making?
A recent multinational, observational cohort study conducted by Jiacai Cho, MBBS, of National University Hospital, Singapore, and colleagues, and published in The Lancet Rheumatology concluded that, given the odds of excess flares associated with tapering of corticosteroids and immunosuppressive therapy in patients with stable SLE, drug tapering warrants careful consideration of risks and benefits and is best reserved for those in complete clinical and serological remission with stable disease for at least 6 months. However, in an accompanying editorial, Yann Nguyen, MD, MPH, and Nathalie Costedoat-Chalumeau, MD, PhD, of the National Referral Center for Rare Autoimmune and Systemic Diseases at Cochin Hospital, Paris, and the Center for Research in Epidemiology and Statistics at Paris City University, argued for tipping the scale back from some of those expressed cautions.
In interviews, experts in the field expressed both strong appreciation for the cohort study and, like the editorialists, cognizance of its limitations.
Dr. Cho and colleagues recruited 3,002 adult patients with SLE (92.2% female, median age 39.5 years), from 25 sites across 13 Asia-Pacific countries. They were receiving routine clinical care and had achieved stable disease in at least one of two or more visits. Stable disease was defined by meeting criteria for Lupus Low Disease Activity State (LLDAS; SLE Disease Activity Index 2000 [SLEDAI-2K] score ≤ 4, Physician Global Assessment [PGA] ≤ 1, and prednisolone ≤ 7.5 mg/day), the 2021 DORIS definition of remission (clinical SLEDAI-2K score 0, PGA score < 0.5, and prednisolone dose ≤ 5 mg/day), or DORIS complete remission on therapy (SLEDAI-2K score 0, PGA score < 0.5, and prednisolone dose ≤ 5 mg/day). Any decrease in dose of corticosteroids or immunosuppressive therapy (mycophenolate mofetil, calcineurin inhibitors, azathioprine, leflunomide, or methotrexate) defined tapering. The investigators compared the odds of disease flares (SELENA-SLEDAI Flare Index) at the visit following tapering among those with tapering versus those who had continued the same drug doses.
Higher odds of flare with tapering
Tapering, compared with continuing with the same dose, was clearly associated with higher odds of flare at the next visit (11.4% with continuing vs. 17.0% with tapering; odds ratio, 1.24; 95% confidence interval, 1.10-1.39; P = .0005). Flares among patients who tapered were also slightly more often severe than with continuing the same dose (21.5% of flares vs. 19.7%). The level of remission at the time of tapering also mattered. Of 2,095 continuous tapering attempts, 860 (41.1%) were initiated in LLDAS, 596 (28.4%) in remission, and 639 (30.5%) in complete remission. Tapering when in LLDAS or remission, compared with complete remission, was associated with a higher likelihood of flare by 1 year (LLDAS: OR, 1.37; 95% CI, 1.03-1.81; P = .029; and remission: OR, 1.45; 95% CI, 1.08-1.94; P = .013). Time to first flare followed the same pattern. Also, sustained LLDAS, remission, or complete remission for at least 6 months just before the time of taper was associated with lower odds of flare at next visit and flares in 1 year, and longer time to flare.
Take baseline disease status, hydroxychloroquine’s effect into account
Dr. Nguyen and Dr. Costedoat-Chalumeau underscored several factors that may soften the risk for flares seen with tapering. They pointed to higher baseline doses of prednisone and immunosuppressants (and thus likely more severe disease that is more likely to flare) in the patients with tapering. Also, the SELENA-SLEDAI Flare Index used in the study classifies some clinically insignificant flares as mild to moderate and ignores the benefit of tapering. (It classifies patients as having a severe flare even when starting a new immunosuppressant prescription, such as azathioprine, methotrexate, or both, in an effort to reduce corticosteroid use.) They wrote that the study did not assess the rate of clinically meaningful flares (“essentially renal flares”), nor did it highlight that the “tiny” increase in absolute risk of severe flares (from 2.2% to 3.7%) could be further contextualized by the offset of the smaller, unmeasured rate of clinically significant flares and the “extremely relevant” risk of concomitant damage from prolonged treatment.
Dr. Nguyen and Dr. Costedoat-Chalumeau urged hydroxychloroquine use for all patients unless clearly contraindicated. In their own research, they have detailed hydroxychloroquine benefits in reducing not only flare risk, but also comorbidities, damage, and mortality. In the current study, the prevalence of hydroxychloroquine use in all the patient visits was only 63.3%. “We can assume that if more patients had been treated with hydroxychloroquine, both the number of flares and the difference between the two strategies would have been lower,” they wrote. They cited findings from a study of patients in remission for 2 years or longer in the Toronto Lupus Cohort in which a gradual taper of corticosteroids over 1 year was safe and feasible and resulted in less damage accrual at 24 months than not tapering. Optimizing tapering can minimize flare risk, they concluded.
Tapering SLE medications always involves some chance of flare and has to be considered a calculated risk, Sasha Bernatsky, MD, the James McGill professor of medicine in the division of rheumatology at McGill University, Montreal, said in an interview. “Long-term prednisone is not good for patients. I have heard it called ‘the miracle drug from hell’ – meaning that, yes, it controls disease, but at a cost of long-term complications. So we must be conscientious about tapering prednisone.” She observed that in the short-term, there may not be a huge risk to keeping a patient on an antimalarial and counseling patients to stay on it because their risk of flare is higher if they taper. Rheumatologists usually agree, however, that after 10 years or more, there is a real chance of retinal toxicity. “In our Montreal cohort, the risk of retinal toxicity was 5% after an average of 12.8 years of antimalarial use. My concern is that if a patient develops SLE in their 20s, how do we decide if we should keep them on an antimalarial for the next 60 or 70 years? If we keep them on the drug from age 25 to 45, and they then get retinal toxicity, they would essentially never be able to be on the drug again. So I do try to keep patients on the lowest dose of an antimalarial that is possible.”
Dr. Bernatsky pointed out further, “We think about tapering other immunosuppressants (such as methotrexate or mycophenolate or azathioprine) quite differently than prednisone tapering. We take our time a bit more, since many patients will tolerate being on standard doses of these drugs fairly well. If or when we do consider tapering these drugs, both our intuition and the literature suggests that someone with worse baseline disease activity or severity, who has needed a lot of steroids and multiple combinations of drugs to control disease, has a higher chance of flaring than someone with milder disease. As the editorial points out, lupus physicians (and their patients) need to think carefully about the patient’s risk profile, and be sure to tailor follow-up based on flare risk.”
Frank discussions with patients about the risks of tapering are needed, she said. “On one hand, there is consensus about how some aspects of lupus should be managed (for example, aggressive treatment of severe nephritis), but on the other hand, when it comes to long-term management and especially discussing tapering, we must have good discussions with patients. When a patient asks if they can taper a drug – many just lower or stop their drugs without asking – I am as honest as I can be, but ultimately have to admit any taper could be associated with a flare. It’s helpful to have actual figures to discuss with patients.”
No surprises
“This is an interesting study, which did not produce any surprises,” Dafna D. Gladman, MD, professor of medicine at University of Toronto and senior scientist at the university’s Schroeder Arthritis Institute, said when asked to comment. “We already knew from previous studies that abrupt withdrawal is not a good idea, and that if you taper when a patient is under conditions of remission, the rate of flare is actually lower than the usual rate of flare that occurs in people who continue on these medications. But the major limitation is that they did not specifically look at those who we would taper in clinical practice. In addition, they do not specify that the patients had to be on low-dose glucocorticoids before tapering, and they combined both immunosuppressive and steroids. It is not clear from the study what the excess flare rate was, or whether the flares were mild or severe. Most flares in patients with SLE are mild, consisting of skin and joint manifestations, while only a few patients have flares in kidney or neurologic manifestations.”
Dr. Gladman described her approach to tapering: “We aim for our patients to be taking no more than 5 mg of prednisone and to be in at least clinical remission with a SLEDAI-2K of 0 for at least 2 years before we would taper to glucocorticoids withdrawal. We always withdraw glucocorticoids first and immunosuppressives later, and keep patients on antimalarials the longest, unless there are specific side effects to the immunosuppressive or antimalarials which require their cessation earlier.”
Uncertainty persists
Other SLE experts weighing in confirmed the view that future research should aim to achieve clarity about the relative risks and benefits of tapering SLE drug regimens to maintain disease remission while minimizing potential for organ damage.
“Steroids are our friend and our enemy,” Joan T. Merrill, MD, professor of medicine at the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “If a person with lupus is in a lot of trouble, corticosteroids are almost universally a good option to get them out. But for too many decades, for too many patients, despite all the improvements we have made in better understanding the disease and developing some promising new treatments, we have yet to shed the inexorable toxicity in multiple organs of steroid dependence.” She continued, “Corticosteroids, even at low dose, may have broad-spectrum effects. But, in fact, so do many of the more ‘targeted’ agents. If all patients were lined up at the beginning of a study while being given azathioprine or a calcineurin inhibitor or belimumab at a stable, tolerable dose, you might see the same data if you tapered that agent down. What we really need is improved individualized guidance about when and how fast to remove immune modulators from stable patients with lupus without disturbing the balance that had been achieved in such a quiescent patient.”
That enduring uncertainty was echoed by Daniel J. Wallace, MD, professor of medicine at Cedars-Sinai Medical Center, Los Angeles: “The take-home message from this interesting paper,” he commented, “is that current lupus biomarkers are not adequate. They do not guide the practitioner well enough, so that all too often medication regimens are tapered even though the risks are not really well known. Also, there is evidence in the literature that fibrosis and ‘damage’ progress even if acute phase reactants such as sedimentation rate, [C-reactive protein], complement 3 and 4, and anti-dsDNA are normal. We don’t have a good metric to detect them.”
Dr. Cho and colleagues’ study was funded by AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck Serono, GlaxoSmithKline, and UCB. Dr. Gladman disclosed consulting and/or research support from AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB.
FROM THE LANCET RHEUMATOLOGY
Menstruation linked to underdiagnosis of type 2 diabetes?
The analysis estimates that an additional 17% of undiagnosed women younger than 50 years could be reclassified as having T2D, and that women under 50 had an A1c distribution that was markedly lower than that of men under 50, by a mean of 1.6 mmol/mol.
In a study that will be presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), the researchers wanted to investigate whether a contributing factor to late diagnosis of T2D in women under 50 may be the difference in A1c levels due to hemoglobin replacement linked to menstrual blood loss.
The study was published online in Diabetes Therapy. “If the threshold for diagnosis of diabetes ... was lowered by 2 mmol/mol in women under the age of 50, an additional 17% of these women (approximately equivalent to 35,000 women in England and Wales) would be diagnosed with diabetes ... which may contribute to up to 64% of the difference in mortality rates between men/women with diabetes mellitus aged 16-50 years,” the researchers noted.
They added that A1c levels in women under 50 years were found to be consistently lower than those in men, and with A1c levels in women reaching the equivalent of those in men up to 10 years later, this “may result in delayed diagnosis of diabetes mellitus in premenopausal women.”
Noting that the study was observational, senior author Adrian Heald, MD, consultant endocrinologist, Salford (England) Royal NHS Foundation Trust, said that it “may be the case that prediabetes and type 2 diabetes in women are not being spotted because the set point needs to be slightly lower, but a systematic study sampling from the population of at-risk individuals is needed further to our findings.
“We also need to refer back to use of the glucose tolerance test, because A1c has been used for the past 15 years but it is not the gold standard,” added Dr. Heald. “Clinicians have often wondered if patients might be missed with A1c measurement, or even overdiagnosed.”
Lucy Chambers, PhD, from Diabetes UK, acknowledged that the research was valuable but added: “More research on sex differences in thresholds for a type 2 diagnosis is needed to inform any changes to clinical practice. In the meantime, we encourage clinicians to follow the current guidance of not ruling out type 2 diabetes based on a one-off A1c below the diagnostic threshold.”
But in support of greater understanding around the sex differences in A1c diagnostic thresholds, Dr. Chambers added: “Receiving an accurate and timely diagnosis ensures that women get the treatment and support needed to manage their type 2 diabetes and avoid long-term complications, including heart disease, where sex-based inequalities in care already contribute to poorer outcomes for women.”
Effect of A1c reference range on T2D diagnosis and associated CVD
Compared with men, women with T2D have poorer glycemic control; a higher risk for cardiovascular (CV) complications; reduced life expectancy (5.3 years shorter vs. 4.5 years shorter); and a higher risk factor burden, such as obesity and hypertension at diagnosis.
In addition, T2D is a stronger risk factor for CV disease (CVD) in women than in men, and those aged 35-59 years who receive a diagnosis have the highest relative CV death risk across all age and sex groups.
The researchers pointed out that previous studies have observed differences in A1c relative to menopause, and they too found that “A1c levels rose after the age of 50 in women.”
However, they noted that the implication of differing A1c reference ranges on delayed diabetes diagnosis with worsening CV risk profile had not been previously recognized and that their study “[h]ighlights for the first time that, while 1.6 mmol/mol may appear only a small difference in terms of laboratory measurement, at population level this has implications for significant number of premenopausal women.”
The researchers initially observed the trend in local data in Salford, in the northwest of England. “These ... data highlighted that women seemed to be diagnosed with type 2 diabetes at an older age, so we wanted to examine what the source of that might be,” study author Mike Stedman, BSc, director, Res Consortium, Andover, England, said in an interview.
Dr. Stedman and his colleagues assessed the sex and age differences of A1c in individuals who had not been diagnosed with diabetes (A1c ≤ 48 mmol/mol [≤ 6.5%]). “We looked at data from other labs [in addition to those in Salford, totaling 938,678 people] to see if this was a local phenomenon. They could only provide more recent data, but these also showed a similar pattern,” he added.
Finally, Dr. Stedman, Dr. Heald, and their colleagues estimated the possible national impact by extrapolating findings based on population data from the UK Office of National Statistics and on National Diabetes Audit data for type 2 diabetes prevalence and related excess mortality. This brought them to the conclusion that T2D would be diagnosed in an additional 17% of women if the threshold were lowered by 2 mmol/mol, to 46 mmol/mol, in women under 50 years.
Lower A1c in women under 50 may delay T2D diagnosis by up to 10 years
The analysis found that the median A1c increased with age, with values in women younger than 50 years consistently being 1 mmol/mol lower than values in men. In contrast, A1c values in women over 50 years were equivalent to those in men.
However, at age 50 years, compared with men, A1c in women was found to lag by approximately 5 years. Women under 50 had an A1c distribution that was lower than that of men by an average of 1.6 mmol/mol (4.7% of mean; P < .0001), whereas this difference in individuals aged 50 years or older was less pronounced (P < .0001).
The authors wrote that “an undermeasurement of approximately 1.6 mmol/mol A1c in women may delay their diabetes ... diagnosis by up to 10 years.”
Further analysis showed that, at an A1c of 48 mmol/mol, 50% fewer women than men under the age of 50 could be diagnosed with T2D, whereas only 20% fewer women than men aged 50 years or older could be diagnosed with T2D.
Lowering the A1c threshold for diagnosis of T2D from 48 mmol/mol to 46 mmol/mol in women under 50 led to an estimate that an additional 35,345 undiagnosed women in England could be reclassified as having a T2D diagnosis.
The authors pointed out that “gender difference in adverse cardiovascular risk factors are known to be present prior to the development of [type 2] diabetes” and that “once diagnosed, atherosclerotic CVD prevalence is twice as high in patients with diabetes ... compared to those without a diagnosis.”
Dr. Heald added that there is always the possibility that other factors might be at play and that the work posed questions rather than presented answers.
Taking a pragmatic view, the researchers suggested that “one alternative approach may be to offer further assessment using fasting plasma glucose or oral glucose tolerance testing in those with A1c values of 46 or 47 mmol/mol.”
“In anyone with an early diagnosis of type 2 diabetes, in addition to dietary modification and especially if there is cardiovascular risk, then one might start them on metformin due to the cardiovascular benefits as well as the sugar-lowering effects,” said Dr. Heald, adding that “we certainly don’t want women missing out on metformin that could have huge benefits in the longer term.”
Dr. Stedman and Dr. Heald declared no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; and no other relationships or activities that could appear to have influenced the submitted work. Dr. Chambers has declared no conflicts.
A version of this article appeared on Medscape.com.
The analysis estimates that an additional 17% of undiagnosed women younger than 50 years could be reclassified as having T2D, and that women under 50 had an A1c distribution that was markedly lower than that of men under 50, by a mean of 1.6 mmol/mol.
In a study that will be presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), the researchers wanted to investigate whether a contributing factor to late diagnosis of T2D in women under 50 may be the difference in A1c levels due to hemoglobin replacement linked to menstrual blood loss.
The study was published online in Diabetes Therapy. “If the threshold for diagnosis of diabetes ... was lowered by 2 mmol/mol in women under the age of 50, an additional 17% of these women (approximately equivalent to 35,000 women in England and Wales) would be diagnosed with diabetes ... which may contribute to up to 64% of the difference in mortality rates between men/women with diabetes mellitus aged 16-50 years,” the researchers noted.
They added that A1c levels in women under 50 years were found to be consistently lower than those in men, and with A1c levels in women reaching the equivalent of those in men up to 10 years later, this “may result in delayed diagnosis of diabetes mellitus in premenopausal women.”
Noting that the study was observational, senior author Adrian Heald, MD, consultant endocrinologist, Salford (England) Royal NHS Foundation Trust, said that it “may be the case that prediabetes and type 2 diabetes in women are not being spotted because the set point needs to be slightly lower, but a systematic study sampling from the population of at-risk individuals is needed further to our findings.
“We also need to refer back to use of the glucose tolerance test, because A1c has been used for the past 15 years but it is not the gold standard,” added Dr. Heald. “Clinicians have often wondered if patients might be missed with A1c measurement, or even overdiagnosed.”
Lucy Chambers, PhD, from Diabetes UK, acknowledged that the research was valuable but added: “More research on sex differences in thresholds for a type 2 diagnosis is needed to inform any changes to clinical practice. In the meantime, we encourage clinicians to follow the current guidance of not ruling out type 2 diabetes based on a one-off A1c below the diagnostic threshold.”
But in support of greater understanding around the sex differences in A1c diagnostic thresholds, Dr. Chambers added: “Receiving an accurate and timely diagnosis ensures that women get the treatment and support needed to manage their type 2 diabetes and avoid long-term complications, including heart disease, where sex-based inequalities in care already contribute to poorer outcomes for women.”
Effect of A1c reference range on T2D diagnosis and associated CVD
Compared with men, women with T2D have poorer glycemic control; a higher risk for cardiovascular (CV) complications; reduced life expectancy (5.3 years shorter vs. 4.5 years shorter); and a higher risk factor burden, such as obesity and hypertension at diagnosis.
In addition, T2D is a stronger risk factor for CV disease (CVD) in women than in men, and those aged 35-59 years who receive a diagnosis have the highest relative CV death risk across all age and sex groups.
The researchers pointed out that previous studies have observed differences in A1c relative to menopause, and they too found that “A1c levels rose after the age of 50 in women.”
However, they noted that the implication of differing A1c reference ranges on delayed diabetes diagnosis with worsening CV risk profile had not been previously recognized and that their study “[h]ighlights for the first time that, while 1.6 mmol/mol may appear only a small difference in terms of laboratory measurement, at population level this has implications for significant number of premenopausal women.”
The researchers initially observed the trend in local data in Salford, in the northwest of England. “These ... data highlighted that women seemed to be diagnosed with type 2 diabetes at an older age, so we wanted to examine what the source of that might be,” study author Mike Stedman, BSc, director, Res Consortium, Andover, England, said in an interview.
Dr. Stedman and his colleagues assessed the sex and age differences of A1c in individuals who had not been diagnosed with diabetes (A1c ≤ 48 mmol/mol [≤ 6.5%]). “We looked at data from other labs [in addition to those in Salford, totaling 938,678 people] to see if this was a local phenomenon. They could only provide more recent data, but these also showed a similar pattern,” he added.
Finally, Dr. Stedman, Dr. Heald, and their colleagues estimated the possible national impact by extrapolating findings based on population data from the UK Office of National Statistics and on National Diabetes Audit data for type 2 diabetes prevalence and related excess mortality. This brought them to the conclusion that T2D would be diagnosed in an additional 17% of women if the threshold were lowered by 2 mmol/mol, to 46 mmol/mol, in women under 50 years.
Lower A1c in women under 50 may delay T2D diagnosis by up to 10 years
The analysis found that the median A1c increased with age, with values in women younger than 50 years consistently being 1 mmol/mol lower than values in men. In contrast, A1c values in women over 50 years were equivalent to those in men.
However, at age 50 years, compared with men, A1c in women was found to lag by approximately 5 years. Women under 50 had an A1c distribution that was lower than that of men by an average of 1.6 mmol/mol (4.7% of mean; P < .0001), whereas this difference in individuals aged 50 years or older was less pronounced (P < .0001).
The authors wrote that “an undermeasurement of approximately 1.6 mmol/mol A1c in women may delay their diabetes ... diagnosis by up to 10 years.”
Further analysis showed that, at an A1c of 48 mmol/mol, 50% fewer women than men under the age of 50 could be diagnosed with T2D, whereas only 20% fewer women than men aged 50 years or older could be diagnosed with T2D.
Lowering the A1c threshold for diagnosis of T2D from 48 mmol/mol to 46 mmol/mol in women under 50 led to an estimate that an additional 35,345 undiagnosed women in England could be reclassified as having a T2D diagnosis.
The authors pointed out that “gender difference in adverse cardiovascular risk factors are known to be present prior to the development of [type 2] diabetes” and that “once diagnosed, atherosclerotic CVD prevalence is twice as high in patients with diabetes ... compared to those without a diagnosis.”
Dr. Heald added that there is always the possibility that other factors might be at play and that the work posed questions rather than presented answers.
Taking a pragmatic view, the researchers suggested that “one alternative approach may be to offer further assessment using fasting plasma glucose or oral glucose tolerance testing in those with A1c values of 46 or 47 mmol/mol.”
“In anyone with an early diagnosis of type 2 diabetes, in addition to dietary modification and especially if there is cardiovascular risk, then one might start them on metformin due to the cardiovascular benefits as well as the sugar-lowering effects,” said Dr. Heald, adding that “we certainly don’t want women missing out on metformin that could have huge benefits in the longer term.”
Dr. Stedman and Dr. Heald declared no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; and no other relationships or activities that could appear to have influenced the submitted work. Dr. Chambers has declared no conflicts.
A version of this article appeared on Medscape.com.
The analysis estimates that an additional 17% of undiagnosed women younger than 50 years could be reclassified as having T2D, and that women under 50 had an A1c distribution that was markedly lower than that of men under 50, by a mean of 1.6 mmol/mol.
In a study that will be presented at this year’s annual meeting of the European Association for the Study of Diabetes (EASD), the researchers wanted to investigate whether a contributing factor to late diagnosis of T2D in women under 50 may be the difference in A1c levels due to hemoglobin replacement linked to menstrual blood loss.
The study was published online in Diabetes Therapy. “If the threshold for diagnosis of diabetes ... was lowered by 2 mmol/mol in women under the age of 50, an additional 17% of these women (approximately equivalent to 35,000 women in England and Wales) would be diagnosed with diabetes ... which may contribute to up to 64% of the difference in mortality rates between men/women with diabetes mellitus aged 16-50 years,” the researchers noted.
They added that A1c levels in women under 50 years were found to be consistently lower than those in men, and with A1c levels in women reaching the equivalent of those in men up to 10 years later, this “may result in delayed diagnosis of diabetes mellitus in premenopausal women.”
Noting that the study was observational, senior author Adrian Heald, MD, consultant endocrinologist, Salford (England) Royal NHS Foundation Trust, said that it “may be the case that prediabetes and type 2 diabetes in women are not being spotted because the set point needs to be slightly lower, but a systematic study sampling from the population of at-risk individuals is needed further to our findings.
“We also need to refer back to use of the glucose tolerance test, because A1c has been used for the past 15 years but it is not the gold standard,” added Dr. Heald. “Clinicians have often wondered if patients might be missed with A1c measurement, or even overdiagnosed.”
Lucy Chambers, PhD, from Diabetes UK, acknowledged that the research was valuable but added: “More research on sex differences in thresholds for a type 2 diagnosis is needed to inform any changes to clinical practice. In the meantime, we encourage clinicians to follow the current guidance of not ruling out type 2 diabetes based on a one-off A1c below the diagnostic threshold.”
But in support of greater understanding around the sex differences in A1c diagnostic thresholds, Dr. Chambers added: “Receiving an accurate and timely diagnosis ensures that women get the treatment and support needed to manage their type 2 diabetes and avoid long-term complications, including heart disease, where sex-based inequalities in care already contribute to poorer outcomes for women.”
Effect of A1c reference range on T2D diagnosis and associated CVD
Compared with men, women with T2D have poorer glycemic control; a higher risk for cardiovascular (CV) complications; reduced life expectancy (5.3 years shorter vs. 4.5 years shorter); and a higher risk factor burden, such as obesity and hypertension at diagnosis.
In addition, T2D is a stronger risk factor for CV disease (CVD) in women than in men, and those aged 35-59 years who receive a diagnosis have the highest relative CV death risk across all age and sex groups.
The researchers pointed out that previous studies have observed differences in A1c relative to menopause, and they too found that “A1c levels rose after the age of 50 in women.”
However, they noted that the implication of differing A1c reference ranges on delayed diabetes diagnosis with worsening CV risk profile had not been previously recognized and that their study “[h]ighlights for the first time that, while 1.6 mmol/mol may appear only a small difference in terms of laboratory measurement, at population level this has implications for significant number of premenopausal women.”
The researchers initially observed the trend in local data in Salford, in the northwest of England. “These ... data highlighted that women seemed to be diagnosed with type 2 diabetes at an older age, so we wanted to examine what the source of that might be,” study author Mike Stedman, BSc, director, Res Consortium, Andover, England, said in an interview.
Dr. Stedman and his colleagues assessed the sex and age differences of A1c in individuals who had not been diagnosed with diabetes (A1c ≤ 48 mmol/mol [≤ 6.5%]). “We looked at data from other labs [in addition to those in Salford, totaling 938,678 people] to see if this was a local phenomenon. They could only provide more recent data, but these also showed a similar pattern,” he added.
Finally, Dr. Stedman, Dr. Heald, and their colleagues estimated the possible national impact by extrapolating findings based on population data from the UK Office of National Statistics and on National Diabetes Audit data for type 2 diabetes prevalence and related excess mortality. This brought them to the conclusion that T2D would be diagnosed in an additional 17% of women if the threshold were lowered by 2 mmol/mol, to 46 mmol/mol, in women under 50 years.
Lower A1c in women under 50 may delay T2D diagnosis by up to 10 years
The analysis found that the median A1c increased with age, with values in women younger than 50 years consistently being 1 mmol/mol lower than values in men. In contrast, A1c values in women over 50 years were equivalent to those in men.
However, at age 50 years, compared with men, A1c in women was found to lag by approximately 5 years. Women under 50 had an A1c distribution that was lower than that of men by an average of 1.6 mmol/mol (4.7% of mean; P < .0001), whereas this difference in individuals aged 50 years or older was less pronounced (P < .0001).
The authors wrote that “an undermeasurement of approximately 1.6 mmol/mol A1c in women may delay their diabetes ... diagnosis by up to 10 years.”
Further analysis showed that, at an A1c of 48 mmol/mol, 50% fewer women than men under the age of 50 could be diagnosed with T2D, whereas only 20% fewer women than men aged 50 years or older could be diagnosed with T2D.
Lowering the A1c threshold for diagnosis of T2D from 48 mmol/mol to 46 mmol/mol in women under 50 led to an estimate that an additional 35,345 undiagnosed women in England could be reclassified as having a T2D diagnosis.
The authors pointed out that “gender difference in adverse cardiovascular risk factors are known to be present prior to the development of [type 2] diabetes” and that “once diagnosed, atherosclerotic CVD prevalence is twice as high in patients with diabetes ... compared to those without a diagnosis.”
Dr. Heald added that there is always the possibility that other factors might be at play and that the work posed questions rather than presented answers.
Taking a pragmatic view, the researchers suggested that “one alternative approach may be to offer further assessment using fasting plasma glucose or oral glucose tolerance testing in those with A1c values of 46 or 47 mmol/mol.”
“In anyone with an early diagnosis of type 2 diabetes, in addition to dietary modification and especially if there is cardiovascular risk, then one might start them on metformin due to the cardiovascular benefits as well as the sugar-lowering effects,” said Dr. Heald, adding that “we certainly don’t want women missing out on metformin that could have huge benefits in the longer term.”
Dr. Stedman and Dr. Heald declared no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; and no other relationships or activities that could appear to have influenced the submitted work. Dr. Chambers has declared no conflicts.
A version of this article appeared on Medscape.com.
FROM EASD 2023
Can zoo poo help manage diabetic foot ulcers?
In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.
The scourge of antibiotic resistance
Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.
A pioneering approach: zoo poo as bioactive goldmine
Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.
What are bacteriophages?
Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).
Findings and future directions
Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.
While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising.
We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.
The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.
This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.
Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.
The scourge of antibiotic resistance
Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.
A pioneering approach: zoo poo as bioactive goldmine
Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.
What are bacteriophages?
Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).
Findings and future directions
Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.
While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising.
We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.
The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.
This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.
Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
In a striking convergence of veterinary biology and medical science, researchers from the University of Sheffield (England) have unveiled findings that could potentially advance the treatment of diabetic foot ulcers, a condition affecting an estimated 18.6 million people worldwide. The unexpected ingredient in this potentially transformative therapy? Feces from endangered species, sourced from Yorkshire Wildlife Park, Doncaster, England.
The scourge of antibiotic resistance
Diabetic foot ulcers are a significant challenge in health care, not only because of their prevalence but also because of the alarming rise of antibiotic-resistant bacterial infections. Current antibiotic treatments frequently fail, leading to life-altering consequences like amputations and significant health care costs – estimated at one-third of the total direct costs of diabetes care. The critical need for alternative therapies has propelled scientists into a pressing search for novel antimicrobial agents.
A pioneering approach: zoo poo as bioactive goldmine
Led by Professor Graham Stafford, chair of molecular microbiology at the University of Sheffield, the research team began to explore a rather unorthodox resource: the fecal matter of endangered animals like Guinea baboons, lemurs, and Visayan pigs. While such a source might seem surprising at first glance, the rationale becomes clear when considering the nature of bacteriophages.
What are bacteriophages?
Bacteriophages, commonly known as phages, are viruses that selectively target and kill bacteria. Despite being the most prevalent biological entities on Earth, their therapeutic potential has remained largely untapped. What makes bacteriophages particularly interesting is their ability to kill antibiotic-resistant bacteria – a feature making them prime candidates for treating otherwise unmanageable diabetic foot ulcers. (Armstrong DG, et al; Fish R, et al).
Findings and future directions
Professor Stafford and his team discovered that the feces of several endangered animals harbored bacteriophages capable of killing bacterial strains resistant to antibiotics. The findings not only hold promise for a groundbreaking treatment but also provide another compelling reason to conserve endangered species: Their inherent biodiversity might contain cures for a range of infectious diseases.
While research is ongoing and clinical trials have not yet begun, the preliminary results are overwhelmingly promising.
We often look to complex technologies and synthetic materials for medical science breakthroughs, yet sometimes the most innovative solutions can be found in the most overlooked places. In this case, the feces of endangered species could turn out to be a vital asset in battling antibiotic resistance, thus affecting diabetic foot care in ways we never imagined possible.
The research conducted at the University of Sheffield also serves as a powerful argument for a One Health approach – a multidisciplinary field focusing on the interconnectedness of human, animal, and environmental health.
This intriguing work reaffirms the need for an interdisciplinary approach in tackling the world’s pressing health care challenges. The collaborative efforts between the University of Sheffield and Yorkshire Wildlife Park exemplify how academic research and conservation can come together to yield solutions for some of the most devastating and costly health conditions, while also underscoring the invaluable role that biodiversity plays in our collective well-being. Here’s to teaming up to act against amputation worldwide.
Dr. Armstrong is professor of surgery and director of limb preservation at University of Southern California, Los Angeles. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
FDA issues letter regarding lebrikizumab review for atopic dermatitis
The Food and Drug Administration has issued a complete response letter regarding lebrikizumab, an investigational biologic for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis, describing concerns about findings made during an inspection of a third-party contract manufacturer that included the “monoclonal antibody drug substance” for lebrikizumab, Eli Lilly announced in an Oct. 2 press release.
Lebrikizumab is under FDA review for treating atopic dermatitis; a complete response letter indicates that the review has been completed, and highlights issues that need to be addressed before a final decision on approval is made.
The press release noted that the agency did not raise any concerns about the clinical data package, safety, or label for lebrikizumab, an investigational, monoclonal antibody that binds to the cytokine interleukin (IL)-13, and is designed to be administered once per month.
In the press release, the company said it would work with the third-party manufacturer and the FDA to address the feedback “in order to make lebrikizumab available to patients.”
The Food and Drug Administration has issued a complete response letter regarding lebrikizumab, an investigational biologic for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis, describing concerns about findings made during an inspection of a third-party contract manufacturer that included the “monoclonal antibody drug substance” for lebrikizumab, Eli Lilly announced in an Oct. 2 press release.
Lebrikizumab is under FDA review for treating atopic dermatitis; a complete response letter indicates that the review has been completed, and highlights issues that need to be addressed before a final decision on approval is made.
The press release noted that the agency did not raise any concerns about the clinical data package, safety, or label for lebrikizumab, an investigational, monoclonal antibody that binds to the cytokine interleukin (IL)-13, and is designed to be administered once per month.
In the press release, the company said it would work with the third-party manufacturer and the FDA to address the feedback “in order to make lebrikizumab available to patients.”
The Food and Drug Administration has issued a complete response letter regarding lebrikizumab, an investigational biologic for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis, describing concerns about findings made during an inspection of a third-party contract manufacturer that included the “monoclonal antibody drug substance” for lebrikizumab, Eli Lilly announced in an Oct. 2 press release.
Lebrikizumab is under FDA review for treating atopic dermatitis; a complete response letter indicates that the review has been completed, and highlights issues that need to be addressed before a final decision on approval is made.
The press release noted that the agency did not raise any concerns about the clinical data package, safety, or label for lebrikizumab, an investigational, monoclonal antibody that binds to the cytokine interleukin (IL)-13, and is designed to be administered once per month.
In the press release, the company said it would work with the third-party manufacturer and the FDA to address the feedback “in order to make lebrikizumab available to patients.”
Measures of PTH predict postthyroidectomy hypocalcemia
according to the results of a prospective study of 60 patients.
Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.
In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.
During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”
Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.
The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.
The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.
“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.
“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.
The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.
So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.
The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.
“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
More proof of PTH’s predictive power
“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.
“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.
In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.
For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.”
However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.
The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships.
A version of this article appeared on Medscape.com.
according to the results of a prospective study of 60 patients.
Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.
In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.
During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”
Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.
The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.
The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.
“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.
“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.
The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.
So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.
The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.
“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
More proof of PTH’s predictive power
“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.
“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.
In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.
For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.”
However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.
The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships.
A version of this article appeared on Medscape.com.
according to the results of a prospective study of 60 patients.
Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.
In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.
During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”
Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.
The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.
The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.
“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.
“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.
The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.
So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.
The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.
“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
More proof of PTH’s predictive power
“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.
“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.
In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.
For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.”
However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.
The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM AAO-HNS ANNUAL MEETING
Hyaluronic acid suppository improves menopause symptoms
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
TOPLINE:
Among women with genitourinary syndrome of menopause, 12 weeks of treatment with vaginal suppositories containing hyaluronic acid (HLA) reduces vulvovaginal symptoms, according to trial results presented at the annual Menopause Meeting. HLA may be a promising nonhormonal therapy for this condition, the researchers said.
METHODOLOGY:
- Investigators randomly assigned 49 women to receive treatment with a vaginal suppository containing 5 mg of HLA or standard-of-care treatment with vaginal estrogen cream (0.01%).
- The trial was conducted between September 2021 and August 2022.
TAKEAWAY:
- Patients in both treatment arms experienced improvements on the Vulvovaginal Symptom Questionnaire (VSQ), the study’s primary outcome.
- The VSQ assesses vulvovaginal symptoms associated with menopause such as itching, burning, and dryness, as well as the emotional toll of symptoms and their effect on sexual activity.
- Change in VSQ score did not significantly differ between the treatment groups. The measure improved from 5.2 to 1.7 in the group that received estrogen, and from 5.8 to 2.5 in those who received HLA (P = .81).
- No treatment-related severe adverse events were reported.
IN PRACTICE:
“Women often need to decide between different therapies for genitourinary syndrome of menopause,” study author Benjamin Brucker, MD, of New York University said in an interview. “Now we can help counsel them about this formulation of HLA.”
SOURCE:
Poster P-1 was presented at the 2023 meeting of the Menopause Society, held Sept. 27-30 in Philadelphia.
DISCLOSURES:
The study was funded by Bonafide Health, a company that sells supplements to treat menopause symptoms, including vaginal suppositories containing HLA.
A version of this article appeared on Medscape.com.
Triple therapy boosts anaplastic thyroid cancer survival
WASHINGTON – - particularly when administered in a neoadjuvant fashion, prior to surgery. Overall survival rates in the study exceeded 5 years.
“The very long median overall survival in the study’s neoadjuvant group is quite remarkable for a group of patients who used to have a very poor prognosis,” senior author Maria E. Cabanillas, MD, associate professor in the department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center in Houston, said in an interview.
“This median overall survival definitely exceeds any other treatments thus far in BRAF-mutated anaplastic thyroid cancer.”
The research was presented at the annual meeting of the American Thyroid Association.
Anaplastic thyroid cancer, though rare, is the most aggressive form of thyroid cancer. It accounts for just 1% of the cancers but causes about 50% of thyroid cancer mortality.
The historical median overall survival is 5-6 months.
With research in recent years showing that as many as 40% of anaplastic thyroid cancers harbor BRAF V600E mutations, the door has opened for potential benefits with the combination of the BRAF inhibitor dabrafenib with the MEK-inhibitor drug trametinib.
The treatment combination was shown in research that included the phase 2 ROAR trial to yield important responses. It was approved by the Food and Drug Administration in 2018 for locally advanced or metastatic BRAF V600E-mutant anaplastic thyroid cancer, as well as other cancers.
However, a key caveat of DT is that patients eventually develop resistance mutations, leading to disease progression.
To overcome the problem, Dr. Cabanillas and her team found two key strategies that show promise – the addition of immunotherapy, such as pembrolizumab to DT, and the use of a neoadjuvant approach, with surgery performed after an initial response to the triplet therapy.
Triple therapy showed highly favorable results
In a study presented at the 2022 ATA annual meeting, researchers reported on the triple therapy of BRAF/MEK inhibitors vemurafenib and cobimetinib plus immunotherapy with atezolizumab. Results were highly favorable, with an overall response rate of 72% and an impressive 2-year survival of 67%.
However, a major limitation was that the study lacked a control arm. In the current study, the addition of pembrolizumab to DT was compared with DT alone. The investigators also sought to determine the survival benefits of a neoadjuvant strategy.
For the study, first author Sarah Hamidi, MD, also of the MD Anderson Cancer Center, and her colleagues identified 94 patients with BRAF-mutated anaplastic thyroid cancer who were treated either with first‐line DT or DT plus pembrolizumab between 2014 and 2023, either outside of a trial or in a reported clinical trial.
The study compared three treatment regimens – DT alone (n = 23), DT with pembrolizumab added before or after disease progression (n = 48), and DT with neoadjuvant pembrolizumab added prior to or after surgery (n = 23).
There were no significant differences in baseline characteristics between the groups. Metastatic disease was present at the start of treatment among 87.0% of the DT group, 79.2% of the pembrolizumab group prior to or after disease progression, and 65.2% of the neoadjuvant pembrolizumab group.
The median follow-up of the three groups was 102 months, 28 months, and 42 months, respectively. The median overall survival was 9 months with DT alone, vs. 17 months with DT plus pembrolizumab before or after progression and 63 months with neoadjuvant pembrolizumab plus DT (P < .001).
The 12- and 24-month survival rates with DT alone were 33.7% and 28.9%, respectively; for DT plus pembrolizumab before or after progression, the rates were 60.2% and 36.5%; and for neoadjuvant pembrolizumab plus DT, the rates were 80.7% and 74.5%.
In an analysis that did not include the neoadjuvant group, median progression-free survival was significantly longer with DT plus pembrolizumab as an initial treatment (11.0 months) compared with DT alone (4.0 months; P = .049).
A subanalysis that evaluated the timing of the addition of pembrolizumab to DT before or after disease progression showed no significant differences between the two in median overall survival (17 months vs. 16 months; P = .554).
“This is valuable information, especially for centers where pembrolizumab cannot be easily obtained as a first-line therapy for anaplastic thyroid cancer,” Dr. Hamidi said in presenting the findings.
She noted, however, that the results should be interpreted with caution, given the small number of patients who received pembrolizumab before progression (n = 34) and especially after progression (n = 14).
In terms of safety, there were no grade 5 adverse events (AEs); 32.4% of patients experienced immune‐related AEs, most frequently, colitis and hepatitis.
Therapies “improve survival”
Overall, the results are important, Dr. Cabanillas said.
The results are “very exciting when you think about the fact that 10 years ago, patients with anaplastic thyroid cancer had a median overall survival measured in months, and now we see that those with a BRAF mutation have a real chance at survival when managed appropriately from the start,” she told this news organization.
She noted that a key caveat is the study’s retrospective nature. Other important considerations are that pembrolizumab adds toxicity as well as cost, and it is largely used off label in anaplastic thyroid cancer.
Nevertheless, “it does feel like there needs to be a call to action in the guidelines for this disease so that it includes neoadjuvant DT or DT plus pembrolizumab as the primary treatment of patients with BRAF-mutated anaplastic thyroid cancer because the initial treatment is critical here,” Dr. Cabanillas said.
She added that a phase 2 trial with neoadjuvant DT plus pembrolizumab is ongoing. Enrollment is expected to be completed soon.
Commenting on the findings, Sarimar Agosto Salgado, MD, of the department of head and neck – endocrine oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla., who was a comoderator of the session, said the results are encouraging.
“These findings are promising because they open the landscape of options of therapies that we can provide these patients,” she said in an interview.
“Anaplastic thyroid cancer has been a disease with a very short survival despite aggressive therapies, but we are seeing that not only have these therapies been able to improve survival but also patients’ quality of life.”
Particularly encouraging is how quickly the therapies can work, Dr. Salgado added.
“Many times when patients present to the clinic, the rapid response to these systemic therapies can even [allow them to avoid] having a tracheostomy, and we’re also seeing that some of these patients are able to go from unresectable disease to resectable disease, and then by having the main tumor out, their survival improves.
“So, this is definitely a big ray of hope for these patients.”
Dr. Cabanillas has received research funding from Merck. Dr. Hamidi has disclosed no relevant financial relationships. Dr. Salgado has relationships with Lilly and Exelixis.
A version of this article appeared on Medscape.com.
WASHINGTON – - particularly when administered in a neoadjuvant fashion, prior to surgery. Overall survival rates in the study exceeded 5 years.
“The very long median overall survival in the study’s neoadjuvant group is quite remarkable for a group of patients who used to have a very poor prognosis,” senior author Maria E. Cabanillas, MD, associate professor in the department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center in Houston, said in an interview.
“This median overall survival definitely exceeds any other treatments thus far in BRAF-mutated anaplastic thyroid cancer.”
The research was presented at the annual meeting of the American Thyroid Association.
Anaplastic thyroid cancer, though rare, is the most aggressive form of thyroid cancer. It accounts for just 1% of the cancers but causes about 50% of thyroid cancer mortality.
The historical median overall survival is 5-6 months.
With research in recent years showing that as many as 40% of anaplastic thyroid cancers harbor BRAF V600E mutations, the door has opened for potential benefits with the combination of the BRAF inhibitor dabrafenib with the MEK-inhibitor drug trametinib.
The treatment combination was shown in research that included the phase 2 ROAR trial to yield important responses. It was approved by the Food and Drug Administration in 2018 for locally advanced or metastatic BRAF V600E-mutant anaplastic thyroid cancer, as well as other cancers.
However, a key caveat of DT is that patients eventually develop resistance mutations, leading to disease progression.
To overcome the problem, Dr. Cabanillas and her team found two key strategies that show promise – the addition of immunotherapy, such as pembrolizumab to DT, and the use of a neoadjuvant approach, with surgery performed after an initial response to the triplet therapy.
Triple therapy showed highly favorable results
In a study presented at the 2022 ATA annual meeting, researchers reported on the triple therapy of BRAF/MEK inhibitors vemurafenib and cobimetinib plus immunotherapy with atezolizumab. Results were highly favorable, with an overall response rate of 72% and an impressive 2-year survival of 67%.
However, a major limitation was that the study lacked a control arm. In the current study, the addition of pembrolizumab to DT was compared with DT alone. The investigators also sought to determine the survival benefits of a neoadjuvant strategy.
For the study, first author Sarah Hamidi, MD, also of the MD Anderson Cancer Center, and her colleagues identified 94 patients with BRAF-mutated anaplastic thyroid cancer who were treated either with first‐line DT or DT plus pembrolizumab between 2014 and 2023, either outside of a trial or in a reported clinical trial.
The study compared three treatment regimens – DT alone (n = 23), DT with pembrolizumab added before or after disease progression (n = 48), and DT with neoadjuvant pembrolizumab added prior to or after surgery (n = 23).
There were no significant differences in baseline characteristics between the groups. Metastatic disease was present at the start of treatment among 87.0% of the DT group, 79.2% of the pembrolizumab group prior to or after disease progression, and 65.2% of the neoadjuvant pembrolizumab group.
The median follow-up of the three groups was 102 months, 28 months, and 42 months, respectively. The median overall survival was 9 months with DT alone, vs. 17 months with DT plus pembrolizumab before or after progression and 63 months with neoadjuvant pembrolizumab plus DT (P < .001).
The 12- and 24-month survival rates with DT alone were 33.7% and 28.9%, respectively; for DT plus pembrolizumab before or after progression, the rates were 60.2% and 36.5%; and for neoadjuvant pembrolizumab plus DT, the rates were 80.7% and 74.5%.
In an analysis that did not include the neoadjuvant group, median progression-free survival was significantly longer with DT plus pembrolizumab as an initial treatment (11.0 months) compared with DT alone (4.0 months; P = .049).
A subanalysis that evaluated the timing of the addition of pembrolizumab to DT before or after disease progression showed no significant differences between the two in median overall survival (17 months vs. 16 months; P = .554).
“This is valuable information, especially for centers where pembrolizumab cannot be easily obtained as a first-line therapy for anaplastic thyroid cancer,” Dr. Hamidi said in presenting the findings.
She noted, however, that the results should be interpreted with caution, given the small number of patients who received pembrolizumab before progression (n = 34) and especially after progression (n = 14).
In terms of safety, there were no grade 5 adverse events (AEs); 32.4% of patients experienced immune‐related AEs, most frequently, colitis and hepatitis.
Therapies “improve survival”
Overall, the results are important, Dr. Cabanillas said.
The results are “very exciting when you think about the fact that 10 years ago, patients with anaplastic thyroid cancer had a median overall survival measured in months, and now we see that those with a BRAF mutation have a real chance at survival when managed appropriately from the start,” she told this news organization.
She noted that a key caveat is the study’s retrospective nature. Other important considerations are that pembrolizumab adds toxicity as well as cost, and it is largely used off label in anaplastic thyroid cancer.
Nevertheless, “it does feel like there needs to be a call to action in the guidelines for this disease so that it includes neoadjuvant DT or DT plus pembrolizumab as the primary treatment of patients with BRAF-mutated anaplastic thyroid cancer because the initial treatment is critical here,” Dr. Cabanillas said.
She added that a phase 2 trial with neoadjuvant DT plus pembrolizumab is ongoing. Enrollment is expected to be completed soon.
Commenting on the findings, Sarimar Agosto Salgado, MD, of the department of head and neck – endocrine oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla., who was a comoderator of the session, said the results are encouraging.
“These findings are promising because they open the landscape of options of therapies that we can provide these patients,” she said in an interview.
“Anaplastic thyroid cancer has been a disease with a very short survival despite aggressive therapies, but we are seeing that not only have these therapies been able to improve survival but also patients’ quality of life.”
Particularly encouraging is how quickly the therapies can work, Dr. Salgado added.
“Many times when patients present to the clinic, the rapid response to these systemic therapies can even [allow them to avoid] having a tracheostomy, and we’re also seeing that some of these patients are able to go from unresectable disease to resectable disease, and then by having the main tumor out, their survival improves.
“So, this is definitely a big ray of hope for these patients.”
Dr. Cabanillas has received research funding from Merck. Dr. Hamidi has disclosed no relevant financial relationships. Dr. Salgado has relationships with Lilly and Exelixis.
A version of this article appeared on Medscape.com.
WASHINGTON – - particularly when administered in a neoadjuvant fashion, prior to surgery. Overall survival rates in the study exceeded 5 years.
“The very long median overall survival in the study’s neoadjuvant group is quite remarkable for a group of patients who used to have a very poor prognosis,” senior author Maria E. Cabanillas, MD, associate professor in the department of endocrine neoplasia and hormonal disorders at the University of Texas MD Anderson Cancer Center in Houston, said in an interview.
“This median overall survival definitely exceeds any other treatments thus far in BRAF-mutated anaplastic thyroid cancer.”
The research was presented at the annual meeting of the American Thyroid Association.
Anaplastic thyroid cancer, though rare, is the most aggressive form of thyroid cancer. It accounts for just 1% of the cancers but causes about 50% of thyroid cancer mortality.
The historical median overall survival is 5-6 months.
With research in recent years showing that as many as 40% of anaplastic thyroid cancers harbor BRAF V600E mutations, the door has opened for potential benefits with the combination of the BRAF inhibitor dabrafenib with the MEK-inhibitor drug trametinib.
The treatment combination was shown in research that included the phase 2 ROAR trial to yield important responses. It was approved by the Food and Drug Administration in 2018 for locally advanced or metastatic BRAF V600E-mutant anaplastic thyroid cancer, as well as other cancers.
However, a key caveat of DT is that patients eventually develop resistance mutations, leading to disease progression.
To overcome the problem, Dr. Cabanillas and her team found two key strategies that show promise – the addition of immunotherapy, such as pembrolizumab to DT, and the use of a neoadjuvant approach, with surgery performed after an initial response to the triplet therapy.
Triple therapy showed highly favorable results
In a study presented at the 2022 ATA annual meeting, researchers reported on the triple therapy of BRAF/MEK inhibitors vemurafenib and cobimetinib plus immunotherapy with atezolizumab. Results were highly favorable, with an overall response rate of 72% and an impressive 2-year survival of 67%.
However, a major limitation was that the study lacked a control arm. In the current study, the addition of pembrolizumab to DT was compared with DT alone. The investigators also sought to determine the survival benefits of a neoadjuvant strategy.
For the study, first author Sarah Hamidi, MD, also of the MD Anderson Cancer Center, and her colleagues identified 94 patients with BRAF-mutated anaplastic thyroid cancer who were treated either with first‐line DT or DT plus pembrolizumab between 2014 and 2023, either outside of a trial or in a reported clinical trial.
The study compared three treatment regimens – DT alone (n = 23), DT with pembrolizumab added before or after disease progression (n = 48), and DT with neoadjuvant pembrolizumab added prior to or after surgery (n = 23).
There were no significant differences in baseline characteristics between the groups. Metastatic disease was present at the start of treatment among 87.0% of the DT group, 79.2% of the pembrolizumab group prior to or after disease progression, and 65.2% of the neoadjuvant pembrolizumab group.
The median follow-up of the three groups was 102 months, 28 months, and 42 months, respectively. The median overall survival was 9 months with DT alone, vs. 17 months with DT plus pembrolizumab before or after progression and 63 months with neoadjuvant pembrolizumab plus DT (P < .001).
The 12- and 24-month survival rates with DT alone were 33.7% and 28.9%, respectively; for DT plus pembrolizumab before or after progression, the rates were 60.2% and 36.5%; and for neoadjuvant pembrolizumab plus DT, the rates were 80.7% and 74.5%.
In an analysis that did not include the neoadjuvant group, median progression-free survival was significantly longer with DT plus pembrolizumab as an initial treatment (11.0 months) compared with DT alone (4.0 months; P = .049).
A subanalysis that evaluated the timing of the addition of pembrolizumab to DT before or after disease progression showed no significant differences between the two in median overall survival (17 months vs. 16 months; P = .554).
“This is valuable information, especially for centers where pembrolizumab cannot be easily obtained as a first-line therapy for anaplastic thyroid cancer,” Dr. Hamidi said in presenting the findings.
She noted, however, that the results should be interpreted with caution, given the small number of patients who received pembrolizumab before progression (n = 34) and especially after progression (n = 14).
In terms of safety, there were no grade 5 adverse events (AEs); 32.4% of patients experienced immune‐related AEs, most frequently, colitis and hepatitis.
Therapies “improve survival”
Overall, the results are important, Dr. Cabanillas said.
The results are “very exciting when you think about the fact that 10 years ago, patients with anaplastic thyroid cancer had a median overall survival measured in months, and now we see that those with a BRAF mutation have a real chance at survival when managed appropriately from the start,” she told this news organization.
She noted that a key caveat is the study’s retrospective nature. Other important considerations are that pembrolizumab adds toxicity as well as cost, and it is largely used off label in anaplastic thyroid cancer.
Nevertheless, “it does feel like there needs to be a call to action in the guidelines for this disease so that it includes neoadjuvant DT or DT plus pembrolizumab as the primary treatment of patients with BRAF-mutated anaplastic thyroid cancer because the initial treatment is critical here,” Dr. Cabanillas said.
She added that a phase 2 trial with neoadjuvant DT plus pembrolizumab is ongoing. Enrollment is expected to be completed soon.
Commenting on the findings, Sarimar Agosto Salgado, MD, of the department of head and neck – endocrine oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Fla., who was a comoderator of the session, said the results are encouraging.
“These findings are promising because they open the landscape of options of therapies that we can provide these patients,” she said in an interview.
“Anaplastic thyroid cancer has been a disease with a very short survival despite aggressive therapies, but we are seeing that not only have these therapies been able to improve survival but also patients’ quality of life.”
Particularly encouraging is how quickly the therapies can work, Dr. Salgado added.
“Many times when patients present to the clinic, the rapid response to these systemic therapies can even [allow them to avoid] having a tracheostomy, and we’re also seeing that some of these patients are able to go from unresectable disease to resectable disease, and then by having the main tumor out, their survival improves.
“So, this is definitely a big ray of hope for these patients.”
Dr. Cabanillas has received research funding from Merck. Dr. Hamidi has disclosed no relevant financial relationships. Dr. Salgado has relationships with Lilly and Exelixis.
A version of this article appeared on Medscape.com.
AT ATA 2023
Jury out on how tea drinking influences colorectal cancer risk
TOPLINE:
A meta-analysis finds that tea drinking may reduce the risk for colorectal cancer (CRC) by 24%, but the estimate is “uncertain,” and the actual effect on CRC risk can range from a reduction of 51% to an increase of 18%, researchers say.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of 15 studies (11 cohort, three case-control, and one randomized controlled trial) with nearly 2.7 million participants.
- The studies were conducted in Asia, North America, Europe, and Oceania between 1986 and 2015 and included black and green tea.
- Tea consumption was dichotomized as < 1 cup vs. ≥ 1 cups daily. A random effects model was used for data analysis.
TAKEAWAY:
- No statistically significant association was found between tea consumption and CRC risk (relative risk, 0.76).
- By geographic region, results of an American subgroup analysis suggested tea drinking might be protective against CRC (RR, 0.33), while data from the United Kingdom (RR, 1.45) and Italian (RR, 1.15) subgroups had opposite results.
- In subgroups by tea type, green tea was associated with a lower CRC risk (RR, 0.05).
- Sensitivity analysis revealed that the effect on CRC risk can range from a reduction of 51% (RR, 0.49) to an increase of 18% (RR, 1.18).
IN PRACTICE:
“Taken together, this meta-analysis suggests that tea consumption may not be linked to the development of CRC. These relationships still need to be confirmed by additional well-designed large prospective studies and randomized clinical trials,” the authors write.
SOURCE:
The study, with co–first authors Yu Huang and Qiang Chen, with the Third Hospital of Hebei Medical University, Shijiazhuang, China, was published online in BMC Gastroenterology.
LIMITATIONS:
There was a high level of heterogeneity in the original studies, as well as variations in the quantity and types of tea consumed and in the design and quality of the studies. Some studies did not account for potentially important variables, such as alcohol use and diet.
DISCLOSURES:
The study was supported by grants from the Hebei Provincial Natural Science Foundation and the Hebei Provincial Department of Science and Technology. The authors have disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
A meta-analysis finds that tea drinking may reduce the risk for colorectal cancer (CRC) by 24%, but the estimate is “uncertain,” and the actual effect on CRC risk can range from a reduction of 51% to an increase of 18%, researchers say.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of 15 studies (11 cohort, three case-control, and one randomized controlled trial) with nearly 2.7 million participants.
- The studies were conducted in Asia, North America, Europe, and Oceania between 1986 and 2015 and included black and green tea.
- Tea consumption was dichotomized as < 1 cup vs. ≥ 1 cups daily. A random effects model was used for data analysis.
TAKEAWAY:
- No statistically significant association was found between tea consumption and CRC risk (relative risk, 0.76).
- By geographic region, results of an American subgroup analysis suggested tea drinking might be protective against CRC (RR, 0.33), while data from the United Kingdom (RR, 1.45) and Italian (RR, 1.15) subgroups had opposite results.
- In subgroups by tea type, green tea was associated with a lower CRC risk (RR, 0.05).
- Sensitivity analysis revealed that the effect on CRC risk can range from a reduction of 51% (RR, 0.49) to an increase of 18% (RR, 1.18).
IN PRACTICE:
“Taken together, this meta-analysis suggests that tea consumption may not be linked to the development of CRC. These relationships still need to be confirmed by additional well-designed large prospective studies and randomized clinical trials,” the authors write.
SOURCE:
The study, with co–first authors Yu Huang and Qiang Chen, with the Third Hospital of Hebei Medical University, Shijiazhuang, China, was published online in BMC Gastroenterology.
LIMITATIONS:
There was a high level of heterogeneity in the original studies, as well as variations in the quantity and types of tea consumed and in the design and quality of the studies. Some studies did not account for potentially important variables, such as alcohol use and diet.
DISCLOSURES:
The study was supported by grants from the Hebei Provincial Natural Science Foundation and the Hebei Provincial Department of Science and Technology. The authors have disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
A meta-analysis finds that tea drinking may reduce the risk for colorectal cancer (CRC) by 24%, but the estimate is “uncertain,” and the actual effect on CRC risk can range from a reduction of 51% to an increase of 18%, researchers say.
METHODOLOGY:
- Researchers conducted a systematic review and meta-analysis of 15 studies (11 cohort, three case-control, and one randomized controlled trial) with nearly 2.7 million participants.
- The studies were conducted in Asia, North America, Europe, and Oceania between 1986 and 2015 and included black and green tea.
- Tea consumption was dichotomized as < 1 cup vs. ≥ 1 cups daily. A random effects model was used for data analysis.
TAKEAWAY:
- No statistically significant association was found between tea consumption and CRC risk (relative risk, 0.76).
- By geographic region, results of an American subgroup analysis suggested tea drinking might be protective against CRC (RR, 0.33), while data from the United Kingdom (RR, 1.45) and Italian (RR, 1.15) subgroups had opposite results.
- In subgroups by tea type, green tea was associated with a lower CRC risk (RR, 0.05).
- Sensitivity analysis revealed that the effect on CRC risk can range from a reduction of 51% (RR, 0.49) to an increase of 18% (RR, 1.18).
IN PRACTICE:
“Taken together, this meta-analysis suggests that tea consumption may not be linked to the development of CRC. These relationships still need to be confirmed by additional well-designed large prospective studies and randomized clinical trials,” the authors write.
SOURCE:
The study, with co–first authors Yu Huang and Qiang Chen, with the Third Hospital of Hebei Medical University, Shijiazhuang, China, was published online in BMC Gastroenterology.
LIMITATIONS:
There was a high level of heterogeneity in the original studies, as well as variations in the quantity and types of tea consumed and in the design and quality of the studies. Some studies did not account for potentially important variables, such as alcohol use and diet.
DISCLOSURES:
The study was supported by grants from the Hebei Provincial Natural Science Foundation and the Hebei Provincial Department of Science and Technology. The authors have disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
Menopausal hormone therapy less prescribed for Black women
PHILADELPHIA – , according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.
The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.
The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.
Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.
Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.
Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
Complex reasons
Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.
Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.
“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.
At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.
“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”
Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.
“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
Educating clinicians
Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.
“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.
Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.
“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.
A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.
Dr. MacPhedran added that education for clinicians is key as well.
“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”
Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.
Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.
Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.
The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.
The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.
PHILADELPHIA – , according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.
The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.
The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.
Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.
Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.
Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
Complex reasons
Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.
Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.
“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.
At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.
“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”
Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.
“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
Educating clinicians
Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.
“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.
Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.
“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.
A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.
Dr. MacPhedran added that education for clinicians is key as well.
“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”
Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.
Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.
Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.
The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.
The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.
PHILADELPHIA – , according to a review of published studies presented at the annual meeting of the Menopause Society (formerly The North American Menopause Society).
“Gaps in treatment can be used to inform health care providers about menopausal HT prescribing disparities, with the goal of improving equitable and advanced patient care among disadvantaged populations,” wrote Danette Conklin, PhD, an assistant professor of psychiatry and reproductive biology at Case Western Reserve University, Cleveland, and a psychologist at University Hospitals Cleveland Medical Center; Sally MacPhedran, MD, an associate professor of reproductive biology at Case Western Reserve University and an ob.gyn at MetroHealth Medical Center, also in Cleveland; and their colleagues.
The researchers combed through PubMed, CINAHL, Cochrane Library, Web of Science and PsychInfo databases to identify all studies conducted in the United States since 1940 that contained data on patient demographics and prescribing patterns for hormone therapy to treat menopausal symptoms. In addition to excluding men, children, teens, trans men, and women who had contraindications for HT, the investigators excluded randomized clinical trials so that prescribing patterns would not be based on protocols or RCT participatory criteria.
The researchers identified 20 studies, ranging from 1973 through 2015, including 9 national studies and the others across different U.S. regions. They then analyzed differences in HT prescribing according to age, race/ethnicity, education, income, insurance type, body mass index, and mental health, including alcohol or substance use.
Seven of the studies assessed HT use based on patient surveys, seven used medical or medication records showing an HT prescription, two studies used insurance claims to show an HT prescription, and one study surveyed patients about whether they received an HT prescription. Another four studies used surveys that asked patients whether they received HT counseling but did not indicate if the patients received a prescription.
Half of the studies showed racial disparities in HT prescribing. In all of them, Black women used or were prescribed or counseled on using HT less than white, Hispanic, or Asian women. White women had greater use, prescribing, or counseling than all other races/ethnicities except one study in which Hispanic women were prescribed vaginal estrogen more often than white women.
Six of the studies showed education disparities in which menopausal women with lower education levels used less HT or were prescribed or counseled on HT less than women with higher education.
Complex reasons
Monica Christmas, MD, an associate professor of obstetrics and gynecology at the University of Chicago and director of the Menopause Program and the Center for Women’s Integrated Health, said the study’s findings were not surprising, but the reasons for the racial disparities are likely complex.
Implicit bias in providers is likely one contributing factor, with some providers not thinking of offering HT to certain patients or not expecting the patients to be interested in it. Providers may also hesitate to prescribe HT to patients with more comorbidities because of concerns about HT risks, so if Black patients have more comorbidities, that could play a role in how many are offered or counseled on HT, she said.
“Probably the biggest take home is that it is important to be asking all of our patients about their symptoms and being proactive about talking about it,” Dr. Christmas said in an interview.
At the same time, in her anecdotal experience at a previous institution, Dr. Christmas noticed that her Black patients were less receptive to using hormone therapy than her White patients even though her Black patients tended to exhibit or report greater or more severe symptoms. But there’s been a “paradigm shift” more recently, Dr. Christmas said. With awareness about menopause growing in the media and particularly on social media, and with greater awareness about racial disparities in menopausal symptoms and care – including that shown in Dr. Christmas’s work in the SWAN Study – Dr. Christmas has had more Black patients asking about HT and other treatments for their menopausal symptoms more recently.
“Just 10 years ago, I was trying to talk to people about hormones, and I’ve been giving them to people that need them for a long time, and I couldn’t,” Dr. Christmas said. “Now people are coming in, saying ‘no one’s ever talked to me about it’ or ‘I deserve this.’ It shows you the persuasion that social media and the Internet have on our thinking too, and I think that’s going to be interesting to look at, to see how that impacts people’s perception about wanting treatment.”
Dr. Conklin agreed that reasons for the disparities likely involve a combination of factors, including providers’ assumptions about different racial groups’ knowledge and receptiveness toward different treatments. One of the studies in their review also reported provider barriers to prescribing HT, which included lack of time, lack of adequate knowledge, and concern about risks to patients’ health.
“Medical providers tend to have less time with their patients compared to PhDs, and that time factor really makes a big difference in terms of what the focus is going to be in that [short] appointment,” Dr. Conklin said in an interview. “Perhaps from a provider point of view, they are prioritizing what they think is more important to their patient and not really listening deeply to what their patient is saying.”
Educating clinicians
Potentially supporting that possibility, Dr. Conklin and Dr. MacPhedran also had a poster at the conference that looked at prescribing of HT in both Black and White women with a diagnosis of depression, anxiety, or bipolar disorder.
“In a population with a high percentage of Black patients known to have more menopause symptoms, the data demonstrated a surprisingly low rate of documented menopause symptoms (11%) compared to prior reports of up to 80%,” the researchers reported. “This low rate may be related to patient reporting, physician inquiry, or physician documentation of menopause symptoms.” They further found that White women with menopause symptoms and one of those psychiatric diagnosis were 40% more likely to receive an HT prescription for menopausal symptoms than Black women with the same diagnoses and symptoms.
Dr. Conklin emphasized the importance of providers not overlooking women who have mental health disorders when it comes to treating menopausal symptoms, particularly since mental health conditions and menopausal symptoms can exacerbate each other.
“Their depression could worsen irritability, and anxiety can worsen during the transition, and it could be overlooked or thought of as another [psychiatric] episode,” Dr. Conklin said. Providers may need to “dig a little deeper,” especially if patients are reporting having hot flashes or brain fog.
A key way to help overcome the racial disparities – whether they result from systemic issues, implicit bias or assumptions, or patients’ own reticence – is education, Dr. Conklin said. She recommended that providers have educational material about menopause and treatments for menopausal symptoms in the waiting room and then ask patients about their symptoms and invite patients to ask questions.
Dr. MacPhedran added that education for clinicians is key as well.
“Now is a great time – menopause is hot, menopause is interesting, and it’s getting a little bit of a push in terms of research dollars,” Dr. MacPhedran said. “That will trickle down to more emphasis in medical education, whether that’s nurse practitioners, physicians, PAs, or midwives. Everybody needs more education on menopause so they can be more comfortable asking and answering these questions.”
Dr. Conklin said she would like to see expanded education on menopause for medical residents and in health psychology curricula as well.
Among the 13 studies that found disparities in prescribing patterns by age, seven studies showed that older women used or were prescribed or counseled on HT more often than younger women. Four studies found the opposite, with older women less likely to use or be prescribed or counseled about HT. One study had mixed results, and one study had expected prescribing patterns.
Five studies found income disparities and five studies found disparities by medical conditions in terms of HT use, prescribing, or counseling. Other disparities identified in smaller numbers of studies (four or fewer) included natural versus surgical menopause, insurance coverage, body mass index, geographic region, smoking and alcohol use.
The two biggest limitations of the research were its heterogeneity and the small number of studies included, which points to how scarce research on racial disparities in HT use really are, Dr. Conklin said.
The research did not use any external funding. The authors had no industry disclosures. Dr. Christmas has done an educational video for FertilityIQ.
AT NAMS 2023
I’ll make a note of that
I’ve worked hard to get rid of paper, or at least minimize it.
I use e-fax for sending and receiving as much as possible. I send scripts and order digitally when I can.
But, 23 years into a paperless practice, the stuff isn’t going away soon. Nor I do I want it to.
For many applications paper is just easier (at least to me) to use. When I have a meeting and know I’ll need to read from notes, I’d much rather have them on paper than a screen, so I print them up. Even a grocery list is easier to scribble down on something and look at as I wander the aisles, rather than navigate to an app every 2 minutes. Paper isn’t susceptible to the whims of battery power, signal strength, being dropped, or software glitches.
I’m also not particularly good at taking notes on a computer. I’m sure most of the current generation of physicians is (or they just use a scribe), but I’m old school. Since day one I’ve had a note pad on my desk, jotting points and observations down on the fly (I use a pencil, too, if anyone remembers what that is). Then, when I have time, I type up my notes from the paper.
I also still have patients who, for whatever reason, want a handwritten prescription. Or sometimes need the legendary “doctor’s note” for work or school. Or need me to fill out forms.
Having grown up with paper, and been through school and residency with paper, it’s not easy to give it up entirely. There’s something reassuring about the tactile nature of flipping pages as opposed to scrolling up and down.
I’m not complaining about its decreased use, though. A digital world is, for the most part, much, much easier. Even now paper is just a transient medium for me. It’s either going to be scanned or shredded (or scanned, then shredded) when I’m done. I don’t want the hassle of paper charts as my repository of information. Currently I have 23 years of charts sitting on a Mac-Mini, and accessible from wherever I am on Earth (as long as I have a decent signal). You definitely can’t do that with paper.
On a larger scale paper has other, more significant, drawbacks: deforestation, pollution, freshwater and petroleum usage, and others. I’m aware of this, use only scratch paper for my scribbles and lists, and buy recycled paper products as much as possible.
Certainly I wish we had less use of it. For one thing, I’d love to be rid of all the junk mail that comes to my house, which far outnumbers anything of importance. I always send it straight to recycling, but it would be far better if it had never been created in the first place.
Realistically, though, it’s still a key part of medical practice and everyday life. I don’t see that changing anytime soon, nor do I really want it to. I’ll leave it to a future generation of doctors to make that break.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve worked hard to get rid of paper, or at least minimize it.
I use e-fax for sending and receiving as much as possible. I send scripts and order digitally when I can.
But, 23 years into a paperless practice, the stuff isn’t going away soon. Nor I do I want it to.
For many applications paper is just easier (at least to me) to use. When I have a meeting and know I’ll need to read from notes, I’d much rather have them on paper than a screen, so I print them up. Even a grocery list is easier to scribble down on something and look at as I wander the aisles, rather than navigate to an app every 2 minutes. Paper isn’t susceptible to the whims of battery power, signal strength, being dropped, or software glitches.
I’m also not particularly good at taking notes on a computer. I’m sure most of the current generation of physicians is (or they just use a scribe), but I’m old school. Since day one I’ve had a note pad on my desk, jotting points and observations down on the fly (I use a pencil, too, if anyone remembers what that is). Then, when I have time, I type up my notes from the paper.
I also still have patients who, for whatever reason, want a handwritten prescription. Or sometimes need the legendary “doctor’s note” for work or school. Or need me to fill out forms.
Having grown up with paper, and been through school and residency with paper, it’s not easy to give it up entirely. There’s something reassuring about the tactile nature of flipping pages as opposed to scrolling up and down.
I’m not complaining about its decreased use, though. A digital world is, for the most part, much, much easier. Even now paper is just a transient medium for me. It’s either going to be scanned or shredded (or scanned, then shredded) when I’m done. I don’t want the hassle of paper charts as my repository of information. Currently I have 23 years of charts sitting on a Mac-Mini, and accessible from wherever I am on Earth (as long as I have a decent signal). You definitely can’t do that with paper.
On a larger scale paper has other, more significant, drawbacks: deforestation, pollution, freshwater and petroleum usage, and others. I’m aware of this, use only scratch paper for my scribbles and lists, and buy recycled paper products as much as possible.
Certainly I wish we had less use of it. For one thing, I’d love to be rid of all the junk mail that comes to my house, which far outnumbers anything of importance. I always send it straight to recycling, but it would be far better if it had never been created in the first place.
Realistically, though, it’s still a key part of medical practice and everyday life. I don’t see that changing anytime soon, nor do I really want it to. I’ll leave it to a future generation of doctors to make that break.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.
I’ve worked hard to get rid of paper, or at least minimize it.
I use e-fax for sending and receiving as much as possible. I send scripts and order digitally when I can.
But, 23 years into a paperless practice, the stuff isn’t going away soon. Nor I do I want it to.
For many applications paper is just easier (at least to me) to use. When I have a meeting and know I’ll need to read from notes, I’d much rather have them on paper than a screen, so I print them up. Even a grocery list is easier to scribble down on something and look at as I wander the aisles, rather than navigate to an app every 2 minutes. Paper isn’t susceptible to the whims of battery power, signal strength, being dropped, or software glitches.
I’m also not particularly good at taking notes on a computer. I’m sure most of the current generation of physicians is (or they just use a scribe), but I’m old school. Since day one I’ve had a note pad on my desk, jotting points and observations down on the fly (I use a pencil, too, if anyone remembers what that is). Then, when I have time, I type up my notes from the paper.
I also still have patients who, for whatever reason, want a handwritten prescription. Or sometimes need the legendary “doctor’s note” for work or school. Or need me to fill out forms.
Having grown up with paper, and been through school and residency with paper, it’s not easy to give it up entirely. There’s something reassuring about the tactile nature of flipping pages as opposed to scrolling up and down.
I’m not complaining about its decreased use, though. A digital world is, for the most part, much, much easier. Even now paper is just a transient medium for me. It’s either going to be scanned or shredded (or scanned, then shredded) when I’m done. I don’t want the hassle of paper charts as my repository of information. Currently I have 23 years of charts sitting on a Mac-Mini, and accessible from wherever I am on Earth (as long as I have a decent signal). You definitely can’t do that with paper.
On a larger scale paper has other, more significant, drawbacks: deforestation, pollution, freshwater and petroleum usage, and others. I’m aware of this, use only scratch paper for my scribbles and lists, and buy recycled paper products as much as possible.
Certainly I wish we had less use of it. For one thing, I’d love to be rid of all the junk mail that comes to my house, which far outnumbers anything of importance. I always send it straight to recycling, but it would be far better if it had never been created in the first place.
Realistically, though, it’s still a key part of medical practice and everyday life. I don’t see that changing anytime soon, nor do I really want it to. I’ll leave it to a future generation of doctors to make that break.
Dr. Block has a solo neurology practice in Scottsdale, Ariz.