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Heart failure guidelines updated
Clinical Question: What new evidence is available to guide heart failure (HF) management?
Background: New data has become available since the 2013 HF guidelines.
Study Design: A focused update.
Setting: Ongoing review of HF literature.
Synopsis: Beta-natriuretic peptide (BNP) is recommended to screen at risk patients (IIaB), on admission (IA), and prior to discharge (IIaB). The combination of ARB and neprilysin inhibitor (ARB-NI) is recommended in symptomatic patients with HF with reduced ejection fraction (HFrEF) who are tolerant of ACE inhibition (IB). For these patients, transitioning from ACE-inhibitor to the ARB-NI combination, valsartan-sacubitril significantly reduced hospitalization and mortality. Optimal dose and titration strategies remain unclear. ARB-NIs should not be used in patients with a history of angioedema (IIIC) or within 36 hours of receiving ACE-inhibitors (IIIB). Ivabradine, a selective inhibitor of the If current in the sinoatrial node, is recommended to reduce hospitalizations for patients with HFrEF with stable symptoms with resting sinus heart rate greater than or equal to 70 despite maximally-tolerated beta-blockade (IIaB). Intravenous iron replacement is recommended to improve function and quality of life for patients with symptomatic HF and iron deficiency (IIbB).
Bottom Line: Updates support use of BNP, ARB-NIs, ivabradine, and IV iron for HFrEF.
Citation: Yancy CW, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: A report of the American college of cardiology/American heart association task force on clinical practice guidelines and the heart failure society of America. Published online, 2017 Apr 28. Circulation. doi: 10.1161/CIR.0000000000000509.
Dr. Sweigart is an assistant professor in the University of Kentucky division of hospital medicine and Lexington VA Medical Center.
Clinical Question: What new evidence is available to guide heart failure (HF) management?
Background: New data has become available since the 2013 HF guidelines.
Study Design: A focused update.
Setting: Ongoing review of HF literature.
Synopsis: Beta-natriuretic peptide (BNP) is recommended to screen at risk patients (IIaB), on admission (IA), and prior to discharge (IIaB). The combination of ARB and neprilysin inhibitor (ARB-NI) is recommended in symptomatic patients with HF with reduced ejection fraction (HFrEF) who are tolerant of ACE inhibition (IB). For these patients, transitioning from ACE-inhibitor to the ARB-NI combination, valsartan-sacubitril significantly reduced hospitalization and mortality. Optimal dose and titration strategies remain unclear. ARB-NIs should not be used in patients with a history of angioedema (IIIC) or within 36 hours of receiving ACE-inhibitors (IIIB). Ivabradine, a selective inhibitor of the If current in the sinoatrial node, is recommended to reduce hospitalizations for patients with HFrEF with stable symptoms with resting sinus heart rate greater than or equal to 70 despite maximally-tolerated beta-blockade (IIaB). Intravenous iron replacement is recommended to improve function and quality of life for patients with symptomatic HF and iron deficiency (IIbB).
Bottom Line: Updates support use of BNP, ARB-NIs, ivabradine, and IV iron for HFrEF.
Citation: Yancy CW, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: A report of the American college of cardiology/American heart association task force on clinical practice guidelines and the heart failure society of America. Published online, 2017 Apr 28. Circulation. doi: 10.1161/CIR.0000000000000509.
Dr. Sweigart is an assistant professor in the University of Kentucky division of hospital medicine and Lexington VA Medical Center.
Clinical Question: What new evidence is available to guide heart failure (HF) management?
Background: New data has become available since the 2013 HF guidelines.
Study Design: A focused update.
Setting: Ongoing review of HF literature.
Synopsis: Beta-natriuretic peptide (BNP) is recommended to screen at risk patients (IIaB), on admission (IA), and prior to discharge (IIaB). The combination of ARB and neprilysin inhibitor (ARB-NI) is recommended in symptomatic patients with HF with reduced ejection fraction (HFrEF) who are tolerant of ACE inhibition (IB). For these patients, transitioning from ACE-inhibitor to the ARB-NI combination, valsartan-sacubitril significantly reduced hospitalization and mortality. Optimal dose and titration strategies remain unclear. ARB-NIs should not be used in patients with a history of angioedema (IIIC) or within 36 hours of receiving ACE-inhibitors (IIIB). Ivabradine, a selective inhibitor of the If current in the sinoatrial node, is recommended to reduce hospitalizations for patients with HFrEF with stable symptoms with resting sinus heart rate greater than or equal to 70 despite maximally-tolerated beta-blockade (IIaB). Intravenous iron replacement is recommended to improve function and quality of life for patients with symptomatic HF and iron deficiency (IIbB).
Bottom Line: Updates support use of BNP, ARB-NIs, ivabradine, and IV iron for HFrEF.
Citation: Yancy CW, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: A report of the American college of cardiology/American heart association task force on clinical practice guidelines and the heart failure society of America. Published online, 2017 Apr 28. Circulation. doi: 10.1161/CIR.0000000000000509.
Dr. Sweigart is an assistant professor in the University of Kentucky division of hospital medicine and Lexington VA Medical Center.
Study linked H2 receptor antagonists, but not PPIs, to dementia
A large prospective study of middle-aged and older women found no convincing evidence that using proton pump inhibitors increased their risk of dementia, investigators reported.
However, using H2 receptor antagonists for at least 9 years was associated with a slight decrease in scores of learning and working memory (mean decrease, –0.2; 95% confidence interval, –0.3 to –0.08; P less than .001), Paul Lochhead, MBChB, PhD, and his associates wrote in the October issue of Gastroenterology (doi: 10.1053/j.gastro.2017.06.061). “Since our primary hypothesis related to PPI [proton pump inhibitor] use, our findings for [H2 receptor antagonists] should be interpreted with caution,” they said.
Source: American Gastroenterological Association
In a recent German study of a medical claims database, use of PPIs was associated with a 44% increase in the likelihood of incident dementia (JAMA Neurol. 2016;73:410-6). “The existence of a causal mechanism linking PPI use to dementia is suggested by observations from cellular and animal models of Alzheimer’s disease, where PPI exposure appears to influence amyloid-beta metabolism,” Dr. Lochhead and his associates wrote. “However, other preclinical data on PPIs and Alzheimer’s disease are conflicting.” Noting that cognitive function predicts dementia later in life, they analyzed prospective data on medications and other potential risk factors from 13,864 participants in the Nurses’ Health Study II who had completed Cogstate, a computerized, self-administered neuropsychological battery.
Study participants averaged 61 years old when they underwent cognitive testing, ranging in age from 50 to 70 years. Users of PPIs tended to be older, had more comorbidities, were less physically active, had higher body mass indexes, had less education, and ate a lower-quality diet than women who did not use PPIs. After adjusting for such confounders, using PPIs for 9-14 years was associated with a modest decrease in scores for psychomotor speed and attention (mean score difference, compared with never users, –0.06; 95% CI, –0.11 to 0.00; P = .03). “For comparison, in multivariable models, a 1-year increase in age was associated with mean score decreases of 0.03 for psychomotor speed and attention, 0.02 for learning and working memory, and 0.03 for overall cognition,” the researchers wrote.
Next, they examined links between use of H2 receptor antagonists and cognitive scores among 10,778 study participants who had used PPIs for 2 years or less. Use of H2 receptor antagonists for 9-14 years predicted poorer scores on learning, working memory, and overall cognition, even after controlling for potential confounders (P less than or equal to .002). “The magnitudes of mean score differences were larger than those observed in the analysis of PPI use, particularly for learning and working memory,” the researchers noted. Additionally, PPI use did not predict lower cognitive scores among individuals who had never used H2 receptor antagonists.
On the other hand, using PPIs for 9-14 years was associated with the equivalent of about 2 years of age-related cognitive decline, and controlling for exposure to H2 receptor antagonists weakened even this modest effect, the investigators said. Users and nonusers of PPIs tend to differ on many measures, and analyses of claims data, such as the German study above, are less able to account for these potential confounders, they noted. “Nonjudicious PPI prescribing is especially frequent among the elderly and those with cognitive impairment,” they added. “Therefore, elderly individuals who have frequent contact with health providers are at increased risk of both PPI prescription and dementia diagnosis. This bias may not be completely mitigated by adjustment for comorbidities or polypharmacy.”
The findings regarding H2 receptor antagonists reflect those of three smaller cohort studies, and these medications are known to cause central nervous system effects in the elderly, including delirium, the researchers said. Ranitidine and cimetidine have anticholinergic effects that also could “pose a risk for adverse cognitive effects with long-term use.”
Dr. Lochhead reported having no conflicts. Two coinvestigators disclosed ties to Bayer Healthcare, Pfizer, Aralez Pharmaceuticals, AbbVie, Samsung Bioepis, and Takeda.
Numerous possible PPI-related adverse events have been reported within the past few years; some resultant media attention has caused anxiety for patients. Dementia is a dreaded diagnosis. Therefore, initial reports that PPI treatment might be associated with an increased risk of dementia attracted considerable media attention, much of which was unbalanced and uninformed. There is no obvious biological rationale for such an association, and the risks reported initially were of small magnitude (for example, hazard ratios of approximately 1.4). However, patients cannot reliably assess levels of risk from media coverage that often veers toward sensationalism.
The study by Lochhead et al. is a welcome contribution to the topic of PPI safety. Using the Nurses’ Health Study II database, the investigators measured cognitive function in a large group of female PPI users and nonusers. Unsurprisingly, PPI users were older and sicker than nonusers. There were quantitatively small changes in some measures of cognitive function among PPI users. However, learning and working memory scores, which are more predictive of Alzheimer’s-type cognitive decline, were unaffected by PPI use.
For those prescribers with residual concerns about any association between PPIs and dementia, these prospectively collected data on cognitive function should provide further reassurance. It is appropriate that this study should have been highlighted in GI & Hepatology News, but since it lacks the potential sensationalism of studies that report a putative association, we should not expect it to be discussed on the TV evening news anytime soon!
Colin W. Howden, MD, AGAF, is chief of gastroenterology at University of Tennessee Health Science Center, Memphis. He has been a consultant, investigator, and/or speaker for all PPI manufacturers at some time. He is currently a consultant for Takeda, Aralez, and Pfizer Consumer Health.
Numerous possible PPI-related adverse events have been reported within the past few years; some resultant media attention has caused anxiety for patients. Dementia is a dreaded diagnosis. Therefore, initial reports that PPI treatment might be associated with an increased risk of dementia attracted considerable media attention, much of which was unbalanced and uninformed. There is no obvious biological rationale for such an association, and the risks reported initially were of small magnitude (for example, hazard ratios of approximately 1.4). However, patients cannot reliably assess levels of risk from media coverage that often veers toward sensationalism.
The study by Lochhead et al. is a welcome contribution to the topic of PPI safety. Using the Nurses’ Health Study II database, the investigators measured cognitive function in a large group of female PPI users and nonusers. Unsurprisingly, PPI users were older and sicker than nonusers. There were quantitatively small changes in some measures of cognitive function among PPI users. However, learning and working memory scores, which are more predictive of Alzheimer’s-type cognitive decline, were unaffected by PPI use.
For those prescribers with residual concerns about any association between PPIs and dementia, these prospectively collected data on cognitive function should provide further reassurance. It is appropriate that this study should have been highlighted in GI & Hepatology News, but since it lacks the potential sensationalism of studies that report a putative association, we should not expect it to be discussed on the TV evening news anytime soon!
Colin W. Howden, MD, AGAF, is chief of gastroenterology at University of Tennessee Health Science Center, Memphis. He has been a consultant, investigator, and/or speaker for all PPI manufacturers at some time. He is currently a consultant for Takeda, Aralez, and Pfizer Consumer Health.
Numerous possible PPI-related adverse events have been reported within the past few years; some resultant media attention has caused anxiety for patients. Dementia is a dreaded diagnosis. Therefore, initial reports that PPI treatment might be associated with an increased risk of dementia attracted considerable media attention, much of which was unbalanced and uninformed. There is no obvious biological rationale for such an association, and the risks reported initially were of small magnitude (for example, hazard ratios of approximately 1.4). However, patients cannot reliably assess levels of risk from media coverage that often veers toward sensationalism.
The study by Lochhead et al. is a welcome contribution to the topic of PPI safety. Using the Nurses’ Health Study II database, the investigators measured cognitive function in a large group of female PPI users and nonusers. Unsurprisingly, PPI users were older and sicker than nonusers. There were quantitatively small changes in some measures of cognitive function among PPI users. However, learning and working memory scores, which are more predictive of Alzheimer’s-type cognitive decline, were unaffected by PPI use.
For those prescribers with residual concerns about any association between PPIs and dementia, these prospectively collected data on cognitive function should provide further reassurance. It is appropriate that this study should have been highlighted in GI & Hepatology News, but since it lacks the potential sensationalism of studies that report a putative association, we should not expect it to be discussed on the TV evening news anytime soon!
Colin W. Howden, MD, AGAF, is chief of gastroenterology at University of Tennessee Health Science Center, Memphis. He has been a consultant, investigator, and/or speaker for all PPI manufacturers at some time. He is currently a consultant for Takeda, Aralez, and Pfizer Consumer Health.
A large prospective study of middle-aged and older women found no convincing evidence that using proton pump inhibitors increased their risk of dementia, investigators reported.
However, using H2 receptor antagonists for at least 9 years was associated with a slight decrease in scores of learning and working memory (mean decrease, –0.2; 95% confidence interval, –0.3 to –0.08; P less than .001), Paul Lochhead, MBChB, PhD, and his associates wrote in the October issue of Gastroenterology (doi: 10.1053/j.gastro.2017.06.061). “Since our primary hypothesis related to PPI [proton pump inhibitor] use, our findings for [H2 receptor antagonists] should be interpreted with caution,” they said.
Source: American Gastroenterological Association
In a recent German study of a medical claims database, use of PPIs was associated with a 44% increase in the likelihood of incident dementia (JAMA Neurol. 2016;73:410-6). “The existence of a causal mechanism linking PPI use to dementia is suggested by observations from cellular and animal models of Alzheimer’s disease, where PPI exposure appears to influence amyloid-beta metabolism,” Dr. Lochhead and his associates wrote. “However, other preclinical data on PPIs and Alzheimer’s disease are conflicting.” Noting that cognitive function predicts dementia later in life, they analyzed prospective data on medications and other potential risk factors from 13,864 participants in the Nurses’ Health Study II who had completed Cogstate, a computerized, self-administered neuropsychological battery.
Study participants averaged 61 years old when they underwent cognitive testing, ranging in age from 50 to 70 years. Users of PPIs tended to be older, had more comorbidities, were less physically active, had higher body mass indexes, had less education, and ate a lower-quality diet than women who did not use PPIs. After adjusting for such confounders, using PPIs for 9-14 years was associated with a modest decrease in scores for psychomotor speed and attention (mean score difference, compared with never users, –0.06; 95% CI, –0.11 to 0.00; P = .03). “For comparison, in multivariable models, a 1-year increase in age was associated with mean score decreases of 0.03 for psychomotor speed and attention, 0.02 for learning and working memory, and 0.03 for overall cognition,” the researchers wrote.
Next, they examined links between use of H2 receptor antagonists and cognitive scores among 10,778 study participants who had used PPIs for 2 years or less. Use of H2 receptor antagonists for 9-14 years predicted poorer scores on learning, working memory, and overall cognition, even after controlling for potential confounders (P less than or equal to .002). “The magnitudes of mean score differences were larger than those observed in the analysis of PPI use, particularly for learning and working memory,” the researchers noted. Additionally, PPI use did not predict lower cognitive scores among individuals who had never used H2 receptor antagonists.
On the other hand, using PPIs for 9-14 years was associated with the equivalent of about 2 years of age-related cognitive decline, and controlling for exposure to H2 receptor antagonists weakened even this modest effect, the investigators said. Users and nonusers of PPIs tend to differ on many measures, and analyses of claims data, such as the German study above, are less able to account for these potential confounders, they noted. “Nonjudicious PPI prescribing is especially frequent among the elderly and those with cognitive impairment,” they added. “Therefore, elderly individuals who have frequent contact with health providers are at increased risk of both PPI prescription and dementia diagnosis. This bias may not be completely mitigated by adjustment for comorbidities or polypharmacy.”
The findings regarding H2 receptor antagonists reflect those of three smaller cohort studies, and these medications are known to cause central nervous system effects in the elderly, including delirium, the researchers said. Ranitidine and cimetidine have anticholinergic effects that also could “pose a risk for adverse cognitive effects with long-term use.”
Dr. Lochhead reported having no conflicts. Two coinvestigators disclosed ties to Bayer Healthcare, Pfizer, Aralez Pharmaceuticals, AbbVie, Samsung Bioepis, and Takeda.
A large prospective study of middle-aged and older women found no convincing evidence that using proton pump inhibitors increased their risk of dementia, investigators reported.
However, using H2 receptor antagonists for at least 9 years was associated with a slight decrease in scores of learning and working memory (mean decrease, –0.2; 95% confidence interval, –0.3 to –0.08; P less than .001), Paul Lochhead, MBChB, PhD, and his associates wrote in the October issue of Gastroenterology (doi: 10.1053/j.gastro.2017.06.061). “Since our primary hypothesis related to PPI [proton pump inhibitor] use, our findings for [H2 receptor antagonists] should be interpreted with caution,” they said.
Source: American Gastroenterological Association
In a recent German study of a medical claims database, use of PPIs was associated with a 44% increase in the likelihood of incident dementia (JAMA Neurol. 2016;73:410-6). “The existence of a causal mechanism linking PPI use to dementia is suggested by observations from cellular and animal models of Alzheimer’s disease, where PPI exposure appears to influence amyloid-beta metabolism,” Dr. Lochhead and his associates wrote. “However, other preclinical data on PPIs and Alzheimer’s disease are conflicting.” Noting that cognitive function predicts dementia later in life, they analyzed prospective data on medications and other potential risk factors from 13,864 participants in the Nurses’ Health Study II who had completed Cogstate, a computerized, self-administered neuropsychological battery.
Study participants averaged 61 years old when they underwent cognitive testing, ranging in age from 50 to 70 years. Users of PPIs tended to be older, had more comorbidities, were less physically active, had higher body mass indexes, had less education, and ate a lower-quality diet than women who did not use PPIs. After adjusting for such confounders, using PPIs for 9-14 years was associated with a modest decrease in scores for psychomotor speed and attention (mean score difference, compared with never users, –0.06; 95% CI, –0.11 to 0.00; P = .03). “For comparison, in multivariable models, a 1-year increase in age was associated with mean score decreases of 0.03 for psychomotor speed and attention, 0.02 for learning and working memory, and 0.03 for overall cognition,” the researchers wrote.
Next, they examined links between use of H2 receptor antagonists and cognitive scores among 10,778 study participants who had used PPIs for 2 years or less. Use of H2 receptor antagonists for 9-14 years predicted poorer scores on learning, working memory, and overall cognition, even after controlling for potential confounders (P less than or equal to .002). “The magnitudes of mean score differences were larger than those observed in the analysis of PPI use, particularly for learning and working memory,” the researchers noted. Additionally, PPI use did not predict lower cognitive scores among individuals who had never used H2 receptor antagonists.
On the other hand, using PPIs for 9-14 years was associated with the equivalent of about 2 years of age-related cognitive decline, and controlling for exposure to H2 receptor antagonists weakened even this modest effect, the investigators said. Users and nonusers of PPIs tend to differ on many measures, and analyses of claims data, such as the German study above, are less able to account for these potential confounders, they noted. “Nonjudicious PPI prescribing is especially frequent among the elderly and those with cognitive impairment,” they added. “Therefore, elderly individuals who have frequent contact with health providers are at increased risk of both PPI prescription and dementia diagnosis. This bias may not be completely mitigated by adjustment for comorbidities or polypharmacy.”
The findings regarding H2 receptor antagonists reflect those of three smaller cohort studies, and these medications are known to cause central nervous system effects in the elderly, including delirium, the researchers said. Ranitidine and cimetidine have anticholinergic effects that also could “pose a risk for adverse cognitive effects with long-term use.”
Dr. Lochhead reported having no conflicts. Two coinvestigators disclosed ties to Bayer Healthcare, Pfizer, Aralez Pharmaceuticals, AbbVie, Samsung Bioepis, and Takeda.
FROM GASTROENTEROLOGY
Key clinical point: A large prospective cohort study linked long-term use of H2 receptor antagonists, but not PPIs, to dementia.
Major finding: Use of PPIs did not significantly predict incident dementia in the adjusted analysis. However, using H2 receptor antagonists for at least 9 years was associated with a slight decrease in scores of learning and working memory (mean decrease, –0.2; P less than .001).
Data source: A population-based cohort study of 13,864 middle-aged and older women.
Disclosures: Dr. Lochhead reported having no conflicts. Two coinvestigators disclosed ties to Bayer Healthcare, Pfizer, Aralez Pharmaceuticals, AbbVie, Samsung Bioepis, and Takeda.
Burden of HCV-induced cirrhosis expected to shift from men to women
Prevalence of hepatitis C virus (HCV) complications among women grew at a rate similar to that of men, while mortality among men was nearly double that of women, according to a study conducted through the Veterans Affairs office.
While men still have a higher prevalence of conditions such as cirrhosis, investigators expect to see a shift in the burden of care as women with HCV complications outlive men with similar diagnoses.
“The current and near-term burden in HCV-related cirrhosis was disproportionately attributed to men,” according to Jennifer Kramer, PhD, investigator at the Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston. “However, the trends are expected to change after 2020.”
The retrospective cohort study analyzed 264,409 HCV-infected veterans, 7,162 of whom were women, between January 2000 and December 2013.
Investigators found annual average prevalence change (AAPC) among men and women was 13.1% and 15.2%, respectively, for cirrhosis, while overall mortality was 28.7% for men, compared with 15.5% for women (J Viral Hepat. 2017 Aug 16. doi: 10.1111/jvh.12728).
Dr. Kramer and her fellow investigators also found similar rates among decompensated cirrhosis between 15.6% and 16.9% for women and men, respectively, and hepatocellular cancer, 21% and 25.3%, respectively.
Women included in the cohort were, on average, younger (48 years vs. 53 years), were less likely to use alcohol (33% vs. 45%), and were less likely to have contracted diabetes (30% vs. 39%).
While men’s prevalence growth was equal to women’s, male patients are 1.7 times more likely to be infected with HCV (J Hepatol. 2012 Jun 2 doi: 10.1016/j.jhep.2012.05.018), which is reflected in overall incidence rates of complications.
As expected, overall incidence of cirrhosis was higher in men than in women, with incidence rates for men at 28.2% compared with 20.1% of women.
Similar differences were found in rates of decompensated cirrhosis, 18.6% in men compared with 12.4% in women, and hepatocellular cancer, 5.3% in men compared with 1.5% in women.
Shifting trends in burden of care toward women have investigators worried about current HCV treatment practices for female patients.
“The increasing burden of HCV complications in women is concerning,” the researchers wrote. “Studies show that women are less likely to receive antiviral treatment than men.”
Contrary to this claim, antiviral treatment rates among men and women in this study were almost identical: 23.6% of women and 23.3% of men.
While the difference in treatment is not evident, the low rate of treatment for both men and women is another concern for Dr. Kramer and her colleagues.
“In the U.S., HCV infection remains undiagnosed in over 50% of all persons with HCV disease,” the investigators wrote. “Access to highly affective yet expensive direct acting antiviral treatment remains a challenge.”
Findings from this study may not be a true representation of the U.S. HCV-infected population because patients were veterans, with differences such as a higher rate of alcohol use among women.
The researchers reported no relevant financial disclosures.
AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
[email protected]
On Twitter @eaztweets
Prevalence of hepatitis C virus (HCV) complications among women grew at a rate similar to that of men, while mortality among men was nearly double that of women, according to a study conducted through the Veterans Affairs office.
While men still have a higher prevalence of conditions such as cirrhosis, investigators expect to see a shift in the burden of care as women with HCV complications outlive men with similar diagnoses.
“The current and near-term burden in HCV-related cirrhosis was disproportionately attributed to men,” according to Jennifer Kramer, PhD, investigator at the Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston. “However, the trends are expected to change after 2020.”
The retrospective cohort study analyzed 264,409 HCV-infected veterans, 7,162 of whom were women, between January 2000 and December 2013.
Investigators found annual average prevalence change (AAPC) among men and women was 13.1% and 15.2%, respectively, for cirrhosis, while overall mortality was 28.7% for men, compared with 15.5% for women (J Viral Hepat. 2017 Aug 16. doi: 10.1111/jvh.12728).
Dr. Kramer and her fellow investigators also found similar rates among decompensated cirrhosis between 15.6% and 16.9% for women and men, respectively, and hepatocellular cancer, 21% and 25.3%, respectively.
Women included in the cohort were, on average, younger (48 years vs. 53 years), were less likely to use alcohol (33% vs. 45%), and were less likely to have contracted diabetes (30% vs. 39%).
While men’s prevalence growth was equal to women’s, male patients are 1.7 times more likely to be infected with HCV (J Hepatol. 2012 Jun 2 doi: 10.1016/j.jhep.2012.05.018), which is reflected in overall incidence rates of complications.
As expected, overall incidence of cirrhosis was higher in men than in women, with incidence rates for men at 28.2% compared with 20.1% of women.
Similar differences were found in rates of decompensated cirrhosis, 18.6% in men compared with 12.4% in women, and hepatocellular cancer, 5.3% in men compared with 1.5% in women.
Shifting trends in burden of care toward women have investigators worried about current HCV treatment practices for female patients.
“The increasing burden of HCV complications in women is concerning,” the researchers wrote. “Studies show that women are less likely to receive antiviral treatment than men.”
Contrary to this claim, antiviral treatment rates among men and women in this study were almost identical: 23.6% of women and 23.3% of men.
While the difference in treatment is not evident, the low rate of treatment for both men and women is another concern for Dr. Kramer and her colleagues.
“In the U.S., HCV infection remains undiagnosed in over 50% of all persons with HCV disease,” the investigators wrote. “Access to highly affective yet expensive direct acting antiviral treatment remains a challenge.”
Findings from this study may not be a true representation of the U.S. HCV-infected population because patients were veterans, with differences such as a higher rate of alcohol use among women.
The researchers reported no relevant financial disclosures.
AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
[email protected]
On Twitter @eaztweets
Prevalence of hepatitis C virus (HCV) complications among women grew at a rate similar to that of men, while mortality among men was nearly double that of women, according to a study conducted through the Veterans Affairs office.
While men still have a higher prevalence of conditions such as cirrhosis, investigators expect to see a shift in the burden of care as women with HCV complications outlive men with similar diagnoses.
“The current and near-term burden in HCV-related cirrhosis was disproportionately attributed to men,” according to Jennifer Kramer, PhD, investigator at the Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston. “However, the trends are expected to change after 2020.”
The retrospective cohort study analyzed 264,409 HCV-infected veterans, 7,162 of whom were women, between January 2000 and December 2013.
Investigators found annual average prevalence change (AAPC) among men and women was 13.1% and 15.2%, respectively, for cirrhosis, while overall mortality was 28.7% for men, compared with 15.5% for women (J Viral Hepat. 2017 Aug 16. doi: 10.1111/jvh.12728).
Dr. Kramer and her fellow investigators also found similar rates among decompensated cirrhosis between 15.6% and 16.9% for women and men, respectively, and hepatocellular cancer, 21% and 25.3%, respectively.
Women included in the cohort were, on average, younger (48 years vs. 53 years), were less likely to use alcohol (33% vs. 45%), and were less likely to have contracted diabetes (30% vs. 39%).
While men’s prevalence growth was equal to women’s, male patients are 1.7 times more likely to be infected with HCV (J Hepatol. 2012 Jun 2 doi: 10.1016/j.jhep.2012.05.018), which is reflected in overall incidence rates of complications.
As expected, overall incidence of cirrhosis was higher in men than in women, with incidence rates for men at 28.2% compared with 20.1% of women.
Similar differences were found in rates of decompensated cirrhosis, 18.6% in men compared with 12.4% in women, and hepatocellular cancer, 5.3% in men compared with 1.5% in women.
Shifting trends in burden of care toward women have investigators worried about current HCV treatment practices for female patients.
“The increasing burden of HCV complications in women is concerning,” the researchers wrote. “Studies show that women are less likely to receive antiviral treatment than men.”
Contrary to this claim, antiviral treatment rates among men and women in this study were almost identical: 23.6% of women and 23.3% of men.
While the difference in treatment is not evident, the low rate of treatment for both men and women is another concern for Dr. Kramer and her colleagues.
“In the U.S., HCV infection remains undiagnosed in over 50% of all persons with HCV disease,” the investigators wrote. “Access to highly affective yet expensive direct acting antiviral treatment remains a challenge.”
Findings from this study may not be a true representation of the U.S. HCV-infected population because patients were veterans, with differences such as a higher rate of alcohol use among women.
The researchers reported no relevant financial disclosures.
AGA Resource
Through the HCV Clinical Service Line, AGA offers tools to help you become more efficient, understand quality standards and improve the process of care for patients. Learn more at http://www.gastro.org/patient-care/conditions-diseases/hepatitis-c
[email protected]
On Twitter @eaztweets
FROM JOURNAL OF VIRAL HEPATITIS
Key clinical point:
Major finding: Average annual change of cirrhosis prevalence in women was 15.2% for women and 13.1% for men, while total mortality was 15.5% compared with 28.7% for women and men, respectively.
Data source: Retrospective cohort study of 264,409 veterans diagnosed with HCV, from the Veterans Affairs corporate wellness data for January 2000 to December 2013.
Disclosures: The investigators reported no relevant financial disclosures.
Burden of HCV-induced cirrhosis expected to shift from men to women
Prevalence of hepatitis C virus (HCV) complications among women grew at a rate similar to that of men, while mortality among men was nearly double that of women, according to a study conducted through the Veterans Affairs office.
While men still have a higher prevalence of conditions such as cirrhosis, investigators expect to see a shift in the burden of care as women with HCV complications outlive men with similar diagnoses.
“The current and near-term burden in HCV-related cirrhosis was disproportionately attributed to men,” according to Jennifer Kramer, PhD, investigator at the Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston. “However, the trends are expected to change after 2020.”
The retrospective cohort study analyzed 264,409 HCV-infected veterans, 7,162 of whom were women, between January 2000 and December 2013.
Investigators found annual average prevalence change (AAPC) among men and women was 13.1% and 15.2%, respectively, for cirrhosis, while overall mortality was 28.7% for men, compared with 15.5% for women (J Viral Hepat. 2017 Aug 16. doi: 10.1111/jvh.12728).
Dr. Kramer and her fellow investigators also found similar rates among decompensated cirrhosis between 15.6% and 16.9% for women and men, respectively, and hepatocellular cancer, 21% and 25.3%, respectively.
Women included in the cohort were, on average, younger (48 years vs. 53 years), were less likely to use alcohol (33% vs. 45%), and were less likely to have contracted diabetes (30% vs. 39%).
While men’s prevalence growth was equal to women’s, male patients are 1.7 times more likely to be infected with HCV (J Hepatol. 2012 Jun 2 doi: 10.1016/j.jhep.2012.05.018), which is reflected in overall incidence rates of complications.
As expected, overall incidence of cirrhosis was higher in men than in women, with incidence rates for men at 28.2% compared with 20.1% of women.
Similar differences were found in rates of decompensated cirrhosis, 18.6% in men compared with 12.4% in women, and hepatocellular cancer, 5.3% in men compared with 1.5% in women.
Shifting trends in burden of care toward women have investigators worried about current HCV treatment practices for female patients.
“The increasing burden of HCV complications in women is concerning,” the researchers wrote. “Studies show that women are less likely to receive antiviral treatment than men.”
Contrary to this claim, antiviral treatment rates among men and women in this study were almost identical: 23.6% of women and 23.3% of men.
While the difference in treatment is not evident, the low rate of treatment for both men and women is another concern for Dr. Kramer and her colleagues.
“In the U.S., HCV infection remains undiagnosed in over 50% of all persons with HCV disease,” the investigators wrote. “Access to highly affective yet expensive direct acting antiviral treatment remains a challenge.”
Findings from this study may not be a true representation of the U.S. HCV-infected population because patients were veterans, with differences such as a higher rate of alcohol use among women.
The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
Prevalence of hepatitis C virus (HCV) complications among women grew at a rate similar to that of men, while mortality among men was nearly double that of women, according to a study conducted through the Veterans Affairs office.
While men still have a higher prevalence of conditions such as cirrhosis, investigators expect to see a shift in the burden of care as women with HCV complications outlive men with similar diagnoses.
“The current and near-term burden in HCV-related cirrhosis was disproportionately attributed to men,” according to Jennifer Kramer, PhD, investigator at the Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston. “However, the trends are expected to change after 2020.”
The retrospective cohort study analyzed 264,409 HCV-infected veterans, 7,162 of whom were women, between January 2000 and December 2013.
Investigators found annual average prevalence change (AAPC) among men and women was 13.1% and 15.2%, respectively, for cirrhosis, while overall mortality was 28.7% for men, compared with 15.5% for women (J Viral Hepat. 2017 Aug 16. doi: 10.1111/jvh.12728).
Dr. Kramer and her fellow investigators also found similar rates among decompensated cirrhosis between 15.6% and 16.9% for women and men, respectively, and hepatocellular cancer, 21% and 25.3%, respectively.
Women included in the cohort were, on average, younger (48 years vs. 53 years), were less likely to use alcohol (33% vs. 45%), and were less likely to have contracted diabetes (30% vs. 39%).
While men’s prevalence growth was equal to women’s, male patients are 1.7 times more likely to be infected with HCV (J Hepatol. 2012 Jun 2 doi: 10.1016/j.jhep.2012.05.018), which is reflected in overall incidence rates of complications.
As expected, overall incidence of cirrhosis was higher in men than in women, with incidence rates for men at 28.2% compared with 20.1% of women.
Similar differences were found in rates of decompensated cirrhosis, 18.6% in men compared with 12.4% in women, and hepatocellular cancer, 5.3% in men compared with 1.5% in women.
Shifting trends in burden of care toward women have investigators worried about current HCV treatment practices for female patients.
“The increasing burden of HCV complications in women is concerning,” the researchers wrote. “Studies show that women are less likely to receive antiviral treatment than men.”
Contrary to this claim, antiviral treatment rates among men and women in this study were almost identical: 23.6% of women and 23.3% of men.
While the difference in treatment is not evident, the low rate of treatment for both men and women is another concern for Dr. Kramer and her colleagues.
“In the U.S., HCV infection remains undiagnosed in over 50% of all persons with HCV disease,” the investigators wrote. “Access to highly affective yet expensive direct acting antiviral treatment remains a challenge.”
Findings from this study may not be a true representation of the U.S. HCV-infected population because patients were veterans, with differences such as a higher rate of alcohol use among women.
The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
Prevalence of hepatitis C virus (HCV) complications among women grew at a rate similar to that of men, while mortality among men was nearly double that of women, according to a study conducted through the Veterans Affairs office.
While men still have a higher prevalence of conditions such as cirrhosis, investigators expect to see a shift in the burden of care as women with HCV complications outlive men with similar diagnoses.
“The current and near-term burden in HCV-related cirrhosis was disproportionately attributed to men,” according to Jennifer Kramer, PhD, investigator at the Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston. “However, the trends are expected to change after 2020.”
The retrospective cohort study analyzed 264,409 HCV-infected veterans, 7,162 of whom were women, between January 2000 and December 2013.
Investigators found annual average prevalence change (AAPC) among men and women was 13.1% and 15.2%, respectively, for cirrhosis, while overall mortality was 28.7% for men, compared with 15.5% for women (J Viral Hepat. 2017 Aug 16. doi: 10.1111/jvh.12728).
Dr. Kramer and her fellow investigators also found similar rates among decompensated cirrhosis between 15.6% and 16.9% for women and men, respectively, and hepatocellular cancer, 21% and 25.3%, respectively.
Women included in the cohort were, on average, younger (48 years vs. 53 years), were less likely to use alcohol (33% vs. 45%), and were less likely to have contracted diabetes (30% vs. 39%).
While men’s prevalence growth was equal to women’s, male patients are 1.7 times more likely to be infected with HCV (J Hepatol. 2012 Jun 2 doi: 10.1016/j.jhep.2012.05.018), which is reflected in overall incidence rates of complications.
As expected, overall incidence of cirrhosis was higher in men than in women, with incidence rates for men at 28.2% compared with 20.1% of women.
Similar differences were found in rates of decompensated cirrhosis, 18.6% in men compared with 12.4% in women, and hepatocellular cancer, 5.3% in men compared with 1.5% in women.
Shifting trends in burden of care toward women have investigators worried about current HCV treatment practices for female patients.
“The increasing burden of HCV complications in women is concerning,” the researchers wrote. “Studies show that women are less likely to receive antiviral treatment than men.”
Contrary to this claim, antiviral treatment rates among men and women in this study were almost identical: 23.6% of women and 23.3% of men.
While the difference in treatment is not evident, the low rate of treatment for both men and women is another concern for Dr. Kramer and her colleagues.
“In the U.S., HCV infection remains undiagnosed in over 50% of all persons with HCV disease,” the investigators wrote. “Access to highly affective yet expensive direct acting antiviral treatment remains a challenge.”
Findings from this study may not be a true representation of the U.S. HCV-infected population because patients were veterans, with differences such as a higher rate of alcohol use among women.
The researchers reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
FROM THE JOURNAL OF VIRAL HEPATITIS
Key clinical point:
Major finding: Average annual change of cirrhosis prevalence in women was 15.2% for women and 13.1% for men, while total mortality was 15.5% compared with 28.7% for women and men, respectively.
Data source: Retrospective cohort study of 264,409 veterans diagnosed with HCV, from the Veterans Affairs corporate wellness data for January 2000 to December 2013.
Disclosures: The investigators reported no relevant financial disclosures.
Statin use cuts risks in compensated cirrhosis
For patients with compensated cirrhosis, statin therapy was associated with about a 46% decrease in the risk of hepatic decompensation and mortality and with a 27% drop in the risk of portal hypertension and variceal bleeding, according to moderate-quality evidence from a systematic review and meta-analysis of 13 studies.
Low-quality data also suggested that statins might help protect against the progression of noncirrhotic chronic liver disease, said Rebecca G. Kim of the University of California at San Diego and her associates. “Large, pragmatic randomized controlled trials in patients with compensated cirrhosis are required to confirm these observations,” they wrote in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.04.039).
Prior studies have reported mixed findings on how statin therapy affects chronic liver disease. For their review, Ms. Kim and her associates searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Cochrane Database and Systematic Reviews, Scopus, Web of Science, and PubMed for randomized controlled trials or cohort studies published through March 25, 2017. They identified 10 cohort studies and three randomized controlled trials of adults with fibrosis without cirrhosis, compensated cirrhosis, or decompensated cirrhosis that evaluated statin exposure and reported associations between exposure and outcomes related to cirrhosis. They excluded case-control studies, cross-sectional studies, and studies that focused only on the relationship between statin use and the risk of hepatocellular carcinoma.
The resulting data set included 121,058 patients with chronic liver diseases, of whom 85% had chronic hepatitis C virus infection. A total of 46% of patients were exposed to statins, which appeared to reduce their risk of hepatic decompensation, variceal bleeding, and mortality. Among 87 such patients in five studies, statin use was associated with a 46% decrease in the risk of hepatic decompensation and death, with risk ratios of 0.54 (95% confidence intervals, 0.46-0.62 and 0.47-0.61, respectively). Statin use also was associated with a 27% lower risk of variceal bleeding or progression of portal hypertension, based on an analysis of 110 events in 236 patients from three trials (RR, 0.73; 95% CI, 0.59-0.91). Finally, statin use also was associated with a 58% lower risk of fibrosis progression or cirrhosis in patients with noncirrhotic chronic liver disease, but the 95% CIs for the risk estimate did not reach statistical significance (0.16-1.11).
Source: American Gastroenterological Association
Most studies lacked data on dose and duration of statin exposure, the researchers said. However, four cohort studies reported dose-dependent effects that were most pronounced after more than a year of treatment. “Similarly, several different types of statins were studied, and observed effects were assumed to be class-specific effects,” the reviewers wrote. “However, it is possible that lipophilic and lipophobic statins may have differential efficacy in decreasing fibrosis progression.”
Together, these findings support prior studies suggesting that statin therapy is safe and can potentially reduce the risk of hepatocellular carcinoma in this patient population, they concluded. Statins “may potentially improve patient-relevant outcomes in patients with chronic liver diseases and improve survival without significant additional costs.”
The reviewers acknowledged the American Gastroenterological Association Foundation, a T. Franklin Williams Scholarship Award, the National Institutes of Health, and the National Library of Medicine. They reported having no relevant conflicts of interest.
This story was updated on 9/13/2017.
The main mechanism in the development of cirrhosis in patients with chronic liver disease (CLD) is increased hepatic fibrogenesis. The initial consequence of cirrhosis is portal hypertension, which is the main driver of decompensation (defined as the presence of ascites, variceal hemorrhage, or encephalopathy). 
Statins are widely used for reducing cholesterol levels and cardiovascular risk. However, statins ameliorate endothelial dysfunction and have additional antifibrotic, anti-inflammatory, and antithrombotic properties, all of them of potential benefit in preventing progression of CLD/cirrhosis. In fact, statins have been shown to reduce portal pressure in cirrhosis.
In a meta-analysis of 13 studies, Kim et al. demonstrated that statin use is associated with a 58% lower risk of developing cirrhosis/fibrosis progression in patients with CLD (not statistically significant), while in patients with compensated cirrhosis of any etiology, statin use was associated with a statistically significant 46% lower risk of developing decompensation and death.
Most studies in the meta-analysis were observational/retrospective. Although the authors jointly analyzed three randomized controlled trials, only one of the trials looked at clinical outcomes. This important double-blind, placebo-controlled study in patients with recent variceal hemorrhage showed a significantly lower mortality in patients randomized to simvastatin.
Therefore, although the evidence is not yet sufficient to recommend the widespread use of statins in patients with CLD/cirrhosis, providers should not avoid using statins in patients with CLD/cirrhosis who otherwise need them. In fact, they should actively look for indications that would justify their use.
Guadalupe Garcia-Tsao, MD, is professor of medicine at Yale University, chief of digestive diseases at the VA-CT Healthcare System, and director of the clinical core of the Yale Liver Center, New Haven, Conn. She had no conflicts of interest.
The main mechanism in the development of cirrhosis in patients with chronic liver disease (CLD) is increased hepatic fibrogenesis. The initial consequence of cirrhosis is portal hypertension, which is the main driver of decompensation (defined as the presence of ascites, variceal hemorrhage, or encephalopathy).
Statins are widely used for reducing cholesterol levels and cardiovascular risk. However, statins ameliorate endothelial dysfunction and have additional antifibrotic, anti-inflammatory, and antithrombotic properties, all of them of potential benefit in preventing progression of CLD/cirrhosis. In fact, statins have been shown to reduce portal pressure in cirrhosis.
In a meta-analysis of 13 studies, Kim et al. demonstrated that statin use is associated with a 58% lower risk of developing cirrhosis/fibrosis progression in patients with CLD (not statistically significant), while in patients with compensated cirrhosis of any etiology, statin use was associated with a statistically significant 46% lower risk of developing decompensation and death.
Most studies in the meta-analysis were observational/retrospective. Although the authors jointly analyzed three randomized controlled trials, only one of the trials looked at clinical outcomes. This important double-blind, placebo-controlled study in patients with recent variceal hemorrhage showed a significantly lower mortality in patients randomized to simvastatin.
Therefore, although the evidence is not yet sufficient to recommend the widespread use of statins in patients with CLD/cirrhosis, providers should not avoid using statins in patients with CLD/cirrhosis who otherwise need them. In fact, they should actively look for indications that would justify their use.
Guadalupe Garcia-Tsao, MD, is professor of medicine at Yale University, chief of digestive diseases at the VA-CT Healthcare System, and director of the clinical core of the Yale Liver Center, New Haven, Conn. She had no conflicts of interest.
The main mechanism in the development of cirrhosis in patients with chronic liver disease (CLD) is increased hepatic fibrogenesis. The initial consequence of cirrhosis is portal hypertension, which is the main driver of decompensation (defined as the presence of ascites, variceal hemorrhage, or encephalopathy).
Statins are widely used for reducing cholesterol levels and cardiovascular risk. However, statins ameliorate endothelial dysfunction and have additional antifibrotic, anti-inflammatory, and antithrombotic properties, all of them of potential benefit in preventing progression of CLD/cirrhosis. In fact, statins have been shown to reduce portal pressure in cirrhosis.
In a meta-analysis of 13 studies, Kim et al. demonstrated that statin use is associated with a 58% lower risk of developing cirrhosis/fibrosis progression in patients with CLD (not statistically significant), while in patients with compensated cirrhosis of any etiology, statin use was associated with a statistically significant 46% lower risk of developing decompensation and death.
Most studies in the meta-analysis were observational/retrospective. Although the authors jointly analyzed three randomized controlled trials, only one of the trials looked at clinical outcomes. This important double-blind, placebo-controlled study in patients with recent variceal hemorrhage showed a significantly lower mortality in patients randomized to simvastatin.
Therefore, although the evidence is not yet sufficient to recommend the widespread use of statins in patients with CLD/cirrhosis, providers should not avoid using statins in patients with CLD/cirrhosis who otherwise need them. In fact, they should actively look for indications that would justify their use.
Guadalupe Garcia-Tsao, MD, is professor of medicine at Yale University, chief of digestive diseases at the VA-CT Healthcare System, and director of the clinical core of the Yale Liver Center, New Haven, Conn. She had no conflicts of interest.
For patients with compensated cirrhosis, statin therapy was associated with about a 46% decrease in the risk of hepatic decompensation and mortality and with a 27% drop in the risk of portal hypertension and variceal bleeding, according to moderate-quality evidence from a systematic review and meta-analysis of 13 studies.
Low-quality data also suggested that statins might help protect against the progression of noncirrhotic chronic liver disease, said Rebecca G. Kim of the University of California at San Diego and her associates. “Large, pragmatic randomized controlled trials in patients with compensated cirrhosis are required to confirm these observations,” they wrote in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.04.039).
Prior studies have reported mixed findings on how statin therapy affects chronic liver disease. For their review, Ms. Kim and her associates searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Cochrane Database and Systematic Reviews, Scopus, Web of Science, and PubMed for randomized controlled trials or cohort studies published through March 25, 2017. They identified 10 cohort studies and three randomized controlled trials of adults with fibrosis without cirrhosis, compensated cirrhosis, or decompensated cirrhosis that evaluated statin exposure and reported associations between exposure and outcomes related to cirrhosis. They excluded case-control studies, cross-sectional studies, and studies that focused only on the relationship between statin use and the risk of hepatocellular carcinoma.
The resulting data set included 121,058 patients with chronic liver diseases, of whom 85% had chronic hepatitis C virus infection. A total of 46% of patients were exposed to statins, which appeared to reduce their risk of hepatic decompensation, variceal bleeding, and mortality. Among 87 such patients in five studies, statin use was associated with a 46% decrease in the risk of hepatic decompensation and death, with risk ratios of 0.54 (95% confidence intervals, 0.46-0.62 and 0.47-0.61, respectively). Statin use also was associated with a 27% lower risk of variceal bleeding or progression of portal hypertension, based on an analysis of 110 events in 236 patients from three trials (RR, 0.73; 95% CI, 0.59-0.91). Finally, statin use also was associated with a 58% lower risk of fibrosis progression or cirrhosis in patients with noncirrhotic chronic liver disease, but the 95% CIs for the risk estimate did not reach statistical significance (0.16-1.11).
Source: American Gastroenterological Association
Most studies lacked data on dose and duration of statin exposure, the researchers said. However, four cohort studies reported dose-dependent effects that were most pronounced after more than a year of treatment. “Similarly, several different types of statins were studied, and observed effects were assumed to be class-specific effects,” the reviewers wrote. “However, it is possible that lipophilic and lipophobic statins may have differential efficacy in decreasing fibrosis progression.”
Together, these findings support prior studies suggesting that statin therapy is safe and can potentially reduce the risk of hepatocellular carcinoma in this patient population, they concluded. Statins “may potentially improve patient-relevant outcomes in patients with chronic liver diseases and improve survival without significant additional costs.”
The reviewers acknowledged the American Gastroenterological Association Foundation, a T. Franklin Williams Scholarship Award, the National Institutes of Health, and the National Library of Medicine. They reported having no relevant conflicts of interest.
This story was updated on 9/13/2017.
For patients with compensated cirrhosis, statin therapy was associated with about a 46% decrease in the risk of hepatic decompensation and mortality and with a 27% drop in the risk of portal hypertension and variceal bleeding, according to moderate-quality evidence from a systematic review and meta-analysis of 13 studies.
Low-quality data also suggested that statins might help protect against the progression of noncirrhotic chronic liver disease, said Rebecca G. Kim of the University of California at San Diego and her associates. “Large, pragmatic randomized controlled trials in patients with compensated cirrhosis are required to confirm these observations,” they wrote in the October issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2017.04.039).
Prior studies have reported mixed findings on how statin therapy affects chronic liver disease. For their review, Ms. Kim and her associates searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, Cochrane Database and Systematic Reviews, Scopus, Web of Science, and PubMed for randomized controlled trials or cohort studies published through March 25, 2017. They identified 10 cohort studies and three randomized controlled trials of adults with fibrosis without cirrhosis, compensated cirrhosis, or decompensated cirrhosis that evaluated statin exposure and reported associations between exposure and outcomes related to cirrhosis. They excluded case-control studies, cross-sectional studies, and studies that focused only on the relationship between statin use and the risk of hepatocellular carcinoma.
The resulting data set included 121,058 patients with chronic liver diseases, of whom 85% had chronic hepatitis C virus infection. A total of 46% of patients were exposed to statins, which appeared to reduce their risk of hepatic decompensation, variceal bleeding, and mortality. Among 87 such patients in five studies, statin use was associated with a 46% decrease in the risk of hepatic decompensation and death, with risk ratios of 0.54 (95% confidence intervals, 0.46-0.62 and 0.47-0.61, respectively). Statin use also was associated with a 27% lower risk of variceal bleeding or progression of portal hypertension, based on an analysis of 110 events in 236 patients from three trials (RR, 0.73; 95% CI, 0.59-0.91). Finally, statin use also was associated with a 58% lower risk of fibrosis progression or cirrhosis in patients with noncirrhotic chronic liver disease, but the 95% CIs for the risk estimate did not reach statistical significance (0.16-1.11).
Source: American Gastroenterological Association
Most studies lacked data on dose and duration of statin exposure, the researchers said. However, four cohort studies reported dose-dependent effects that were most pronounced after more than a year of treatment. “Similarly, several different types of statins were studied, and observed effects were assumed to be class-specific effects,” the reviewers wrote. “However, it is possible that lipophilic and lipophobic statins may have differential efficacy in decreasing fibrosis progression.”
Together, these findings support prior studies suggesting that statin therapy is safe and can potentially reduce the risk of hepatocellular carcinoma in this patient population, they concluded. Statins “may potentially improve patient-relevant outcomes in patients with chronic liver diseases and improve survival without significant additional costs.”
The reviewers acknowledged the American Gastroenterological Association Foundation, a T. Franklin Williams Scholarship Award, the National Institutes of Health, and the National Library of Medicine. They reported having no relevant conflicts of interest.
This story was updated on 9/13/2017.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: Statin therapy was associated with a significantly lower risk of hepatic decompensation and death in patients with compensated cirrhosis.
Major finding: Statin therapy was associated with a 46% decrease in the risk of both hepatic decompensation and mortality (risk ratios, 0.54) and with a 27% drop in the risk of portal hypertension and variceal bleeding (RR, 0.73).
Data source: A systematic review and meta-analysis of 10 cohort studies and three randomized controlled trials (121,058 patients).
Disclosures: The reviewers acknowledged the American Gastroenterological Association Foundation, a T. Franklin Williams Scholarship Award, the National Institutes of Health, and the National Library of Medicine. They reported having no relevant conflicts of interest.
Check children’s eyes early for best corrections
or its risk factors with the goal of improving visual acuity, publishing its final recommendation statement and evidence summary online Sept. 5 in JAMA.
A review of the latest evidence supports a B recommendation for vision screening at least once in children aged 3-5 years, but the evidence is insufficient to determine the balance of risks and benefits for vision screening in children younger than 3 years (meriting an I statement from the USPSTF). The recommendation updates the 2011 USPSTF recommendation, which also recommended vision screening for children aged 3-5 years with a B recommendation.
“The prevalence of amblyopia, strabismus, and anisometropia ranges from 1% to 6% among children younger than 6 years in the United States,” which can lead to permanent vision loss if left untreated, chair and corresponding author David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, and colleagues noted in the recommendation statement (JAMA. 2017;318:836-44).
The USPSTF found “inadequate evidence that treatment reduced the incidence of long-term amblyopia or improved school performance, functioning, or quality of life.” However, the USPSTF concluded that the harms of screening and treating preschool children for amblyopia and its risk factors were small, and that treatment improved visual acuity, “which is likely to result in permanent improvements throughout life.”
The benefits of early treatment were characterized as moderate because of the risk of permanent, uncorrectable vision loss associated with untreated amblyopia, “and the benefits of screening and treatment can be experienced over a child’s lifetime,” the researchers said.
The evidence report accompanying the recommendations contained data from 40 studies with 34,709 participants, and addressed issues including the benefits of screening, accuracy of vision screening tests, and the potential harms and benefits of treatments including eye patches and glasses (JAMA. 2017;318:845-58).
“Studies directly evaluating the effectiveness of screening were limited and do not establish whether vision screening in preschool children is better than no screening,” Daniel E. Jonas, MD, of RTI International–University of North Carolina at Chapel Hill Evidence-based Practice Center and his colleagues wrote in the evidence report.
Therefore, the Task Force called for additional research while recommending at least one screening.
The study was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
Read the complete recommendations online at http://www.uspreventiveservicestaskforce.org.
or its risk factors with the goal of improving visual acuity, publishing its final recommendation statement and evidence summary online Sept. 5 in JAMA.
A review of the latest evidence supports a B recommendation for vision screening at least once in children aged 3-5 years, but the evidence is insufficient to determine the balance of risks and benefits for vision screening in children younger than 3 years (meriting an I statement from the USPSTF). The recommendation updates the 2011 USPSTF recommendation, which also recommended vision screening for children aged 3-5 years with a B recommendation.
“The prevalence of amblyopia, strabismus, and anisometropia ranges from 1% to 6% among children younger than 6 years in the United States,” which can lead to permanent vision loss if left untreated, chair and corresponding author David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, and colleagues noted in the recommendation statement (JAMA. 2017;318:836-44).
The USPSTF found “inadequate evidence that treatment reduced the incidence of long-term amblyopia or improved school performance, functioning, or quality of life.” However, the USPSTF concluded that the harms of screening and treating preschool children for amblyopia and its risk factors were small, and that treatment improved visual acuity, “which is likely to result in permanent improvements throughout life.”
The benefits of early treatment were characterized as moderate because of the risk of permanent, uncorrectable vision loss associated with untreated amblyopia, “and the benefits of screening and treatment can be experienced over a child’s lifetime,” the researchers said.
The evidence report accompanying the recommendations contained data from 40 studies with 34,709 participants, and addressed issues including the benefits of screening, accuracy of vision screening tests, and the potential harms and benefits of treatments including eye patches and glasses (JAMA. 2017;318:845-58).
“Studies directly evaluating the effectiveness of screening were limited and do not establish whether vision screening in preschool children is better than no screening,” Daniel E. Jonas, MD, of RTI International–University of North Carolina at Chapel Hill Evidence-based Practice Center and his colleagues wrote in the evidence report.
Therefore, the Task Force called for additional research while recommending at least one screening.
The study was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
Read the complete recommendations online at http://www.uspreventiveservicestaskforce.org.
or its risk factors with the goal of improving visual acuity, publishing its final recommendation statement and evidence summary online Sept. 5 in JAMA.
A review of the latest evidence supports a B recommendation for vision screening at least once in children aged 3-5 years, but the evidence is insufficient to determine the balance of risks and benefits for vision screening in children younger than 3 years (meriting an I statement from the USPSTF). The recommendation updates the 2011 USPSTF recommendation, which also recommended vision screening for children aged 3-5 years with a B recommendation.
“The prevalence of amblyopia, strabismus, and anisometropia ranges from 1% to 6% among children younger than 6 years in the United States,” which can lead to permanent vision loss if left untreated, chair and corresponding author David C. Grossman, MD, of Kaiser Permanente Washington Health Research Institute, Seattle, and colleagues noted in the recommendation statement (JAMA. 2017;318:836-44).
The USPSTF found “inadequate evidence that treatment reduced the incidence of long-term amblyopia or improved school performance, functioning, or quality of life.” However, the USPSTF concluded that the harms of screening and treating preschool children for amblyopia and its risk factors were small, and that treatment improved visual acuity, “which is likely to result in permanent improvements throughout life.”
The benefits of early treatment were characterized as moderate because of the risk of permanent, uncorrectable vision loss associated with untreated amblyopia, “and the benefits of screening and treatment can be experienced over a child’s lifetime,” the researchers said.
The evidence report accompanying the recommendations contained data from 40 studies with 34,709 participants, and addressed issues including the benefits of screening, accuracy of vision screening tests, and the potential harms and benefits of treatments including eye patches and glasses (JAMA. 2017;318:845-58).
“Studies directly evaluating the effectiveness of screening were limited and do not establish whether vision screening in preschool children is better than no screening,” Daniel E. Jonas, MD, of RTI International–University of North Carolina at Chapel Hill Evidence-based Practice Center and his colleagues wrote in the evidence report.
Therefore, the Task Force called for additional research while recommending at least one screening.
The study was funded by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose.
Read the complete recommendations online at http://www.uspreventiveservicestaskforce.org.
FROM JAMA
Q&A: CDC director Brenda Fitzgerald stresses ‘science and service’
Brenda Fitzgerald, MD, an ob.gyn. and most recently the public health commissioner for Georgia, was named the 17th director of the Centers for Disease Control and Prevention in July.
Dr. Fitzgerald comes to the CDC after 6 years as commissioner and state health officer for the Georgia Department of Public Health. She also has been a health care policy adviser to former House Speaker Newt Gingrich (R-Ga.) and ran for Congress herself in the 1990s. In addition to practicing medicine for 3 decades, she has served on the board and as president of the Georgia Obstetrical and Gynecological Society.
Question: What are you looking forward to as the new CDC director, and what are some of your top goals during your tenure?
Answer: The federal government holds responsibility to provide for the common defense. And CDC provides the common defense of the country against health threats. That’s why CDC’s mission of saving lives and protecting people means so much to me. As a doctor and a mother, I want to do everything I can to protect our future generations and keep them safe, whether it be from infectious or chronic diseases, natural or man-made disasters.
We are going to continue a legacy of protecting Americans from the things that we’ve been fighting for a long time, like heart disease and cancer, and from newer things like opioid overdose and the Zika virus. And we’ll continue to prepare for the next health threat, whatever it may be.
Q: How does your experience as an ob.gyn. shape your approach to this job?
A: There are two things that are important at CDC: science and service. CDC researchers are at the forefront of scientific research – and also provide a service by using scientific discoveries to improve health. That is the same approach I used as a practicing ob.gyn.: I brought the clinical lens that looked at the science, and then my work with my patients emphasized the service part.
As a practicing ob.gyn., it was my responsibility to address the questions and concerns of my patients. At CDC, I am just as committed to making science-based decisions and working with our experts to make sure doctors and patients have the state-of-the-art health information they need. I said when I went from being a clinician to being the state health official for Georgia that I went from treating one patient at a time to treating 10 million at a time. Now that’s changed to over 300 million.
Even though I am now CDC director and protecting the health of millions of people, my experiences as an ob.gyn. for 3 decades will forever shape how I work to improve the health of individual people and patients.
Q: What are the next steps for the agency in terms of its response to Zika virus?
A: Zika is the first infectious disease in 50 years that has been linked to birth defects. We know that the virus attacks neural tissue. We know that about 10% of babies are born with severe birth defects – and some babies born apparently normal later turned out to have neurologic problems, like blindness or deafness. And we suspect that there may be other problems we don’t know about yet.
I’m particularly concerned about developmental delays, as we know that early brain development is key to health and achievement for a child’s future. We are still learning more about Zika every day. It’s crucial that we – the health care and public health communities – work together and remain vigilant to ensure these babies receive the care they need. What Zika has taught us is that we need to establish a pregnancy and infant registry that can flag patterns of concerning health issues so that we can work together with health officials and clinicians to get ahead of emerging health threats.
Q: How can clinicians stay up to date on the rapidly changing guidance during an outbreak like Zika?
A: During outbreaks like Zika, public health officials are continually updating guidance so clinicians can get the latest information. You can check the latest CDC guidance about testing and follow-up care for pregnant women at www.cdc.gov/zika/hc-providers. Health care providers can also contact their state, local, or territorial health department to ensure the appropriate tests are ordered and interpreted correctly. CDC also maintains a 24/7 Zika consultation service for health officials and healthcare providers caring for pregnant women with possible Zika exposure.
Q: What steps will you take to decrease maternal mortality and to understand why this number is rising?
A: As an obstetrician, survival of mothers and babies is paramount to me. It’s so basic: mothers shouldn’t die. Sadly, about 700 women die each year in the U.S. as a result of pregnancy or delivery complications.
We know the leading causes of maternal mortality: cardiovascular disease, infections or sepsis, hemorrhage, and cardiomyopathy. We also know that an increasing number of pregnant women in the U.S. have chronic health conditions such as high blood pressure, diabetes, or heart disease that puts them at risk of pregnancy complications or death.
CDC is committed to preventing pregnancy-related deaths and ensuring the best possible birth outcomes. We do this by conducting surveillance, supporting states in developing recommendations, and working with partners to promote evidence-based recommendations and best practices. State-based initiatives are important allies in bringing together OBs and the public health sector to show the importance of statewide efforts to reduce maternal mortality. There has been some exciting work done by the California Maternal Quality Care Collaborative, which has created a series of toolkits designed to help health care providers with pregnancy or childbirth complications. CMQCC’s work is inspiring other states to follow suit.
The best coalitions are between ob.gyns., public health, and hospital associations. For example, AWHONN’s [Association of Women’s Health, Obstetric and Neonatal Nurses] Postpartum Hemorrhage initiative in Georgia, New Jersey, and the District of Columbia aimed to improve the treatment of obstetric hemorrhage. Even though 54% to 93% of maternal hemorrhage-related deaths are preventable with improved clinical response, not one single hospital in Georgia or New Jersey had implemented all the recommended preparedness elements for postpartum hemorrhage events. We can save mothers’ lives – we know what to do. It just takes all of us – ob.gyns., public health and hospital associations – leading the way to make sure it happens.
Q: How can we increase HPV vaccination?
A: The latest news is that more girls and boys are getting the HPV vaccine. New CDC data showed that 60% of teens aged 13-17 had received one or more doses of HPV vaccine in 2016 – an increase of 4% from 2015. Plus, the latest statistics show that HPV vaccination has led to significant drops in HPV infections: HPV-related cancers and genital warts dropped by 71% among teen girls and 61% among young women. Still, too many children aren’t completing the HPV vaccine series, leaving them vulnerable to cancers caused by HPV infection.
Providers can help increase HPV vaccination rates by using every patient visit to review vaccination histories, providing strong clinical recommendations and education to parents for HPV and other recommended vaccines, and implementing systems to minimize missed opportunities.
[email protected]
On Twitter @legal_med
Brenda Fitzgerald, MD, an ob.gyn. and most recently the public health commissioner for Georgia, was named the 17th director of the Centers for Disease Control and Prevention in July.
Dr. Fitzgerald comes to the CDC after 6 years as commissioner and state health officer for the Georgia Department of Public Health. She also has been a health care policy adviser to former House Speaker Newt Gingrich (R-Ga.) and ran for Congress herself in the 1990s. In addition to practicing medicine for 3 decades, she has served on the board and as president of the Georgia Obstetrical and Gynecological Society.
Question: What are you looking forward to as the new CDC director, and what are some of your top goals during your tenure?
Answer: The federal government holds responsibility to provide for the common defense. And CDC provides the common defense of the country against health threats. That’s why CDC’s mission of saving lives and protecting people means so much to me. As a doctor and a mother, I want to do everything I can to protect our future generations and keep them safe, whether it be from infectious or chronic diseases, natural or man-made disasters.
We are going to continue a legacy of protecting Americans from the things that we’ve been fighting for a long time, like heart disease and cancer, and from newer things like opioid overdose and the Zika virus. And we’ll continue to prepare for the next health threat, whatever it may be.
Q: How does your experience as an ob.gyn. shape your approach to this job?
A: There are two things that are important at CDC: science and service. CDC researchers are at the forefront of scientific research – and also provide a service by using scientific discoveries to improve health. That is the same approach I used as a practicing ob.gyn.: I brought the clinical lens that looked at the science, and then my work with my patients emphasized the service part.
As a practicing ob.gyn., it was my responsibility to address the questions and concerns of my patients. At CDC, I am just as committed to making science-based decisions and working with our experts to make sure doctors and patients have the state-of-the-art health information they need. I said when I went from being a clinician to being the state health official for Georgia that I went from treating one patient at a time to treating 10 million at a time. Now that’s changed to over 300 million.
Even though I am now CDC director and protecting the health of millions of people, my experiences as an ob.gyn. for 3 decades will forever shape how I work to improve the health of individual people and patients.
Q: What are the next steps for the agency in terms of its response to Zika virus?
A: Zika is the first infectious disease in 50 years that has been linked to birth defects. We know that the virus attacks neural tissue. We know that about 10% of babies are born with severe birth defects – and some babies born apparently normal later turned out to have neurologic problems, like blindness or deafness. And we suspect that there may be other problems we don’t know about yet.
I’m particularly concerned about developmental delays, as we know that early brain development is key to health and achievement for a child’s future. We are still learning more about Zika every day. It’s crucial that we – the health care and public health communities – work together and remain vigilant to ensure these babies receive the care they need. What Zika has taught us is that we need to establish a pregnancy and infant registry that can flag patterns of concerning health issues so that we can work together with health officials and clinicians to get ahead of emerging health threats.
Q: How can clinicians stay up to date on the rapidly changing guidance during an outbreak like Zika?
A: During outbreaks like Zika, public health officials are continually updating guidance so clinicians can get the latest information. You can check the latest CDC guidance about testing and follow-up care for pregnant women at www.cdc.gov/zika/hc-providers. Health care providers can also contact their state, local, or territorial health department to ensure the appropriate tests are ordered and interpreted correctly. CDC also maintains a 24/7 Zika consultation service for health officials and healthcare providers caring for pregnant women with possible Zika exposure.
Q: What steps will you take to decrease maternal mortality and to understand why this number is rising?
A: As an obstetrician, survival of mothers and babies is paramount to me. It’s so basic: mothers shouldn’t die. Sadly, about 700 women die each year in the U.S. as a result of pregnancy or delivery complications.
We know the leading causes of maternal mortality: cardiovascular disease, infections or sepsis, hemorrhage, and cardiomyopathy. We also know that an increasing number of pregnant women in the U.S. have chronic health conditions such as high blood pressure, diabetes, or heart disease that puts them at risk of pregnancy complications or death.
CDC is committed to preventing pregnancy-related deaths and ensuring the best possible birth outcomes. We do this by conducting surveillance, supporting states in developing recommendations, and working with partners to promote evidence-based recommendations and best practices. State-based initiatives are important allies in bringing together OBs and the public health sector to show the importance of statewide efforts to reduce maternal mortality. There has been some exciting work done by the California Maternal Quality Care Collaborative, which has created a series of toolkits designed to help health care providers with pregnancy or childbirth complications. CMQCC’s work is inspiring other states to follow suit.
The best coalitions are between ob.gyns., public health, and hospital associations. For example, AWHONN’s [Association of Women’s Health, Obstetric and Neonatal Nurses] Postpartum Hemorrhage initiative in Georgia, New Jersey, and the District of Columbia aimed to improve the treatment of obstetric hemorrhage. Even though 54% to 93% of maternal hemorrhage-related deaths are preventable with improved clinical response, not one single hospital in Georgia or New Jersey had implemented all the recommended preparedness elements for postpartum hemorrhage events. We can save mothers’ lives – we know what to do. It just takes all of us – ob.gyns., public health and hospital associations – leading the way to make sure it happens.
Q: How can we increase HPV vaccination?
A: The latest news is that more girls and boys are getting the HPV vaccine. New CDC data showed that 60% of teens aged 13-17 had received one or more doses of HPV vaccine in 2016 – an increase of 4% from 2015. Plus, the latest statistics show that HPV vaccination has led to significant drops in HPV infections: HPV-related cancers and genital warts dropped by 71% among teen girls and 61% among young women. Still, too many children aren’t completing the HPV vaccine series, leaving them vulnerable to cancers caused by HPV infection.
Providers can help increase HPV vaccination rates by using every patient visit to review vaccination histories, providing strong clinical recommendations and education to parents for HPV and other recommended vaccines, and implementing systems to minimize missed opportunities.
[email protected]
On Twitter @legal_med
Brenda Fitzgerald, MD, an ob.gyn. and most recently the public health commissioner for Georgia, was named the 17th director of the Centers for Disease Control and Prevention in July.
Dr. Fitzgerald comes to the CDC after 6 years as commissioner and state health officer for the Georgia Department of Public Health. She also has been a health care policy adviser to former House Speaker Newt Gingrich (R-Ga.) and ran for Congress herself in the 1990s. In addition to practicing medicine for 3 decades, she has served on the board and as president of the Georgia Obstetrical and Gynecological Society.
Question: What are you looking forward to as the new CDC director, and what are some of your top goals during your tenure?
Answer: The federal government holds responsibility to provide for the common defense. And CDC provides the common defense of the country against health threats. That’s why CDC’s mission of saving lives and protecting people means so much to me. As a doctor and a mother, I want to do everything I can to protect our future generations and keep them safe, whether it be from infectious or chronic diseases, natural or man-made disasters.
We are going to continue a legacy of protecting Americans from the things that we’ve been fighting for a long time, like heart disease and cancer, and from newer things like opioid overdose and the Zika virus. And we’ll continue to prepare for the next health threat, whatever it may be.
Q: How does your experience as an ob.gyn. shape your approach to this job?
A: There are two things that are important at CDC: science and service. CDC researchers are at the forefront of scientific research – and also provide a service by using scientific discoveries to improve health. That is the same approach I used as a practicing ob.gyn.: I brought the clinical lens that looked at the science, and then my work with my patients emphasized the service part.
As a practicing ob.gyn., it was my responsibility to address the questions and concerns of my patients. At CDC, I am just as committed to making science-based decisions and working with our experts to make sure doctors and patients have the state-of-the-art health information they need. I said when I went from being a clinician to being the state health official for Georgia that I went from treating one patient at a time to treating 10 million at a time. Now that’s changed to over 300 million.
Even though I am now CDC director and protecting the health of millions of people, my experiences as an ob.gyn. for 3 decades will forever shape how I work to improve the health of individual people and patients.
Q: What are the next steps for the agency in terms of its response to Zika virus?
A: Zika is the first infectious disease in 50 years that has been linked to birth defects. We know that the virus attacks neural tissue. We know that about 10% of babies are born with severe birth defects – and some babies born apparently normal later turned out to have neurologic problems, like blindness or deafness. And we suspect that there may be other problems we don’t know about yet.
I’m particularly concerned about developmental delays, as we know that early brain development is key to health and achievement for a child’s future. We are still learning more about Zika every day. It’s crucial that we – the health care and public health communities – work together and remain vigilant to ensure these babies receive the care they need. What Zika has taught us is that we need to establish a pregnancy and infant registry that can flag patterns of concerning health issues so that we can work together with health officials and clinicians to get ahead of emerging health threats.
Q: How can clinicians stay up to date on the rapidly changing guidance during an outbreak like Zika?
A: During outbreaks like Zika, public health officials are continually updating guidance so clinicians can get the latest information. You can check the latest CDC guidance about testing and follow-up care for pregnant women at www.cdc.gov/zika/hc-providers. Health care providers can also contact their state, local, or territorial health department to ensure the appropriate tests are ordered and interpreted correctly. CDC also maintains a 24/7 Zika consultation service for health officials and healthcare providers caring for pregnant women with possible Zika exposure.
Q: What steps will you take to decrease maternal mortality and to understand why this number is rising?
A: As an obstetrician, survival of mothers and babies is paramount to me. It’s so basic: mothers shouldn’t die. Sadly, about 700 women die each year in the U.S. as a result of pregnancy or delivery complications.
We know the leading causes of maternal mortality: cardiovascular disease, infections or sepsis, hemorrhage, and cardiomyopathy. We also know that an increasing number of pregnant women in the U.S. have chronic health conditions such as high blood pressure, diabetes, or heart disease that puts them at risk of pregnancy complications or death.
CDC is committed to preventing pregnancy-related deaths and ensuring the best possible birth outcomes. We do this by conducting surveillance, supporting states in developing recommendations, and working with partners to promote evidence-based recommendations and best practices. State-based initiatives are important allies in bringing together OBs and the public health sector to show the importance of statewide efforts to reduce maternal mortality. There has been some exciting work done by the California Maternal Quality Care Collaborative, which has created a series of toolkits designed to help health care providers with pregnancy or childbirth complications. CMQCC’s work is inspiring other states to follow suit.
The best coalitions are between ob.gyns., public health, and hospital associations. For example, AWHONN’s [Association of Women’s Health, Obstetric and Neonatal Nurses] Postpartum Hemorrhage initiative in Georgia, New Jersey, and the District of Columbia aimed to improve the treatment of obstetric hemorrhage. Even though 54% to 93% of maternal hemorrhage-related deaths are preventable with improved clinical response, not one single hospital in Georgia or New Jersey had implemented all the recommended preparedness elements for postpartum hemorrhage events. We can save mothers’ lives – we know what to do. It just takes all of us – ob.gyns., public health and hospital associations – leading the way to make sure it happens.
Q: How can we increase HPV vaccination?
A: The latest news is that more girls and boys are getting the HPV vaccine. New CDC data showed that 60% of teens aged 13-17 had received one or more doses of HPV vaccine in 2016 – an increase of 4% from 2015. Plus, the latest statistics show that HPV vaccination has led to significant drops in HPV infections: HPV-related cancers and genital warts dropped by 71% among teen girls and 61% among young women. Still, too many children aren’t completing the HPV vaccine series, leaving them vulnerable to cancers caused by HPV infection.
Providers can help increase HPV vaccination rates by using every patient visit to review vaccination histories, providing strong clinical recommendations and education to parents for HPV and other recommended vaccines, and implementing systems to minimize missed opportunities.
[email protected]
On Twitter @legal_med
Enhanced disinfection of duodenoscopes did not reduce contamination
Duodenoscopes had similar rates of contamination after double high-level disinfection, standard high-level disinfection, or standard high-level disinfection followed by ethylene oxide gas sterilization, a randomized, prospective study of 516 bacterial cultures of 18 duodenoscopes showed.
“Our results do not support the routine use of double high-level disinfection or ethylene oxide sterilization for duodenoscope reprocessing,” wrote Graham M. Snyder, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and his associates. They stopped the study after 3 months because none of the duodenoscopes cultured multidrug-resistant organisms, the primary endpoint. “[We] found that in the nonoutbreak setting, duodenoscope contamination by multidrug-resistant organisms is extremely uncommon,” they wrote in the October issue of Gastroenterology (doi: 10.1053/j.gastro.2017.06.052). However, 16% of duodenoscopes cultured at least one colony-forming unit (CFU) after either standard high-level or double high-level disinfection, and 23% of duodenoscopes produced at least one CFU despite standard high-level disinfection followed by ethylene gas sterilization (P = .2), the investigators reported.
Outbreaks of carbapenem-resistant Enterobacteriaceae infections have been traced to duodenoscopes, even though they were reprocessed according to manufacturer instructions. In 2015, the Food and Drug Administration responded by warning that the design of duodenoscopes might preclude effective cleaning. Reasons for residual contamination remain uncertain, but biofilms, which are notoriously resistant to standard disinfection methods, might be a culprit, Dr. Snyder and his associates noted. Accordingly, some experts have suggested repeating the reprocessing cycle or adding ethylene oxide sterilization, but these measures are costly, time intensive, and not widely available. Furthermore, their efficacy “has never been systematically studied in a nonoutbreak setting,” the researchers wrote.
In response, they studied 516 cultures of elevator mechanisms and working channels from 18 reprocessed duodenoscopes (Olympus, model TJF-Q180). Immediately after use, each duodenoscope was manually wiped with enzymatic solution (EmPower), and then was manually reprocessed within an hour before undergoing automated reprocessing (System 83 Plus 9) with ortho-phthalaldehyde disinfectant (MetriCide OPA Plus) followed by ethanol flush. One-third of the duodenoscopes were randomly assigned to undergo double high-level disinfection with two automated reprocessing cycles, and another third underwent standard high-level disinfection followed by ethylene oxide gas sterilization (Steri-Vac sterilizer/aerator). All instruments were stored by hanging them vertically in an unventilated cabinet.
Multidrug-resistant organisms were cultured from 3% of rectal swabs and duodenal aspirates, but not from any of the cultures of duodenoscopes. Therefore, the study was stopped for futility. The enhanced disinfection methods failed to prevent contamination, compared with standard high-level disinfection, the researchers noted. Ten or more CFUs grew in 2% of duodenoscopes that underwent standard high-level disinfection, 4% of those that underwent double high-level disinfection, and 4% of those that underwent high-level disinfection followed by ethylene oxide sterilization (P = .4).
“There is no consensus on what parts of the standard high-level disinfection process should be repeated,” the investigators wrote. “It is uncertain if the addition of a second cycle of manual reprocessing might have improved the effectiveness of double high-level disinfection.”
Funders included the American Society for Gastrointestinal Endoscopy and Beth Israel Deaconess Medical Center. The investigators reported having no conflicts of interest.
Duodenoscopes had similar rates of contamination after double high-level disinfection, standard high-level disinfection, or standard high-level disinfection followed by ethylene oxide gas sterilization, a randomized, prospective study of 516 bacterial cultures of 18 duodenoscopes showed.
“Our results do not support the routine use of double high-level disinfection or ethylene oxide sterilization for duodenoscope reprocessing,” wrote Graham M. Snyder, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and his associates. They stopped the study after 3 months because none of the duodenoscopes cultured multidrug-resistant organisms, the primary endpoint. “[We] found that in the nonoutbreak setting, duodenoscope contamination by multidrug-resistant organisms is extremely uncommon,” they wrote in the October issue of Gastroenterology (doi: 10.1053/j.gastro.2017.06.052). However, 16% of duodenoscopes cultured at least one colony-forming unit (CFU) after either standard high-level or double high-level disinfection, and 23% of duodenoscopes produced at least one CFU despite standard high-level disinfection followed by ethylene gas sterilization (P = .2), the investigators reported.
Outbreaks of carbapenem-resistant Enterobacteriaceae infections have been traced to duodenoscopes, even though they were reprocessed according to manufacturer instructions. In 2015, the Food and Drug Administration responded by warning that the design of duodenoscopes might preclude effective cleaning. Reasons for residual contamination remain uncertain, but biofilms, which are notoriously resistant to standard disinfection methods, might be a culprit, Dr. Snyder and his associates noted. Accordingly, some experts have suggested repeating the reprocessing cycle or adding ethylene oxide sterilization, but these measures are costly, time intensive, and not widely available. Furthermore, their efficacy “has never been systematically studied in a nonoutbreak setting,” the researchers wrote.
In response, they studied 516 cultures of elevator mechanisms and working channels from 18 reprocessed duodenoscopes (Olympus, model TJF-Q180). Immediately after use, each duodenoscope was manually wiped with enzymatic solution (EmPower), and then was manually reprocessed within an hour before undergoing automated reprocessing (System 83 Plus 9) with ortho-phthalaldehyde disinfectant (MetriCide OPA Plus) followed by ethanol flush. One-third of the duodenoscopes were randomly assigned to undergo double high-level disinfection with two automated reprocessing cycles, and another third underwent standard high-level disinfection followed by ethylene oxide gas sterilization (Steri-Vac sterilizer/aerator). All instruments were stored by hanging them vertically in an unventilated cabinet.
Multidrug-resistant organisms were cultured from 3% of rectal swabs and duodenal aspirates, but not from any of the cultures of duodenoscopes. Therefore, the study was stopped for futility. The enhanced disinfection methods failed to prevent contamination, compared with standard high-level disinfection, the researchers noted. Ten or more CFUs grew in 2% of duodenoscopes that underwent standard high-level disinfection, 4% of those that underwent double high-level disinfection, and 4% of those that underwent high-level disinfection followed by ethylene oxide sterilization (P = .4).
“There is no consensus on what parts of the standard high-level disinfection process should be repeated,” the investigators wrote. “It is uncertain if the addition of a second cycle of manual reprocessing might have improved the effectiveness of double high-level disinfection.”
Funders included the American Society for Gastrointestinal Endoscopy and Beth Israel Deaconess Medical Center. The investigators reported having no conflicts of interest.
Duodenoscopes had similar rates of contamination after double high-level disinfection, standard high-level disinfection, or standard high-level disinfection followed by ethylene oxide gas sterilization, a randomized, prospective study of 516 bacterial cultures of 18 duodenoscopes showed.
“Our results do not support the routine use of double high-level disinfection or ethylene oxide sterilization for duodenoscope reprocessing,” wrote Graham M. Snyder, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, and his associates. They stopped the study after 3 months because none of the duodenoscopes cultured multidrug-resistant organisms, the primary endpoint. “[We] found that in the nonoutbreak setting, duodenoscope contamination by multidrug-resistant organisms is extremely uncommon,” they wrote in the October issue of Gastroenterology (doi: 10.1053/j.gastro.2017.06.052). However, 16% of duodenoscopes cultured at least one colony-forming unit (CFU) after either standard high-level or double high-level disinfection, and 23% of duodenoscopes produced at least one CFU despite standard high-level disinfection followed by ethylene gas sterilization (P = .2), the investigators reported.
Outbreaks of carbapenem-resistant Enterobacteriaceae infections have been traced to duodenoscopes, even though they were reprocessed according to manufacturer instructions. In 2015, the Food and Drug Administration responded by warning that the design of duodenoscopes might preclude effective cleaning. Reasons for residual contamination remain uncertain, but biofilms, which are notoriously resistant to standard disinfection methods, might be a culprit, Dr. Snyder and his associates noted. Accordingly, some experts have suggested repeating the reprocessing cycle or adding ethylene oxide sterilization, but these measures are costly, time intensive, and not widely available. Furthermore, their efficacy “has never been systematically studied in a nonoutbreak setting,” the researchers wrote.
In response, they studied 516 cultures of elevator mechanisms and working channels from 18 reprocessed duodenoscopes (Olympus, model TJF-Q180). Immediately after use, each duodenoscope was manually wiped with enzymatic solution (EmPower), and then was manually reprocessed within an hour before undergoing automated reprocessing (System 83 Plus 9) with ortho-phthalaldehyde disinfectant (MetriCide OPA Plus) followed by ethanol flush. One-third of the duodenoscopes were randomly assigned to undergo double high-level disinfection with two automated reprocessing cycles, and another third underwent standard high-level disinfection followed by ethylene oxide gas sterilization (Steri-Vac sterilizer/aerator). All instruments were stored by hanging them vertically in an unventilated cabinet.
Multidrug-resistant organisms were cultured from 3% of rectal swabs and duodenal aspirates, but not from any of the cultures of duodenoscopes. Therefore, the study was stopped for futility. The enhanced disinfection methods failed to prevent contamination, compared with standard high-level disinfection, the researchers noted. Ten or more CFUs grew in 2% of duodenoscopes that underwent standard high-level disinfection, 4% of those that underwent double high-level disinfection, and 4% of those that underwent high-level disinfection followed by ethylene oxide sterilization (P = .4).
“There is no consensus on what parts of the standard high-level disinfection process should be repeated,” the investigators wrote. “It is uncertain if the addition of a second cycle of manual reprocessing might have improved the effectiveness of double high-level disinfection.”
Funders included the American Society for Gastrointestinal Endoscopy and Beth Israel Deaconess Medical Center. The investigators reported having no conflicts of interest.
FROM GASTROENTEROLOGY
Key clinical point: Enhanced disinfection of duodenoscopes did not provide additional protection against contamination.
Major finding: No cultures were positive for multidrug-resistant organisms, but 16% of duodenoscopes had at least one colony-forming unit despite standard high-level disinfection or double high-level disinfection. Standard high-level disinfection followed by ethylene oxide gas failed to sterilize 23% of duodenoscopes (P = .2).
Data source: A single-center, prospective randomized study of 516 cultures of 18 duodenoscopes.
Disclosures: Funders included the American Society for Gastrointestinal Endoscopy and Beth Israel Deaconess Medical Center. The investigators reported having no conflicts of interest.
Light alcohol use did not affect liver fibrosis progression in HIV/HCV-coinfected women
Women coinfected with HIV and hepatitis C virus who drank light and moderate amounts of alcohol did not experience significant progression of liver fibrosis, compared with those who drank heavily, results from a large cohort study found.
“Although heavy alcohol use is clearly detrimental to the health of patients with CHC [chronic hepatitis C], it is unclear whether consumption of smaller quantities of alcohol impact fibrosis progression,” researchers led by Erin M. Kelly, MD, wrote in a study published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix716). “Many patients with CHC consume alcohol and are unable or unwilling to completely abstain. Some studies have suggested a linear dose-response relationship for fibrosis progression even at lower quantities, while others have not clearly demonstrated a risk for fibrosis progression below 20-50 g of alcohol per day. HIV/HCV [hepatitis C virus]-coinfected patients have accelerated fibrosis progression, compared with HCV monoinfected individuals. Whether regular consumption of small quantities of alcohol further increase the rate of fibrosis progression is unknown.”
At baseline, the mean age of study participants was 40 years, their mean body mass index was 26 kg/m2, 17% had diabetes, and 11% had significant fibrosis, defined as a FIB-4 index of greater than 3.25. Nearly half (46%) reported no alcohol use; 26.8% reported light use; 7.1%, moderate use; and 19.7%, heavy use. The median FIB-4 scores at entry were similar between groups. On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively). On the other hand, those who reported very heavy drinking showed significant fibrosis acceleration, compared with abstainers (0.25 FIB-4 units/year), while those who reported drinking 8-14 drinks per week showed minimal acceleration of fibrosis progression (0.04 FIB-4 units/year).
“Of interest, despite WIHS research clinicians recommending limiting or avoiding alcohol at semiannual visits, most women who consumed alcohol at WIHS entry continued to have periods of alcohol use in follow-up,” Dr. Kelly and her associates wrote. “This suggests that, despite being enrolled in a long-term observational cohort study, patients did not change their drinking behaviors, limiting any potential bias in changing behaviors due to participation in a research study.”
The investigators acknowledged certain limitations of the study, including the fact that while current alcohol use was captured at study entry and at follow-up, lifetime alcohol exposure was not collected. “Women categorized as abstinent may have had a prior history of alcohol use,” they noted. “Some of these women may represent ‘sick abstainers’ that have ceased alcohol consumption due to the severity of their liver disease. This may explain the finding that entry fibrosis scores were similar between groups, when one would expect heavy users to have higher fibrosis scores, as compared to abstinent patients.”
The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Institute on Mental Health; and the University of California, San Francisco, Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
This study highlights the importance of assessing alcohol consumption during routine practice (for example, with the Alcohol Use Disorders Identification Test) to classify patients’ level of use. HIV/HCV-coinfected women should be counseled to minimize alcohol consumption, and any patient with evidence of advanced hepatic fibrosis/cirrhosis should avoid alcohol use, given that the risk of liver complications, such as decompensated cirrhosis and hepatocellular carcinoma, associated with light or moderate use remains unknown in this group. However, some may be unable or unwilling to completely abstain from alcohol because of mental health or substance use disorders. This study suggests that light or moderate alcohol use by coinfected women is not associated with accelerated liver fibrosis progression, as measured by changes in the FIB-4 score.
Future studies should determine the effects of light and moderate alcohol consumption on changes in other noninvasive measures of liver fibrosis, such as transient elastography, and on rates of liver complications, such as hepatic decompensation and hepatocellular carcinoma, in HIV/HCV-coinfected men and women to confirm this study’s findings. Additional research also is needed to evaluate the effects of alcohol use categories on adherence to direct-acting antiviral therapy and HCV treatment response to examine whether these outcomes differ by HIV status and sex. These data will further help inform whether there is a “safe” level of alcohol intake in HIV/HCV patients.
This text is taken from a commentary published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix720). Vincent Lo Re III, MD, MSCE, is with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, Philadelphia. He disclosed having received research grant support from the University of Pennsylvania, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and AstraZeneca.
This study highlights the importance of assessing alcohol consumption during routine practice (for example, with the Alcohol Use Disorders Identification Test) to classify patients’ level of use. HIV/HCV-coinfected women should be counseled to minimize alcohol consumption, and any patient with evidence of advanced hepatic fibrosis/cirrhosis should avoid alcohol use, given that the risk of liver complications, such as decompensated cirrhosis and hepatocellular carcinoma, associated with light or moderate use remains unknown in this group. However, some may be unable or unwilling to completely abstain from alcohol because of mental health or substance use disorders. This study suggests that light or moderate alcohol use by coinfected women is not associated with accelerated liver fibrosis progression, as measured by changes in the FIB-4 score.
Future studies should determine the effects of light and moderate alcohol consumption on changes in other noninvasive measures of liver fibrosis, such as transient elastography, and on rates of liver complications, such as hepatic decompensation and hepatocellular carcinoma, in HIV/HCV-coinfected men and women to confirm this study’s findings. Additional research also is needed to evaluate the effects of alcohol use categories on adherence to direct-acting antiviral therapy and HCV treatment response to examine whether these outcomes differ by HIV status and sex. These data will further help inform whether there is a “safe” level of alcohol intake in HIV/HCV patients.
This text is taken from a commentary published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix720). Vincent Lo Re III, MD, MSCE, is with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, Philadelphia. He disclosed having received research grant support from the University of Pennsylvania, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and AstraZeneca.
This study highlights the importance of assessing alcohol consumption during routine practice (for example, with the Alcohol Use Disorders Identification Test) to classify patients’ level of use. HIV/HCV-coinfected women should be counseled to minimize alcohol consumption, and any patient with evidence of advanced hepatic fibrosis/cirrhosis should avoid alcohol use, given that the risk of liver complications, such as decompensated cirrhosis and hepatocellular carcinoma, associated with light or moderate use remains unknown in this group. However, some may be unable or unwilling to completely abstain from alcohol because of mental health or substance use disorders. This study suggests that light or moderate alcohol use by coinfected women is not associated with accelerated liver fibrosis progression, as measured by changes in the FIB-4 score.
Future studies should determine the effects of light and moderate alcohol consumption on changes in other noninvasive measures of liver fibrosis, such as transient elastography, and on rates of liver complications, such as hepatic decompensation and hepatocellular carcinoma, in HIV/HCV-coinfected men and women to confirm this study’s findings. Additional research also is needed to evaluate the effects of alcohol use categories on adherence to direct-acting antiviral therapy and HCV treatment response to examine whether these outcomes differ by HIV status and sex. These data will further help inform whether there is a “safe” level of alcohol intake in HIV/HCV patients.
This text is taken from a commentary published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix720). Vincent Lo Re III, MD, MSCE, is with the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania, Philadelphia. He disclosed having received research grant support from the University of Pennsylvania, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and AstraZeneca.
Women coinfected with HIV and hepatitis C virus who drank light and moderate amounts of alcohol did not experience significant progression of liver fibrosis, compared with those who drank heavily, results from a large cohort study found.
“Although heavy alcohol use is clearly detrimental to the health of patients with CHC [chronic hepatitis C], it is unclear whether consumption of smaller quantities of alcohol impact fibrosis progression,” researchers led by Erin M. Kelly, MD, wrote in a study published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix716). “Many patients with CHC consume alcohol and are unable or unwilling to completely abstain. Some studies have suggested a linear dose-response relationship for fibrosis progression even at lower quantities, while others have not clearly demonstrated a risk for fibrosis progression below 20-50 g of alcohol per day. HIV/HCV [hepatitis C virus]-coinfected patients have accelerated fibrosis progression, compared with HCV monoinfected individuals. Whether regular consumption of small quantities of alcohol further increase the rate of fibrosis progression is unknown.”
At baseline, the mean age of study participants was 40 years, their mean body mass index was 26 kg/m2, 17% had diabetes, and 11% had significant fibrosis, defined as a FIB-4 index of greater than 3.25. Nearly half (46%) reported no alcohol use; 26.8% reported light use; 7.1%, moderate use; and 19.7%, heavy use. The median FIB-4 scores at entry were similar between groups. On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively). On the other hand, those who reported very heavy drinking showed significant fibrosis acceleration, compared with abstainers (0.25 FIB-4 units/year), while those who reported drinking 8-14 drinks per week showed minimal acceleration of fibrosis progression (0.04 FIB-4 units/year).
“Of interest, despite WIHS research clinicians recommending limiting or avoiding alcohol at semiannual visits, most women who consumed alcohol at WIHS entry continued to have periods of alcohol use in follow-up,” Dr. Kelly and her associates wrote. “This suggests that, despite being enrolled in a long-term observational cohort study, patients did not change their drinking behaviors, limiting any potential bias in changing behaviors due to participation in a research study.”
The investigators acknowledged certain limitations of the study, including the fact that while current alcohol use was captured at study entry and at follow-up, lifetime alcohol exposure was not collected. “Women categorized as abstinent may have had a prior history of alcohol use,” they noted. “Some of these women may represent ‘sick abstainers’ that have ceased alcohol consumption due to the severity of their liver disease. This may explain the finding that entry fibrosis scores were similar between groups, when one would expect heavy users to have higher fibrosis scores, as compared to abstinent patients.”
The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Institute on Mental Health; and the University of California, San Francisco, Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
Women coinfected with HIV and hepatitis C virus who drank light and moderate amounts of alcohol did not experience significant progression of liver fibrosis, compared with those who drank heavily, results from a large cohort study found.
“Although heavy alcohol use is clearly detrimental to the health of patients with CHC [chronic hepatitis C], it is unclear whether consumption of smaller quantities of alcohol impact fibrosis progression,” researchers led by Erin M. Kelly, MD, wrote in a study published online Aug. 16 in Clinical Infectious Diseases (doi: 10.1093/cid/cix716). “Many patients with CHC consume alcohol and are unable or unwilling to completely abstain. Some studies have suggested a linear dose-response relationship for fibrosis progression even at lower quantities, while others have not clearly demonstrated a risk for fibrosis progression below 20-50 g of alcohol per day. HIV/HCV [hepatitis C virus]-coinfected patients have accelerated fibrosis progression, compared with HCV monoinfected individuals. Whether regular consumption of small quantities of alcohol further increase the rate of fibrosis progression is unknown.”
At baseline, the mean age of study participants was 40 years, their mean body mass index was 26 kg/m2, 17% had diabetes, and 11% had significant fibrosis, defined as a FIB-4 index of greater than 3.25. Nearly half (46%) reported no alcohol use; 26.8% reported light use; 7.1%, moderate use; and 19.7%, heavy use. The median FIB-4 scores at entry were similar between groups. On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively). On the other hand, those who reported very heavy drinking showed significant fibrosis acceleration, compared with abstainers (0.25 FIB-4 units/year), while those who reported drinking 8-14 drinks per week showed minimal acceleration of fibrosis progression (0.04 FIB-4 units/year).
“Of interest, despite WIHS research clinicians recommending limiting or avoiding alcohol at semiannual visits, most women who consumed alcohol at WIHS entry continued to have periods of alcohol use in follow-up,” Dr. Kelly and her associates wrote. “This suggests that, despite being enrolled in a long-term observational cohort study, patients did not change their drinking behaviors, limiting any potential bias in changing behaviors due to participation in a research study.”
The investigators acknowledged certain limitations of the study, including the fact that while current alcohol use was captured at study entry and at follow-up, lifetime alcohol exposure was not collected. “Women categorized as abstinent may have had a prior history of alcohol use,” they noted. “Some of these women may represent ‘sick abstainers’ that have ceased alcohol consumption due to the severity of their liver disease. This may explain the finding that entry fibrosis scores were similar between groups, when one would expect heavy users to have higher fibrosis scores, as compared to abstinent patients.”
The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development; the National Cancer Institute; the National Institute on Drug Abuse; the National Institute on Mental Health; and the University of California, San Francisco, Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point:
Major finding: On multivariable analysis, no significant difference in fibrosis progression was observed in abstainers, compared with those who reported light and moderate alcohol use (0.004 and 0.006 FIB-4 units/year, respectively).
Data source: A cohort study of 686 participants in the multicenter Women’s Interagency HIV Study.
Disclosures: The study was supported by the National Institute of Allergy and Infectious Diseases, with additional cofunding from the National Institute of Child Health and Human Development, the National Cancer Institute, the National Institute on Drug Abuse, the National Institute on Mental Health, and the UCSF Liver Center Biostatistics Core. The researchers reported having no financial disclosures.
Pembrolizumab, nivolumab linked to 3% rate of neurologic events
Three percent of patients developed immune-related adverse neurologic events within 12 months of receiving nivolumab or pembrolizumab, according to the results of a single-center retrospective study.
These syndromes included myopathy, axonal thoracolumbar polyradiculopathy, severe demyelinating length-dependent peripheral neuropathy with axonal loss, a facial diplegic variant of Guillain-Barré syndrome, asymmetric vasculitic neuropathy, cerebellar ataxia with dysarthria, autoimmune retinopathy, bilateral internuclear ophthalmoplegia, and headache, reported Justin C. Kao, MD, of Mayo Clinic, Rochester, Minn., and his coinvestigators. Most patients improved after stopping treatment and starting corticosteroids, but one patient developed necrotizing myopathy and died after withdrawal of ventilator support.
Nivolumab and pembrolizumab, which inhibit the programmed death–1 (PD-1) receptor, are approved for treating metastatic melanoma, non–small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck cancers, and urothelial carcinoma. In response to a surge in reports of neurologic events associated with anti–PD-1 therapy, the investigators searched the Mayo Clinic pharmacy database and identified 347 patients treated with pembrolizumab or nivolumab between 2014 and 2016. Ten patients (2.9%) developed neurologic complications within 12 months of anti–PD-1 exposure, including eight men and two women. The median age was 71 years. None of their neurologic symptoms could be directly attributed to other treatments or to metastatic disease. Most had mild to moderate disability, with modified Rankin Scale (mRS) scores of 2, and symptom severity peaked between 1 day and more than 3 months after starting anti–PD-1 treatment (JAMA Neurol. 2017 Sep 5. doi: 10.1001/jamaneurol.2017.1912).
Stopping anti–PD-1 treatment and starting high-dose corticosteroids led to substantial neurologic improvements (mRS scores, 0-3), except in the case of fatal necrotizing myopathy, the researchers said. That patient, who was receiving pembrolizumab for stage 4 melanoma, developed extraocular, bulbar, and proximal limb girdle weakness that worsened over a period of 3 weeks and did not respond to prednisone (80 mg daily) or to three sessions of plasmapheresis.
If a patient on anti–PD-1 therapy develops neurologic symptoms, clinicians should promptly stop treatment and pursue a full work-up, including electrodiagnostic studies and consideration of muscle or nerve biopsy to clarify underlying pathophysiologic mechanisms, the researchers said. “If the clinical examination demonstrates severe clinical deficits at onset or worsens despite medication discontinuation, additional immune suppressant treatment should be considered,” they said. They recommended prednisone (1 mg/kg) with a taper over a 1-month period. Intravenous immunoglobulin therapy or plasma exchange may be warranted if patients continue to worsen, they said.
The investigators did not report external funding sources. Mr. Kao had no disclosures. Two coinvestigators disclosed ties to the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Academy of Neurology, the Continuum: Lifelong Learning in Neurology, Ionis Pharmaceuticals, Alnylam, and Oxford University Press. The remaining coinvestigators reported having no conflicts of interest.
Neurologic symptoms have been and continue to be one of the most common reasons for admission to a cancer center. Neurotoxic chemotherapy, direct invasion of cancer, and other neurologic complications of treatment contribute to the substantial cross talk between oncologists and neurologists. Over the past 5 years, oncology has witnessed an explosion of new immunotherapeutics that are revolutionizing drug development and patient care in oncology today. In contrast to traditional chemotherapy, which targets rapidly dividing cancer cells and can lead to adverse effects in other organs with rapid cell turnover, immunotherapies target and activate the immune system, potentially leading to a wide range of inflammatory and immune-mediated adverse events, including those in the nervous system.
Only 5 of the 10 patients described by Kao et al. experienced nonneurologic immune-related adverse events, suggesting that neurologic complications may be the only defining symptom of an immune-related reaction. Consultation calls from the cancer center are all too familiar for neurologists, and this pattern appears likely to persist in the era of immunotherapy. The horizon of new checkpoint targets continues to expand, and combination therapies are beginning to emerge. Neurologists and oncologists need to be aware of the important checkpoints ahead in patient care.
Roy E. Strowd III, MD, is with the section on hematology and oncology, department of neurology and internal medicine, Wake Forest University, Winston-Salem, N.C. He reported having no conflicts of interest. These comments are excerpted from his editorial (JAMA Neurol. 2017 Sep 5. doi: 10.1001/jamaneurol.2017.1916).
Neurologic symptoms have been and continue to be one of the most common reasons for admission to a cancer center. Neurotoxic chemotherapy, direct invasion of cancer, and other neurologic complications of treatment contribute to the substantial cross talk between oncologists and neurologists. Over the past 5 years, oncology has witnessed an explosion of new immunotherapeutics that are revolutionizing drug development and patient care in oncology today. In contrast to traditional chemotherapy, which targets rapidly dividing cancer cells and can lead to adverse effects in other organs with rapid cell turnover, immunotherapies target and activate the immune system, potentially leading to a wide range of inflammatory and immune-mediated adverse events, including those in the nervous system.
Only 5 of the 10 patients described by Kao et al. experienced nonneurologic immune-related adverse events, suggesting that neurologic complications may be the only defining symptom of an immune-related reaction. Consultation calls from the cancer center are all too familiar for neurologists, and this pattern appears likely to persist in the era of immunotherapy. The horizon of new checkpoint targets continues to expand, and combination therapies are beginning to emerge. Neurologists and oncologists need to be aware of the important checkpoints ahead in patient care.
Roy E. Strowd III, MD, is with the section on hematology and oncology, department of neurology and internal medicine, Wake Forest University, Winston-Salem, N.C. He reported having no conflicts of interest. These comments are excerpted from his editorial (JAMA Neurol. 2017 Sep 5. doi: 10.1001/jamaneurol.2017.1916).
Neurologic symptoms have been and continue to be one of the most common reasons for admission to a cancer center. Neurotoxic chemotherapy, direct invasion of cancer, and other neurologic complications of treatment contribute to the substantial cross talk between oncologists and neurologists. Over the past 5 years, oncology has witnessed an explosion of new immunotherapeutics that are revolutionizing drug development and patient care in oncology today. In contrast to traditional chemotherapy, which targets rapidly dividing cancer cells and can lead to adverse effects in other organs with rapid cell turnover, immunotherapies target and activate the immune system, potentially leading to a wide range of inflammatory and immune-mediated adverse events, including those in the nervous system.
Only 5 of the 10 patients described by Kao et al. experienced nonneurologic immune-related adverse events, suggesting that neurologic complications may be the only defining symptom of an immune-related reaction. Consultation calls from the cancer center are all too familiar for neurologists, and this pattern appears likely to persist in the era of immunotherapy. The horizon of new checkpoint targets continues to expand, and combination therapies are beginning to emerge. Neurologists and oncologists need to be aware of the important checkpoints ahead in patient care.
Roy E. Strowd III, MD, is with the section on hematology and oncology, department of neurology and internal medicine, Wake Forest University, Winston-Salem, N.C. He reported having no conflicts of interest. These comments are excerpted from his editorial (JAMA Neurol. 2017 Sep 5. doi: 10.1001/jamaneurol.2017.1916).
Three percent of patients developed immune-related adverse neurologic events within 12 months of receiving nivolumab or pembrolizumab, according to the results of a single-center retrospective study.
These syndromes included myopathy, axonal thoracolumbar polyradiculopathy, severe demyelinating length-dependent peripheral neuropathy with axonal loss, a facial diplegic variant of Guillain-Barré syndrome, asymmetric vasculitic neuropathy, cerebellar ataxia with dysarthria, autoimmune retinopathy, bilateral internuclear ophthalmoplegia, and headache, reported Justin C. Kao, MD, of Mayo Clinic, Rochester, Minn., and his coinvestigators. Most patients improved after stopping treatment and starting corticosteroids, but one patient developed necrotizing myopathy and died after withdrawal of ventilator support.
Nivolumab and pembrolizumab, which inhibit the programmed death–1 (PD-1) receptor, are approved for treating metastatic melanoma, non–small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck cancers, and urothelial carcinoma. In response to a surge in reports of neurologic events associated with anti–PD-1 therapy, the investigators searched the Mayo Clinic pharmacy database and identified 347 patients treated with pembrolizumab or nivolumab between 2014 and 2016. Ten patients (2.9%) developed neurologic complications within 12 months of anti–PD-1 exposure, including eight men and two women. The median age was 71 years. None of their neurologic symptoms could be directly attributed to other treatments or to metastatic disease. Most had mild to moderate disability, with modified Rankin Scale (mRS) scores of 2, and symptom severity peaked between 1 day and more than 3 months after starting anti–PD-1 treatment (JAMA Neurol. 2017 Sep 5. doi: 10.1001/jamaneurol.2017.1912).
Stopping anti–PD-1 treatment and starting high-dose corticosteroids led to substantial neurologic improvements (mRS scores, 0-3), except in the case of fatal necrotizing myopathy, the researchers said. That patient, who was receiving pembrolizumab for stage 4 melanoma, developed extraocular, bulbar, and proximal limb girdle weakness that worsened over a period of 3 weeks and did not respond to prednisone (80 mg daily) or to three sessions of plasmapheresis.
If a patient on anti–PD-1 therapy develops neurologic symptoms, clinicians should promptly stop treatment and pursue a full work-up, including electrodiagnostic studies and consideration of muscle or nerve biopsy to clarify underlying pathophysiologic mechanisms, the researchers said. “If the clinical examination demonstrates severe clinical deficits at onset or worsens despite medication discontinuation, additional immune suppressant treatment should be considered,” they said. They recommended prednisone (1 mg/kg) with a taper over a 1-month period. Intravenous immunoglobulin therapy or plasma exchange may be warranted if patients continue to worsen, they said.
The investigators did not report external funding sources. Mr. Kao had no disclosures. Two coinvestigators disclosed ties to the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Academy of Neurology, the Continuum: Lifelong Learning in Neurology, Ionis Pharmaceuticals, Alnylam, and Oxford University Press. The remaining coinvestigators reported having no conflicts of interest.
Three percent of patients developed immune-related adverse neurologic events within 12 months of receiving nivolumab or pembrolizumab, according to the results of a single-center retrospective study.
These syndromes included myopathy, axonal thoracolumbar polyradiculopathy, severe demyelinating length-dependent peripheral neuropathy with axonal loss, a facial diplegic variant of Guillain-Barré syndrome, asymmetric vasculitic neuropathy, cerebellar ataxia with dysarthria, autoimmune retinopathy, bilateral internuclear ophthalmoplegia, and headache, reported Justin C. Kao, MD, of Mayo Clinic, Rochester, Minn., and his coinvestigators. Most patients improved after stopping treatment and starting corticosteroids, but one patient developed necrotizing myopathy and died after withdrawal of ventilator support.
Nivolumab and pembrolizumab, which inhibit the programmed death–1 (PD-1) receptor, are approved for treating metastatic melanoma, non–small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck cancers, and urothelial carcinoma. In response to a surge in reports of neurologic events associated with anti–PD-1 therapy, the investigators searched the Mayo Clinic pharmacy database and identified 347 patients treated with pembrolizumab or nivolumab between 2014 and 2016. Ten patients (2.9%) developed neurologic complications within 12 months of anti–PD-1 exposure, including eight men and two women. The median age was 71 years. None of their neurologic symptoms could be directly attributed to other treatments or to metastatic disease. Most had mild to moderate disability, with modified Rankin Scale (mRS) scores of 2, and symptom severity peaked between 1 day and more than 3 months after starting anti–PD-1 treatment (JAMA Neurol. 2017 Sep 5. doi: 10.1001/jamaneurol.2017.1912).
Stopping anti–PD-1 treatment and starting high-dose corticosteroids led to substantial neurologic improvements (mRS scores, 0-3), except in the case of fatal necrotizing myopathy, the researchers said. That patient, who was receiving pembrolizumab for stage 4 melanoma, developed extraocular, bulbar, and proximal limb girdle weakness that worsened over a period of 3 weeks and did not respond to prednisone (80 mg daily) or to three sessions of plasmapheresis.
If a patient on anti–PD-1 therapy develops neurologic symptoms, clinicians should promptly stop treatment and pursue a full work-up, including electrodiagnostic studies and consideration of muscle or nerve biopsy to clarify underlying pathophysiologic mechanisms, the researchers said. “If the clinical examination demonstrates severe clinical deficits at onset or worsens despite medication discontinuation, additional immune suppressant treatment should be considered,” they said. They recommended prednisone (1 mg/kg) with a taper over a 1-month period. Intravenous immunoglobulin therapy or plasma exchange may be warranted if patients continue to worsen, they said.
The investigators did not report external funding sources. Mr. Kao had no disclosures. Two coinvestigators disclosed ties to the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Academy of Neurology, the Continuum: Lifelong Learning in Neurology, Ionis Pharmaceuticals, Alnylam, and Oxford University Press. The remaining coinvestigators reported having no conflicts of interest.
FROM JAMA NEUROLOGY
Key clinical point: Watch for immune-related adverse effects of nivolumab and pembrolizumab.
Major finding: Ten of 347 patients (2.9%) developed subacute neurologic immune-related adverse events, typically neuromuscular syndromes.
Data source: A single-center, retrospective cohort study of 347 patients who received pembrolizumab or nivolumab for metastatic melanoma or solid tumors.
Disclosures: The investigators did not report external funding sources. Mr. Kao had no disclosures. Two coinvestigators disclosed ties to the American Association of Neuromuscular & Electrodiagnostic Medicine, the American Academy of Neurology, the Continuum: Lifelong Learning in Neurology, Ionis Pharmaceuticals, Alnylam, and Oxford University Press. The remaining coinvestigators reported having no conflicts of interest.