The risk for disease recurrence, and specifically distant relapse, for women with high-risk early breast cancer highlights the need for novel therapies in this population.^2,3 The phase 3 randomized monarchE trial investigated the role of the CDK4/6 inhibitor abemaciclib combined with endocrine therapy vs standard endocrine therapy alone in 5637 patients with high-risk (≥ 4 positive axillary nodes or 1-3 positive nodes and either grade 3 tumor, tumor size ≥ 5 cm or Ki-67 ≥ 20%) hormone receptor–positive/HER2-negative early breast cancer. At a median follow-up of 42 months, the median invasive disease-free survival (iDFS) benefit was sustained with abemaciclib + endocrine therapy vs endocrine therapy alone (HR 0.664; nominal P < .0001); the absolute 4-year iDFS benefit was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group). Furthermore, this effect appeared to deepen over time, as the previous absolute iDFS differences were 2.8% (2 years) and 4.8% (3 years). Abemaciclib was associated with a higher rate of grade 3 or higher adverse events (49.9% vs 16.9%), the most common being neutropenia, leukopenia, and diarrhea (Johnston et al). Although adjuvant palbociclib trials (PALLAS⁴ and PENELOPE-B⁵) did not meet their primary endpoint, longer follow-up of monarchE and results from NATALEE with ribociclib are anxiously awaited to further define the role of CDK4/6 inhibitors in this space.

Aromatase inhibitors (AI) are an integral component of treatment for hormone receptor–positive breast cancer for many women. However, joint pain and stiffness associated with these agents can affect compliance. Various management strategies, including trials of alternative AI or endocrine therapies and pharmacologic (duloxetine) and non-pharmacologic (acupuncture,⁶ exercise) modalities, have been investigated. A randomized trial including 226 women with early-stage breast cancer receiving AI therapy with baseline joint pain (Brief Pain Inventory Worst Pain [BPI-WP] item score of ≥ 3) evaluated whether true acupuncture (TA) provided a sustained reduction in pain symptoms compared with sham acupuncture (SA) or waiting-list control (WC). Acupuncture protocols consisted of 6 weeks of intervention (2 sessions per week) followed by 1 session per week for another 6 weeks. At 52 weeks, mean BPI-WP scores were 1.08 points lower in the TA group compared with the SA group (P = .01) and were 0.99 points lower in the TA group compared with the WC group (P = .03) (Hershman et al). These data support consideration of acupuncture as a mechanism to help maintain patients on aromatase inhibitors, particularly for patients who wish to avoid or have not received benefit from pharmacologic therapy.

Additional References

1. Puglisi F, Gerratana L, Lambertini M, et al. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer. NPJ Breast Cancer. 2021;7:82. Doi: 10.1038/s41523-021-00286-w
2. Salvo EM, Ramirez AO, Cueto J, et al. Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis. Breast. 2021;57:5-17. Doi: 10.1016/j.breast.2021.02.009
3. Sheffield KM, Peachey JR, Method M, et al. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol.2022;18:2667-2682. Doi: 10.2217/fon-2022-0310
4. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. Doi: Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial. J Clin Oncol. 2021;39(14):1518-1530. Doi: Liu X, Lu J, Wang G, et al. Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer: A systematic review and meta-analysis. Integr Cancer Ther. 2021;20:1534735420980811. Doi: 10.1177/1534735420980811

The risk for disease recurrence, and specifically distant relapse, for women with high-risk early breast cancer highlights the need for novel therapies in this population.^2,3 The phase 3 randomized monarchE trial investigated the role of the CDK4/6 inhibitor abemaciclib combined with endocrine therapy vs standard endocrine therapy alone in 5637 patients with high-risk (≥ 4 positive axillary nodes or 1-3 positive nodes and either grade 3 tumor, tumor size ≥ 5 cm or Ki-67 ≥ 20%) hormone receptor–positive/HER2-negative early breast cancer. At a median follow-up of 42 months, the median invasive disease-free survival (iDFS) benefit was sustained with abemaciclib + endocrine therapy vs endocrine therapy alone (HR 0.664; nominal P < .0001); the absolute 4-year iDFS benefit was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group). Furthermore, this effect appeared to deepen over time, as the previous absolute iDFS differences were 2.8% (2 years) and 4.8% (3 years). Abemaciclib was associated with a higher rate of grade 3 or higher adverse events (49.9% vs 16.9%), the most common being neutropenia, leukopenia, and diarrhea (Johnston et al). Although adjuvant palbociclib trials (PALLAS⁴ and PENELOPE-B⁵) did not meet their primary endpoint, longer follow-up of monarchE and results from NATALEE with ribociclib are anxiously awaited to further define the role of CDK4/6 inhibitors in this space.

Aromatase inhibitors (AI) are an integral component of treatment for hormone receptor–positive breast cancer for many women. However, joint pain and stiffness associated with these agents can affect compliance. Various management strategies, including trials of alternative AI or endocrine therapies and pharmacologic (duloxetine) and non-pharmacologic (acupuncture,⁶ exercise) modalities, have been investigated. A randomized trial including 226 women with early-stage breast cancer receiving AI therapy with baseline joint pain (Brief Pain Inventory Worst Pain [BPI-WP] item score of ≥ 3) evaluated whether true acupuncture (TA) provided a sustained reduction in pain symptoms compared with sham acupuncture (SA) or waiting-list control (WC). Acupuncture protocols consisted of 6 weeks of intervention (2 sessions per week) followed by 1 session per week for another 6 weeks. At 52 weeks, mean BPI-WP scores were 1.08 points lower in the TA group compared with the SA group (P = .01) and were 0.99 points lower in the TA group compared with the WC group (P = .03) (Hershman et al). These data support consideration of acupuncture as a mechanism to help maintain patients on aromatase inhibitors, particularly for patients who wish to avoid or have not received benefit from pharmacologic therapy.

Additional References

1. Puglisi F, Gerratana L, Lambertini M, et al. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer. NPJ Breast Cancer. 2021;7:82. Doi: 10.1038/s41523-021-00286-w
2. Salvo EM, Ramirez AO, Cueto J, et al. Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis. Breast. 2021;57:5-17. Doi: 10.1016/j.breast.2021.02.009
3. Sheffield KM, Peachey JR, Method M, et al. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol.2022;18:2667-2682. Doi: 10.2217/fon-2022-0310
4. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. Doi: Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial. J Clin Oncol. 2021;39(14):1518-1530. Doi: Liu X, Lu J, Wang G, et al. Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer: A systematic review and meta-analysis. Integr Cancer Ther. 2021;20:1534735420980811. Doi: 10.1177/1534735420980811

The risk for disease recurrence, and specifically distant relapse, for women with high-risk early breast cancer highlights the need for novel therapies in this population.^2,3 The phase 3 randomized monarchE trial investigated the role of the CDK4/6 inhibitor abemaciclib combined with endocrine therapy vs standard endocrine therapy alone in 5637 patients with high-risk (≥ 4 positive axillary nodes or 1-3 positive nodes and either grade 3 tumor, tumor size ≥ 5 cm or Ki-67 ≥ 20%) hormone receptor–positive/HER2-negative early breast cancer. At a median follow-up of 42 months, the median invasive disease-free survival (iDFS) benefit was sustained with abemaciclib + endocrine therapy vs endocrine therapy alone (HR 0.664; nominal P < .0001); the absolute 4-year iDFS benefit was 6.4% (85.8% in the abemaciclib + endocrine therapy group vs 79.4% in the endocrine therapy–alone group). Furthermore, this effect appeared to deepen over time, as the previous absolute iDFS differences were 2.8% (2 years) and 4.8% (3 years). Abemaciclib was associated with a higher rate of grade 3 or higher adverse events (49.9% vs 16.9%), the most common being neutropenia, leukopenia, and diarrhea (Johnston et al). Although adjuvant palbociclib trials (PALLAS⁴ and PENELOPE-B⁵) did not meet their primary endpoint, longer follow-up of monarchE and results from NATALEE with ribociclib are anxiously awaited to further define the role of CDK4/6 inhibitors in this space.

Aromatase inhibitors (AI) are an integral component of treatment for hormone receptor–positive breast cancer for many women. However, joint pain and stiffness associated with these agents can affect compliance. Various management strategies, including trials of alternative AI or endocrine therapies and pharmacologic (duloxetine) and non-pharmacologic (acupuncture,⁶ exercise) modalities, have been investigated. A randomized trial including 226 women with early-stage breast cancer receiving AI therapy with baseline joint pain (Brief Pain Inventory Worst Pain [BPI-WP] item score of ≥ 3) evaluated whether true acupuncture (TA) provided a sustained reduction in pain symptoms compared with sham acupuncture (SA) or waiting-list control (WC). Acupuncture protocols consisted of 6 weeks of intervention (2 sessions per week) followed by 1 session per week for another 6 weeks. At 52 weeks, mean BPI-WP scores were 1.08 points lower in the TA group compared with the SA group (P = .01) and were 0.99 points lower in the TA group compared with the WC group (P = .03) (Hershman et al). These data support consideration of acupuncture as a mechanism to help maintain patients on aromatase inhibitors, particularly for patients who wish to avoid or have not received benefit from pharmacologic therapy.

Additional References

1. Puglisi F, Gerratana L, Lambertini M, et al. Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer. NPJ Breast Cancer. 2021;7:82. Doi: 10.1038/s41523-021-00286-w
2. Salvo EM, Ramirez AO, Cueto J, et al. Risk of recurrence among patients with HR-positive, HER2-negative, early breast cancer receiving adjuvant endocrine therapy: A systematic review and meta-analysis. Breast. 2021;57:5-17. Doi: 10.1016/j.breast.2021.02.009
3. Sheffield KM, Peachey JR, Method M, et al. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol.2022;18:2667-2682. Doi: 10.2217/fon-2022-0310
4. Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): Interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212-222. Doi: Loibl S, Marmé F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-The Penelope-B trial. J Clin Oncol. 2021;39(14):1518-1530. Doi: Liu X, Lu J, Wang G, et al. Acupuncture for arthralgia induced by aromatase inhibitors in patients with breast cancer: A systematic review and meta-analysis. Integr Cancer Ther. 2021;20:1534735420980811. Doi: 10.1177/1534735420980811

Fecal microbiota transplantation (FMT) does not appear to contribute to weight loss for patients who undergo bariatric surgery, according to results of a randomized controlled trial.

The small study by Perttu Lahtinen, MD, with Päijät-Häme Central Hospital in Lahti, Finland, and colleagues was published online in JAMA Network Open.

Bariatric surgery remains the most effective strategy for treating severe obesity. Yet some patients achieve only minimal weight loss or regain weight after surgery, the researchers noted.

There is much interest in the gut microbiota as a potential target for the treatment of obesity. FMT from a lean donor has shown promise in treating obesity in mouse models (Science. 2013 Sep 6. doi: 10.1126/science.1241214).

The Finnish trial, however, does not support that conclusion.

The study included 41 adults (71% women; mean age, 48.7 years) with severe obesity (mean body mass index, 42.5 kg/m²). Twenty-one received FMT from a lean donor, and 20 received FMT from their own feces (autologous placebo). FMT was administered by gastroscopy into the duodenum 6 months before laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. All patients also consumed a very-low-calorie diet approximately 4 weeks before the surgery.

Bariatric surgery led to equal weight reductions for both groups, but there was no additive benefit in terms of weight loss with FMT.

Six months after the administration of FMT, and before the surgery was performed, the percentage of total weight loss, the main outcome, was 4.8% (P < .001) in the FMT group and 4.6% (P = .006) in the placebo group. There was no statistically significant difference between the groups (absolute difference, 0.2%).

At 18 months (12 months after surgery), the percentage of total weight loss was 25.3% (P < .001) in the FMT group and 25.2% (P < .001) in the placebo group – an absolute difference of 0.1%.

The researchers said the main limitation of their study is the small number of patients. Because there were few patients, the study may be inadequate to show possible minor effects of FMT on weight; it’s unclear whether a much larger sample size would have yielded any differences between the groups.

Nonetheless, the study suggests that FMT does not affect weight loss for patients who undergo bariatric surgery, the researchers said.

The study was supported by governmental research grants and the Sigrid Juselius Foundation. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Fecal microbiota transplantation (FMT) does not appear to contribute to weight loss for patients who undergo bariatric surgery, according to results of a randomized controlled trial.

The small study by Perttu Lahtinen, MD, with Päijät-Häme Central Hospital in Lahti, Finland, and colleagues was published online in JAMA Network Open.

Bariatric surgery remains the most effective strategy for treating severe obesity. Yet some patients achieve only minimal weight loss or regain weight after surgery, the researchers noted.

There is much interest in the gut microbiota as a potential target for the treatment of obesity. FMT from a lean donor has shown promise in treating obesity in mouse models (Science. 2013 Sep 6. doi: 10.1126/science.1241214).

The Finnish trial, however, does not support that conclusion.

The study included 41 adults (71% women; mean age, 48.7 years) with severe obesity (mean body mass index, 42.5 kg/m²). Twenty-one received FMT from a lean donor, and 20 received FMT from their own feces (autologous placebo). FMT was administered by gastroscopy into the duodenum 6 months before laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. All patients also consumed a very-low-calorie diet approximately 4 weeks before the surgery.

Bariatric surgery led to equal weight reductions for both groups, but there was no additive benefit in terms of weight loss with FMT.

Six months after the administration of FMT, and before the surgery was performed, the percentage of total weight loss, the main outcome, was 4.8% (P < .001) in the FMT group and 4.6% (P = .006) in the placebo group. There was no statistically significant difference between the groups (absolute difference, 0.2%).

At 18 months (12 months after surgery), the percentage of total weight loss was 25.3% (P < .001) in the FMT group and 25.2% (P < .001) in the placebo group – an absolute difference of 0.1%.

The researchers said the main limitation of their study is the small number of patients. Because there were few patients, the study may be inadequate to show possible minor effects of FMT on weight; it’s unclear whether a much larger sample size would have yielded any differences between the groups.

Nonetheless, the study suggests that FMT does not affect weight loss for patients who undergo bariatric surgery, the researchers said.

The study was supported by governmental research grants and the Sigrid Juselius Foundation. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Fecal microbiota transplantation (FMT) does not appear to contribute to weight loss for patients who undergo bariatric surgery, according to results of a randomized controlled trial.

The small study by Perttu Lahtinen, MD, with Päijät-Häme Central Hospital in Lahti, Finland, and colleagues was published online in JAMA Network Open.

Bariatric surgery remains the most effective strategy for treating severe obesity. Yet some patients achieve only minimal weight loss or regain weight after surgery, the researchers noted.

There is much interest in the gut microbiota as a potential target for the treatment of obesity. FMT from a lean donor has shown promise in treating obesity in mouse models (Science. 2013 Sep 6. doi: 10.1126/science.1241214).

The Finnish trial, however, does not support that conclusion.

The study included 41 adults (71% women; mean age, 48.7 years) with severe obesity (mean body mass index, 42.5 kg/m²). Twenty-one received FMT from a lean donor, and 20 received FMT from their own feces (autologous placebo). FMT was administered by gastroscopy into the duodenum 6 months before laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy. All patients also consumed a very-low-calorie diet approximately 4 weeks before the surgery.

Bariatric surgery led to equal weight reductions for both groups, but there was no additive benefit in terms of weight loss with FMT.

Six months after the administration of FMT, and before the surgery was performed, the percentage of total weight loss, the main outcome, was 4.8% (P < .001) in the FMT group and 4.6% (P = .006) in the placebo group. There was no statistically significant difference between the groups (absolute difference, 0.2%).

At 18 months (12 months after surgery), the percentage of total weight loss was 25.3% (P < .001) in the FMT group and 25.2% (P < .001) in the placebo group – an absolute difference of 0.1%.

The researchers said the main limitation of their study is the small number of patients. Because there were few patients, the study may be inadequate to show possible minor effects of FMT on weight; it’s unclear whether a much larger sample size would have yielded any differences between the groups.

Nonetheless, the study suggests that FMT does not affect weight loss for patients who undergo bariatric surgery, the researchers said.

The study was supported by governmental research grants and the Sigrid Juselius Foundation. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nonheavy alcohol use – fewer than 14 drinks per week for women and fewer than 21 drinks per week for men – is associated with liver fibrosis and nonalcoholic steatohepatitis (NASH), according to a new report.

An analysis of current drinkers in the Framingham Heart Study found that a higher number of drinks per week and higher frequency of drinking were associated with increased odds of fibrosis among patients whose consumption fell below the threshold for heavy alcohol use.

“Although the detrimental effects of heavy alcohol use are well accepted, there is no consensus guideline on how to counsel patients about how nonheavy alcohol use may affect liver health,” Brooke Rice, MD, an internal medicine resident at Boston University, said in an interview.

“Current terminology classifies fatty liver disease as either alcoholic or nonalcoholic,” she said. “Our results call this strict categorization into question, suggesting that even nonheavy alcohol use should be considered as a factor contributing to more advanced nonalcoholic fatty liver disease [NAFLD] phenotypes.”

The study was published online in Clinical Gastroenterology and Hepatology.
 

Analyzing associations

NAFLD and alcohol-related liver disease, which are the most common causes of chronic liver disease worldwide, are histologically identical but distinguished by the presence of significant alcohol use, the study authors wrote.

Heavy alcohol use, based on guidelines from the American Association for the Study of Liver Diseases, is defined as more than 14 drinks per week for women or more than 21 drinks per week for men.

Although heavy alcohol use is consistently associated with cirrhosis and steatohepatitis, studies of nonheavy alcohol use have shown conflicting results, the authors wrote. However, evidence suggests that the pattern of alcohol consumption – particularly increased weekly drinking and binge drinking – may be an important predictor.

Dr. Rice and colleagues conducted a cross-sectional study of 2,629 current drinkers in the Framingham Heart Study who completed alcohol-use questionnaires and vibration-controlled transient elastography between April 2016 and April 2019. They analyzed the association between fibrosis and several alcohol-use measures, including total consumption and drinking patterns, among nonheavy alcohol users whose liver disease would be classified as “nonalcoholic” by current nomenclature.

The research team defined clinically significant fibrosis as a liver stiffness measurement of 8.2 kPa or higher. For at-risk NASH, the researchers used two FibroScan-AST (FAST) score thresholds – greater than 0.35 or 0.67 and higher. They also considered additional metabolic factors such as physical activity, body mass index, blood pressure, glucose measures, and metabolic syndrome.

Participants were asked to estimate the frequency of alcohol use (average number of drinking days per week during the past year) and the usual quantity of alcohol consumed (average number of drinks on a typical drinking day during the past year). Researchers multiplied the figures to estimate the average total number of drinks per week.

Among the 2,629 current drinkers (53% women, 47% men), the average age was 54 years, 7.2% had diabetes, and 26.9% met the criteria for metabolic syndrome. Participants drank about 3 days per week on average with a usual consumption of two drinks per drinking day, averaging a total weekly alcohol consumption of six drinks.

The average liver stiffness measurement was 5.6 kPa, and 8.2% had significant fibrosis.

At the FAST score threshold of 0.67 or greater, 1.9% of participants were likely to have at-risk NASH, with a higher prevalence in those with obesity (4.5%) or diabetes (9.5%). At the FAST score threshold of greater than 0.35, the prevalence of at-risk NASH was 12.4%, which was higher in those with obesity (26.3%) or diabetes (34.4%).

Overall, an increased total number of drinks per week and higher frequency of drinking days were associated with increased odds of fibrosis.

Almost 17.5% of participants engaged in risky weekly drinking, which was defined as 8 or more drinks per week for women and 15 or more drinks per week for men. Risky weekly drinking was also associated with higher odds of fibrosis.

After excluding 158 heavy drinkers, the prevalence of fibrosis was unchanged at 8%, and an increased total of drinks per week remained significantly associated with fibrosis.

In addition, multiple alcohol-use measures were positively associated with a FAST score greater than 0.35 and were similar after excluding heavy alcohol users. These measures include the number of drinks per week, the frequency of drinking days, and binge drinking.

“We showed that nonheavy alcohol use is associated with fibrosis and at-risk NASH, which are both predictors of long-term liver-related morbidity and mortality,” Dr. Rice said.
 

Implications for patient care

The findings have important implications for both NAFLD clinical trials and patient care, the study authors wrote. For instance, the U.S. Dietary Guidelines for Americans recommend limiting alcohol use to one drink per day for women and two drinks per day for men.

“Our results reinforce the importance of encouraging all patients to reduce alcohol intake as much as possible and to at least adhere to current U.S. Dietary Guidelines recommended limits,” Dr. Rice said. “Almost half of participants in our study consumed in excess of these limits, which strongly associated with at-risk NASH.”

Additional long-term studies are needed to determine the benefits of limiting alcohol consumption to reduce liver-related morbidity and mortality, the authors wrote.

The effect of alcohol consumption on liver health “has been controversial, since some studies have suggested that nonheavy alcohol use can even have some beneficial metabolic effects and has been associated with reduced risk of fatty liver disease, while other studies have found that nonheavy alcohol use is associated with increased risk for liver-related clinical outcomes,” Fredrik Åberg, MD, PhD, a hepatologist and liver transplant specialist at Helsinki University Hospital, said in an interview.

Dr. Åberg wasn’t involved with this study but has researched alcohol consumption and liver disease. Among non–heavy alcohol users, drinking more alcohol per week is associated with increased hospitalization for liver disease, hepatocellular carcinoma, and liver-related death, he and his colleagues have found.

“We concluded that the net effect of non-heavy drinking on the liver is harm,” he said. “Overall, this study by Rice and colleagues supports the recommendation that persons with mild liver disease should reduce their drinking, and persons with severe liver disease (cirrhosis and advanced fibrosis) should abstain from alcohol use.”

The study authors are supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, a Doris Duke Charitable Foundation Grant, a Gilead Sciences Research Scholars Award, the Boston University Department of Medicine Career Investment Award, and the Boston University Clinical Translational Science Institute. The Framingham Heart Study is supported in part by the National Heart, Lung, and Blood Institute. The authors and Dr. Åberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nonheavy alcohol use – fewer than 14 drinks per week for women and fewer than 21 drinks per week for men – is associated with liver fibrosis and nonalcoholic steatohepatitis (NASH), according to a new report.

An analysis of current drinkers in the Framingham Heart Study found that a higher number of drinks per week and higher frequency of drinking were associated with increased odds of fibrosis among patients whose consumption fell below the threshold for heavy alcohol use.

“Although the detrimental effects of heavy alcohol use are well accepted, there is no consensus guideline on how to counsel patients about how nonheavy alcohol use may affect liver health,” Brooke Rice, MD, an internal medicine resident at Boston University, said in an interview.

“Current terminology classifies fatty liver disease as either alcoholic or nonalcoholic,” she said. “Our results call this strict categorization into question, suggesting that even nonheavy alcohol use should be considered as a factor contributing to more advanced nonalcoholic fatty liver disease [NAFLD] phenotypes.”

The study was published online in Clinical Gastroenterology and Hepatology.
 

Analyzing associations

NAFLD and alcohol-related liver disease, which are the most common causes of chronic liver disease worldwide, are histologically identical but distinguished by the presence of significant alcohol use, the study authors wrote.

Heavy alcohol use, based on guidelines from the American Association for the Study of Liver Diseases, is defined as more than 14 drinks per week for women or more than 21 drinks per week for men.

Although heavy alcohol use is consistently associated with cirrhosis and steatohepatitis, studies of nonheavy alcohol use have shown conflicting results, the authors wrote. However, evidence suggests that the pattern of alcohol consumption – particularly increased weekly drinking and binge drinking – may be an important predictor.

Dr. Rice and colleagues conducted a cross-sectional study of 2,629 current drinkers in the Framingham Heart Study who completed alcohol-use questionnaires and vibration-controlled transient elastography between April 2016 and April 2019. They analyzed the association between fibrosis and several alcohol-use measures, including total consumption and drinking patterns, among nonheavy alcohol users whose liver disease would be classified as “nonalcoholic” by current nomenclature.

The research team defined clinically significant fibrosis as a liver stiffness measurement of 8.2 kPa or higher. For at-risk NASH, the researchers used two FibroScan-AST (FAST) score thresholds – greater than 0.35 or 0.67 and higher. They also considered additional metabolic factors such as physical activity, body mass index, blood pressure, glucose measures, and metabolic syndrome.

Participants were asked to estimate the frequency of alcohol use (average number of drinking days per week during the past year) and the usual quantity of alcohol consumed (average number of drinks on a typical drinking day during the past year). Researchers multiplied the figures to estimate the average total number of drinks per week.

Among the 2,629 current drinkers (53% women, 47% men), the average age was 54 years, 7.2% had diabetes, and 26.9% met the criteria for metabolic syndrome. Participants drank about 3 days per week on average with a usual consumption of two drinks per drinking day, averaging a total weekly alcohol consumption of six drinks.

The average liver stiffness measurement was 5.6 kPa, and 8.2% had significant fibrosis.

At the FAST score threshold of 0.67 or greater, 1.9% of participants were likely to have at-risk NASH, with a higher prevalence in those with obesity (4.5%) or diabetes (9.5%). At the FAST score threshold of greater than 0.35, the prevalence of at-risk NASH was 12.4%, which was higher in those with obesity (26.3%) or diabetes (34.4%).

Overall, an increased total number of drinks per week and higher frequency of drinking days were associated with increased odds of fibrosis.

Almost 17.5% of participants engaged in risky weekly drinking, which was defined as 8 or more drinks per week for women and 15 or more drinks per week for men. Risky weekly drinking was also associated with higher odds of fibrosis.

After excluding 158 heavy drinkers, the prevalence of fibrosis was unchanged at 8%, and an increased total of drinks per week remained significantly associated with fibrosis.

In addition, multiple alcohol-use measures were positively associated with a FAST score greater than 0.35 and were similar after excluding heavy alcohol users. These measures include the number of drinks per week, the frequency of drinking days, and binge drinking.

“We showed that nonheavy alcohol use is associated with fibrosis and at-risk NASH, which are both predictors of long-term liver-related morbidity and mortality,” Dr. Rice said.
 

Implications for patient care

The findings have important implications for both NAFLD clinical trials and patient care, the study authors wrote. For instance, the U.S. Dietary Guidelines for Americans recommend limiting alcohol use to one drink per day for women and two drinks per day for men.

“Our results reinforce the importance of encouraging all patients to reduce alcohol intake as much as possible and to at least adhere to current U.S. Dietary Guidelines recommended limits,” Dr. Rice said. “Almost half of participants in our study consumed in excess of these limits, which strongly associated with at-risk NASH.”

Additional long-term studies are needed to determine the benefits of limiting alcohol consumption to reduce liver-related morbidity and mortality, the authors wrote.

The effect of alcohol consumption on liver health “has been controversial, since some studies have suggested that nonheavy alcohol use can even have some beneficial metabolic effects and has been associated with reduced risk of fatty liver disease, while other studies have found that nonheavy alcohol use is associated with increased risk for liver-related clinical outcomes,” Fredrik Åberg, MD, PhD, a hepatologist and liver transplant specialist at Helsinki University Hospital, said in an interview.

Dr. Åberg wasn’t involved with this study but has researched alcohol consumption and liver disease. Among non–heavy alcohol users, drinking more alcohol per week is associated with increased hospitalization for liver disease, hepatocellular carcinoma, and liver-related death, he and his colleagues have found.

“We concluded that the net effect of non-heavy drinking on the liver is harm,” he said. “Overall, this study by Rice and colleagues supports the recommendation that persons with mild liver disease should reduce their drinking, and persons with severe liver disease (cirrhosis and advanced fibrosis) should abstain from alcohol use.”

The study authors are supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, a Doris Duke Charitable Foundation Grant, a Gilead Sciences Research Scholars Award, the Boston University Department of Medicine Career Investment Award, and the Boston University Clinical Translational Science Institute. The Framingham Heart Study is supported in part by the National Heart, Lung, and Blood Institute. The authors and Dr. Åberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nonheavy alcohol use – fewer than 14 drinks per week for women and fewer than 21 drinks per week for men – is associated with liver fibrosis and nonalcoholic steatohepatitis (NASH), according to a new report.

An analysis of current drinkers in the Framingham Heart Study found that a higher number of drinks per week and higher frequency of drinking were associated with increased odds of fibrosis among patients whose consumption fell below the threshold for heavy alcohol use.

“Although the detrimental effects of heavy alcohol use are well accepted, there is no consensus guideline on how to counsel patients about how nonheavy alcohol use may affect liver health,” Brooke Rice, MD, an internal medicine resident at Boston University, said in an interview.

“Current terminology classifies fatty liver disease as either alcoholic or nonalcoholic,” she said. “Our results call this strict categorization into question, suggesting that even nonheavy alcohol use should be considered as a factor contributing to more advanced nonalcoholic fatty liver disease [NAFLD] phenotypes.”

The study was published online in Clinical Gastroenterology and Hepatology.
 

Analyzing associations

NAFLD and alcohol-related liver disease, which are the most common causes of chronic liver disease worldwide, are histologically identical but distinguished by the presence of significant alcohol use, the study authors wrote.

Heavy alcohol use, based on guidelines from the American Association for the Study of Liver Diseases, is defined as more than 14 drinks per week for women or more than 21 drinks per week for men.

Although heavy alcohol use is consistently associated with cirrhosis and steatohepatitis, studies of nonheavy alcohol use have shown conflicting results, the authors wrote. However, evidence suggests that the pattern of alcohol consumption – particularly increased weekly drinking and binge drinking – may be an important predictor.

Dr. Rice and colleagues conducted a cross-sectional study of 2,629 current drinkers in the Framingham Heart Study who completed alcohol-use questionnaires and vibration-controlled transient elastography between April 2016 and April 2019. They analyzed the association between fibrosis and several alcohol-use measures, including total consumption and drinking patterns, among nonheavy alcohol users whose liver disease would be classified as “nonalcoholic” by current nomenclature.

The research team defined clinically significant fibrosis as a liver stiffness measurement of 8.2 kPa or higher. For at-risk NASH, the researchers used two FibroScan-AST (FAST) score thresholds – greater than 0.35 or 0.67 and higher. They also considered additional metabolic factors such as physical activity, body mass index, blood pressure, glucose measures, and metabolic syndrome.

Participants were asked to estimate the frequency of alcohol use (average number of drinking days per week during the past year) and the usual quantity of alcohol consumed (average number of drinks on a typical drinking day during the past year). Researchers multiplied the figures to estimate the average total number of drinks per week.

Among the 2,629 current drinkers (53% women, 47% men), the average age was 54 years, 7.2% had diabetes, and 26.9% met the criteria for metabolic syndrome. Participants drank about 3 days per week on average with a usual consumption of two drinks per drinking day, averaging a total weekly alcohol consumption of six drinks.

The average liver stiffness measurement was 5.6 kPa, and 8.2% had significant fibrosis.

At the FAST score threshold of 0.67 or greater, 1.9% of participants were likely to have at-risk NASH, with a higher prevalence in those with obesity (4.5%) or diabetes (9.5%). At the FAST score threshold of greater than 0.35, the prevalence of at-risk NASH was 12.4%, which was higher in those with obesity (26.3%) or diabetes (34.4%).

Overall, an increased total number of drinks per week and higher frequency of drinking days were associated with increased odds of fibrosis.

Almost 17.5% of participants engaged in risky weekly drinking, which was defined as 8 or more drinks per week for women and 15 or more drinks per week for men. Risky weekly drinking was also associated with higher odds of fibrosis.

After excluding 158 heavy drinkers, the prevalence of fibrosis was unchanged at 8%, and an increased total of drinks per week remained significantly associated with fibrosis.

In addition, multiple alcohol-use measures were positively associated with a FAST score greater than 0.35 and were similar after excluding heavy alcohol users. These measures include the number of drinks per week, the frequency of drinking days, and binge drinking.

“We showed that nonheavy alcohol use is associated with fibrosis and at-risk NASH, which are both predictors of long-term liver-related morbidity and mortality,” Dr. Rice said.
 

Implications for patient care

The findings have important implications for both NAFLD clinical trials and patient care, the study authors wrote. For instance, the U.S. Dietary Guidelines for Americans recommend limiting alcohol use to one drink per day for women and two drinks per day for men.

“Our results reinforce the importance of encouraging all patients to reduce alcohol intake as much as possible and to at least adhere to current U.S. Dietary Guidelines recommended limits,” Dr. Rice said. “Almost half of participants in our study consumed in excess of these limits, which strongly associated with at-risk NASH.”

Additional long-term studies are needed to determine the benefits of limiting alcohol consumption to reduce liver-related morbidity and mortality, the authors wrote.

The effect of alcohol consumption on liver health “has been controversial, since some studies have suggested that nonheavy alcohol use can even have some beneficial metabolic effects and has been associated with reduced risk of fatty liver disease, while other studies have found that nonheavy alcohol use is associated with increased risk for liver-related clinical outcomes,” Fredrik Åberg, MD, PhD, a hepatologist and liver transplant specialist at Helsinki University Hospital, said in an interview.

Dr. Åberg wasn’t involved with this study but has researched alcohol consumption and liver disease. Among non–heavy alcohol users, drinking more alcohol per week is associated with increased hospitalization for liver disease, hepatocellular carcinoma, and liver-related death, he and his colleagues have found.

“We concluded that the net effect of non-heavy drinking on the liver is harm,” he said. “Overall, this study by Rice and colleagues supports the recommendation that persons with mild liver disease should reduce their drinking, and persons with severe liver disease (cirrhosis and advanced fibrosis) should abstain from alcohol use.”

The study authors are supported in part by the National Institute of Diabetes and Digestive and Kidney Diseases, a Doris Duke Charitable Foundation Grant, a Gilead Sciences Research Scholars Award, the Boston University Department of Medicine Career Investment Award, and the Boston University Clinical Translational Science Institute. The Framingham Heart Study is supported in part by the National Heart, Lung, and Blood Institute. The authors and Dr. Åberg reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A smartphone chatbot that gives lifestyle advice may help people with nonalcoholic steatohepatitis (NASH) improve their liver health, researchers say.

After 48 weeks, nonalcoholic fatty liver disease activity scores (NAS) improved in 13 out of 19 patients who used the NASH app developed by CureApp, according to Masaya Sato of the University of Tokyo and colleagues.

If confirmed by a controlled trial, these preliminary results could show promise for digital therapeutics, the researchers stated in an article published in The American Journal of Gastroenterology.

“The widespread use of smartphones, which can process and communicate data in real time, makes them an ideal platform for therapeutic interventions,” they said.

Although lifestyle changes can reduce NASH activity, many patients have difficulty keeping up these changes. Not enough counselors are available to guide patients in healthy practices, and hiring the counselors is expensive, the researchers wrote.

Smartphone applications aimed at instilling healthy behavior have been tried in diabetes, smoking, hypertension, alcoholism, and even cancer, they noted. They wanted to see whether something similar could be done with NASH.

The researchers recruited 19 patients with biopsy-confirmed NASH who consumed no more than moderate amounts of alcohol and had a body mass index (BMI) of at least 25 kg/m². Their mean age was 52 years, mean BMI was 32, and mean NAS was 5.0.

The patients downloaded the NASH app onto their phones and entered their baseline profile information, including age, gender, diet and exercise practices, and social characteristics. On the basis of this information and daily weight measurements, the system proposed lifestyle improvement programs tailored to each individual. Its chatbot presented them in the form of behavioral goals and lectures from virtual nurses.

While patients used the app for 48 weeks, they also received standard outpatient care for NASH from live physicians, who also promoted the use of the app and provided additional education related to NASH.

The patients underwent liver biopsies within 90 days prior to beginning the study and at the end of 48 weeks. The researchers compared the changes in these patients versus those in a hypothetical control group, which they based on the placebo group in a previous study.

In the patients who used the app, the mean NAS change from baseline to week 48, the main endpoint, was –2.05 (95% confidence interval, –3.00 to –1.11). This result was statistically significant compared with the hypothetical control group, in which the mean change in NAS was –0.7 (P < .001).

In 11 of the patients, NAS decreased by at least 2 points without worsening of liver fibrosis. In eight patients, the researchers observed resolution of steatohepatitis, which they defined as disappearance of hepatocyte ballooning.

In 12 patients with stage F2 or F3 fibrosis, the average stage went from 2.5 to 2.0 (P = .02). No patient with stage F1 fibrosis showed a reduction in fibrosis stage. The scores for steatosis decreased in 11 patients, for lobular inflammation in 9 patients, and for ballooning in 10 patients.

The patients lost an average of 8.3% of their body weight, which was significant, compared with their baseline (P < .001). The patients also notched significant reductions in average serum levels of AST, ALT, gamma-glutamyltransferase, alkaline phosphatase, and triglycerides.

The researchers noted that the lack of a real control group and the small size of the study population limited the importance of their findings. A larger randomized, controlled trial is needed to confirm their results.

During the study, physicians browsed the patients’ data and provided them with feedback about it, the researchers wrote. But the study did not measure the amount of time the physicians spent on this activity.

CureApp founded the study, and one of the authors is a consultant for the company.

A version of this article first appeared on Medscape.com.

A smartphone chatbot that gives lifestyle advice may help people with nonalcoholic steatohepatitis (NASH) improve their liver health, researchers say.

After 48 weeks, nonalcoholic fatty liver disease activity scores (NAS) improved in 13 out of 19 patients who used the NASH app developed by CureApp, according to Masaya Sato of the University of Tokyo and colleagues.

If confirmed by a controlled trial, these preliminary results could show promise for digital therapeutics, the researchers stated in an article published in The American Journal of Gastroenterology.

“The widespread use of smartphones, which can process and communicate data in real time, makes them an ideal platform for therapeutic interventions,” they said.

Although lifestyle changes can reduce NASH activity, many patients have difficulty keeping up these changes. Not enough counselors are available to guide patients in healthy practices, and hiring the counselors is expensive, the researchers wrote.

Smartphone applications aimed at instilling healthy behavior have been tried in diabetes, smoking, hypertension, alcoholism, and even cancer, they noted. They wanted to see whether something similar could be done with NASH.

The researchers recruited 19 patients with biopsy-confirmed NASH who consumed no more than moderate amounts of alcohol and had a body mass index (BMI) of at least 25 kg/m². Their mean age was 52 years, mean BMI was 32, and mean NAS was 5.0.

The patients downloaded the NASH app onto their phones and entered their baseline profile information, including age, gender, diet and exercise practices, and social characteristics. On the basis of this information and daily weight measurements, the system proposed lifestyle improvement programs tailored to each individual. Its chatbot presented them in the form of behavioral goals and lectures from virtual nurses.

While patients used the app for 48 weeks, they also received standard outpatient care for NASH from live physicians, who also promoted the use of the app and provided additional education related to NASH.

The patients underwent liver biopsies within 90 days prior to beginning the study and at the end of 48 weeks. The researchers compared the changes in these patients versus those in a hypothetical control group, which they based on the placebo group in a previous study.

In the patients who used the app, the mean NAS change from baseline to week 48, the main endpoint, was –2.05 (95% confidence interval, –3.00 to –1.11). This result was statistically significant compared with the hypothetical control group, in which the mean change in NAS was –0.7 (P < .001).

In 11 of the patients, NAS decreased by at least 2 points without worsening of liver fibrosis. In eight patients, the researchers observed resolution of steatohepatitis, which they defined as disappearance of hepatocyte ballooning.

In 12 patients with stage F2 or F3 fibrosis, the average stage went from 2.5 to 2.0 (P = .02). No patient with stage F1 fibrosis showed a reduction in fibrosis stage. The scores for steatosis decreased in 11 patients, for lobular inflammation in 9 patients, and for ballooning in 10 patients.

The patients lost an average of 8.3% of their body weight, which was significant, compared with their baseline (P < .001). The patients also notched significant reductions in average serum levels of AST, ALT, gamma-glutamyltransferase, alkaline phosphatase, and triglycerides.

The researchers noted that the lack of a real control group and the small size of the study population limited the importance of their findings. A larger randomized, controlled trial is needed to confirm their results.

During the study, physicians browsed the patients’ data and provided them with feedback about it, the researchers wrote. But the study did not measure the amount of time the physicians spent on this activity.

CureApp founded the study, and one of the authors is a consultant for the company.

A version of this article first appeared on Medscape.com.

A smartphone chatbot that gives lifestyle advice may help people with nonalcoholic steatohepatitis (NASH) improve their liver health, researchers say.

After 48 weeks, nonalcoholic fatty liver disease activity scores (NAS) improved in 13 out of 19 patients who used the NASH app developed by CureApp, according to Masaya Sato of the University of Tokyo and colleagues.

If confirmed by a controlled trial, these preliminary results could show promise for digital therapeutics, the researchers stated in an article published in The American Journal of Gastroenterology.

“The widespread use of smartphones, which can process and communicate data in real time, makes them an ideal platform for therapeutic interventions,” they said.

Although lifestyle changes can reduce NASH activity, many patients have difficulty keeping up these changes. Not enough counselors are available to guide patients in healthy practices, and hiring the counselors is expensive, the researchers wrote.

Smartphone applications aimed at instilling healthy behavior have been tried in diabetes, smoking, hypertension, alcoholism, and even cancer, they noted. They wanted to see whether something similar could be done with NASH.

The researchers recruited 19 patients with biopsy-confirmed NASH who consumed no more than moderate amounts of alcohol and had a body mass index (BMI) of at least 25 kg/m². Their mean age was 52 years, mean BMI was 32, and mean NAS was 5.0.

The patients downloaded the NASH app onto their phones and entered their baseline profile information, including age, gender, diet and exercise practices, and social characteristics. On the basis of this information and daily weight measurements, the system proposed lifestyle improvement programs tailored to each individual. Its chatbot presented them in the form of behavioral goals and lectures from virtual nurses.

While patients used the app for 48 weeks, they also received standard outpatient care for NASH from live physicians, who also promoted the use of the app and provided additional education related to NASH.

The patients underwent liver biopsies within 90 days prior to beginning the study and at the end of 48 weeks. The researchers compared the changes in these patients versus those in a hypothetical control group, which they based on the placebo group in a previous study.

In the patients who used the app, the mean NAS change from baseline to week 48, the main endpoint, was –2.05 (95% confidence interval, –3.00 to –1.11). This result was statistically significant compared with the hypothetical control group, in which the mean change in NAS was –0.7 (P < .001).

In 11 of the patients, NAS decreased by at least 2 points without worsening of liver fibrosis. In eight patients, the researchers observed resolution of steatohepatitis, which they defined as disappearance of hepatocyte ballooning.

In 12 patients with stage F2 or F3 fibrosis, the average stage went from 2.5 to 2.0 (P = .02). No patient with stage F1 fibrosis showed a reduction in fibrosis stage. The scores for steatosis decreased in 11 patients, for lobular inflammation in 9 patients, and for ballooning in 10 patients.

The patients lost an average of 8.3% of their body weight, which was significant, compared with their baseline (P < .001). The patients also notched significant reductions in average serum levels of AST, ALT, gamma-glutamyltransferase, alkaline phosphatase, and triglycerides.

The researchers noted that the lack of a real control group and the small size of the study population limited the importance of their findings. A larger randomized, controlled trial is needed to confirm their results.

During the study, physicians browsed the patients’ data and provided them with feedback about it, the researchers wrote. But the study did not measure the amount of time the physicians spent on this activity.

CureApp founded the study, and one of the authors is a consultant for the company.

A version of this article first appeared on Medscape.com.

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new study provides more evidence that endocarditis associated with drug use is a significant and growing health concern, and further demonstrates that this risk has been exacerbated by the COVID-19 pandemic.

The rate of infective endocarditis among individuals in the United States with opioid or cocaine use disorder increased in the 11-year period 2011 to 2022, with the steepest increase logged during the COVID-19 pandemic (2021-2022), according to the study.

A diagnosis of COVID-19 more than doubled the risk for a new diagnosis of endocarditis in patients with either cocaine (hazard ratio, 2.24) or opioid use disorder (HR, 2.23).

“Our data suggests that, in addition to the major social disruption from the pandemic, including disrupted access to health care, COVID-19 infection itself is a significant risk factor for new diagnosis of endocarditis in drug using populations,” authors Nora Volkow, MD, director of the National Institute on Drug Abuse, and colleagues wrote.

“Drug-using populations, particularly those who use cocaine or opioids, have some of the highest risk for endocarditis, and here we show that having a COVID-19 diagnoses further increases this risk,” they added.

The study was published online in Molecular Psychiatry.

The researchers analyzed electronic health record data collected from January 2011 to August 2022 for more than 109 million people across the United States, including more than 736,000 with an opioid use disorder and more than 379,000 with a cocaine use disorder.

In 2011, there were 4 cases of endocarditis per day for every 1 million people with opioid use disorder. By 2022, the rate had increased to 30 cases per day per 1 million people with opioid use disorder.

For people with cocaine use disorder, cases of endocarditis increased from 5 per 1 million in 2011 to 23 per 1 million in 2022.

Among individuals with cocaine or opioid use disorder, the risk of being hospitalized within 180 days following a diagnosis of endocarditis was higher in those with than without COVID-19 (67.5% vs. 58.7%; HR, 1.21). 

The risk of dying within 180 days following new diagnosis of endocarditis was also higher in those with than without COVID-19 (9.2% vs. 8%; HR, 1.16).

The study also showed that Black and Hispanic individuals had a lower risk for COVID-19-associated endocarditis than non-Hispanic White individuals, which is consistent with a higher prevalence of injection drug use in non-Hispanic White populations, compared with Black or Hispanic populations, the researchers pointed out.

Dr. Volkow and colleagues said their findings highlight the need to screen drug users for endocarditis and link them to infectious disease and addiction treatment if they contract COVID-19.

“People with substance use disorder already face major impediments to proper health care due to lack of access and stigma,” Dr. Volkow said in a news release. 

“Proven techniques like syringe service programs, which help people avoid infection from reused or shared injection equipment, can help prevent this often fatal and costly condition,” Dr. Volkow added.

The authors said it will also be important to determine exactly how SARS-CoV-2 viral infection exacerbates the risk for endocarditis in drug users.

Support for the study was provided by the National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute Case Comprehensive Cancer Center. The authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

MADRID – With type 1 diabetes, there can be great differences in terms of epidemiology, genetics, and possible constituent causes, as well as in the course of the disease before and after diagnosis. This point was made evident in the Can We Perform Precision Medicine in T1D? conference.

At the 63rd Congress of the Spanish Society of Endocrinology (SEEN), María José Redondo, MD, PhD, director of research in the division of diabetes and endocrinology at Texas Children’s Hospital Baylor College of Medicine in Houston, noted that delving into this evidence is the “clue” to implementing precision medicine strategies.

“Physiopathologically, there are different forms of type 1 diabetes that must be considered in the therapeutic approach. The objective is to describe this heterogeneity to discover the etiopathogenesis underlying it, so that endotypes can be defined and thus apply precision medicine. This is the paradigm followed by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and other organizations,” said Dr. Redondo.

She added that there have been significant advances in knowledge of factors that account for these epidemiologic and genetic variations. “For example, immunological processes appear to be different in children who develop type 1 diabetes at a young age, compared with those who present with the disease later in life.”

Metabolic factors are also involved in the development of type 1 diabetes in adolescents and adults, “and this metabolic heterogeneity is a very important aspect, since we currently use only glucose to diagnose diabetes and especially to classify it as type 1 when other factors should really be measured, such as C-peptide, since it has been seen that people with high levels of this peptide present a process that is closer to type 2 diabetes and have atypical characteristics for type 1 diabetes that are more like type 2 diabetes (obesity, older age, lack of typically genetic factors associated with type 1 diabetes),” noted Dr. Redondo.
 

Eluding classification

The specialist added that this evidence suggests a need to review the classification of the different types of diabetes. “The current general classification distinguishes type 1 diabetes, type 2 diabetes, gestational diabetes, monogenic (neonatal) diabetes, monogenic diabetes associated with cystic fibrosis, pancreatogenic, steroid-induced, and posttransplantation diabetes. However, in clinical practice, cases that are very difficult to diagnose and classify emerge, such as autoimmune diabetes, type 1 diabetes in people with insulin resistance, positive antibodies for type 2 diabetes, for example, in children with obesity (in which it is not known whether it is type 1 or type 2 diabetes), drug-induced diabetes in cases of insulin resistance, autoimmune type 1 diabetes with persistent C-peptide, or monogenic diabetes in people with obesity.

“Therefore, the current classification does not help to guide prevention or treatment, and the heterogeneity of the pathology is not as clear as we would like. Since, for example, insulin resistance affects both types of diabetes, inflammation exists in both cases, and the genes that give beta cell secretion defects exist in monogenic diabetes and probably in type 2 diabetes as well. It can be argued that type 2 diabetes is like a backdrop to a lot of diabetes that we know of so far and that it interacts with other factors that have happened to the particular person,” said Dr. Redondo.

“Furthermore, it has been shown that metformin can improve insulin resistance and cardiovascular events in patients with type 1 diabetes with obesity. On the other hand, most patients with type 2 diabetes do not need insulin after diagnosis, except for pediatric patients and those with positive antibodies who require insulin quickly. Added to this is the inability to differentiate between responders and nonresponders to immunomodulators in the prevention of type 1 diabetes, all of which highlights that there are pathogenic processes that can appear in different types of diabetes, which is why the current classification leaves out cases that do not clearly fit into a single disease type, while many people with the same diagnosis actually have very different diseases,” she pointed out.
 

Toward precision diagnostics

“Encapsulating” all these factors is the first step to applying precision medicine in type 1 diabetes, an area, Dr. Redondo explained, in which concrete actions are being carried out. “One of these actions is to determine BMI [body mass index], which has been incorporated into the diabetes prediction strategy that we use in clinical trials, since we know that people with a high BMI, along with other factors, clearly have a different risk. Likewise, we’ve seen that teplizumab could work better in the prevention of type 1 diabetes in individuals with anti-islet antibodies and that people who have the DR4 gene respond better than those who don’t have it and that those with the DR3 gene respond worse.”

Other recent advances along these lines involve the identification of treatments that can delay or even prevent the development of type 1 diabetes in people with positive antibodies, as well as the development of algorithms and models to predict who will develop the disease, thus placing preventive treatments within reach.

“The objective is to use all available information from each individual to understand the etiology and pathogenesis of the disease at a given moment, knowing that changes occur throughout life, and this also applies to other types of diabetes. The next step is to discover and test pathogenesis-focused therapeutic strategies with the most clinical impact in each patient at any given time,” said Dr. Redondo.
 

Technological tools

The specialist referred to recent advances in diabetes technology, especially semiclosed systems (such as a sensor/pump) that, in her opinion, have radically changed the control of the disease. “However, the main objective is to make type 1 diabetes preventable or reversible in people who have developed it,” she said.

Fernando Gómez-Peralta, MD, PhD, elected coordinator of the Diabetes Department at SEEN and head of the endocrinology and nutrition unit of General Hospital of Segovia, Spain, spoke about these technological advances in his presentation, “Technology and Diabetes: Clinical Experiences,” which was organized in collaboration with the Spanish Diabetes Society.

According to this expert, technological and digital tools are changing the daily lives of people with this disease. “Continuous glucose monitoring and new connected insulin pen and cap systems have increased the benefits for users of treatment with new insulins, for example,” said Dr. Gómez-Peralta.

He explained that most systems make it possible to access complete data regarding glycemic control and the treatment received and to share them with caregivers, professionals, and family members. “Some integrated insulin pump and sensor systems have self-adjusting insulin therapy algorithms that have been shown to greatly increase time-to-target glucose and reduce hypoglycemic events,” he said.

“Regarding glucose monitoring, there are devices with a longer duration (up to 2 weeks) and precision that are characterized by easier use for the patient, avoiding the need for calibration, with annoying capillary blood glucose levels.”

In the case of insulin administration, it is anticipated that in the future, some models will have very interesting features, Dr. Gómez-Peralta said. “Integrated closed-loop glucose sensor and insulin pump systems that have self-adjusting algorithms, regardless of the user, are highly effective and safe, and clearly improve glycemic control.

“For users of insulin injections, connected pens allow the integration of dynamic glucose information with doses, as well as the integration of user support tools for insulin adjustment,” Dr. Gómez-Peralta added.

The specialist stressed that a challenge for the future is to reduce the digital divide so as to increase the capacity and motivation to access these options. “In the coming years, health systems will have to face significant cost so that these systems are made available to all patients, and it is necessary to provide the systems with more material and human resources so that they can be integrated with our endocrinology and diabetes services and units.”

Dr. Redondo and Dr. Gómez-Peralta have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish edition and a version appeared on Medscape.com.

MADRID – With type 1 diabetes, there can be great differences in terms of epidemiology, genetics, and possible constituent causes, as well as in the course of the disease before and after diagnosis. This point was made evident in the Can We Perform Precision Medicine in T1D? conference.

At the 63rd Congress of the Spanish Society of Endocrinology (SEEN), María José Redondo, MD, PhD, director of research in the division of diabetes and endocrinology at Texas Children’s Hospital Baylor College of Medicine in Houston, noted that delving into this evidence is the “clue” to implementing precision medicine strategies.

“Physiopathologically, there are different forms of type 1 diabetes that must be considered in the therapeutic approach. The objective is to describe this heterogeneity to discover the etiopathogenesis underlying it, so that endotypes can be defined and thus apply precision medicine. This is the paradigm followed by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and other organizations,” said Dr. Redondo.

She added that there have been significant advances in knowledge of factors that account for these epidemiologic and genetic variations. “For example, immunological processes appear to be different in children who develop type 1 diabetes at a young age, compared with those who present with the disease later in life.”

Metabolic factors are also involved in the development of type 1 diabetes in adolescents and adults, “and this metabolic heterogeneity is a very important aspect, since we currently use only glucose to diagnose diabetes and especially to classify it as type 1 when other factors should really be measured, such as C-peptide, since it has been seen that people with high levels of this peptide present a process that is closer to type 2 diabetes and have atypical characteristics for type 1 diabetes that are more like type 2 diabetes (obesity, older age, lack of typically genetic factors associated with type 1 diabetes),” noted Dr. Redondo.
 

Eluding classification

The specialist added that this evidence suggests a need to review the classification of the different types of diabetes. “The current general classification distinguishes type 1 diabetes, type 2 diabetes, gestational diabetes, monogenic (neonatal) diabetes, monogenic diabetes associated with cystic fibrosis, pancreatogenic, steroid-induced, and posttransplantation diabetes. However, in clinical practice, cases that are very difficult to diagnose and classify emerge, such as autoimmune diabetes, type 1 diabetes in people with insulin resistance, positive antibodies for type 2 diabetes, for example, in children with obesity (in which it is not known whether it is type 1 or type 2 diabetes), drug-induced diabetes in cases of insulin resistance, autoimmune type 1 diabetes with persistent C-peptide, or monogenic diabetes in people with obesity.

“Therefore, the current classification does not help to guide prevention or treatment, and the heterogeneity of the pathology is not as clear as we would like. Since, for example, insulin resistance affects both types of diabetes, inflammation exists in both cases, and the genes that give beta cell secretion defects exist in monogenic diabetes and probably in type 2 diabetes as well. It can be argued that type 2 diabetes is like a backdrop to a lot of diabetes that we know of so far and that it interacts with other factors that have happened to the particular person,” said Dr. Redondo.

“Furthermore, it has been shown that metformin can improve insulin resistance and cardiovascular events in patients with type 1 diabetes with obesity. On the other hand, most patients with type 2 diabetes do not need insulin after diagnosis, except for pediatric patients and those with positive antibodies who require insulin quickly. Added to this is the inability to differentiate between responders and nonresponders to immunomodulators in the prevention of type 1 diabetes, all of which highlights that there are pathogenic processes that can appear in different types of diabetes, which is why the current classification leaves out cases that do not clearly fit into a single disease type, while many people with the same diagnosis actually have very different diseases,” she pointed out.
 

Toward precision diagnostics

“Encapsulating” all these factors is the first step to applying precision medicine in type 1 diabetes, an area, Dr. Redondo explained, in which concrete actions are being carried out. “One of these actions is to determine BMI [body mass index], which has been incorporated into the diabetes prediction strategy that we use in clinical trials, since we know that people with a high BMI, along with other factors, clearly have a different risk. Likewise, we’ve seen that teplizumab could work better in the prevention of type 1 diabetes in individuals with anti-islet antibodies and that people who have the DR4 gene respond better than those who don’t have it and that those with the DR3 gene respond worse.”

Other recent advances along these lines involve the identification of treatments that can delay or even prevent the development of type 1 diabetes in people with positive antibodies, as well as the development of algorithms and models to predict who will develop the disease, thus placing preventive treatments within reach.

“The objective is to use all available information from each individual to understand the etiology and pathogenesis of the disease at a given moment, knowing that changes occur throughout life, and this also applies to other types of diabetes. The next step is to discover and test pathogenesis-focused therapeutic strategies with the most clinical impact in each patient at any given time,” said Dr. Redondo.
 

Technological tools

The specialist referred to recent advances in diabetes technology, especially semiclosed systems (such as a sensor/pump) that, in her opinion, have radically changed the control of the disease. “However, the main objective is to make type 1 diabetes preventable or reversible in people who have developed it,” she said.

Fernando Gómez-Peralta, MD, PhD, elected coordinator of the Diabetes Department at SEEN and head of the endocrinology and nutrition unit of General Hospital of Segovia, Spain, spoke about these technological advances in his presentation, “Technology and Diabetes: Clinical Experiences,” which was organized in collaboration with the Spanish Diabetes Society.

According to this expert, technological and digital tools are changing the daily lives of people with this disease. “Continuous glucose monitoring and new connected insulin pen and cap systems have increased the benefits for users of treatment with new insulins, for example,” said Dr. Gómez-Peralta.

He explained that most systems make it possible to access complete data regarding glycemic control and the treatment received and to share them with caregivers, professionals, and family members. “Some integrated insulin pump and sensor systems have self-adjusting insulin therapy algorithms that have been shown to greatly increase time-to-target glucose and reduce hypoglycemic events,” he said.

“Regarding glucose monitoring, there are devices with a longer duration (up to 2 weeks) and precision that are characterized by easier use for the patient, avoiding the need for calibration, with annoying capillary blood glucose levels.”

In the case of insulin administration, it is anticipated that in the future, some models will have very interesting features, Dr. Gómez-Peralta said. “Integrated closed-loop glucose sensor and insulin pump systems that have self-adjusting algorithms, regardless of the user, are highly effective and safe, and clearly improve glycemic control.

“For users of insulin injections, connected pens allow the integration of dynamic glucose information with doses, as well as the integration of user support tools for insulin adjustment,” Dr. Gómez-Peralta added.

The specialist stressed that a challenge for the future is to reduce the digital divide so as to increase the capacity and motivation to access these options. “In the coming years, health systems will have to face significant cost so that these systems are made available to all patients, and it is necessary to provide the systems with more material and human resources so that they can be integrated with our endocrinology and diabetes services and units.”

Dr. Redondo and Dr. Gómez-Peralta have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish edition and a version appeared on Medscape.com.

MADRID – With type 1 diabetes, there can be great differences in terms of epidemiology, genetics, and possible constituent causes, as well as in the course of the disease before and after diagnosis. This point was made evident in the Can We Perform Precision Medicine in T1D? conference.

At the 63rd Congress of the Spanish Society of Endocrinology (SEEN), María José Redondo, MD, PhD, director of research in the division of diabetes and endocrinology at Texas Children’s Hospital Baylor College of Medicine in Houston, noted that delving into this evidence is the “clue” to implementing precision medicine strategies.

“Physiopathologically, there are different forms of type 1 diabetes that must be considered in the therapeutic approach. The objective is to describe this heterogeneity to discover the etiopathogenesis underlying it, so that endotypes can be defined and thus apply precision medicine. This is the paradigm followed by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and other organizations,” said Dr. Redondo.

She added that there have been significant advances in knowledge of factors that account for these epidemiologic and genetic variations. “For example, immunological processes appear to be different in children who develop type 1 diabetes at a young age, compared with those who present with the disease later in life.”

Metabolic factors are also involved in the development of type 1 diabetes in adolescents and adults, “and this metabolic heterogeneity is a very important aspect, since we currently use only glucose to diagnose diabetes and especially to classify it as type 1 when other factors should really be measured, such as C-peptide, since it has been seen that people with high levels of this peptide present a process that is closer to type 2 diabetes and have atypical characteristics for type 1 diabetes that are more like type 2 diabetes (obesity, older age, lack of typically genetic factors associated with type 1 diabetes),” noted Dr. Redondo.
 

Eluding classification

The specialist added that this evidence suggests a need to review the classification of the different types of diabetes. “The current general classification distinguishes type 1 diabetes, type 2 diabetes, gestational diabetes, monogenic (neonatal) diabetes, monogenic diabetes associated with cystic fibrosis, pancreatogenic, steroid-induced, and posttransplantation diabetes. However, in clinical practice, cases that are very difficult to diagnose and classify emerge, such as autoimmune diabetes, type 1 diabetes in people with insulin resistance, positive antibodies for type 2 diabetes, for example, in children with obesity (in which it is not known whether it is type 1 or type 2 diabetes), drug-induced diabetes in cases of insulin resistance, autoimmune type 1 diabetes with persistent C-peptide, or monogenic diabetes in people with obesity.

“Therefore, the current classification does not help to guide prevention or treatment, and the heterogeneity of the pathology is not as clear as we would like. Since, for example, insulin resistance affects both types of diabetes, inflammation exists in both cases, and the genes that give beta cell secretion defects exist in monogenic diabetes and probably in type 2 diabetes as well. It can be argued that type 2 diabetes is like a backdrop to a lot of diabetes that we know of so far and that it interacts with other factors that have happened to the particular person,” said Dr. Redondo.

“Furthermore, it has been shown that metformin can improve insulin resistance and cardiovascular events in patients with type 1 diabetes with obesity. On the other hand, most patients with type 2 diabetes do not need insulin after diagnosis, except for pediatric patients and those with positive antibodies who require insulin quickly. Added to this is the inability to differentiate between responders and nonresponders to immunomodulators in the prevention of type 1 diabetes, all of which highlights that there are pathogenic processes that can appear in different types of diabetes, which is why the current classification leaves out cases that do not clearly fit into a single disease type, while many people with the same diagnosis actually have very different diseases,” she pointed out.
 

Toward precision diagnostics

“Encapsulating” all these factors is the first step to applying precision medicine in type 1 diabetes, an area, Dr. Redondo explained, in which concrete actions are being carried out. “One of these actions is to determine BMI [body mass index], which has been incorporated into the diabetes prediction strategy that we use in clinical trials, since we know that people with a high BMI, along with other factors, clearly have a different risk. Likewise, we’ve seen that teplizumab could work better in the prevention of type 1 diabetes in individuals with anti-islet antibodies and that people who have the DR4 gene respond better than those who don’t have it and that those with the DR3 gene respond worse.”

Other recent advances along these lines involve the identification of treatments that can delay or even prevent the development of type 1 diabetes in people with positive antibodies, as well as the development of algorithms and models to predict who will develop the disease, thus placing preventive treatments within reach.

“The objective is to use all available information from each individual to understand the etiology and pathogenesis of the disease at a given moment, knowing that changes occur throughout life, and this also applies to other types of diabetes. The next step is to discover and test pathogenesis-focused therapeutic strategies with the most clinical impact in each patient at any given time,” said Dr. Redondo.
 

Technological tools

The specialist referred to recent advances in diabetes technology, especially semiclosed systems (such as a sensor/pump) that, in her opinion, have radically changed the control of the disease. “However, the main objective is to make type 1 diabetes preventable or reversible in people who have developed it,” she said.

Fernando Gómez-Peralta, MD, PhD, elected coordinator of the Diabetes Department at SEEN and head of the endocrinology and nutrition unit of General Hospital of Segovia, Spain, spoke about these technological advances in his presentation, “Technology and Diabetes: Clinical Experiences,” which was organized in collaboration with the Spanish Diabetes Society.

According to this expert, technological and digital tools are changing the daily lives of people with this disease. “Continuous glucose monitoring and new connected insulin pen and cap systems have increased the benefits for users of treatment with new insulins, for example,” said Dr. Gómez-Peralta.

He explained that most systems make it possible to access complete data regarding glycemic control and the treatment received and to share them with caregivers, professionals, and family members. “Some integrated insulin pump and sensor systems have self-adjusting insulin therapy algorithms that have been shown to greatly increase time-to-target glucose and reduce hypoglycemic events,” he said.

“Regarding glucose monitoring, there are devices with a longer duration (up to 2 weeks) and precision that are characterized by easier use for the patient, avoiding the need for calibration, with annoying capillary blood glucose levels.”

In the case of insulin administration, it is anticipated that in the future, some models will have very interesting features, Dr. Gómez-Peralta said. “Integrated closed-loop glucose sensor and insulin pump systems that have self-adjusting algorithms, regardless of the user, are highly effective and safe, and clearly improve glycemic control.

“For users of insulin injections, connected pens allow the integration of dynamic glucose information with doses, as well as the integration of user support tools for insulin adjustment,” Dr. Gómez-Peralta added.

The specialist stressed that a challenge for the future is to reduce the digital divide so as to increase the capacity and motivation to access these options. “In the coming years, health systems will have to face significant cost so that these systems are made available to all patients, and it is necessary to provide the systems with more material and human resources so that they can be integrated with our endocrinology and diabetes services and units.”

Dr. Redondo and Dr. Gómez-Peralta have disclosed no relevant financial relationships.

This article was translated from the Medscape Spanish edition and a version appeared on Medscape.com.

The patient is diagnosed with atopic dermatitis (AD) complicated by skin infection. 

AD is the most common chronic pruritic inflammatory skin disorder that affects both children and adults. In the United States, up to 18% of children and 7% of adults are affected. Atopic dermatitis is associated with diminished quality of life, including disruption in activities of daily living, sleep disturbance, depression, and anxiety. Moreover, patients with AD have an increased risk for infections. A significantly higher prevalence of cutaneous and systemic infections is seen in patients with AD compared with individuals without AD.

Bacterial infections are common in AD and are usually caused by Staphylococcus aureus. Examples include impetigo, which typically presents with oozing serum that dries, resulting in a honey-crusted appearance surrounded by an erythematous base. Fluid-filled blisters (bullous impetigo) may also be present, which can be mistaken for eczema herpeticum (EH).

Nonpurulent skin and soft tissue infections (SSTIs) include erysipelas and cellulitis. In most cases, these infections begin in a focal skin area but spread rapidly across the affected sites such as the arms, legs, trunk, or face. Signs typically include focal erythema, swelling, warmth, and tenderness; fever and bacteremia may also be present. 

Purulent SSTIs present as skin abscesses, involving fluctuant or nonfluctuant nodules or pustules surrounded by an erythematous swelling; the lesions may also be tender and warm. Methicillin-resistant S aureus (MRSA) is a common cause of purulent SSTIs. 

Systemic complications of SSTI in AD may include bacteremia, osteomyelitis, septic arthritis, or bursitis; less often, endocarditis and staphylococcal scalded skin syndrome may occur. Clinicians should maintain a high index of suspicion for these complications in patients who present with an ill-looking appearance, lethargy, focal point tenderness of the bone, joint swelling, heart murmur, and widespread desquamation. Persistent elevated inflammatory markers (eg, C-reactive protein or erythrocyte sedimentation rate) should increase the level of suspicion.

Nonbacterial infections can occur concurrently with bacterial skin infections and the two can be difficult to distinguish. For example, EH results from the local spread of herpes simplex virus, which has a predilection for AD lesions. Early during EH, skin lesions appear as superficial clusters of dome‐shaped vesicles and/or small, round, punched‐out erosions. With progression, the lesions may become superficially infected with S aureus and may develop the characteristic honey-colored scale of impetigo.

Factors that contribute to the increased prevalence of infections in AD include skin barrier defects, suppression of cutaneous innate immunity by type 2 inflammation, S aureus colonization, allergen sensitivity, filaggrin loss-of-function mutation, and cutaneous dysbiosis. 

Daily skin hydration and moisturization is a fundamental component of treatment for any patient with AD, both to treat the AD and prevent infection. Patients with AD should bathe daily, followed by gentle drying and application of a moisturizer or a prescribed topical medication. Standard topical anti-inflammatory medications, including topical corticosteroids and topical calcineurin inhibitors, improve skin barrier functions and have been reported to decrease S aureus colonization in AD lesions. Similarly, the monoclonal antibody dupilumab has been shown to decrease S aureus colonization and increase microbial diversity.
 
In the presence of an uncomplicated, nonpurulent skin infection, a beta-lactam antibiotic that covers both S aureus and beta-hemolytic streptococci (eg, cefazolin or cephalexin) may be sufficient, depending on clinical response or culture and in consideration of local epidemiology and resistance patterns. For patients with AD who present with a skin abscess, history of MRSA colonization, close contacts with a history of skin infections, or recent hospitalization, coverage for MRSA should be considered. Acceptable oral options for MRSA skin infections include clindamycin, doxycycline, trimethoprim-sulfamethoxazole, and linezolid, assuming that the isolate is susceptible in vitro. Topical mupirocin ointment can be used for patients with minor, localized skin infections (eg, impetigo). 

William D. James, MD, Professor, Department of Dermatology, University of Pennsylvania, Philadelphia.

Disclosure: William D. James, MD, has disclosed the following relevant financial relationships:
Received income in an amount equal to or greater than $250 from: Elsevier.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The patient is diagnosed with atopic dermatitis (AD) complicated by skin infection. 

AD is the most common chronic pruritic inflammatory skin disorder that affects both children and adults. In the United States, up to 18% of children and 7% of adults are affected. Atopic dermatitis is associated with diminished quality of life, including disruption in activities of daily living, sleep disturbance, depression, and anxiety. Moreover, patients with AD have an increased risk for infections. A significantly higher prevalence of cutaneous and systemic infections is seen in patients with AD compared with individuals without AD.

Bacterial infections are common in AD and are usually caused by Staphylococcus aureus. Examples include impetigo, which typically presents with oozing serum that dries, resulting in a honey-crusted appearance surrounded by an erythematous base. Fluid-filled blisters (bullous impetigo) may also be present, which can be mistaken for eczema herpeticum (EH).

Nonpurulent skin and soft tissue infections (SSTIs) include erysipelas and cellulitis. In most cases, these infections begin in a focal skin area but spread rapidly across the affected sites such as the arms, legs, trunk, or face. Signs typically include focal erythema, swelling, warmth, and tenderness; fever and bacteremia may also be present. 

Purulent SSTIs present as skin abscesses, involving fluctuant or nonfluctuant nodules or pustules surrounded by an erythematous swelling; the lesions may also be tender and warm. Methicillin-resistant S aureus (MRSA) is a common cause of purulent SSTIs. 

Systemic complications of SSTI in AD may include bacteremia, osteomyelitis, septic arthritis, or bursitis; less often, endocarditis and staphylococcal scalded skin syndrome may occur. Clinicians should maintain a high index of suspicion for these complications in patients who present with an ill-looking appearance, lethargy, focal point tenderness of the bone, joint swelling, heart murmur, and widespread desquamation. Persistent elevated inflammatory markers (eg, C-reactive protein or erythrocyte sedimentation rate) should increase the level of suspicion.

Nonbacterial infections can occur concurrently with bacterial skin infections and the two can be difficult to distinguish. For example, EH results from the local spread of herpes simplex virus, which has a predilection for AD lesions. Early during EH, skin lesions appear as superficial clusters of dome‐shaped vesicles and/or small, round, punched‐out erosions. With progression, the lesions may become superficially infected with S aureus and may develop the characteristic honey-colored scale of impetigo.

Factors that contribute to the increased prevalence of infections in AD include skin barrier defects, suppression of cutaneous innate immunity by type 2 inflammation, S aureus colonization, allergen sensitivity, filaggrin loss-of-function mutation, and cutaneous dysbiosis. 

Daily skin hydration and moisturization is a fundamental component of treatment for any patient with AD, both to treat the AD and prevent infection. Patients with AD should bathe daily, followed by gentle drying and application of a moisturizer or a prescribed topical medication. Standard topical anti-inflammatory medications, including topical corticosteroids and topical calcineurin inhibitors, improve skin barrier functions and have been reported to decrease S aureus colonization in AD lesions. Similarly, the monoclonal antibody dupilumab has been shown to decrease S aureus colonization and increase microbial diversity.
 
In the presence of an uncomplicated, nonpurulent skin infection, a beta-lactam antibiotic that covers both S aureus and beta-hemolytic streptococci (eg, cefazolin or cephalexin) may be sufficient, depending on clinical response or culture and in consideration of local epidemiology and resistance patterns. For patients with AD who present with a skin abscess, history of MRSA colonization, close contacts with a history of skin infections, or recent hospitalization, coverage for MRSA should be considered. Acceptable oral options for MRSA skin infections include clindamycin, doxycycline, trimethoprim-sulfamethoxazole, and linezolid, assuming that the isolate is susceptible in vitro. Topical mupirocin ointment can be used for patients with minor, localized skin infections (eg, impetigo). 

William D. James, MD, Professor, Department of Dermatology, University of Pennsylvania, Philadelphia.

Disclosure: William D. James, MD, has disclosed the following relevant financial relationships:
Received income in an amount equal to or greater than $250 from: Elsevier.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The patient is diagnosed with atopic dermatitis (AD) complicated by skin infection. 

AD is the most common chronic pruritic inflammatory skin disorder that affects both children and adults. In the United States, up to 18% of children and 7% of adults are affected. Atopic dermatitis is associated with diminished quality of life, including disruption in activities of daily living, sleep disturbance, depression, and anxiety. Moreover, patients with AD have an increased risk for infections. A significantly higher prevalence of cutaneous and systemic infections is seen in patients with AD compared with individuals without AD.

Bacterial infections are common in AD and are usually caused by Staphylococcus aureus. Examples include impetigo, which typically presents with oozing serum that dries, resulting in a honey-crusted appearance surrounded by an erythematous base. Fluid-filled blisters (bullous impetigo) may also be present, which can be mistaken for eczema herpeticum (EH).

Nonpurulent skin and soft tissue infections (SSTIs) include erysipelas and cellulitis. In most cases, these infections begin in a focal skin area but spread rapidly across the affected sites such as the arms, legs, trunk, or face. Signs typically include focal erythema, swelling, warmth, and tenderness; fever and bacteremia may also be present. 

Purulent SSTIs present as skin abscesses, involving fluctuant or nonfluctuant nodules or pustules surrounded by an erythematous swelling; the lesions may also be tender and warm. Methicillin-resistant S aureus (MRSA) is a common cause of purulent SSTIs. 

Systemic complications of SSTI in AD may include bacteremia, osteomyelitis, septic arthritis, or bursitis; less often, endocarditis and staphylococcal scalded skin syndrome may occur. Clinicians should maintain a high index of suspicion for these complications in patients who present with an ill-looking appearance, lethargy, focal point tenderness of the bone, joint swelling, heart murmur, and widespread desquamation. Persistent elevated inflammatory markers (eg, C-reactive protein or erythrocyte sedimentation rate) should increase the level of suspicion.

Nonbacterial infections can occur concurrently with bacterial skin infections and the two can be difficult to distinguish. For example, EH results from the local spread of herpes simplex virus, which has a predilection for AD lesions. Early during EH, skin lesions appear as superficial clusters of dome‐shaped vesicles and/or small, round, punched‐out erosions. With progression, the lesions may become superficially infected with S aureus and may develop the characteristic honey-colored scale of impetigo.

Factors that contribute to the increased prevalence of infections in AD include skin barrier defects, suppression of cutaneous innate immunity by type 2 inflammation, S aureus colonization, allergen sensitivity, filaggrin loss-of-function mutation, and cutaneous dysbiosis. 

Daily skin hydration and moisturization is a fundamental component of treatment for any patient with AD, both to treat the AD and prevent infection. Patients with AD should bathe daily, followed by gentle drying and application of a moisturizer or a prescribed topical medication. Standard topical anti-inflammatory medications, including topical corticosteroids and topical calcineurin inhibitors, improve skin barrier functions and have been reported to decrease S aureus colonization in AD lesions. Similarly, the monoclonal antibody dupilumab has been shown to decrease S aureus colonization and increase microbial diversity.
 
In the presence of an uncomplicated, nonpurulent skin infection, a beta-lactam antibiotic that covers both S aureus and beta-hemolytic streptococci (eg, cefazolin or cephalexin) may be sufficient, depending on clinical response or culture and in consideration of local epidemiology and resistance patterns. For patients with AD who present with a skin abscess, history of MRSA colonization, close contacts with a history of skin infections, or recent hospitalization, coverage for MRSA should be considered. Acceptable oral options for MRSA skin infections include clindamycin, doxycycline, trimethoprim-sulfamethoxazole, and linezolid, assuming that the isolate is susceptible in vitro. Topical mupirocin ointment can be used for patients with minor, localized skin infections (eg, impetigo). 

William D. James, MD, Professor, Department of Dermatology, University of Pennsylvania, Philadelphia.

Disclosure: William D. James, MD, has disclosed the following relevant financial relationships:
Received income in an amount equal to or greater than $250 from: Elsevier.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

A new drug application for a first-in-class photodynamic (PDT) therapy for treating early-stage cutaneous T-cell lymphoma (CTCL) has been submitted to the Food and Drug Administration based on phase 3 findings published in JAMA Dermatology.

The treatment employs an ointment formulation of synthetic hypericin (HyBryte), a photosensitizer, that is preferentially absorbed into malignant cells and activated with visible light – rather than ultraviolet light – approximately 24 hours later. Investigators saw significant clinical responses in both patch and plaque type lesions and across races during the 24-week placebo-controlled, double-blinded, phase 3, randomized clinical trial.

“Traditional phototherapy, ultraviolet B phototherapy, has a limited depth of penetration, so patients with thicker plaque lesions don’t respond as well ... and UVB phototherapy typically is less effective in penetrating pigmented skin,” Ellen J. Kim, MD, lead author of the FLASH phase 3 trial, said in an interview.

Visible light in the yellow-red spectrum (500-650 nm) “penetrates deeper into the skin” and is nonmutagenic in vitro, so “theoretically it should have a much more favorable long-term safety profile,” said Dr. Kim, a dermatologist at the University of Pennsylvania, Philadelphia.

Currently, she said, the risk of secondary malignancies inherent with UV PDT, including melanoma, is a deterrent for some patients, especially “patients with really fair skin and a history of skin cancer.”

Hypericin PDT also seems well suited for use with an at-home light unit. “In our field, it’s not about which therapy is [universally] better or best, but a matter of what works best for each patient at that moment in time, depending on the side-effect profile and other issues such as access,” Dr. Kim said. “It will be great to have another option for an incurable disease that requires chronic management.”

Mycosis fungoides (MF)/CTCL is considered an orphan disease, and the treatment has received orphan drug and fast track designations from the FDA, and orphan designation from the European Medicines Agency, according to a press release from its developer, Soligenix. The company is anticipating potential approval in the second half of 2023 and is targeting early 2024 for a U.S. launch, the statement said.

Phase 3 results

The pivotal trial involved 169 patients at 39 academic and community-based U.S. medical centers and consisted of several 6-week cycles of twice-weekly treatment punctuated by 2-week breaks. In cycle 1, patients were randomized 2:1 to receive hypericin or placebo treatment of three index lesions. Cycle 2 involved the crossover of placebo patients to active treatment of index lesions, and cycle 3 (optional) involved open-label treatment of all desired lesions (index and nonindex).

The trial defined the primary endpoint in phase 1 as 50% or greater improvement in the modified Composite Assessment of Index Lesion Severity score – a tool that’s endorsed by U.S. and international MF/CTCL specialty group consensus guidelines. For cycles 2 and 3, open-label response rates were secondary endpoints. Responses were assessed after 2-week rest periods to allow for treatment-induced skin reactions to subside.

After one cycle of treatment, topical hypericin PDT was more effective than placebo (an index lesion response rate of 16% vs. 4%; P =.04). The index lesion response rate with treatment increased to 40% after two cycles and 49% after three cycles. All were statistically significant changes.

Response rates were similar in patch and plaque-type lesions and regardless of age, sex, race, stage IA versus IB, time since diagnosis, and number of prior therapies. Adverse events were primarily mild application-site skin reactions. No serious drug-related adverse events occurred, Dr. Kim said, and “we had a low drop-out rate overall.”
 

Into the real world

The 24-week phase 3 trial duration is short, considering that “typically, phototherapy takes between 4 to 24 months [to achieve] full responses in CTCL,” Dr. Kim said in the interview.

So with real-world application, she said, “we’ll want to see where the overall response peaks with longer treatment, what the effects are of continuous treatment without any built-in breaks, and whether we will indeed see less skin cancer development in patients who are at higher risk of developing skin cancers from light treatment.”

Such questions will be explored as part of a new 4-year, 50-patient, open-label, multicenter study with the primary aim of investigating home-based hypericin PDT therapy in a supervised setting, said Dr. Kim, principal investigator of this study. Patients who are doing well after 6 weeks of twice-weekly therapy will be given at-home light units to continue therapy and achieve 1 year of treatment with no breaks. They will be monitored with video-based telemedicine.

“Long term, having a home unit should really improve patient access and compliance and hopefully effectiveness,” Dr. Kim said. Based on the phase 3 experience, “we think that continuous treatment will be well tolerated and that we may see greater responses.”

On Dec. 19, Soligenix announced that enrollment had begun in a phase 2a study of synthetic hypericin for treating patients with mild to moderate psoriasis.

Dr. Kim reported to JAMA Dermatology grants from Innate Pharma and Galderma; consulting/advisory fees from Almirall, Galderma, and Helsinn; and honoraria from Ology and UptoDate.

A new drug application for a first-in-class photodynamic (PDT) therapy for treating early-stage cutaneous T-cell lymphoma (CTCL) has been submitted to the Food and Drug Administration based on phase 3 findings published in JAMA Dermatology.

The treatment employs an ointment formulation of synthetic hypericin (HyBryte), a photosensitizer, that is preferentially absorbed into malignant cells and activated with visible light – rather than ultraviolet light – approximately 24 hours later. Investigators saw significant clinical responses in both patch and plaque type lesions and across races during the 24-week placebo-controlled, double-blinded, phase 3, randomized clinical trial.

“Traditional phototherapy, ultraviolet B phototherapy, has a limited depth of penetration, so patients with thicker plaque lesions don’t respond as well ... and UVB phototherapy typically is less effective in penetrating pigmented skin,” Ellen J. Kim, MD, lead author of the FLASH phase 3 trial, said in an interview.

Visible light in the yellow-red spectrum (500-650 nm) “penetrates deeper into the skin” and is nonmutagenic in vitro, so “theoretically it should have a much more favorable long-term safety profile,” said Dr. Kim, a dermatologist at the University of Pennsylvania, Philadelphia.

Currently, she said, the risk of secondary malignancies inherent with UV PDT, including melanoma, is a deterrent for some patients, especially “patients with really fair skin and a history of skin cancer.”

Hypericin PDT also seems well suited for use with an at-home light unit. “In our field, it’s not about which therapy is [universally] better or best, but a matter of what works best for each patient at that moment in time, depending on the side-effect profile and other issues such as access,” Dr. Kim said. “It will be great to have another option for an incurable disease that requires chronic management.”

Mycosis fungoides (MF)/CTCL is considered an orphan disease, and the treatment has received orphan drug and fast track designations from the FDA, and orphan designation from the European Medicines Agency, according to a press release from its developer, Soligenix. The company is anticipating potential approval in the second half of 2023 and is targeting early 2024 for a U.S. launch, the statement said.

Phase 3 results

The pivotal trial involved 169 patients at 39 academic and community-based U.S. medical centers and consisted of several 6-week cycles of twice-weekly treatment punctuated by 2-week breaks. In cycle 1, patients were randomized 2:1 to receive hypericin or placebo treatment of three index lesions. Cycle 2 involved the crossover of placebo patients to active treatment of index lesions, and cycle 3 (optional) involved open-label treatment of all desired lesions (index and nonindex).

The trial defined the primary endpoint in phase 1 as 50% or greater improvement in the modified Composite Assessment of Index Lesion Severity score – a tool that’s endorsed by U.S. and international MF/CTCL specialty group consensus guidelines. For cycles 2 and 3, open-label response rates were secondary endpoints. Responses were assessed after 2-week rest periods to allow for treatment-induced skin reactions to subside.

After one cycle of treatment, topical hypericin PDT was more effective than placebo (an index lesion response rate of 16% vs. 4%; P =.04). The index lesion response rate with treatment increased to 40% after two cycles and 49% after three cycles. All were statistically significant changes.

Response rates were similar in patch and plaque-type lesions and regardless of age, sex, race, stage IA versus IB, time since diagnosis, and number of prior therapies. Adverse events were primarily mild application-site skin reactions. No serious drug-related adverse events occurred, Dr. Kim said, and “we had a low drop-out rate overall.”
 

Into the real world

The 24-week phase 3 trial duration is short, considering that “typically, phototherapy takes between 4 to 24 months [to achieve] full responses in CTCL,” Dr. Kim said in the interview.

So with real-world application, she said, “we’ll want to see where the overall response peaks with longer treatment, what the effects are of continuous treatment without any built-in breaks, and whether we will indeed see less skin cancer development in patients who are at higher risk of developing skin cancers from light treatment.”

Such questions will be explored as part of a new 4-year, 50-patient, open-label, multicenter study with the primary aim of investigating home-based hypericin PDT therapy in a supervised setting, said Dr. Kim, principal investigator of this study. Patients who are doing well after 6 weeks of twice-weekly therapy will be given at-home light units to continue therapy and achieve 1 year of treatment with no breaks. They will be monitored with video-based telemedicine.

“Long term, having a home unit should really improve patient access and compliance and hopefully effectiveness,” Dr. Kim said. Based on the phase 3 experience, “we think that continuous treatment will be well tolerated and that we may see greater responses.”

On Dec. 19, Soligenix announced that enrollment had begun in a phase 2a study of synthetic hypericin for treating patients with mild to moderate psoriasis.

Dr. Kim reported to JAMA Dermatology grants from Innate Pharma and Galderma; consulting/advisory fees from Almirall, Galderma, and Helsinn; and honoraria from Ology and UptoDate.

A new drug application for a first-in-class photodynamic (PDT) therapy for treating early-stage cutaneous T-cell lymphoma (CTCL) has been submitted to the Food and Drug Administration based on phase 3 findings published in JAMA Dermatology.

The treatment employs an ointment formulation of synthetic hypericin (HyBryte), a photosensitizer, that is preferentially absorbed into malignant cells and activated with visible light – rather than ultraviolet light – approximately 24 hours later. Investigators saw significant clinical responses in both patch and plaque type lesions and across races during the 24-week placebo-controlled, double-blinded, phase 3, randomized clinical trial.

“Traditional phototherapy, ultraviolet B phototherapy, has a limited depth of penetration, so patients with thicker plaque lesions don’t respond as well ... and UVB phototherapy typically is less effective in penetrating pigmented skin,” Ellen J. Kim, MD, lead author of the FLASH phase 3 trial, said in an interview.

Visible light in the yellow-red spectrum (500-650 nm) “penetrates deeper into the skin” and is nonmutagenic in vitro, so “theoretically it should have a much more favorable long-term safety profile,” said Dr. Kim, a dermatologist at the University of Pennsylvania, Philadelphia.

Currently, she said, the risk of secondary malignancies inherent with UV PDT, including melanoma, is a deterrent for some patients, especially “patients with really fair skin and a history of skin cancer.”

Hypericin PDT also seems well suited for use with an at-home light unit. “In our field, it’s not about which therapy is [universally] better or best, but a matter of what works best for each patient at that moment in time, depending on the side-effect profile and other issues such as access,” Dr. Kim said. “It will be great to have another option for an incurable disease that requires chronic management.”

Mycosis fungoides (MF)/CTCL is considered an orphan disease, and the treatment has received orphan drug and fast track designations from the FDA, and orphan designation from the European Medicines Agency, according to a press release from its developer, Soligenix. The company is anticipating potential approval in the second half of 2023 and is targeting early 2024 for a U.S. launch, the statement said.

Phase 3 results

The pivotal trial involved 169 patients at 39 academic and community-based U.S. medical centers and consisted of several 6-week cycles of twice-weekly treatment punctuated by 2-week breaks. In cycle 1, patients were randomized 2:1 to receive hypericin or placebo treatment of three index lesions. Cycle 2 involved the crossover of placebo patients to active treatment of index lesions, and cycle 3 (optional) involved open-label treatment of all desired lesions (index and nonindex).

The trial defined the primary endpoint in phase 1 as 50% or greater improvement in the modified Composite Assessment of Index Lesion Severity score – a tool that’s endorsed by U.S. and international MF/CTCL specialty group consensus guidelines. For cycles 2 and 3, open-label response rates were secondary endpoints. Responses were assessed after 2-week rest periods to allow for treatment-induced skin reactions to subside.

After one cycle of treatment, topical hypericin PDT was more effective than placebo (an index lesion response rate of 16% vs. 4%; P =.04). The index lesion response rate with treatment increased to 40% after two cycles and 49% after three cycles. All were statistically significant changes.

Response rates were similar in patch and plaque-type lesions and regardless of age, sex, race, stage IA versus IB, time since diagnosis, and number of prior therapies. Adverse events were primarily mild application-site skin reactions. No serious drug-related adverse events occurred, Dr. Kim said, and “we had a low drop-out rate overall.”
 

Into the real world

The 24-week phase 3 trial duration is short, considering that “typically, phototherapy takes between 4 to 24 months [to achieve] full responses in CTCL,” Dr. Kim said in the interview.

So with real-world application, she said, “we’ll want to see where the overall response peaks with longer treatment, what the effects are of continuous treatment without any built-in breaks, and whether we will indeed see less skin cancer development in patients who are at higher risk of developing skin cancers from light treatment.”

Such questions will be explored as part of a new 4-year, 50-patient, open-label, multicenter study with the primary aim of investigating home-based hypericin PDT therapy in a supervised setting, said Dr. Kim, principal investigator of this study. Patients who are doing well after 6 weeks of twice-weekly therapy will be given at-home light units to continue therapy and achieve 1 year of treatment with no breaks. They will be monitored with video-based telemedicine.

“Long term, having a home unit should really improve patient access and compliance and hopefully effectiveness,” Dr. Kim said. Based on the phase 3 experience, “we think that continuous treatment will be well tolerated and that we may see greater responses.”

On Dec. 19, Soligenix announced that enrollment had begun in a phase 2a study of synthetic hypericin for treating patients with mild to moderate psoriasis.

Dr. Kim reported to JAMA Dermatology grants from Innate Pharma and Galderma; consulting/advisory fees from Almirall, Galderma, and Helsinn; and honoraria from Ology and UptoDate.

Some solid food diets may aid in the treatment of inflammatory bowel disease (IBD), though the overall quality of evidence remains low and additional data are needed, according to a new report.

For Crohn’s disease, a diet low in refined carbohydrates and a symptoms-guided diet appeared to help with remission, yet reduction of refined carbohydrates or red meat didn’t reduce the risk of relapse. For ulcerative colitis, solid food diets were similar to control measures.

“The Internet has a dizzying array of diet variants touted to benefit inflammation and IBD, which has led to much confusion among patients, and even clinicians, over what is truly effective or not,” Berkeley Limketkai, MD, PhD, director of clinical research at the Center for Inflammatory Bowel Disease at the University of California, Los Angeles, said in an interview.

“Even experiences shared by well-meaning individuals might not be generalizable to others,” he said. “The lack of clarity on what is or is not effective motivated us to perform this systematic review and meta-analysis.”

The study was published online in Clinical Gastroenterology and Hepatology.
 

Analyzing diets

Some nutritional therapies, such as exclusive enteral nutrition, have good evidence to support their use in the treatment of IBD, Dr. Limketkai said. However, patients often find maintaining a liquid diet difficult, particularly over a long period of time, so clinicians and patients have been interested in solid food diets as a treatment for IBD.

In 2019, Dr. Limketkai and colleagues conducted a systematic review and meta-analysis of randomized controlled trials focused on solid food diets for IBD that was published with the Cochrane Collaboration. At that time, the data were considered sparse, and the certainty of evidence was very low or low. Since then, several high-quality trials have been published.

For this study, Dr. Limketkai and colleagues conducted an updated review of 36 studies and a meta-analysis of 27 studies that compared a solid food diet with a control diet in patients with Crohn’s disease or ulcerative colitis. The intervention arm had to involve a well-defined diet, not merely a “usual” diet.

Among the studies, 12 evaluated dietary interventions for inducing clinical remission in patients with active Crohn’s disease, and 639 patients were involved. Overall, a low–refined carbohydrate diet was superior to a high-carbohydrate diet or a low-fiber diet. In addition, a symptoms-guided diet, which sequentially eliminated foods that aggravated a patient’s symptoms, was superior to conventional nutrition advice. However, the studies had serious imprecisions and very low certainty of evidence.

Compared with respective controls, a highly restrictive organic diet, a low-microparticle diet, and a low-calcium diet were ineffective at inducing remission of Crohn’s disease. Studies focused on immunoglobulin G-based measures were also inconsistent.

When comparing diets touted to benefit patients with Crohn’s disease, the Specific Carbohydrate Diet was similar to the Mediterranean diet and the whole-food diet, though the certainty of evidence was low. Partial enteral nutrition was similar to exclusive enteral nutrition, though there was substantial statistical heterogeneity between studies and very low certainty of evidence.

For maintenance of Crohn’s disease remission, researchers evaluated 14 studies that included 1,211 patients with inactive disease. Partial enteral nutrition appeared to reduce the risk of relapse, although evidence certainty was very low. In contrast, reducing red meat or refined carbohydrates did not lower the risk of relapse.

“These findings seemingly contradict our belief that red meat and refined carbohydrates have proinflammatory effects, although there are other studies that appear to show inconsistent, weak, or no association between consumption of unprocessed red meat and disease,” Dr. Limketkai said. “The caveat is that our findings are based on weak evidence, which may change as more studies are performed over time.”

For induction of remission in ulcerative colitis, researchers evaluated three studies that included 124 participants with active disease. When compared with participants’ usual diet, there was no benefit from a diet that excluded symptom-provoking foods, fried foods, refined carbohydrates, additives, preservatives, most condiments, spices, and beverages other than boiled water. Other studies found no benefit from eliminating cow milk protein or gluten.

For maintenance of ulcerative colitis remission, they looked at four studies that included 101 patients with inactive disease. Overall, there was no benefit from a carrageenan-free diet, anti-inflammatory diet, or cow milk protein elimination diet.
 

Helping patients

Although the certainty of evidence remains very low or low for most dietary trials in IBD, the emerging data suggest that nutrition plays an important role in IBD management and should be considered in the overall treatment plan for patients, the study authors wrote.

“Patients continue to look for ways to control their IBD, particularly with diet. Providers continue to struggle with making evidence-based recommendations about dietary interventions for IBD. This systematic review is a useful tool for providers to advise their patients,” James D. Lewis, MD, associate director of the inflammatory bowel diseases program at the University of Pennsylvania, Philadelphia, said in an interview.

Dr. Lewis, who wasn’t involved with this study, has researched dietary interventions for IBD. He and his colleagues have found that reducing red meat does not lower the rate of Crohn’s disease flares and that the Mediterranean diet and Specific Carbohydrate Diet appear to be similar for inducing clinical remission.

Based on this review, partial enteral nutrition could be an option for patients with Crohn’s disease, Dr. Lewis said.

“Partial enteral nutrition is much easier than exclusive enteral nutrition for patients,” he said. “However, there remains uncertainty as to whether the solid food component of a partial enteral nutrition approach impacts outcomes.”

As more dietary studies become available, the certainty of evidence could improve and lead to better recommendations for patients, Dr. Limketkai and colleagues wrote. They are conducting several studies focused on the concept of precision nutrition.

“While certain diets may be helpful and effective for IBD, different diets work differently in different people. This concept is no different than the fact that different IBD medications work differently in different individuals,” Dr. Limketkai said. “However, given the current state of evidence for dietary interventions in IBD, we still have a long path of research ahead of us.”

The study received no funding. The study authors reported no conflicts of interest. Dr. Lewis reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Some solid food diets may aid in the treatment of inflammatory bowel disease (IBD), though the overall quality of evidence remains low and additional data are needed, according to a new report.

For Crohn’s disease, a diet low in refined carbohydrates and a symptoms-guided diet appeared to help with remission, yet reduction of refined carbohydrates or red meat didn’t reduce the risk of relapse. For ulcerative colitis, solid food diets were similar to control measures.

“The Internet has a dizzying array of diet variants touted to benefit inflammation and IBD, which has led to much confusion among patients, and even clinicians, over what is truly effective or not,” Berkeley Limketkai, MD, PhD, director of clinical research at the Center for Inflammatory Bowel Disease at the University of California, Los Angeles, said in an interview.

“Even experiences shared by well-meaning individuals might not be generalizable to others,” he said. “The lack of clarity on what is or is not effective motivated us to perform this systematic review and meta-analysis.”

The study was published online in Clinical Gastroenterology and Hepatology.
 

Analyzing diets

Some nutritional therapies, such as exclusive enteral nutrition, have good evidence to support their use in the treatment of IBD, Dr. Limketkai said. However, patients often find maintaining a liquid diet difficult, particularly over a long period of time, so clinicians and patients have been interested in solid food diets as a treatment for IBD.

In 2019, Dr. Limketkai and colleagues conducted a systematic review and meta-analysis of randomized controlled trials focused on solid food diets for IBD that was published with the Cochrane Collaboration. At that time, the data were considered sparse, and the certainty of evidence was very low or low. Since then, several high-quality trials have been published.

For this study, Dr. Limketkai and colleagues conducted an updated review of 36 studies and a meta-analysis of 27 studies that compared a solid food diet with a control diet in patients with Crohn’s disease or ulcerative colitis. The intervention arm had to involve a well-defined diet, not merely a “usual” diet.

Among the studies, 12 evaluated dietary interventions for inducing clinical remission in patients with active Crohn’s disease, and 639 patients were involved. Overall, a low–refined carbohydrate diet was superior to a high-carbohydrate diet or a low-fiber diet. In addition, a symptoms-guided diet, which sequentially eliminated foods that aggravated a patient’s symptoms, was superior to conventional nutrition advice. However, the studies had serious imprecisions and very low certainty of evidence.

Compared with respective controls, a highly restrictive organic diet, a low-microparticle diet, and a low-calcium diet were ineffective at inducing remission of Crohn’s disease. Studies focused on immunoglobulin G-based measures were also inconsistent.

When comparing diets touted to benefit patients with Crohn’s disease, the Specific Carbohydrate Diet was similar to the Mediterranean diet and the whole-food diet, though the certainty of evidence was low. Partial enteral nutrition was similar to exclusive enteral nutrition, though there was substantial statistical heterogeneity between studies and very low certainty of evidence.

For maintenance of Crohn’s disease remission, researchers evaluated 14 studies that included 1,211 patients with inactive disease. Partial enteral nutrition appeared to reduce the risk of relapse, although evidence certainty was very low. In contrast, reducing red meat or refined carbohydrates did not lower the risk of relapse.

“These findings seemingly contradict our belief that red meat and refined carbohydrates have proinflammatory effects, although there are other studies that appear to show inconsistent, weak, or no association between consumption of unprocessed red meat and disease,” Dr. Limketkai said. “The caveat is that our findings are based on weak evidence, which may change as more studies are performed over time.”

For induction of remission in ulcerative colitis, researchers evaluated three studies that included 124 participants with active disease. When compared with participants’ usual diet, there was no benefit from a diet that excluded symptom-provoking foods, fried foods, refined carbohydrates, additives, preservatives, most condiments, spices, and beverages other than boiled water. Other studies found no benefit from eliminating cow milk protein or gluten.

For maintenance of ulcerative colitis remission, they looked at four studies that included 101 patients with inactive disease. Overall, there was no benefit from a carrageenan-free diet, anti-inflammatory diet, or cow milk protein elimination diet.
 

Helping patients

Although the certainty of evidence remains very low or low for most dietary trials in IBD, the emerging data suggest that nutrition plays an important role in IBD management and should be considered in the overall treatment plan for patients, the study authors wrote.

“Patients continue to look for ways to control their IBD, particularly with diet. Providers continue to struggle with making evidence-based recommendations about dietary interventions for IBD. This systematic review is a useful tool for providers to advise their patients,” James D. Lewis, MD, associate director of the inflammatory bowel diseases program at the University of Pennsylvania, Philadelphia, said in an interview.

Dr. Lewis, who wasn’t involved with this study, has researched dietary interventions for IBD. He and his colleagues have found that reducing red meat does not lower the rate of Crohn’s disease flares and that the Mediterranean diet and Specific Carbohydrate Diet appear to be similar for inducing clinical remission.

Based on this review, partial enteral nutrition could be an option for patients with Crohn’s disease, Dr. Lewis said.

“Partial enteral nutrition is much easier than exclusive enteral nutrition for patients,” he said. “However, there remains uncertainty as to whether the solid food component of a partial enteral nutrition approach impacts outcomes.”

As more dietary studies become available, the certainty of evidence could improve and lead to better recommendations for patients, Dr. Limketkai and colleagues wrote. They are conducting several studies focused on the concept of precision nutrition.

“While certain diets may be helpful and effective for IBD, different diets work differently in different people. This concept is no different than the fact that different IBD medications work differently in different individuals,” Dr. Limketkai said. “However, given the current state of evidence for dietary interventions in IBD, we still have a long path of research ahead of us.”

The study received no funding. The study authors reported no conflicts of interest. Dr. Lewis reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Some solid food diets may aid in the treatment of inflammatory bowel disease (IBD), though the overall quality of evidence remains low and additional data are needed, according to a new report.

For Crohn’s disease, a diet low in refined carbohydrates and a symptoms-guided diet appeared to help with remission, yet reduction of refined carbohydrates or red meat didn’t reduce the risk of relapse. For ulcerative colitis, solid food diets were similar to control measures.

“The Internet has a dizzying array of diet variants touted to benefit inflammation and IBD, which has led to much confusion among patients, and even clinicians, over what is truly effective or not,” Berkeley Limketkai, MD, PhD, director of clinical research at the Center for Inflammatory Bowel Disease at the University of California, Los Angeles, said in an interview.

“Even experiences shared by well-meaning individuals might not be generalizable to others,” he said. “The lack of clarity on what is or is not effective motivated us to perform this systematic review and meta-analysis.”

The study was published online in Clinical Gastroenterology and Hepatology.
 

Analyzing diets

Some nutritional therapies, such as exclusive enteral nutrition, have good evidence to support their use in the treatment of IBD, Dr. Limketkai said. However, patients often find maintaining a liquid diet difficult, particularly over a long period of time, so clinicians and patients have been interested in solid food diets as a treatment for IBD.

In 2019, Dr. Limketkai and colleagues conducted a systematic review and meta-analysis of randomized controlled trials focused on solid food diets for IBD that was published with the Cochrane Collaboration. At that time, the data were considered sparse, and the certainty of evidence was very low or low. Since then, several high-quality trials have been published.

For this study, Dr. Limketkai and colleagues conducted an updated review of 36 studies and a meta-analysis of 27 studies that compared a solid food diet with a control diet in patients with Crohn’s disease or ulcerative colitis. The intervention arm had to involve a well-defined diet, not merely a “usual” diet.

Among the studies, 12 evaluated dietary interventions for inducing clinical remission in patients with active Crohn’s disease, and 639 patients were involved. Overall, a low–refined carbohydrate diet was superior to a high-carbohydrate diet or a low-fiber diet. In addition, a symptoms-guided diet, which sequentially eliminated foods that aggravated a patient’s symptoms, was superior to conventional nutrition advice. However, the studies had serious imprecisions and very low certainty of evidence.

Compared with respective controls, a highly restrictive organic diet, a low-microparticle diet, and a low-calcium diet were ineffective at inducing remission of Crohn’s disease. Studies focused on immunoglobulin G-based measures were also inconsistent.

When comparing diets touted to benefit patients with Crohn’s disease, the Specific Carbohydrate Diet was similar to the Mediterranean diet and the whole-food diet, though the certainty of evidence was low. Partial enteral nutrition was similar to exclusive enteral nutrition, though there was substantial statistical heterogeneity between studies and very low certainty of evidence.

For maintenance of Crohn’s disease remission, researchers evaluated 14 studies that included 1,211 patients with inactive disease. Partial enteral nutrition appeared to reduce the risk of relapse, although evidence certainty was very low. In contrast, reducing red meat or refined carbohydrates did not lower the risk of relapse.

“These findings seemingly contradict our belief that red meat and refined carbohydrates have proinflammatory effects, although there are other studies that appear to show inconsistent, weak, or no association between consumption of unprocessed red meat and disease,” Dr. Limketkai said. “The caveat is that our findings are based on weak evidence, which may change as more studies are performed over time.”

For induction of remission in ulcerative colitis, researchers evaluated three studies that included 124 participants with active disease. When compared with participants’ usual diet, there was no benefit from a diet that excluded symptom-provoking foods, fried foods, refined carbohydrates, additives, preservatives, most condiments, spices, and beverages other than boiled water. Other studies found no benefit from eliminating cow milk protein or gluten.

For maintenance of ulcerative colitis remission, they looked at four studies that included 101 patients with inactive disease. Overall, there was no benefit from a carrageenan-free diet, anti-inflammatory diet, or cow milk protein elimination diet.
 

Helping patients

Although the certainty of evidence remains very low or low for most dietary trials in IBD, the emerging data suggest that nutrition plays an important role in IBD management and should be considered in the overall treatment plan for patients, the study authors wrote.

“Patients continue to look for ways to control their IBD, particularly with diet. Providers continue to struggle with making evidence-based recommendations about dietary interventions for IBD. This systematic review is a useful tool for providers to advise their patients,” James D. Lewis, MD, associate director of the inflammatory bowel diseases program at the University of Pennsylvania, Philadelphia, said in an interview.

Dr. Lewis, who wasn’t involved with this study, has researched dietary interventions for IBD. He and his colleagues have found that reducing red meat does not lower the rate of Crohn’s disease flares and that the Mediterranean diet and Specific Carbohydrate Diet appear to be similar for inducing clinical remission.

Based on this review, partial enteral nutrition could be an option for patients with Crohn’s disease, Dr. Lewis said.

“Partial enteral nutrition is much easier than exclusive enteral nutrition for patients,” he said. “However, there remains uncertainty as to whether the solid food component of a partial enteral nutrition approach impacts outcomes.”

As more dietary studies become available, the certainty of evidence could improve and lead to better recommendations for patients, Dr. Limketkai and colleagues wrote. They are conducting several studies focused on the concept of precision nutrition.

“While certain diets may be helpful and effective for IBD, different diets work differently in different people. This concept is no different than the fact that different IBD medications work differently in different individuals,” Dr. Limketkai said. “However, given the current state of evidence for dietary interventions in IBD, we still have a long path of research ahead of us.”

The study received no funding. The study authors reported no conflicts of interest. Dr. Lewis reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Three cups of tea, two biscuit packs, and a Christmas study from the BMJ

Warning: The following content may contain excessive Britishness. Continue at your own risk.

It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.

PxHere

It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.

In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.

It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.

The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.

In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”

Now there’s a Christmas sentiment we can all get behind.
 

We come not to bury sugar, but to improve it

When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.

Vassiliy Vassilenko/thinkstockphotos.com

The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.

The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.

How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.

This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
 

New genes, or not new genes? That is the question

… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.

Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?

Gio_tto/Thinkstock

Three cups of tea, two biscuit packs, and a Christmas study from the BMJ

Warning: The following content may contain excessive Britishness. Continue at your own risk.

It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.

PxHere

It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.

In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.

It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.

The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.

In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”

Now there’s a Christmas sentiment we can all get behind.
 

We come not to bury sugar, but to improve it

When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.

Vassiliy Vassilenko/thinkstockphotos.com

The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.

The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.

How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.

This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
 

New genes, or not new genes? That is the question

… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.

Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?

Gio_tto/Thinkstock

Three cups of tea, two biscuit packs, and a Christmas study from the BMJ

Warning: The following content may contain excessive Britishness. Continue at your own risk.

It’s no secret that the world economy is in an … interesting spot right now. Belt tightening is occurring around the world despite the holiday season, and hospitals across the pond in Great Britain are no exception.

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It was a simple sign that prompted the study, published in the Christmas edition of the BMJ: “Please do not take excessive quantities of these refreshments.” And if we all know one thing, you do not get between Brits and their tea and biscuits. So the researchers behind the study drafted a survey and sent it around to nearly 2,000 British health care workers and asked what they considered to be excessive consumption of work-provided hot drinks and biscuits.

In the hot drinks department (tea and coffee, though we appreciate the two people who voiced a preference for free hot whiskey, if it was available) the survey participants decreed that 3.32 drinks was the maximum before consumption became excessive. That’s pretty close to the actual number of hot drinks respondents drank daily (3.04), so it’s pretty fair to say that British health care workers do a good job of self-limiting.

It’s much the same story with biscuits: Health care workers reported that consuming 2.25 packets of free biscuits would be excessive. Notably, doctors would take more than nondoctors (2.35 vs. 2.14 – typical doctor behavior), and those who had been in their role for less than 2 years would consume nearly 3 packets a day before calling it quits.

The study did not include an official cost analysis, but calculations conducted on a biscuit wrapper (that’s not a joke, by the way) estimated that the combined cost for providing every National Health Service employee with three free drinks and two free biscuit packages a day would be about 160 million pounds a year. Now, that’s a lot of money for tea and biscuits, but, they added, it’s a meager 0.1% of the NHS annual budget. They also noted that most employees consider free hot drinks a more valuable workplace perk than free support for mental health.

In conclusion, the authors wrote, “As a target for cost-saving initiatives, limiting free refreshment consumption is really scraping the biscuit barrel (although some limits on hot whiskey availability may be necessary), and implementing, or continuing, perks that improve staff morale seems justifiable. … Healthcare employers should allow biscuits and hot drinks to be freely available to staff, and they should leave these grateful recipients to judge for themselves what constitutes reasonable consumption.”

Now there’s a Christmas sentiment we can all get behind.
 

We come not to bury sugar, but to improve it

When we think about sugar, healthy isn’t the first thing that comes to mind. Research also shows that artificial sweeteners, as well as processed foods in general, are bad for your body and brain. People, however, love the stuff. That’s why one of the leading brands in processed foods, Kraft Heinz, partnered with the Wyss Institute for Biologically Inspired Engineering at Harvard to find a way to reduce consumers’ sugar consumption.

Vassiliy Vassilenko/thinkstockphotos.com

The question that Kraft Heinz presented to Wyss was this: How could it reduce the fructose in its products without losing the functionality of regular sugar.

The Wyss team’s approach seems pretty simple: Use a naturally occurring enzyme to convert sugar to fiber. The trick was to add the enzymes into the food so they could convert the sugar to fiber after being consumed. The enzymes also needed to be able to be added to existing food products without changing their existing recipes, Kraft Heinz insisted.

How does it work? The crafted enzyme is encapsulated to remain dormant in the food until exposed to an increased pH level, as is found in the GI tract between the stomach and the intestine. It reduces the amount of sugar absorbed in the bloodstream and creates a healthy prebiotic fiber, the institute explained.

This opens a whole new window for consumers. People with diabetes can enjoy their favorite cookies from time to time, while parents can feel less guilty about their children bathing their chicken nuggets in unholy amounts of ketchup.
 

New genes, or not new genes? That is the question

… and the police report that no capybaras were harmed in the incident. What a relief. Now Action News 8 brings you Carol Espinosa’s exclusive interview with legendary scientist and zombie, Charles Darwin.

Carol: Thanks, Daryl. Tell us, Prof. Darwin, what have you been up to lately?

Gio_tto/Thinkstock