TOPLINE:

Deaths caused by both substance use (SU) and cardiovascular disease (CVD) increased substantially in the United States between 1999 and 2019, with the most pronounced rise among women, American Indians, younger people, rural residents, and users of cannabis and psychostimulants, results of new research suggest.

METHODOLOGY:

• From the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database and using International Classification of Diseases (ICD) codes, researchers collected data on deaths within the United States where both SU and CVD (SU+CVD) were a contributing or an underlying cause and gathered information on location of death (medical facility, home, hospice, nursing home/long-term care facility), demographics (sex, race/ethnicity, age), and region (urban-rural, state).
• Researchers determined crude and age-adjusted mortality rates (AAMRs) per 100,000 population, identified trends in AAMR using annual percent change (APC) and calculated the weighted average of APCs (AAPCs).
• Between 1999 and 2019, there were 636,572 deaths related to CVD+SU, 75.6% of which were among men and 70.6% among non-Hispanic White individuals, with 65% related to alcohol, and where location of death was available, 47.7% occurred in medical facilities.

TAKEAWAY:

• The overall SU+CVD-related AAMR from 1999 to 2019 was 14.3 (95% CI, 14.3-14.3) per 100,000 individuals, with the rate being higher in men (22.5) than in women (6.8) and highest in American Indians or Alaska Natives (37.7) compared with other races/ethnicities.
• Rural areas had higher SU+CVD-related AAMR (15.2; 95% CI, 15.1-15.3) than urban areas, with the District of Columbia having the highest AAMR geographically (25.4), individuals aged 55-69 years having the highest rate agewise (25.1), and alcohol accounting for the highest rate (9.09) among substance types.
• Temporal trends show that the overall SU+CVD-related AAMR increased from 9.9 in 1999 to 21.4 in 2019, a rate that started accelerating in 2012, with an AAPC of 4.0% (95% CI, 3.7-4.3); increases were across all ethnicities and age groups and were particularly pronounced among women (4.8%; 95% CI, 4.5-5.1).
• Cannabis had the highest AAPC of all substances (12.7%), but stimulants had an APC of 21.4 (95% CI, 20.0-22.8) from 2009 to 2019, a period during which stimulants were the fastest-growing substance abuse category.

IN PRACTICE:

These new results identify high-risk groups, which “is crucial for prioritizing preventive measures aiming to reduce substance use and cardiovascular disease-related mortality in these populations,” the researchers wrote.

SOURCE:

Abdul Mannan Khan Minhas, MD, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, and Jakrin Kewcharoen, MD, Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, were co-first authors of the study, which was published online in the Journal of the American Heart Association.

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

TOPLINE:

Deaths caused by both substance use (SU) and cardiovascular disease (CVD) increased substantially in the United States between 1999 and 2019, with the most pronounced rise among women, American Indians, younger people, rural residents, and users of cannabis and psychostimulants, results of new research suggest.

METHODOLOGY:

• From the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database and using International Classification of Diseases (ICD) codes, researchers collected data on deaths within the United States where both SU and CVD (SU+CVD) were a contributing or an underlying cause and gathered information on location of death (medical facility, home, hospice, nursing home/long-term care facility), demographics (sex, race/ethnicity, age), and region (urban-rural, state).
• Researchers determined crude and age-adjusted mortality rates (AAMRs) per 100,000 population, identified trends in AAMR using annual percent change (APC) and calculated the weighted average of APCs (AAPCs).
• Between 1999 and 2019, there were 636,572 deaths related to CVD+SU, 75.6% of which were among men and 70.6% among non-Hispanic White individuals, with 65% related to alcohol, and where location of death was available, 47.7% occurred in medical facilities.

TAKEAWAY:

• The overall SU+CVD-related AAMR from 1999 to 2019 was 14.3 (95% CI, 14.3-14.3) per 100,000 individuals, with the rate being higher in men (22.5) than in women (6.8) and highest in American Indians or Alaska Natives (37.7) compared with other races/ethnicities.
• Rural areas had higher SU+CVD-related AAMR (15.2; 95% CI, 15.1-15.3) than urban areas, with the District of Columbia having the highest AAMR geographically (25.4), individuals aged 55-69 years having the highest rate agewise (25.1), and alcohol accounting for the highest rate (9.09) among substance types.
• Temporal trends show that the overall SU+CVD-related AAMR increased from 9.9 in 1999 to 21.4 in 2019, a rate that started accelerating in 2012, with an AAPC of 4.0% (95% CI, 3.7-4.3); increases were across all ethnicities and age groups and were particularly pronounced among women (4.8%; 95% CI, 4.5-5.1).
• Cannabis had the highest AAPC of all substances (12.7%), but stimulants had an APC of 21.4 (95% CI, 20.0-22.8) from 2009 to 2019, a period during which stimulants were the fastest-growing substance abuse category.

IN PRACTICE:

These new results identify high-risk groups, which “is crucial for prioritizing preventive measures aiming to reduce substance use and cardiovascular disease-related mortality in these populations,” the researchers wrote.

SOURCE:

Abdul Mannan Khan Minhas, MD, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, and Jakrin Kewcharoen, MD, Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, were co-first authors of the study, which was published online in the Journal of the American Heart Association.

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

TOPLINE:

Deaths caused by both substance use (SU) and cardiovascular disease (CVD) increased substantially in the United States between 1999 and 2019, with the most pronounced rise among women, American Indians, younger people, rural residents, and users of cannabis and psychostimulants, results of new research suggest.

METHODOLOGY:

• From the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research (CDC WONDER) database and using International Classification of Diseases (ICD) codes, researchers collected data on deaths within the United States where both SU and CVD (SU+CVD) were a contributing or an underlying cause and gathered information on location of death (medical facility, home, hospice, nursing home/long-term care facility), demographics (sex, race/ethnicity, age), and region (urban-rural, state).
• Researchers determined crude and age-adjusted mortality rates (AAMRs) per 100,000 population, identified trends in AAMR using annual percent change (APC) and calculated the weighted average of APCs (AAPCs).
• Between 1999 and 2019, there were 636,572 deaths related to CVD+SU, 75.6% of which were among men and 70.6% among non-Hispanic White individuals, with 65% related to alcohol, and where location of death was available, 47.7% occurred in medical facilities.

TAKEAWAY:

• The overall SU+CVD-related AAMR from 1999 to 2019 was 14.3 (95% CI, 14.3-14.3) per 100,000 individuals, with the rate being higher in men (22.5) than in women (6.8) and highest in American Indians or Alaska Natives (37.7) compared with other races/ethnicities.
• Rural areas had higher SU+CVD-related AAMR (15.2; 95% CI, 15.1-15.3) than urban areas, with the District of Columbia having the highest AAMR geographically (25.4), individuals aged 55-69 years having the highest rate agewise (25.1), and alcohol accounting for the highest rate (9.09) among substance types.
• Temporal trends show that the overall SU+CVD-related AAMR increased from 9.9 in 1999 to 21.4 in 2019, a rate that started accelerating in 2012, with an AAPC of 4.0% (95% CI, 3.7-4.3); increases were across all ethnicities and age groups and were particularly pronounced among women (4.8%; 95% CI, 4.5-5.1).
• Cannabis had the highest AAPC of all substances (12.7%), but stimulants had an APC of 21.4 (95% CI, 20.0-22.8) from 2009 to 2019, a period during which stimulants were the fastest-growing substance abuse category.

IN PRACTICE:

These new results identify high-risk groups, which “is crucial for prioritizing preventive measures aiming to reduce substance use and cardiovascular disease-related mortality in these populations,” the researchers wrote.

SOURCE:

Abdul Mannan Khan Minhas, MD, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, and Jakrin Kewcharoen, MD, Division of Cardiology, Loma Linda University Medical Center, Loma Linda, California, were co-first authors of the study, which was published online in the Journal of the American Heart Association.

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

Gastroenterology

October 2023

El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.



Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.



Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.



November 2023

Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.



Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.



December 2023

Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.



Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.


 

Clinical Gastroenterology and Hepatology

October 2023

Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.



Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.



November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.



Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.



Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.



December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.



Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.



Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.


 

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.



Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003


 

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.



Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

Gastroenterology

October 2023

El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.



Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.



Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.



November 2023

Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.



Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.



December 2023

Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.



Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.


 

Clinical Gastroenterology and Hepatology

October 2023

Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.



Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.



November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.



Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.



Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.



December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.



Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.



Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.


 

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.



Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003


 

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.



Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

Gastroenterology

October 2023

El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.



Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.



Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.



November 2023

Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.



Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.



December 2023

Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.



Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.


 

Clinical Gastroenterology and Hepatology

October 2023

Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.



Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.



November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.



Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.



Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.



December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.



Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.



Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.


 

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.



Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003


 

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.



Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

When clinicians suspect lung fibrosis and particularly its most devastating form, idiopathic pulmonary fibrosis (IPF), a noninvasive artificial intelligence (AI)-driven digital diagnostic tool may identify subtype classifications facilitating proper treatment at earlier disease stages. On January 16, 2024, the tool, Fibresolve, developed and produced by the digital biomarker company IMVARIA Inc., received the first-ever US Food and Drug Administration (FDA) marketing authorization of a Breakthrough Designated AI diagnostic tool. Simultaneously, the American Medical Association adopted relevant CPT [Current Procedural Terminology] billing codes, according to an IMVARIA Inc. press release.

Diagnosis and treatment of the lung inflammation and fibrosis that drive IPF lung function decline are often long delayed, Joshua Reicher, MD, CEO of IMVARIA Inc. and an adjunct clinical professor at Stanford (California) University said in an interview for CHEST Physician.

“There are multiple challenges with this somewhat uncommon condition. Part of the frequent delays in diagnosis is the lack of access to local experts. Another part is vague presenting symptoms like general fatigue, for example, which can have an overlap with a lot of other conditions. The published median average delay in diagnosis after first presenting symptoms is about 2.2 years. But it’s often longer.”
 

Determining Type of Lung Fibrosis

Conventional diagnosis based on lab tests for inflammatory biomarkers and extensive clinical history is “fairly straightforward,” Dr. Reicher continued, for determining that a patient has some form of lung fibrosis. “The critical element is to find out what type of lung fibrosis and then begin appropriate therapy. The literature lists about 200 different subtypes, but the top 5 make up the majority of cases. The focus with Fibresolve is on improving noninvasive sensitivity, especially for the cases that are less straightforward, but rather indeterminate and therefore particularly challenging,” Dr. Reicher stated.

Will adjunctive diagnostic use of Fibresolve obviate the need for invasive confirmatory tests? Dr. Reicher was cautious. “We like to be thoughtful about our positioning of artificial intelligence and prefer to say that it puts complementary information in the hands of the physician. It’s really up to the clinicians to decide if they have sufficient information to avoid that biopsy.” The uniqueness of Fibresolve, Dr. Reicher pointed out, is that it is widely accessible and does not require hyper-specialized providers. “You can use it at any center that has standard CT scans.”
 

Reducing Burden on Physicians

An essential feature of Fibresolve use is that its software analysis is conducted centrally. “Part of our goal is to reduce the burden on the clinicians as much as possible, and we try to offload as much of the technical work from them as we can.”

The clinicians send images to IMVARIA Inc. (typically electronically) where they are processed rapidly, and a report is generated with outputs identifying the specific classification, perhaps with one indicating that the findings are suggestive of IPF. Dr. Reicher observed that the Fibresolve’s deep learning algorithm was trained on thousands of cases. “We’re very confident in the results that it puts out,” he said.

“We’re very excited. This is the first FDA-authorized diagnostic tool of any type in lung fibrosis. We really think this supports doctors and patients in areas where there’s a high unmet need,” Dr. Reicher said.

IMVARIA is next developing, in collaboration with the Mayo Clinic, a Fibresolve application for use in lung cancer, he said.

When clinicians suspect lung fibrosis and particularly its most devastating form, idiopathic pulmonary fibrosis (IPF), a noninvasive artificial intelligence (AI)-driven digital diagnostic tool may identify subtype classifications facilitating proper treatment at earlier disease stages. On January 16, 2024, the tool, Fibresolve, developed and produced by the digital biomarker company IMVARIA Inc., received the first-ever US Food and Drug Administration (FDA) marketing authorization of a Breakthrough Designated AI diagnostic tool. Simultaneously, the American Medical Association adopted relevant CPT [Current Procedural Terminology] billing codes, according to an IMVARIA Inc. press release.

Diagnosis and treatment of the lung inflammation and fibrosis that drive IPF lung function decline are often long delayed, Joshua Reicher, MD, CEO of IMVARIA Inc. and an adjunct clinical professor at Stanford (California) University said in an interview for CHEST Physician.

“There are multiple challenges with this somewhat uncommon condition. Part of the frequent delays in diagnosis is the lack of access to local experts. Another part is vague presenting symptoms like general fatigue, for example, which can have an overlap with a lot of other conditions. The published median average delay in diagnosis after first presenting symptoms is about 2.2 years. But it’s often longer.”
 

Determining Type of Lung Fibrosis

Conventional diagnosis based on lab tests for inflammatory biomarkers and extensive clinical history is “fairly straightforward,” Dr. Reicher continued, for determining that a patient has some form of lung fibrosis. “The critical element is to find out what type of lung fibrosis and then begin appropriate therapy. The literature lists about 200 different subtypes, but the top 5 make up the majority of cases. The focus with Fibresolve is on improving noninvasive sensitivity, especially for the cases that are less straightforward, but rather indeterminate and therefore particularly challenging,” Dr. Reicher stated.

Will adjunctive diagnostic use of Fibresolve obviate the need for invasive confirmatory tests? Dr. Reicher was cautious. “We like to be thoughtful about our positioning of artificial intelligence and prefer to say that it puts complementary information in the hands of the physician. It’s really up to the clinicians to decide if they have sufficient information to avoid that biopsy.” The uniqueness of Fibresolve, Dr. Reicher pointed out, is that it is widely accessible and does not require hyper-specialized providers. “You can use it at any center that has standard CT scans.”
 

Reducing Burden on Physicians

An essential feature of Fibresolve use is that its software analysis is conducted centrally. “Part of our goal is to reduce the burden on the clinicians as much as possible, and we try to offload as much of the technical work from them as we can.”

The clinicians send images to IMVARIA Inc. (typically electronically) where they are processed rapidly, and a report is generated with outputs identifying the specific classification, perhaps with one indicating that the findings are suggestive of IPF. Dr. Reicher observed that the Fibresolve’s deep learning algorithm was trained on thousands of cases. “We’re very confident in the results that it puts out,” he said.

“We’re very excited. This is the first FDA-authorized diagnostic tool of any type in lung fibrosis. We really think this supports doctors and patients in areas where there’s a high unmet need,” Dr. Reicher said.

IMVARIA is next developing, in collaboration with the Mayo Clinic, a Fibresolve application for use in lung cancer, he said.

When clinicians suspect lung fibrosis and particularly its most devastating form, idiopathic pulmonary fibrosis (IPF), a noninvasive artificial intelligence (AI)-driven digital diagnostic tool may identify subtype classifications facilitating proper treatment at earlier disease stages. On January 16, 2024, the tool, Fibresolve, developed and produced by the digital biomarker company IMVARIA Inc., received the first-ever US Food and Drug Administration (FDA) marketing authorization of a Breakthrough Designated AI diagnostic tool. Simultaneously, the American Medical Association adopted relevant CPT [Current Procedural Terminology] billing codes, according to an IMVARIA Inc. press release.

Diagnosis and treatment of the lung inflammation and fibrosis that drive IPF lung function decline are often long delayed, Joshua Reicher, MD, CEO of IMVARIA Inc. and an adjunct clinical professor at Stanford (California) University said in an interview for CHEST Physician.

“There are multiple challenges with this somewhat uncommon condition. Part of the frequent delays in diagnosis is the lack of access to local experts. Another part is vague presenting symptoms like general fatigue, for example, which can have an overlap with a lot of other conditions. The published median average delay in diagnosis after first presenting symptoms is about 2.2 years. But it’s often longer.”
 

Determining Type of Lung Fibrosis

Conventional diagnosis based on lab tests for inflammatory biomarkers and extensive clinical history is “fairly straightforward,” Dr. Reicher continued, for determining that a patient has some form of lung fibrosis. “The critical element is to find out what type of lung fibrosis and then begin appropriate therapy. The literature lists about 200 different subtypes, but the top 5 make up the majority of cases. The focus with Fibresolve is on improving noninvasive sensitivity, especially for the cases that are less straightforward, but rather indeterminate and therefore particularly challenging,” Dr. Reicher stated.

Will adjunctive diagnostic use of Fibresolve obviate the need for invasive confirmatory tests? Dr. Reicher was cautious. “We like to be thoughtful about our positioning of artificial intelligence and prefer to say that it puts complementary information in the hands of the physician. It’s really up to the clinicians to decide if they have sufficient information to avoid that biopsy.” The uniqueness of Fibresolve, Dr. Reicher pointed out, is that it is widely accessible and does not require hyper-specialized providers. “You can use it at any center that has standard CT scans.”
 

Reducing Burden on Physicians

An essential feature of Fibresolve use is that its software analysis is conducted centrally. “Part of our goal is to reduce the burden on the clinicians as much as possible, and we try to offload as much of the technical work from them as we can.”

The clinicians send images to IMVARIA Inc. (typically electronically) where they are processed rapidly, and a report is generated with outputs identifying the specific classification, perhaps with one indicating that the findings are suggestive of IPF. Dr. Reicher observed that the Fibresolve’s deep learning algorithm was trained on thousands of cases. “We’re very confident in the results that it puts out,” he said.

“We’re very excited. This is the first FDA-authorized diagnostic tool of any type in lung fibrosis. We really think this supports doctors and patients in areas where there’s a high unmet need,” Dr. Reicher said.

IMVARIA is next developing, in collaboration with the Mayo Clinic, a Fibresolve application for use in lung cancer, he said.

A post hoc analysis of three clinical trials of tenapanor (Ibsrela, Ardelyx) shows the drug works within weeks to improve bowel function and abdominal symptoms in people with irritable bowel syndrome with constipation (IBS-C).

“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.

Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.

Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.

Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.

The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.

Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.

“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.

Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.

This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.

They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.

The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.

The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.

“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.

In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.

The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.

“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.

Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.

Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.

Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.

The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.

“It also reinforces for clinicians not to be impatient,” he said.

Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.

A post hoc analysis of three clinical trials of tenapanor (Ibsrela, Ardelyx) shows the drug works within weeks to improve bowel function and abdominal symptoms in people with irritable bowel syndrome with constipation (IBS-C).

“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.

Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.

Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.

Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.

The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.

Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.

“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.

Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.

This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.

They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.

The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.

The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.

“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.

In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.

The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.

“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.

Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.

Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.

Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.

The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.

“It also reinforces for clinicians not to be impatient,” he said.

Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.

A post hoc analysis of three clinical trials of tenapanor (Ibsrela, Ardelyx) shows the drug works within weeks to improve bowel function and abdominal symptoms in people with irritable bowel syndrome with constipation (IBS-C).

“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.

Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.

Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.

Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.

The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.

Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.

“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.

Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.

This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.

They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.

The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.

The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.

“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.

In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.

The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.

“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.

Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.

Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.

Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.

The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.

“It also reinforces for clinicians not to be impatient,” he said.

Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE:

Intra-articular corticosteroid (IACS) injections pose a minimal risk of accelerating diabetes for most people, despite temporarily elevating blood glucose levels, according to a study published in Clinical Diabetes.

METHODOLOGY:

• Almost half of Americans with diabetes have arthritis, so glycemic control is a concern for many receiving IACS injections.
• IACS injections are known to cause short-term hyperglycemia, but their long-term effects on glycemic control are not well studied.
• For the retrospective cohort study, researchers at Mayo Clinic in Rochester, Minnesota, used electronic health records from 1169 adults who had received an IACS injection in one large joint between 2012 and 2018.
• They analyzed data on A1C levels for study participants from 18 months before and after the injections.
• Researchers assessed if participants had a greater-than-expected (defined as an increase of more than 0.5% above expected) concentration of A1C after the injection, and examined rates of diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in the 30 days following an injection.

TAKEAWAY:

• Nearly 16% of people experienced a greater-than-expected A1C level after receiving an injection.
• A1C levels rose by an average of 1.2% in the greater-than-expected group, but decreased by an average of 0.2% in the average group.
• One patient had an episode of severe hyperglycemia that was linked to the injection.
• A baseline level of A1C above 8% was the only factor associated with a greater-than-expected increase in the marker after an IACS injection.

IN PRACTICE:

“Although most patients do not experience an increase in A1C after IACS, clinicians should counsel patients with suboptimally controlled diabetes about risks of further hyperglycemia after IACS administration,” the researchers wrote. 

SOURCE: 

The study was led by Terin T. Sytsma, MD, of Mayo Clinic in Rochester, Minnesota.

LIMITATIONS: 

The study was retrospective and could not establish causation. In addition, the population was of residents from one county in Minnesota, and was not racially or ethnically diverse. Details about the injection, such as location and total dose, were not available. The study also did not include a control group. 

DISCLOSURES:

The study was funded by Mayo Clinic and the National Center for Advancing Translational Sciences. The authors reported no relevant disclosures.

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

TOPLINE: 

Among patients hospitalized with a first ischemic stroke, 80% were rehospitalized, primarily because of subsequent primary cardiovascular and cerebrovascular diagnoses.

METHODOLOGY:

• To gather information on post-stroke hospital admission, investigators followed 1412 participants (mean age, 72.4 years; 52.1% women, 35.3% Black individuals) from the Atherosclerosis Risk in Communities (ARIC) study who were living in Maryland, Minnesota, North Carolina, and Mississippi.
• Participants were recruited between 1987 and 1989 when they were 45-64 years old and were followed on an annual and then semiannual basis from the index discharge until discharge after their second hospitalization, death, or end of the study in December 2019.
• Specific diagnoses for each hospitalization were based on hospital records, discharge diagnoses, and annual and semiannual phone interviews.

TAKEAWAY: 

• During the study period, 1143 hospitalizations occurred over 41,849 person-months.
• 81% of participants were hospitalized over a maximum of 26.6 years of follow-up. Primary cardiovascular and cerebrovascular diagnoses were reported for half of readmissions.
• Over the follow-up period, compared with cardioembolic stroke, readmission risk was lower for thrombotic/lacunar stroke (adjusted hazard ratio [aHR], 0.82; 95% CI, 0.71-0.95) and hemorrhagic stroke (aHR, 0.74; 95% CI, 0.58-0.93). However, when adjusting for atrial fibrillation and competing risk for death, there were no significant differences between stroke subtypes.
• Compared with cardioembolic stroke, thrombotic/lacunar stroke was associated with lower readmission risk within 1 month (aHR, 0.66; 95% CI, 0.46-0.93) and from 1 month to 1 year (aHR, 0.78; 95% CI, 0.62-0.97), and hemorrhagic stroke was associated with lower risk from 1 month to 1 year (aHR, 0.60; 95% CI, 0.41-0.87).

IN PRACTICE:

“These results suggest that prevention strategies focused on cardiovascular and cerebrovascular health warrant further investigation, especially within the first year after incident stroke and perhaps particularly among individuals with an incident cardioembolic stroke,” the authors wrote.

SOURCE:

Kelly Sloane, MD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, led the study along with colleagues at the National Institute of Neurological Disorders and Stroke, Johns Hopkins University in Baltimore, and the University of North Carolina, Chapel Hill. The article was published online on January 5 in Neurology.

LIMITATIONS:

The ARIC study classification of stroke subtype grouped embolic strokes of undetermined source as thrombotic strokes, and investigators were unable to distinguish between the groups. In addition, there was no way to measure stroke severity, which could have played a role in readmission risk.

DISCLOSURES:

The study was funded by the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institutes of Health.

A version of this article appeared on Medscape.com.

TOPLINE: 

Among patients hospitalized with a first ischemic stroke, 80% were rehospitalized, primarily because of subsequent primary cardiovascular and cerebrovascular diagnoses.

METHODOLOGY:

• To gather information on post-stroke hospital admission, investigators followed 1412 participants (mean age, 72.4 years; 52.1% women, 35.3% Black individuals) from the Atherosclerosis Risk in Communities (ARIC) study who were living in Maryland, Minnesota, North Carolina, and Mississippi.
• Participants were recruited between 1987 and 1989 when they were 45-64 years old and were followed on an annual and then semiannual basis from the index discharge until discharge after their second hospitalization, death, or end of the study in December 2019.
• Specific diagnoses for each hospitalization were based on hospital records, discharge diagnoses, and annual and semiannual phone interviews.

TAKEAWAY: 

• During the study period, 1143 hospitalizations occurred over 41,849 person-months.
• 81% of participants were hospitalized over a maximum of 26.6 years of follow-up. Primary cardiovascular and cerebrovascular diagnoses were reported for half of readmissions.
• Over the follow-up period, compared with cardioembolic stroke, readmission risk was lower for thrombotic/lacunar stroke (adjusted hazard ratio [aHR], 0.82; 95% CI, 0.71-0.95) and hemorrhagic stroke (aHR, 0.74; 95% CI, 0.58-0.93). However, when adjusting for atrial fibrillation and competing risk for death, there were no significant differences between stroke subtypes.
• Compared with cardioembolic stroke, thrombotic/lacunar stroke was associated with lower readmission risk within 1 month (aHR, 0.66; 95% CI, 0.46-0.93) and from 1 month to 1 year (aHR, 0.78; 95% CI, 0.62-0.97), and hemorrhagic stroke was associated with lower risk from 1 month to 1 year (aHR, 0.60; 95% CI, 0.41-0.87).

IN PRACTICE:

“These results suggest that prevention strategies focused on cardiovascular and cerebrovascular health warrant further investigation, especially within the first year after incident stroke and perhaps particularly among individuals with an incident cardioembolic stroke,” the authors wrote.

SOURCE:

Kelly Sloane, MD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, led the study along with colleagues at the National Institute of Neurological Disorders and Stroke, Johns Hopkins University in Baltimore, and the University of North Carolina, Chapel Hill. The article was published online on January 5 in Neurology.

LIMITATIONS:

The ARIC study classification of stroke subtype grouped embolic strokes of undetermined source as thrombotic strokes, and investigators were unable to distinguish between the groups. In addition, there was no way to measure stroke severity, which could have played a role in readmission risk.

DISCLOSURES:

The study was funded by the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institutes of Health.

A version of this article appeared on Medscape.com.

TOPLINE: 

Among patients hospitalized with a first ischemic stroke, 80% were rehospitalized, primarily because of subsequent primary cardiovascular and cerebrovascular diagnoses.

METHODOLOGY:

• To gather information on post-stroke hospital admission, investigators followed 1412 participants (mean age, 72.4 years; 52.1% women, 35.3% Black individuals) from the Atherosclerosis Risk in Communities (ARIC) study who were living in Maryland, Minnesota, North Carolina, and Mississippi.
• Participants were recruited between 1987 and 1989 when they were 45-64 years old and were followed on an annual and then semiannual basis from the index discharge until discharge after their second hospitalization, death, or end of the study in December 2019.
• Specific diagnoses for each hospitalization were based on hospital records, discharge diagnoses, and annual and semiannual phone interviews.

TAKEAWAY: 

• During the study period, 1143 hospitalizations occurred over 41,849 person-months.
• 81% of participants were hospitalized over a maximum of 26.6 years of follow-up. Primary cardiovascular and cerebrovascular diagnoses were reported for half of readmissions.
• Over the follow-up period, compared with cardioembolic stroke, readmission risk was lower for thrombotic/lacunar stroke (adjusted hazard ratio [aHR], 0.82; 95% CI, 0.71-0.95) and hemorrhagic stroke (aHR, 0.74; 95% CI, 0.58-0.93). However, when adjusting for atrial fibrillation and competing risk for death, there were no significant differences between stroke subtypes.
• Compared with cardioembolic stroke, thrombotic/lacunar stroke was associated with lower readmission risk within 1 month (aHR, 0.66; 95% CI, 0.46-0.93) and from 1 month to 1 year (aHR, 0.78; 95% CI, 0.62-0.97), and hemorrhagic stroke was associated with lower risk from 1 month to 1 year (aHR, 0.60; 95% CI, 0.41-0.87).

IN PRACTICE:

“These results suggest that prevention strategies focused on cardiovascular and cerebrovascular health warrant further investigation, especially within the first year after incident stroke and perhaps particularly among individuals with an incident cardioembolic stroke,” the authors wrote.

SOURCE:

Kelly Sloane, MD, of the University of Pennsylvania Perelman School of Medicine in Philadelphia, led the study along with colleagues at the National Institute of Neurological Disorders and Stroke, Johns Hopkins University in Baltimore, and the University of North Carolina, Chapel Hill. The article was published online on January 5 in Neurology.

LIMITATIONS:

The ARIC study classification of stroke subtype grouped embolic strokes of undetermined source as thrombotic strokes, and investigators were unable to distinguish between the groups. In addition, there was no way to measure stroke severity, which could have played a role in readmission risk.

DISCLOSURES:

The study was funded by the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and the National Institutes of Health.

A version of this article appeared on Medscape.com.

TOPLINE:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk for sight-threatening retinopathy than other second-line glucose-lowering medications in patients with type 2 diabetes (T2D).

METHODOLOGY:

• Researchers conducted a nationwide cohort study including 3,544,383 patients with newly diagnosed T2D.
• During the 5-year study period, 159,965 patients were treated with SGLT2 inhibitors, 304,383 received dipeptidyl peptidase-4 (DPP-4) inhibitors, 108,420 took pioglitazone, and 189,618 received sulfonylurea.
• The propensity score matching found 65,930 pairs of patients treated with SGLT2 inhibitors vs DPP-4 inhibitors, 93,760 pairs treated with SGLT2 inhibitors vs pioglitazone, and 42,121 pairs treated with SGLT2 inhibitors vs sulfonylurea.
• The main outcome was sight-threatening retinopathy in patients with at least two outpatient visits or one hospitalization or anti-vascular endothelial growth factor injections.

TAKEAWAY:

• SGLT2 inhibitors reduced sight-threatening retinopathy risk by 43% vs DPP-4 inhibitors (adjusted hazard ratio [aHR], 0.57), 38% vs sulfonylurea (aHR, 0.62), and 25% vs pioglitazone (aHR, 0.75; P < .001 for all).
• Similarly, the cumulative incidence of sight-threatening retinopathy was significantly lower with SGLT2 inhibitors vs DPP-4i, pioglitazone, or sulfonylurea (P < .001 for all).
• All three SGLT2 inhibitor treatments, namely, empagliflozin, dapagliflozin, and canagliflozin, were more effective than DPP-4 inhibitors, pioglitazone, or sulfonylurea in reducing the risk for sight-threatening retinopathy.

IN PRACTICE:

“SGLT2i treatments were as safe and effective in slowing the progression of diabetic retinopathy as in lowering the risk for diabetic nephropathy in patients with T2D,” the authors wrote.

SOURCE:

This study was led by Fu-Shun Yen, MD, a private practitioner from Taiwan, and was published online on December 20, 2023, in JAMA Network Open.

LIMITATIONS:

There were insufficient data regarding the participants’ alcohol use, physical activity, smoking status, and family history, which may have had an impact on the results.

The study mainly involved individuals of Taiwanese ethnicity.

DISCLOSURES:

This study was supported partly by the Taiwan Ministry of Health and Welfare Clinical Trial Center, the MOST Clinical Trial Consortium for Stroke, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk for sight-threatening retinopathy than other second-line glucose-lowering medications in patients with type 2 diabetes (T2D).

METHODOLOGY:

• Researchers conducted a nationwide cohort study including 3,544,383 patients with newly diagnosed T2D.
• During the 5-year study period, 159,965 patients were treated with SGLT2 inhibitors, 304,383 received dipeptidyl peptidase-4 (DPP-4) inhibitors, 108,420 took pioglitazone, and 189,618 received sulfonylurea.
• The propensity score matching found 65,930 pairs of patients treated with SGLT2 inhibitors vs DPP-4 inhibitors, 93,760 pairs treated with SGLT2 inhibitors vs pioglitazone, and 42,121 pairs treated with SGLT2 inhibitors vs sulfonylurea.
• The main outcome was sight-threatening retinopathy in patients with at least two outpatient visits or one hospitalization or anti-vascular endothelial growth factor injections.

TAKEAWAY:

• SGLT2 inhibitors reduced sight-threatening retinopathy risk by 43% vs DPP-4 inhibitors (adjusted hazard ratio [aHR], 0.57), 38% vs sulfonylurea (aHR, 0.62), and 25% vs pioglitazone (aHR, 0.75; P < .001 for all).
• Similarly, the cumulative incidence of sight-threatening retinopathy was significantly lower with SGLT2 inhibitors vs DPP-4i, pioglitazone, or sulfonylurea (P < .001 for all).
• All three SGLT2 inhibitor treatments, namely, empagliflozin, dapagliflozin, and canagliflozin, were more effective than DPP-4 inhibitors, pioglitazone, or sulfonylurea in reducing the risk for sight-threatening retinopathy.

IN PRACTICE:

“SGLT2i treatments were as safe and effective in slowing the progression of diabetic retinopathy as in lowering the risk for diabetic nephropathy in patients with T2D,” the authors wrote.

SOURCE:

This study was led by Fu-Shun Yen, MD, a private practitioner from Taiwan, and was published online on December 20, 2023, in JAMA Network Open.

LIMITATIONS:

There were insufficient data regarding the participants’ alcohol use, physical activity, smoking status, and family history, which may have had an impact on the results.

The study mainly involved individuals of Taiwanese ethnicity.

DISCLOSURES:

This study was supported partly by the Taiwan Ministry of Health and Welfare Clinical Trial Center, the MOST Clinical Trial Consortium for Stroke, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk for sight-threatening retinopathy than other second-line glucose-lowering medications in patients with type 2 diabetes (T2D).

METHODOLOGY:

• Researchers conducted a nationwide cohort study including 3,544,383 patients with newly diagnosed T2D.
• During the 5-year study period, 159,965 patients were treated with SGLT2 inhibitors, 304,383 received dipeptidyl peptidase-4 (DPP-4) inhibitors, 108,420 took pioglitazone, and 189,618 received sulfonylurea.
• The propensity score matching found 65,930 pairs of patients treated with SGLT2 inhibitors vs DPP-4 inhibitors, 93,760 pairs treated with SGLT2 inhibitors vs pioglitazone, and 42,121 pairs treated with SGLT2 inhibitors vs sulfonylurea.
• The main outcome was sight-threatening retinopathy in patients with at least two outpatient visits or one hospitalization or anti-vascular endothelial growth factor injections.

TAKEAWAY:

• SGLT2 inhibitors reduced sight-threatening retinopathy risk by 43% vs DPP-4 inhibitors (adjusted hazard ratio [aHR], 0.57), 38% vs sulfonylurea (aHR, 0.62), and 25% vs pioglitazone (aHR, 0.75; P < .001 for all).
• Similarly, the cumulative incidence of sight-threatening retinopathy was significantly lower with SGLT2 inhibitors vs DPP-4i, pioglitazone, or sulfonylurea (P < .001 for all).
• All three SGLT2 inhibitor treatments, namely, empagliflozin, dapagliflozin, and canagliflozin, were more effective than DPP-4 inhibitors, pioglitazone, or sulfonylurea in reducing the risk for sight-threatening retinopathy.

IN PRACTICE:

“SGLT2i treatments were as safe and effective in slowing the progression of diabetic retinopathy as in lowering the risk for diabetic nephropathy in patients with T2D,” the authors wrote.

SOURCE:

This study was led by Fu-Shun Yen, MD, a private practitioner from Taiwan, and was published online on December 20, 2023, in JAMA Network Open.

LIMITATIONS:

There were insufficient data regarding the participants’ alcohol use, physical activity, smoking status, and family history, which may have had an impact on the results.

The study mainly involved individuals of Taiwanese ethnicity.

DISCLOSURES:

This study was supported partly by the Taiwan Ministry of Health and Welfare Clinical Trial Center, the MOST Clinical Trial Consortium for Stroke, and other sources. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

In late December 2023, Brazil’s National Health Surveillance Agency (ANVISA) suspended the commercialization of approximately 1200 hair creams because of reports of eye irritation and temporary blindness.

A similar measure encompassing all hair creams sold in the country had already been announced by the agency in March. However, after a few weeks, ANVISA issued a resolution with rules for the products’ commercialization, allowing them back on the shelves.

With the new resolution, the sale of products that do not comply with the standards has once again been suspended. The reason is that reports of adverse events have reemerged. These events include temporary vision loss, headaches, and burning, tearing, itching, redness, and swelling of the eyes. According to reports, these adverse effects occurred mainly in people who used the specific products before swimming in the sea or in pools, or even going out in the rain.

The banned products contain 20% or more ethoxylated alcohols in their formulations. Products containing methylchloroisothiazolinone and methylisothiazolinone were already prohibited. These substances, used as preservatives, are considered toxic to the skin and mucous membranes, potentially causing allergies and burns to the eyes and skin. They also have a high pulmonary and neurological toxicity. All these substances are eye irritants and can cause chemical keratitis. In extreme cases, corneal ulcers may develop, leading to vision loss.

The Brazilian Council of Ophthalmology also issued a warning on these products. It emphasized that, in addition to the sales prohibition, consumers should check the labels of hair creams to make sure that these toxic substances are not present in the product formulation.

The ANVISA website contains a list of creams that are considered safe and have not had their commercialization suspended, along with links to adverse event notifications reported by healthcare professionals or consumers.

For consumers who have recently used hair creams, the agency advises careful hair washing, including tilting the head backward to prevent the product from coming into contact with the eye area. If there is accidental eye contact, the eyes should be washed with plenty of water.

If there are any undesired effects after using these products, users should immediately seek the nearest healthcare service. Treatment should be individualized, possibly including ocular occlusion and the use of eye drops containing antibiotics or corticosteroids, among other medications.

Not every patient has easy access to an ophthalmologist in an emergency, so it is crucial for general practitioners to be prepared for initial care. In this regard, one of the most important measures is eye washing with copious amounts of clean water or saline solution for 5-10 minutes.

Eye itching is a frequent manifestation of using hair creams, and scratching the area may worsen the condition. Ocular occlusion can protect the cornea until an evaluation can be performed by a specialist.

Although we prefer our patients to stay away from these creams, it is also important to disseminate this information and advise them to read labels and use safe cosmetics.
 

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

In late December 2023, Brazil’s National Health Surveillance Agency (ANVISA) suspended the commercialization of approximately 1200 hair creams because of reports of eye irritation and temporary blindness.

A similar measure encompassing all hair creams sold in the country had already been announced by the agency in March. However, after a few weeks, ANVISA issued a resolution with rules for the products’ commercialization, allowing them back on the shelves.

With the new resolution, the sale of products that do not comply with the standards has once again been suspended. The reason is that reports of adverse events have reemerged. These events include temporary vision loss, headaches, and burning, tearing, itching, redness, and swelling of the eyes. According to reports, these adverse effects occurred mainly in people who used the specific products before swimming in the sea or in pools, or even going out in the rain.

The banned products contain 20% or more ethoxylated alcohols in their formulations. Products containing methylchloroisothiazolinone and methylisothiazolinone were already prohibited. These substances, used as preservatives, are considered toxic to the skin and mucous membranes, potentially causing allergies and burns to the eyes and skin. They also have a high pulmonary and neurological toxicity. All these substances are eye irritants and can cause chemical keratitis. In extreme cases, corneal ulcers may develop, leading to vision loss.

The Brazilian Council of Ophthalmology also issued a warning on these products. It emphasized that, in addition to the sales prohibition, consumers should check the labels of hair creams to make sure that these toxic substances are not present in the product formulation.

The ANVISA website contains a list of creams that are considered safe and have not had their commercialization suspended, along with links to adverse event notifications reported by healthcare professionals or consumers.

For consumers who have recently used hair creams, the agency advises careful hair washing, including tilting the head backward to prevent the product from coming into contact with the eye area. If there is accidental eye contact, the eyes should be washed with plenty of water.

If there are any undesired effects after using these products, users should immediately seek the nearest healthcare service. Treatment should be individualized, possibly including ocular occlusion and the use of eye drops containing antibiotics or corticosteroids, among other medications.

Not every patient has easy access to an ophthalmologist in an emergency, so it is crucial for general practitioners to be prepared for initial care. In this regard, one of the most important measures is eye washing with copious amounts of clean water or saline solution for 5-10 minutes.

Eye itching is a frequent manifestation of using hair creams, and scratching the area may worsen the condition. Ocular occlusion can protect the cornea until an evaluation can be performed by a specialist.

Although we prefer our patients to stay away from these creams, it is also important to disseminate this information and advise them to read labels and use safe cosmetics.
 

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

In late December 2023, Brazil’s National Health Surveillance Agency (ANVISA) suspended the commercialization of approximately 1200 hair creams because of reports of eye irritation and temporary blindness.

A similar measure encompassing all hair creams sold in the country had already been announced by the agency in March. However, after a few weeks, ANVISA issued a resolution with rules for the products’ commercialization, allowing them back on the shelves.

With the new resolution, the sale of products that do not comply with the standards has once again been suspended. The reason is that reports of adverse events have reemerged. These events include temporary vision loss, headaches, and burning, tearing, itching, redness, and swelling of the eyes. According to reports, these adverse effects occurred mainly in people who used the specific products before swimming in the sea or in pools, or even going out in the rain.

The banned products contain 20% or more ethoxylated alcohols in their formulations. Products containing methylchloroisothiazolinone and methylisothiazolinone were already prohibited. These substances, used as preservatives, are considered toxic to the skin and mucous membranes, potentially causing allergies and burns to the eyes and skin. They also have a high pulmonary and neurological toxicity. All these substances are eye irritants and can cause chemical keratitis. In extreme cases, corneal ulcers may develop, leading to vision loss.

The Brazilian Council of Ophthalmology also issued a warning on these products. It emphasized that, in addition to the sales prohibition, consumers should check the labels of hair creams to make sure that these toxic substances are not present in the product formulation.

The ANVISA website contains a list of creams that are considered safe and have not had their commercialization suspended, along with links to adverse event notifications reported by healthcare professionals or consumers.

For consumers who have recently used hair creams, the agency advises careful hair washing, including tilting the head backward to prevent the product from coming into contact with the eye area. If there is accidental eye contact, the eyes should be washed with plenty of water.

If there are any undesired effects after using these products, users should immediately seek the nearest healthcare service. Treatment should be individualized, possibly including ocular occlusion and the use of eye drops containing antibiotics or corticosteroids, among other medications.

Not every patient has easy access to an ophthalmologist in an emergency, so it is crucial for general practitioners to be prepared for initial care. In this regard, one of the most important measures is eye washing with copious amounts of clean water or saline solution for 5-10 minutes.

Eye itching is a frequent manifestation of using hair creams, and scratching the area may worsen the condition. Ocular occlusion can protect the cornea until an evaluation can be performed by a specialist.

Although we prefer our patients to stay away from these creams, it is also important to disseminate this information and advise them to read labels and use safe cosmetics.
 

This article was translated from the Medscape Portuguese edition. A version of this article appeared on Medscape.com.

TOPLINE: 

Pet ownership is associated with slower cognitive decline in seniors who live alone, a new longitudinal cohort study showed. Investigators note the findings are important because previous research suggests older adults who live alone are at higher risk for dementia.

METHODOLOGY:

• Investigators analyzed data on 7945 participants aged 50 years and older (56% female; mean age, 66 years) from the English Longitudinal Study of Ageing (ELSA) and determined whether they lived alone or had a pet.
• Every couple of years for the next 8 years after baseline, participants were assessed for verbal cognition, verbal memory, and verbal fluency. Information about covariates including age, sex, employment status, educational level, and health was also collected.
• 35% of participants were pet owners, and 27% lived alone.

TAKEAWAY: 

• Pet owners who lived alone had a slower rate of decline in verbal cognition (P = .009), verbal memory (P = .04), and verbal fluency (P = .03) compared with those without pets who lived alone.
• Stratified analysis showed that pet ownership was associated with slower rates of decline in composite verbal cognition, verbal memory, and verbal fluency but only among those who lived alone (all P < .001).
• There was no significant difference in rates of decline in composite verbal cognition, verbal memory, or verbal fluency between pet owners living alone and pet owners living with others.

IN PRACTICE:

“Pet ownership completely offset the associations of living alone with declining rates in verbal memory, verbal fluency, and composite verbal cognition. Our findings provide innovative insights for developing public health policies to slow cognitive decline in older adults living alone,” the authors wrote. 

SOURCE:

Ciyong Lu, PhD, of Sun Yat-sen University in Guangzhou, China, led the study, which was published online on December 26, 2023, in JAMA Network Open.

LIMITATIONS:

Whereas cognitive function includes multiple components, the study only assessed verbal memory and verbal fluency. Also, the study did not gather information on the duration of pet ownership after baseline.

DISCLOSURES:

The investigators reported no disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Pet ownership is associated with slower cognitive decline in seniors who live alone, a new longitudinal cohort study showed. Investigators note the findings are important because previous research suggests older adults who live alone are at higher risk for dementia.

METHODOLOGY:

• Investigators analyzed data on 7945 participants aged 50 years and older (56% female; mean age, 66 years) from the English Longitudinal Study of Ageing (ELSA) and determined whether they lived alone or had a pet.
• Every couple of years for the next 8 years after baseline, participants were assessed for verbal cognition, verbal memory, and verbal fluency. Information about covariates including age, sex, employment status, educational level, and health was also collected.
• 35% of participants were pet owners, and 27% lived alone.

TAKEAWAY: 

• Pet owners who lived alone had a slower rate of decline in verbal cognition (P = .009), verbal memory (P = .04), and verbal fluency (P = .03) compared with those without pets who lived alone.
• Stratified analysis showed that pet ownership was associated with slower rates of decline in composite verbal cognition, verbal memory, and verbal fluency but only among those who lived alone (all P < .001).
• There was no significant difference in rates of decline in composite verbal cognition, verbal memory, or verbal fluency between pet owners living alone and pet owners living with others.

IN PRACTICE:

“Pet ownership completely offset the associations of living alone with declining rates in verbal memory, verbal fluency, and composite verbal cognition. Our findings provide innovative insights for developing public health policies to slow cognitive decline in older adults living alone,” the authors wrote. 

SOURCE:

Ciyong Lu, PhD, of Sun Yat-sen University in Guangzhou, China, led the study, which was published online on December 26, 2023, in JAMA Network Open.

LIMITATIONS:

Whereas cognitive function includes multiple components, the study only assessed verbal memory and verbal fluency. Also, the study did not gather information on the duration of pet ownership after baseline.

DISCLOSURES:

The investigators reported no disclosures.
 

A version of this article appeared on Medscape.com.

TOPLINE: 

Pet ownership is associated with slower cognitive decline in seniors who live alone, a new longitudinal cohort study showed. Investigators note the findings are important because previous research suggests older adults who live alone are at higher risk for dementia.

METHODOLOGY:

• Investigators analyzed data on 7945 participants aged 50 years and older (56% female; mean age, 66 years) from the English Longitudinal Study of Ageing (ELSA) and determined whether they lived alone or had a pet.
• Every couple of years for the next 8 years after baseline, participants were assessed for verbal cognition, verbal memory, and verbal fluency. Information about covariates including age, sex, employment status, educational level, and health was also collected.
• 35% of participants were pet owners, and 27% lived alone.

TAKEAWAY: 

• Pet owners who lived alone had a slower rate of decline in verbal cognition (P = .009), verbal memory (P = .04), and verbal fluency (P = .03) compared with those without pets who lived alone.
• Stratified analysis showed that pet ownership was associated with slower rates of decline in composite verbal cognition, verbal memory, and verbal fluency but only among those who lived alone (all P < .001).
• There was no significant difference in rates of decline in composite verbal cognition, verbal memory, or verbal fluency between pet owners living alone and pet owners living with others.

IN PRACTICE:

“Pet ownership completely offset the associations of living alone with declining rates in verbal memory, verbal fluency, and composite verbal cognition. Our findings provide innovative insights for developing public health policies to slow cognitive decline in older adults living alone,” the authors wrote. 

SOURCE:

Ciyong Lu, PhD, of Sun Yat-sen University in Guangzhou, China, led the study, which was published online on December 26, 2023, in JAMA Network Open.

LIMITATIONS:

Whereas cognitive function includes multiple components, the study only assessed verbal memory and verbal fluency. Also, the study did not gather information on the duration of pet ownership after baseline.

DISCLOSURES:

The investigators reported no disclosures.
 

A version of this article appeared on Medscape.com.

A combination of adjuvant abemaciclib and endocrine therapy significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–), node-positive early breast cancer, in updated results of a trial.

This was based on data collected over a median follow-up of 54 months. Previously reported data from this phase III study, known as monarchE, showed the same outcomes but over a 2-year treatment period, the researchers said.

Risk of cancer recurrence may be as much as 30% at 5 years in these high-risk patients, who will likely need more intense treatment, wrote Priya Rastogi, MD, of the University of Pittsburgh Medical Center, and colleagues.

In the new study published in the Journal of Clinical Oncology (2023 Jan 9. doi: 10.1200/JCO.23.019), the researchers reported 5-year efficacy results from an interim analysis of overall survival in the monarchE trial.

The intent-to-treat population included 2808 individuals randomized to abemaciclib plus ET and 2814 to ET alone; the median age was 51 years, and approximately 70% of the participants were White.

The addition of abemaciclib significantly reduced the risk of IDFS and DRFS over a median follow-up period of 54 months with hazard ratios of 0.680 and 0.675, respectively. Adjuvant abemaciclib also significantly improved DRFS over ET alone (HR 0.675).

The findings were limited by the lack of statistical significance for overall survival with abemaciclib. However, the increased benefits for IDFS and DRFS with abemaciclib plus ET vs. ET alone were consistent across all subgroups, and the benefit of abemaciclib was consistent regardless of the number of nodes involved, the researchers wrote.

“Prior reports from this trial with shorter follow-up demonstrated benefit of abemaciclib. However, with longer follow-up of a median 54 months, we see that the benefit of the drug is not only sustained (32% reduction in the risk of a disease event), but that there is further separation of the curves with an absolute difference in IDFS and DRFS rates of 7.6% and 6.7, comparing the ET alone vs. ET plus abemaciclib arms,” study coauthor Matthew P. Goetz, MD, said in an interview.

Although statistical significance was not reached for overall survival, fewer deaths occurred in the abemaciclib-plus-ET group compared with the ET-only group, said Dr. Goetz, of the Mayo Clinic, Rochester, Minnesota. However, patients with the worst prognosis (Ki-67–high subgroup) tended to have higher overall survival.

A total of 208 deaths occurred in the combination group vs. 234 in the ET-only group, and no new safety signals were observed. The occurrence of serious adverse events of any cause was similar in the abemaciclib group and the ET-only group (6.5% vs. 7.3%).

“These data are a pleasant surprise, as there were concerns that the benefit of the drug seen with shorter follow-up would wane over time,” Dr. Goetz said. “However, the opposite has occurred; with increasing length of follow-up, the curves continue to separate.”

Based on the new results, “we have high confidence that for patients with ER+/HER2- breast cancer at high risk of recurrence, the addition of 2 years of adjuvant abemaciclib to ET results in clinically significant improvements in IDFS,” he said.

Looking ahead, “we need additional follow-up to determine whether the benefit we now see in terms of IDFS will eventually translate into improvements in overall survival,” Dr. Goetz said. “We need to identify biomarkers that can identify patients at risk for early recurrence despite administration of adjuvant abemaciclib and further, biomarkers that will allow us to select patients that can be safely treated with ET alone.”

 

Findings Confirm Value of Combined Treatment

“It was reassuring to see the continued benefit at 5 years with adjuvant abemaciclib in combination with endocrine therapy compared to endocrine therapy alone in this high-risk HR+, HER2– EBC [early breast cancer] population,” Manali Ajay Bhave, MD, a medical oncologist at Emory University, Atlanta, said in an interview.

“While the interim overall survival analysis was not significant, further follow-up is necessary to truly discern a survival benefit particularly in this patient population where a survival advantage may not be seen for several years,” she added.

The current study supports the continued use of adjuvant abemaciclib in high-risk HR+, HER2– EBC patients, Dr. Bhave said. “Investigation of novel endocrine agents in the adjuvant setting for patients with high risk, HR+ HER2– EBC is needed to further improve outcomes.”
 

Urgent Need to Improve Adjuvant Therapy

“The monarchE study is a timely study aimed at improving adjuvant treatments in ER+ breast cancer to reduce risk of late recurrences,” Malinda T. West, MD, of the University of Wisconsin, said in an interview. “Late recurrences occurring decades later is a risk associated with ER+ breast cancer, and the risk of breast cancer recurrence is highest in those with larger tumors and nodal involvement.

“Abemaciclib is one of the three FDA-approved cyclin-dependent kinase 4/6 inhibitors in metastatic ER+ breast cancer based on demonstrated efficacy and safety in the metastatic setting compared to endocrine therapy alone, which was the rationale for expanded use of abemaciclib into the adjuvant setting for those at high risk for recurrence and basis of the monarchE trial,” said Dr. West.

An important criterion for inclusion was the randomization to abemaciclib required within 16 months of definitive breast cancer surgery, which reflected a window of time in which to start adjuvant abemaciclib, Dr. West said. “Exclusion criteria were those with a history of thromboembolic events, as abemaciclib carries a warning for venous thromboembolism,” she added.

In the monarchE follow-up, Dr. West said she was encouraged by the persistent and widening benefit with 2 years of added abemaciclib to endocrine therapy in reducing IDFS and DRFS compared to endocrine therapy alone.

Dr. West advised clinicians to consider initiating the therapy for up to 16 months after definitive breast surgery, because doing so may allow for recovery from surgery, chemotherapy, and radiation.

The findings tell physicians to “use caution with adding abemaciclib in those with a history of thromboembolic events or VTE risk factors as abemaciclib has a known VTE warning and this population was excluded in the monarchE trial,” she noted.

“Continued long-term follow up of those in this study will be important to determine survival benefits and how the predictive biomarker Ki-67 may impact survival outcomes,” she said.

The study was supported by Eli Lilly. Lead author Dr. Rastogi disclosed travel, accommodations, and expenses from Genentech/Roche, Lilly, and AstraZeneca. Several coauthors disclosed stock or ownership interests and/or other relationships with Lilly and other pharmaceutical companies. Dr. Goetz receives research funding from the National Institutes of Health. Dr. Bhave and Dr. West had no financial conflicts to disclose.

A combination of adjuvant abemaciclib and endocrine therapy significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–), node-positive early breast cancer, in updated results of a trial.

This was based on data collected over a median follow-up of 54 months. Previously reported data from this phase III study, known as monarchE, showed the same outcomes but over a 2-year treatment period, the researchers said.

Risk of cancer recurrence may be as much as 30% at 5 years in these high-risk patients, who will likely need more intense treatment, wrote Priya Rastogi, MD, of the University of Pittsburgh Medical Center, and colleagues.

In the new study published in the Journal of Clinical Oncology (2023 Jan 9. doi: 10.1200/JCO.23.019), the researchers reported 5-year efficacy results from an interim analysis of overall survival in the monarchE trial.

The intent-to-treat population included 2808 individuals randomized to abemaciclib plus ET and 2814 to ET alone; the median age was 51 years, and approximately 70% of the participants were White.

The addition of abemaciclib significantly reduced the risk of IDFS and DRFS over a median follow-up period of 54 months with hazard ratios of 0.680 and 0.675, respectively. Adjuvant abemaciclib also significantly improved DRFS over ET alone (HR 0.675).

The findings were limited by the lack of statistical significance for overall survival with abemaciclib. However, the increased benefits for IDFS and DRFS with abemaciclib plus ET vs. ET alone were consistent across all subgroups, and the benefit of abemaciclib was consistent regardless of the number of nodes involved, the researchers wrote.

“Prior reports from this trial with shorter follow-up demonstrated benefit of abemaciclib. However, with longer follow-up of a median 54 months, we see that the benefit of the drug is not only sustained (32% reduction in the risk of a disease event), but that there is further separation of the curves with an absolute difference in IDFS and DRFS rates of 7.6% and 6.7, comparing the ET alone vs. ET plus abemaciclib arms,” study coauthor Matthew P. Goetz, MD, said in an interview.

Although statistical significance was not reached for overall survival, fewer deaths occurred in the abemaciclib-plus-ET group compared with the ET-only group, said Dr. Goetz, of the Mayo Clinic, Rochester, Minnesota. However, patients with the worst prognosis (Ki-67–high subgroup) tended to have higher overall survival.

A total of 208 deaths occurred in the combination group vs. 234 in the ET-only group, and no new safety signals were observed. The occurrence of serious adverse events of any cause was similar in the abemaciclib group and the ET-only group (6.5% vs. 7.3%).

“These data are a pleasant surprise, as there were concerns that the benefit of the drug seen with shorter follow-up would wane over time,” Dr. Goetz said. “However, the opposite has occurred; with increasing length of follow-up, the curves continue to separate.”

Based on the new results, “we have high confidence that for patients with ER+/HER2- breast cancer at high risk of recurrence, the addition of 2 years of adjuvant abemaciclib to ET results in clinically significant improvements in IDFS,” he said.

Looking ahead, “we need additional follow-up to determine whether the benefit we now see in terms of IDFS will eventually translate into improvements in overall survival,” Dr. Goetz said. “We need to identify biomarkers that can identify patients at risk for early recurrence despite administration of adjuvant abemaciclib and further, biomarkers that will allow us to select patients that can be safely treated with ET alone.”

 

Findings Confirm Value of Combined Treatment

“It was reassuring to see the continued benefit at 5 years with adjuvant abemaciclib in combination with endocrine therapy compared to endocrine therapy alone in this high-risk HR+, HER2– EBC [early breast cancer] population,” Manali Ajay Bhave, MD, a medical oncologist at Emory University, Atlanta, said in an interview.

“While the interim overall survival analysis was not significant, further follow-up is necessary to truly discern a survival benefit particularly in this patient population where a survival advantage may not be seen for several years,” she added.

The current study supports the continued use of adjuvant abemaciclib in high-risk HR+, HER2– EBC patients, Dr. Bhave said. “Investigation of novel endocrine agents in the adjuvant setting for patients with high risk, HR+ HER2– EBC is needed to further improve outcomes.”
 

Urgent Need to Improve Adjuvant Therapy

“The monarchE study is a timely study aimed at improving adjuvant treatments in ER+ breast cancer to reduce risk of late recurrences,” Malinda T. West, MD, of the University of Wisconsin, said in an interview. “Late recurrences occurring decades later is a risk associated with ER+ breast cancer, and the risk of breast cancer recurrence is highest in those with larger tumors and nodal involvement.

“Abemaciclib is one of the three FDA-approved cyclin-dependent kinase 4/6 inhibitors in metastatic ER+ breast cancer based on demonstrated efficacy and safety in the metastatic setting compared to endocrine therapy alone, which was the rationale for expanded use of abemaciclib into the adjuvant setting for those at high risk for recurrence and basis of the monarchE trial,” said Dr. West.

An important criterion for inclusion was the randomization to abemaciclib required within 16 months of definitive breast cancer surgery, which reflected a window of time in which to start adjuvant abemaciclib, Dr. West said. “Exclusion criteria were those with a history of thromboembolic events, as abemaciclib carries a warning for venous thromboembolism,” she added.

In the monarchE follow-up, Dr. West said she was encouraged by the persistent and widening benefit with 2 years of added abemaciclib to endocrine therapy in reducing IDFS and DRFS compared to endocrine therapy alone.

Dr. West advised clinicians to consider initiating the therapy for up to 16 months after definitive breast surgery, because doing so may allow for recovery from surgery, chemotherapy, and radiation.

The findings tell physicians to “use caution with adding abemaciclib in those with a history of thromboembolic events or VTE risk factors as abemaciclib has a known VTE warning and this population was excluded in the monarchE trial,” she noted.

“Continued long-term follow up of those in this study will be important to determine survival benefits and how the predictive biomarker Ki-67 may impact survival outcomes,” she said.

The study was supported by Eli Lilly. Lead author Dr. Rastogi disclosed travel, accommodations, and expenses from Genentech/Roche, Lilly, and AstraZeneca. Several coauthors disclosed stock or ownership interests and/or other relationships with Lilly and other pharmaceutical companies. Dr. Goetz receives research funding from the National Institutes of Health. Dr. Bhave and Dr. West had no financial conflicts to disclose.

A combination of adjuvant abemaciclib and endocrine therapy significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–), node-positive early breast cancer, in updated results of a trial.

This was based on data collected over a median follow-up of 54 months. Previously reported data from this phase III study, known as monarchE, showed the same outcomes but over a 2-year treatment period, the researchers said.

Risk of cancer recurrence may be as much as 30% at 5 years in these high-risk patients, who will likely need more intense treatment, wrote Priya Rastogi, MD, of the University of Pittsburgh Medical Center, and colleagues.

In the new study published in the Journal of Clinical Oncology (2023 Jan 9. doi: 10.1200/JCO.23.019), the researchers reported 5-year efficacy results from an interim analysis of overall survival in the monarchE trial.

The intent-to-treat population included 2808 individuals randomized to abemaciclib plus ET and 2814 to ET alone; the median age was 51 years, and approximately 70% of the participants were White.

The addition of abemaciclib significantly reduced the risk of IDFS and DRFS over a median follow-up period of 54 months with hazard ratios of 0.680 and 0.675, respectively. Adjuvant abemaciclib also significantly improved DRFS over ET alone (HR 0.675).

The findings were limited by the lack of statistical significance for overall survival with abemaciclib. However, the increased benefits for IDFS and DRFS with abemaciclib plus ET vs. ET alone were consistent across all subgroups, and the benefit of abemaciclib was consistent regardless of the number of nodes involved, the researchers wrote.

“Prior reports from this trial with shorter follow-up demonstrated benefit of abemaciclib. However, with longer follow-up of a median 54 months, we see that the benefit of the drug is not only sustained (32% reduction in the risk of a disease event), but that there is further separation of the curves with an absolute difference in IDFS and DRFS rates of 7.6% and 6.7, comparing the ET alone vs. ET plus abemaciclib arms,” study coauthor Matthew P. Goetz, MD, said in an interview.

Although statistical significance was not reached for overall survival, fewer deaths occurred in the abemaciclib-plus-ET group compared with the ET-only group, said Dr. Goetz, of the Mayo Clinic, Rochester, Minnesota. However, patients with the worst prognosis (Ki-67–high subgroup) tended to have higher overall survival.

A total of 208 deaths occurred in the combination group vs. 234 in the ET-only group, and no new safety signals were observed. The occurrence of serious adverse events of any cause was similar in the abemaciclib group and the ET-only group (6.5% vs. 7.3%).

“These data are a pleasant surprise, as there were concerns that the benefit of the drug seen with shorter follow-up would wane over time,” Dr. Goetz said. “However, the opposite has occurred; with increasing length of follow-up, the curves continue to separate.”

Based on the new results, “we have high confidence that for patients with ER+/HER2- breast cancer at high risk of recurrence, the addition of 2 years of adjuvant abemaciclib to ET results in clinically significant improvements in IDFS,” he said.

Looking ahead, “we need additional follow-up to determine whether the benefit we now see in terms of IDFS will eventually translate into improvements in overall survival,” Dr. Goetz said. “We need to identify biomarkers that can identify patients at risk for early recurrence despite administration of adjuvant abemaciclib and further, biomarkers that will allow us to select patients that can be safely treated with ET alone.”

 

Findings Confirm Value of Combined Treatment

“It was reassuring to see the continued benefit at 5 years with adjuvant abemaciclib in combination with endocrine therapy compared to endocrine therapy alone in this high-risk HR+, HER2– EBC [early breast cancer] population,” Manali Ajay Bhave, MD, a medical oncologist at Emory University, Atlanta, said in an interview.

“While the interim overall survival analysis was not significant, further follow-up is necessary to truly discern a survival benefit particularly in this patient population where a survival advantage may not be seen for several years,” she added.

The current study supports the continued use of adjuvant abemaciclib in high-risk HR+, HER2– EBC patients, Dr. Bhave said. “Investigation of novel endocrine agents in the adjuvant setting for patients with high risk, HR+ HER2– EBC is needed to further improve outcomes.”
 

Urgent Need to Improve Adjuvant Therapy

“The monarchE study is a timely study aimed at improving adjuvant treatments in ER+ breast cancer to reduce risk of late recurrences,” Malinda T. West, MD, of the University of Wisconsin, said in an interview. “Late recurrences occurring decades later is a risk associated with ER+ breast cancer, and the risk of breast cancer recurrence is highest in those with larger tumors and nodal involvement.

“Abemaciclib is one of the three FDA-approved cyclin-dependent kinase 4/6 inhibitors in metastatic ER+ breast cancer based on demonstrated efficacy and safety in the metastatic setting compared to endocrine therapy alone, which was the rationale for expanded use of abemaciclib into the adjuvant setting for those at high risk for recurrence and basis of the monarchE trial,” said Dr. West.

An important criterion for inclusion was the randomization to abemaciclib required within 16 months of definitive breast cancer surgery, which reflected a window of time in which to start adjuvant abemaciclib, Dr. West said. “Exclusion criteria were those with a history of thromboembolic events, as abemaciclib carries a warning for venous thromboembolism,” she added.

In the monarchE follow-up, Dr. West said she was encouraged by the persistent and widening benefit with 2 years of added abemaciclib to endocrine therapy in reducing IDFS and DRFS compared to endocrine therapy alone.

Dr. West advised clinicians to consider initiating the therapy for up to 16 months after definitive breast surgery, because doing so may allow for recovery from surgery, chemotherapy, and radiation.

The findings tell physicians to “use caution with adding abemaciclib in those with a history of thromboembolic events or VTE risk factors as abemaciclib has a known VTE warning and this population was excluded in the monarchE trial,” she noted.

“Continued long-term follow up of those in this study will be important to determine survival benefits and how the predictive biomarker Ki-67 may impact survival outcomes,” she said.

The study was supported by Eli Lilly. Lead author Dr. Rastogi disclosed travel, accommodations, and expenses from Genentech/Roche, Lilly, and AstraZeneca. Several coauthors disclosed stock or ownership interests and/or other relationships with Lilly and other pharmaceutical companies. Dr. Goetz receives research funding from the National Institutes of Health. Dr. Bhave and Dr. West had no financial conflicts to disclose.