News and Updates in Diabetes at AHA 2024
Nov 21, 06:01 PM
In this episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, take a deep dive into 3 pieces of news related to diabetes management and incretin therapies, including the BPROAD trial, tirzepatide in heart failure with preserved ejection fraction with obesity, and an NHANES analysis suggesting more than 50% of US adults qualify for semaglutide.
BPROAD
Presented at the American Heart Association (AHA) Annual Scientific Sessions 2024, BPROAD examined the effects of 120 mmHg vs 140 mmHg blood pressure goals among a cohort of 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. With a follow-up period lasting up to 5 years, the trial’s primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes.
Upon analysis, results suggested the mean SBP levels in participants at the 4-year visit were 120.6 mmHg in the intensive treatment group and 132.1 mmHg in the standard treatment group. Those receiving the intensive treatment regimen experienced a 21% lower relative risk of major cardiovascular events during the follow-up period, compared with those on standard treatment (HR 0.79; 95% Cl, 0.69 to 0.90; P <.001).
SUMMIT
Presented at AHA 2024, SUMMIT was a phase 3, placebo-controlled, double-blind, international trial assessing the safety and efficacy of tirzepatide among 731 adult patient adults with HFpEF and obesity, with or without type 2 diabetes, from 10 countries across 4 continents.
Results of the trial suggested a primary composite endpoint event occurred among 9.9% of the tirzepatide group and 15.3% of the placebo group (HR, 0.62; 95% CI, 0.41 to 0.95; P = .026). Analysis of KCCQ-CSS at 52 weeks suggested use of tirzepatide was associated with a mean change of 19.5 (SD, 1.2) from baseline to week 52 compared to a change of 12.7 (SD, 1.3) among the placebo group (between-group difference, 6.9; 95% CI, 3.3 to 10.6; P <.001).
Semaglutide Eligibility in US Adults
An analysis leveraging NHANES data from 2015-2020 and eligibility criteria from pivotal trials for semaglutide’s approvals in type 2 diabetes, weight management, and secondary prevention of cardiovascular disease suggest more than half of all US adults would be considered eligible under these criteria.
From 25,531 survey participants, investigators identified 8504 individuals eligible for semaglutide, which is representative of 136.8 million (95%CI, 128.4 million to 145.2 million) US adults. Led by investigators at Harvard, Northwestern, and other leading institutions, concluded 35.0 million adults qualified for use based on its diabetes indication, 129.2 million were eligible based on its weight management indication, and 8.9 million were considered eligible based on its indication for secondary prevention of cardiovascular disease.
Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.
BPROAD
Presented at the American Heart Association (AHA) Annual Scientific Sessions 2024, BPROAD examined the effects of 120 mmHg vs 140 mmHg blood pressure goals among a cohort of 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. With a follow-up period lasting up to 5 years, the trial’s primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes.
Upon analysis, results suggested the mean SBP levels in participants at the 4-year visit were 120.6 mmHg in the intensive treatment group and 132.1 mmHg in the standard treatment group. Those receiving the intensive treatment regimen experienced a 21% lower relative risk of major cardiovascular events during the follow-up period, compared with those on standard treatment (HR 0.79; 95% Cl, 0.69 to 0.90; P <.001).
SUMMIT
Presented at AHA 2024, SUMMIT was a phase 3, placebo-controlled, double-blind, international trial assessing the safety and efficacy of tirzepatide among 731 adult patient adults with HFpEF and obesity, with or without type 2 diabetes, from 10 countries across 4 continents.
Results of the trial suggested a primary composite endpoint event occurred among 9.9% of the tirzepatide group and 15.3% of the placebo group (HR, 0.62; 95% CI, 0.41 to 0.95; P = .026). Analysis of KCCQ-CSS at 52 weeks suggested use of tirzepatide was associated with a mean change of 19.5 (SD, 1.2) from baseline to week 52 compared to a change of 12.7 (SD, 1.3) among the placebo group (between-group difference, 6.9; 95% CI, 3.3 to 10.6; P <.001).
Semaglutide Eligibility in US Adults
An analysis leveraging NHANES data from 2015-2020 and eligibility criteria from pivotal trials for semaglutide’s approvals in type 2 diabetes, weight management, and secondary prevention of cardiovascular disease suggest more than half of all US adults would be considered eligible under these criteria.
From 25,531 survey participants, investigators identified 8504 individuals eligible for semaglutide, which is representative of 136.8 million (95%CI, 128.4 million to 145.2 million) US adults. Led by investigators at Harvard, Northwestern, and other leading institutions, concluded 35.0 million adults qualified for use based on its diabetes indication, 129.2 million were eligible based on its weight management indication, and 8.9 million were considered eligible based on its indication for secondary prevention of cardiovascular disease.
Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.