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Liraglutide, semaglutide beneficial in diabetes regardless of baseline BMI, BP
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CHICAGO — Two post-hoc analyses of data from the LEADER and SUSTAIN 6 trials presented at the American Heart Association Scientific Sessions indicate that CV and renal benefits of the GLP-1 receptor agonists liraglutide and semaglutide are consistent across baseline BMI and BP categories in patients with type 2 diabetes.
“The benefits of liraglutide and semaglutide are also consistent in individuals who achieved above or below median weight loss,” Subodh Verma, MD, PhD, FRCSC, from the division of cardiac surgery at St. Michael’s Hospital, University of Toronto, said during a presentation. “I think that is a very important message that the ability of these agents to lower body weight is not necessarily associated with its CV efficacy.”
Benefits across BMI
In the LEADER trial, 9,340 patients with type 2 diabetes and established CVD or multiple CVD risk factors were randomly assigned to liraglutide therapy or placebo. According to Verma, 9% of patients had a baseline BMI below 25 kg/m2, 30% had a BMI of 25 kg/m2 to 30 kg/m2, another 30% had a BMI of 30 kg/m2 to 35 kg/m2; and the last 30% had a BMI of more than 35 kg/m2. A similar distribution of BMI was seen among the 3,297 patients enrolled in the SUSTAIN 6 trial who were randomly assigned to semaglutide (Novo Nordisk) or placebo.
In LEADER, the relative risk reduction for primary MACE (13%), expanded MACE outcomes (12%) and CV death (22%) was consistent across the baseline BMI categories, Verma said. Renal outcomes, which included new or persistent macroalbuminuria, doubling of serum creatine, ESRD or death due to kidney disease, all showed consistent benefits regardless of baseline BMI category. Overall, liraglutide was associated with a 22% reduction in renal outcomes.
“We saw a similar pattern in SUSTAIN 6,” Verma said.
In this trial, there was a 26% relative risk reduction in primary MACE. Expanded MACE outcomes and CV death rates were consistently “neutral” across BMI groups. Renal outcomes were also similar, with the overall HR being 0.64 (95% CI, 0.46-0.88).
Benefits across BP
In a separate presentation, Lawrence A. Leiter, MDCM, FRCPC, FACP, FACE, FAHA, director of the Lipid Clinic at St. Michael’s Hospital, presented results about the cardiorenal benefits of liraglutide and semaglutide across BP categories. Investigators defined the baseline BP categories for patients in the two studies as normal (BP of less than 120/80 mm Hg; 15% of patients in each study); elevated (systolic BP of 121 mm Hg to 129 mm Hg and diastolic BP less than 80 mm Hg; 13% to 14% of patients); stage 1 hypertension (systolic BP of 130 mm Hg to 139 mm Hg or diastolic BP of 80 mm Hg to 89 mm Hg; 30% of patients); and stage 2 hypertension (systolic BP of 140 mm Hg or more or diastolic BP of 90 mm Hg or more; 40% of patients).
There was a trend toward greater reduction of both primary MACE and nephropathy in patients with stage 1 or 2 hypertension, but this finding did not achieve statistical significance, Leiter said.
For SUSTAIN-6, Leiter noted a “fairly consistent benefit” for MACE across the baseline BP categories. He also saw a “very wide confidence interval” due to the size of the study, but “overall, fairly similar risk reductions” for risk of nephropathy across BP categories .
“In both LEADER and SUSTAIN 6, liraglutide and semaglutide demonstrated improvements in both CV, as well as renal outcomes, across baseline BP categories,” Leiter concluded. “This analysis adds to those done across BMI [and] across LDL cholesterol levels, which was published a few months ago, and strongly suggests that the CV benefits observed with these two GLP-1 receptor agonists is above and beyond the effects on traditional CV risk factors.” – by Gina Brockenbrough, MA
References:
Leiter LA, et al. Abstract 167. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.
Verma S, et al. Abstract 163. Presented at: American Heart Association Scientific Sessions; Nov. 10-12, 2018; Chicago.
Disclosures: Leiter reports receiving consultancy fees from AstraZeneca, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novo Nordisk, Sanofi and Servier; and grant funding for CME activity from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novo Nordisk and Sanofi. Verma reports receiving research grants and honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Novo Nordisk, Sanofi Pasteur and Valeant.