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Semaglutide Approved for Cardiovascular Risk Reduction in Adults With T2D
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Novo Nordisk announced Thursday the FDA has approved injectable semaglutide (Ozempic) for adult patients with type 2 diabetes (T2D) and known heart disease.
Novo Nordisk announced Thursday the FDA has approved injectable semaglutide (Ozempic) for adult patients with type 2 diabetes (T2D) and known heart disease.
With the new indication, 0.5 mg or 1 mg doses of the glucagon-like peptide-1 receptor agonist can be prescribed to reduce the risk of “major adverse cardiovascular events (MACE) such as heart attack, stroke, or death” in adults with both diseases.
Cardiovascular disease (CVD) is the leading cause of death and disabilities in patients with T2D, and adults with T2D are 2 to 4 times more likely to develop CVD than adults without diabetes, according to the press release.
In a 2-year long SUSTAIN 6 cardiovascular outcomes trial (CVOT), the medication “significantly reduced the risk of the occurrence of a 3-component MACE endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke.” Results concluded the relative risk reduction of MACE with semaglutide was 26% compared with a placebo (hazard ratio [HR], 0.74; 95% CI, 0.58-0.95; P <.001).
Those receiving the medication during the trial reported higher frequencies of gastrointestinal adverse events, the majority of which took place within the first 30 weeks of the trial. Additional possible adverse effects of the drug are thyroid tumors which could lead to cancer, inflammation of the pancreas, changes in vision, low blood sugar, kidney problems, and serious allergic reactions.
Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, stated, “Today's milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease."
The company also updated the label for oral semaglutide (Rybelsus), adding additional details to tablets of 7 mg or 14 mg. “The Rybelsus prescribing information has been updated in section 14 (clinical studies) to include an analysis from the primary endpoint of the PIONEER 6 CVOT showing the hazard ratio for time to first three-component MACE (HR 0.79 [95% CI: 0.57, 1.11]),” according to the press release.
