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.
Increasing Lp(a) Awareness for Better Cardiovascular Health: Dr Mary McGowan
March 24th 2024For Lp(a) Awareness Day, Mary McGowan, MD, FNLA, chief medical officer of the Family Heart Foundation, highlights how most people with elevated Lp(a) are completely unaware that they have this increased risk and calls for increased testing.
Read More
For National Women’s Health Week, One Company Emphasizes Cardiovascular Risk Management
May 10th 2022On this episode of Managed Care Cast, we speak with Joanne Armstrong, MD, MPH, vice president and chief medical officer for Women’s Health and Genomics at CVS Health, on the distinct pathophysiology of cardiovascular disease in women and how her own health experiences have influenced her perspective on cardiovascular disease management.
Listen
How Can Employers Leverage the DPP to Improve Diabetes Rates?
February 15th 2022On this episode of Managed Care Cast, Jill Hutt, vice president of member services at the Greater Philadelphia Business Coalition on Health, explains the Coalition’s efforts to reduce diabetes rates through the Diabetes Prevention Program (DPP).
Listen