2024-03-11| Trials & Approvals

Wegovy Expands Its Reach: First Weight-Loss Medication Approved to Reduce Cardiovascular Risk

by Oscar Wu
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The U.S. Food and Drug Administration (FDA) has expanded the approved uses of Wegovy (semaglutide) injection. In a landmark decision, Wegovy is now indicated to reduce the risk of cardiovascular death, heart attack, and stroke in adults with established cardiovascular disease (CVD) and either obesity or overweight.

This marks a significant step forward, as Wegovy becomes the first weight-loss medication approved with the specific aim of preventing life-threatening cardiovascular events in this high-risk patient population.

Beyond the Weight-Loss Pill, New CVD Medication Emerge

Obesity and overweight are major public health concerns in the United States, affecting an estimated 70% of American adults. These conditions significantly increase the risk of premature death and various health problems, including heart attack and stroke.

The FDA’s approval of Wegovy for cardiovascular risk reduction acknowledges this critical public health issue and offers a new weapon in the fight against heart disease and stroke in individuals with both CVD and weight concerns.

Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist and should not be used with other products containing semaglutide or other GLP-1 receptor agonists. The FDA granted this new indication a Priority Review designation, highlighting its potential public health impact. The approval was granted to Novo Nordisk A/S, the drug’s manufacturer. Wegovy is also approved for chronic weight management in certain adults and children with obesity, used in conjunction with a reduced calorie diet and increased physical activity.

This expansion of Wegovy’s use represents a significant advancement in cardiovascular disease prevention. By offering a weight-loss medication with documented cardiovascular risk reduction benefits, healthcare professionals have a new tool to help manage the health of at-risk individuals. However, it’s crucial to weigh the potential risks and benefits and engage in regular check-ups with a doctor while using Wegovy.

Efficacy and Safety Supported by Clinical Research

The approval of Wegovy for cardiovascular risk reduction is based on robust clinical research. A large, placebo-controlled trial involving over 17,600 participants evaluated the drug’s effectiveness. The study demonstrated a significant reduction in major adverse cardiovascular events (MACE), including heart attack, stroke, and cardiovascular death, compared to the placebo group.

However, it’s important to note that Wegovy comes with potential risks and side effects. These include the risk of developing thyroid C-cell tumors, pancreatitis, gallbladder problems, low blood sugar (hypoglycemia), acute kidney injury, and hypersensitivity reactions. Additionally, individuals with a history of diabetic retinopathy should exercise caution when using Wegovy, as it may worsen the condition. 

Other potential side effects include increased heart rate and concerningly, suicidal behavior or thinking. It’s crucial to discuss these potential risks and benefits with a healthcare professional before starting Wegovy. Common side effects reported during the trials included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, belching, low blood sugar, flatulence, and heartburn.

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