What to advise a patient without diabetes who wants to start Ozempic (semaglutide) for weight loss?

Advising Patients Without Diabetes About Semaglutide (Ozempic) for Weight Loss

For patients without diabetes who want to start Ozempic for weight loss, recommend FDA-approved semaglutide formulations (Wegovy) specifically indicated for obesity treatment rather than off-label use of Ozempic, which is only approved for diabetes management.

FDA-Approved Indications and Eligibility

Semaglutide for weight management is FDA-approved under specific conditions:

• Wegovy (semaglutide 2.4mg) is approved for weight management in patients with:
  • BMI ≥30 kg/m² OR
  • BMI ≥27 kg/m² with at least one weight-related condition (e.g., hypertension, dyslipidemia) 1
• Ozempic is only FDA-approved for diabetes management, not for weight loss in non-diabetic patients

Efficacy in Non-Diabetic Patients with Obesity

Recent evidence strongly supports semaglutide's effectiveness for weight loss in non-diabetic patients:

• Semaglutide produces substantial weight loss in patients without diabetes:
  • Mean weight reduction of 11.85% compared to placebo 2
  • Long-term studies show weight loss of 12.1% at 68+ weeks 3
  • In the SELECT trial, weight loss was sustained for up to 4 years with a 10.2% reduction versus 1.5% with placebo 4
• 33.4% of patients achieved ≥20% weight loss compared to only 2.2% with placebo in long-term studies 3

Cardiovascular Benefits Beyond Weight Loss

Semaglutide offers significant cardiovascular benefits:

• The SELECT trial demonstrated a 20% reduction in major adverse cardiovascular events in adults with preexisting cardiovascular disease and obesity without diabetes 4
• Semaglutide 2.4mg reduced the composite incidence of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (hazard ratio 0.80) 5

Important Counseling Points

1. Long-term commitment required:

   • Weight regain occurs after discontinuation
   • After 68 weeks of treatment followed by discontinuation, mean weight regain was 11.6% 5
   • Continuous therapy is needed to maintain benefits 5

2. Side effects:

   • Gastrointestinal adverse events are 1.59 times more likely with semaglutide 2
   • Most side effects are transient and mild-to-moderate in severity 3
   • Risk of discontinuation due to adverse events is twice as likely compared to placebo 2
   • Serious adverse events (including pancreatitis and cholelithiasis) are 1.6 times more likely 2

3. "Ozempic face" phenomenon:

   • Rapid facial weight loss may lead to a distorted facial appearance 1
   • Patients should be counseled about this potential cosmetic effect

Practical Recommendations

1. Appropriate medication selection:

   • Recommend Wegovy (semaglutide 2.4mg) which is FDA-approved for obesity, not Ozempic
   • If insurance coverage is an issue, discuss cost considerations and alternatives

2. Monitoring protocol:

   • Assess effectiveness and safety monthly for first 3 months, then quarterly 5
   • Early responders (>5% weight loss after 3 months) have better long-term outcomes 5
   • Consider discontinuing if <5% weight loss after 3 months

3. Lifestyle modifications:

   • Emphasize that medication must be used in conjunction with lifestyle changes 5
   • Recommend reduced-calorie diet and 150-200 minutes/week of physical activity 5

4. Insurance and cost considerations:

   • Medicare excludes coverage of FDA-approved antiobesity medications for obesity alone 5
   • These medications can be costly and global shortages exist 5

Alternatives to Consider

If semaglutide is not appropriate or available:

1. Other FDA-approved medications:

   • Tirzepatide (recently FDA-approved for obesity) with superior weight loss (15-20.9%) 5
   • Liraglutide (8% weight loss at 56 weeks) 5
   • Phentermine-topiramate (5.1-10.9% weight loss) 5

2. Non-pharmacological options:

   • Intensive lifestyle interventions
   • Bariatric endoscopic procedures for eligible patients 5

Common Pitfalls to Avoid

1. Off-label prescribing of Ozempic:

   • Growing public interest in off-label use driven by social media and celebrity influence 6
   • Prescribing Ozempic instead of Wegovy may contribute to shortages for diabetes patients

2. Inadequate patient education:

   • Failing to discuss the need for lifelong therapy
   • Not preparing patients for side effects or weight regain after discontinuation

3. Ignoring comorbidities:

   • Not screening for conditions that might benefit from or be worsened by treatment