Drug updated on 11/1/2024
Dosage Form | Capsule (oral; phentermine/topiramate: 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg) |
Drug Class | Sympathomimetic amine anorectics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity
- Indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with overweight in the presence of at least one weight-related comorbid condition
Latest News
Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Body Weight Loss: Phentermine/topiramate (P/T) demonstrated significant weight reduction in individuals with obesity and overweight across multiple reviews, showing a mean difference of -8.10 kg (95% CI (confidence interval): -10.14, -6.05) at 12 months compared to placebo, with dose-specific losses of 3.55 kg (95% CI: 2.22-4.88) for 3.75/23 mg, 7.27 kg (95% CI: 6.40-8.13) for 7.5/46 mg, and 8.25 kg (95% CI: 6.92-9.79) for 15/92 mg.
- Waist Circumference Reduction: P/T was associated with a waist circumference reduction at 12 months, yielding a mean difference of -6.20 cm (95% CI: -7.46, -4.94) compared to placebo.
- Blood Pressure: P/T led to reductions in systolic blood pressure by -2.0 to -4.2 mm Hg and diastolic blood pressure by -1.3 to -1.9 mm Hg over a 13-month period compared to placebo.
- AOMs (Anti-obesity medications), including phentermine/topiramate (P/T), were associated with mild to moderate adverse events without unexpected safety signals, with the most frequent side effects being dry mouth and paraesthesia.
- Specific adverse events for P/T included dysgeusia (OR (odds ratio) = 8.86), paresthesia (OR = 8.51), dry mouth (OR = 6.71), disturbance in attention (OR = 4.48), irritability (OR = 4.10), hypoesthesia (OR = 3.81), constipation (OR = 2.43), and dizziness (OR = 2.26).
- Studies indicate relevant population types or subgroups, specifically targeting adults with obesity or overweight (BMI ≥ 27 kg/m²) and hypertensive adults, with notable findings such as effective weight loss across these populations and blood pressure reductions observed specifically in hypertensive adults.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Qsymia (phentermine and topiramate) Prescribing Information. | 2024 | VIVUS LLC, Campbell, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Clinical outcomes associated with drugs for obesity and overweight: A systematic review and network meta-analysis of randomized controlled trials | 2023 | Diabetes, Obesity & Metabolism |
The effects of weight-lowering pharmacotherapies on physical activity, function and fitness: A systematic review and meta-analysis of randomized controlled trials | 2023 | Obesity Reviews |
Clinical outcomes associated with anti-obesity medications in real-world practice: A systematic literature review | 2021 | Obesity Reviews |
Efficacy and Safety of Phentermine/Topiramate in Adults with Overweight or Obesity: A Systematic Review and Meta-Analysis | 2021 | Obesity |
Long-term effects of weight-reducing drugs in people with hypertension | 2021 | The Cochrane Database of Systematic Reviews |
Pharmacotherapy in obesity: a systematic review and meta-analysis of randomized controlled trials of anti-obesity drugs | 2020 | Expert Review of Clinical Pharmacology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Approved Anti-Obesity Medications in 2022 KSSO Guidelines and the Promise of Phase 3 Clinical Trials: Anti-Obesity Drugs in the Sky and on the Horizon | 2023 | Journal of Obesity & Metabolic Syndrome |
AGA Clinical Practice Guideline on Pharmacological Interventions for Adults With Obesity | 2022 | Gastroenterology |