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Phentermine and topiramate

(Qsymia®)

Qsymia®

Drug updated on 11/1/2024

Dosage FormCapsule (oral; phentermine/topiramate: 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg)
Drug ClassSympathomimetic amines and anticonvulsants
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

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Summary
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  • 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.