Achieve and maintain weight loss that is clinically meaningful for 1 year1 In Study 2, the CONQUER Trial, 2,487 overweight or obese patients (BMI* 27 or greater and less than or equal to 45) with 2 or more weight-related comorbidities were evaluated for 1 year 1 5% weight loss or greater† was achieved by 70% of patients who took the Qsymia™ 15 mg/92 mg dose and 62% who took the 7.5 mg/46 mg dose, compared with 21% in the placebo group (P<0.0001)1 • In CONQUER, patients randomized to Qsymia 7.5 mg/46 mg or 15 mg/92 mg achieved, on average, at least 5% weight loss within 8 weeks1,2 In CONQUER, 84% of patients randomized to Qsymia 7.5 mg/46 mg responded to treatment. Responders were defined as patients who achieved at least 3% weight loss at 12 weeks1,2 In CONQUER, Qsymia provided clinically meaningful weight loss, even in obese patients taking SSRIs, SNRIs, or bupropion1,2
QSYMIA (phentermine and topiramate extended-release) capsules CIV VS PLACEBO FOR 1 YEAR OF TREATMENT (P<0.0001) 1,2‡ COMPLETERS
Percent Weight Loss (LS mean)
0
1.6%
ITT-LOCF†
1.2%
Placebo (n=564) Qsymia 7.5 mg/ 46 mg (n=344)
4
7.8%
8
9.6% 9.8%
Qsymia 15 mg/ 92 mg (n=634)
12.4%
12
16 8
12
24
36
48
56
56
Time (Weeks) At the beginning of the study, the average weight and BMI of patients were 227 pounds and 36.6, respectively.1 Eligible comorbidities included hypertension with an elevated blood pressure (greater than or equal to 140/90 mmHg, or greater than or equal to 130/85 mmHg for diabetics) or requirement for greater than or equal to 2 antihypertensive medications; high cholesterol with triglycerides greater than 200-400 mg/dL or were receiving treatment with 2 or more lipid-lowering agents; diabetes with an elevated fasting blood glucose (greater than 100 mg/dL) or diabetes; waist circumference of 102 cm or greater in men, 88 cm or greater in women.1 For all patients, a well-balanced, reduced-calorie diet (decrease of 500 kcal/day) was recommended, and nutritional and lifestyle modification counseling was also offered.1 66% of patients in the Qsymia groups completed 1 year of treatment vs 57% in the placebo group.2
Qsymia is not indicated for the treatment of hypertension, type 2 diabetes mellitus, or dyslipidemia1
Safety profile evaluated for 1 year1 Most common adverse reactions (incidence 5% or greater and at least 1.5 times placebo) are: paraesthesia,§ dizziness, dysgeusia, insomnia, constipation, and dry mouth1 *BMI is measured in kg/m2. †Primary endpoint. Intent-to-treat, last observation carried forward.1 ‡Completers data (from subjects who had a 1-year evaluation within 7 days of their last dose). 2 § Reports of paraesthesia were typically characterized as tingling in the hands, feet, or face.1
Please see brief summary of Qsymia Prescribing Information on the following pages and Qsymia Full Prescribing Information available at www.Qsymia.com.
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