Overweight and obese patients with comorbidities achieved significant weight loss1
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QSYMIA (phentermine and topiramate extended-release) capsules CIV vs placebo for 1 year of treatment (P<0.0001)1,2‡
- 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 evaluated1
- 66% of patients in the Qsymia groups completed the trial vs 57% in the placebo group2
- Most common reasons for discontinuation were withdrawal of consent (11.0%), loss to follow-up (10.2%), and adverse event (4.9%)2
Co-primary endpoints1
- Overall percent weight loss from baseline, ITT-LOCF analysis‡
- 9.8% weight loss achieved by patients who took the top dose (15 mg/92 mg) of Qsymia and 7.8% for patients who took the recommended dose (7.5 mg/46 mg), compared with 1.2% in the placebo group (P<0.0001)1
- 84% of patients responded to Qsymia who were randomized to the 7.5 mg/46 mg cohort. Responders were defined as patients who achieved at least 3% weight loss at 12 weeks1,2
- Within 8 weeks, patients achieved at least 5% weight loss, on average; these patients were randomized to Qsymia 7.5 mg/46 mg or 15 mg/92 mg1
- Patients achieving at least 5% weight loss at end of study
- 70% of patients who took the top dose (15 mg/92 mg) and 62% who took the recommended dose (7.5 mg/46 mg) achieved 5% or greater weight loss after 1 year vs 21% of those who took placebo (P<0.0001)1
- 10% or greater weight loss was achieved by 48% and 37% of patients in the Qsymia groups vs 7% in the placebo group (P<0.0001)1
- 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
Secondary metabolic parameters1
STUDY 2—CONQUER: Treatment difference§ from placebo in risk factors following 1 year of treatment1
Qsymia — Placebo: LS Mean | |||||
---|---|---|---|---|---|
STUDY 2 (OVERWEIGHT AND OBESE WITH COMORBIDITIES) | PLACEBO (N=979) | Qsymia® 7.5 mg/46 mg (N=488) | Qsymia 15 mg/92 mg (N=981) | Qsymia 7.5 mg/46 mg | Qsymia 15 mg/92 mg |
HEART RATE, BPM | |||||
BASELINE MEAN (SD) | 72.1 (9.9) | 72.2 (10.1) | 72.6 (10.1) | +0.6 | +1.7 |
LS MEAN CHANGE (SE) | -0.3 (0.3) | +0.3 (0.4) | +1.4 (0.3) | ||
SYSTOLIC BLOOD PRESSURE, mmHg | |||||
BASELINE MEAN (SD) | 128.9 (13.5) | 128.5 (13.6) | 127.9 (13.4) | -2.3 | -3.2 |
LS MEAN CHANGE (SE) | -2.4 (0.48) | -4.7 (0.63) | -5.6 (0.5) | ||
DIASTOLIC BLOOD PRESSURE, mmHg | |||||
BASELINE MEAN (SD) | 81.1 (9.2) | 80.6 (8.7) | 80.2 (9.1) | -0.7 | -1.1 |
LS MEAN CHANGE (SE) | -2.7 (0.3) | -3.4 (0.4) | -3.8 (0.3) | ||
TOTAL CHOLESTEROL, % | |||||
BASELINE MEAN (SD) | 205.8 (41.7) | 201.0 (37.9) | 205.4 (40.4) | -1.6 | -3.0 |
LS MEAN CHANGE (SE) | -3.3 (0.5) | -4.9 (0.7) | -6.3 (0.5) | ||
LDL-CHOLESTEROL, % | |||||
BASELINE MEAN (SD) | 124.2 (36.2) | 120.3 (33.7) | 123.9 (35.6) | +0.4 | -2.8 |
LS MEAN CHANGE (SE) | -4.1 (0.9) | -3.7 (1.1) | -6.9 (0.9) | ||
HDL-CHOLESTEROL, % | |||||
BASELINE MEAN (SD) | 48.9 (13.8) | 48.5 (12.8) | 49.1 (13.8) | +4.0 | +5.6 |
LS MEAN CHANGE (SE) | +1.2 (0.7) | +5.2 (0.9) | +6.8 (0.7) | ||
TRIGLYCERIDES, % | |||||
BASELINE MEAN (SD) | 163.5 (76.3) | 161.1 (72.2) | 161.9 (73.4) | -13.3 | -15.3 |
LS MEAN CHANGE (SE) | +4.7 (1.7) | -8.6 (2.2) | -10.6 (1.7) | ||
FASTING INSULIN, QIU/mL | |||||
BASELINE MEAN (SD) | 17.8 (13.2) | 18.0 (12.9) | 18.4 (17.5) | -4.2 | -4.7 |
LS MEAN CHANGE (SE) | +0.7 (0.8) | -3.5 (1.1) | -4.0 (0.8) | ||
FASTING GLUCOSE, mg/dL | |||||
BASELINE MEAN (SD) | 106.6 (23.7) | 106.2 (21.0) | 105.7 (21.4) | -2.4 | -3.6 |
LS MEAN CHANGE (SE) | +2.3 (0.6) | -0.1 (0.8) | -1.3 (0.6) | ||
WAIST CIRCUMFERENCE, cm | |||||
BASELINE MEAN (SD) | 113.4 (12.2) | 112.7 (12.4) | 113.2 (12.2) | -5.2§ | -6.8§ |
LS MEAN CHANGE (SE) | -2.4 (0.3) | -7.6 (0.4) | -9.2 (0.3) |
- The effect of Qsymia (phentermine and topiramate extended-release) capsules CIV on cardiovascular morbidity and mortality has not been established1
- Among the 388 subjects with type 2 diabetes treated in study 2, reductions in HbA1c from baseline (6.8%) were 0.1% for placebo compared to 0.4% and 0.4% with Qsymia 7.5 mg/46 mg and Qsymia 15 mg/92 mg, respectively1
- Qsymia patients with Type 2 diabetes achieved an average HbA1c level below AACE- recommend HbA1c levels of 6.5%1,11
- Qsymia is not indicated for the treatment of hypertension, type 2 diabetes mellitus, stroke, or heart disease
Study design1
- Qsymia was specifically studied in overweight patients with comorbidities including:
- Hypertension: 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: Triglycerides greater than 200-400 mg/dL or were receiving treatment with 2 or more lipid-lowering agents
- Diabetes: Elevated fasting blood glucose (greater than 100 mg/dL) or diabetes
- Waist circumference: 102 cm or greater in men, 88 cm or greater in women
- At the beginning of the study, the average weight and BMI of patients was 227 pounds and 36.6 kg/m2, respectively
- 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
‡Intent-to-treat, last observation carried forward