Study 2: CONQUER

Overweight and obese patients with comorbidities achieved significant weight loss

In this section
Study design
Co-primary endpoints
Secondary metabolic parameters

QSYMIA® (phentermine and topiramate extended-release) capsules CIV vs placebo for 1 year of treatment (P<0.0001)1,2,†

Enlarge chart

LS Mean percentage weight loss for one year of treatment was 9.8% for Qsymia top dose, 7.8% for Qsymia recommended dose and 1.2% for placebo.

  • 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 group1
    • 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

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  • 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

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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)

SD=standard deviation; SE=standard error. Least-squares (LS) mean. Study 1 adjusted for baseline body weight and diabetic status. §Statistically significant versus placebo based on the pre-specified method for controlling Type I error across multiple doses.

  • 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%1,3
  • Qsymia is not indicated for the treatment of hypertension, type 2 diabetes mellitus, stroke, or heart disease

Study design1

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  • 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
BMI is measured in kg/m2

Choose Qsymia as first-line choice for a range of overweight and obese patient types who need to achieve significant weight loss1,2

Qsymia has been clinically proven to provide effective and well-tolerated treatment for a range of overweight and obese patient types1-2

Review Data by Patient Type

Choose Qsymia as first-line for obesity treatment1,2

1.2 MILLION QSYMIA RXS HAVE BEEN FILLED TO HELP PATIENTS ACHIEVE THEIR WEIGHT-LOSS GOALS1

Source: McKesson Specialty Health, 2015.

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