Study 2: CONQUER clinical trial

Overweight and obese patients with comorbidities achieved significant weight loss1

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

ENLARGE CHART  

  • 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

 
BACK TO TOP
 

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)
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%1,11
  • Qsymia is not indicated for the treatment of hypertension, type 2 diabetes mellitus, stroke, or heart disease

 
BACK TO TOP
 

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
 

BACK TO TOP

Additional clinical trial information

Prescribing and dosing for Qsymia

Initiating therapy and ongoing assessment of Qsymia patients

Identifying potential Qsymia patients

Qsymia can help you treat many of the patients you see in your practice1,2

Important Safety Information

Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

VIEW ALL +
Online ordering with convenient home delivery.
You pay only $98 across all doses.§
Exclusively priced for cash patients. Additional shipping and handling costs will apply.
LEARN MORE
LEARN MORE AND SAVE