Study 1: EQUIP

Obese patients 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 10.9% for Qsymia top dose, 5.1% for Qsymia starting dose and 1.6% for placebo.

  • 1,267 obese patients were evaluated1
  • The BMI of participating patients ranged from 35 to 791
  • Qsymia is the only prescription weight‑loss medicine proven to provide weight loss in excess of 14% for year 12
  • 58% of patients in the Qsymia® groups completed 1 year of treatment vs 47% in the placebo group2
  • Most common reasons for discontinuation were loss to follow-up (14.7%), withdrawal of consent (13.1%), and adverse event (5.4%)2

Co-primary endpoints1

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  • Overall percent weight loss from baseline, ITT-LOCF analysis
    • 10.9% weight loss achieved by patients who took the top dose (15 mg/​92 mg) of Qsymia and 5.1% for patients who took the starting dose (3.75 mg/​23 mg), compared with 1.6% in the placebo group (P<0.0001)1
  • Provided clinically meaningful weight loss, even in obese patients taking SSRIs, SNRIs, or bupropion1,2

  • Patients achieving at least 5% weight loss at end of study
    • 67% of patients who took the top dose (15 mg/​92 mg) and 45% who took the starting dose (3.75 mg/23 mg) achieved 5% or greater weight loss after 1 year vs 17% of those who took placebo (P<0.0001)1
    • 10% or greater weight loss was achieved by 47% and 19% of patients in the Qsymia groups vs 7% in the placebo group (P<0.0001)1
  • Patients randomized to Qsymia 15 mg/​92 mg achieved, on average, at least 5% weight loss within 8 weeks1,2

Secondary metabolic parameters1

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STUDY 1—EQUIP: Treatment difference from placebo in risk factors following 1 year of treatment1

  PLACEBO: LS MEAN
STUDY 1 (OBESITY) PLACEBO (N=498) QSYMIA 7.5 mg/​46 mg (N=234) QSYMIA 15 mg/​92 mg (N=498) QSYMIA 7.5 mg/​46 mg QSYMIA 15 mg/​92 mg
HEART RATE, BPM  
Baseline Mean (SD) 73.2 (8.8) 72.3 (9.2) 73.1 (9.6) +1.1 +1.8
LS Mean Change (SE) -0.8 (0.5) +0.3 (0.6) +1.0 (0.5)
SYSTOLIC BLOOD PRESSURE, mmHg  
Baseline Mean (SD) 121.9 (11.5) 122.5 (11.1) 121.9 (11.6) -2.8 -3.8
LS Mean Change (SE) +0.9 (0.6) -1.8 (0.8) -2.9 (0.6)
DIASTOLIC BLOOD PRESSURE, mmHg  
Baseline Mean (SD) 77.2 (7.9) 77.8 (7.5) 77.4 (7.7) -0.5 -1.9
LS Mean Change (SE) +0.4 (0.4) -0.1 (0.6) -1.5 (0.4)
TOTAL CHOLESTEROL, %  
Baseline Mean (SD) 194.3 (36.7) 196.3 (36.5) 192.7 (33.9) -1.9 -2.5
LS Mean Change (SE) -3.5 (0.6) -5.4 (0.9) -6.0 (0.6)
LDL-CHOLESTEROL, %  
Baseline Mean (SD) 120.9 (32.2) 122.8 (33.4) 120.0 (30.1) -2.2 -2.8
LS Mean Change (SE) -5.5 (1.0) -7.7 (1.3) -8.4 (0.9)
HDL-CHOLESTEROL, %  
Baseline Mean (SD) 49.5 (13.3) 50.0 (11.1) 49.7 (11.7) +0.5 +3.5
LS Mean Change (SE) +0.0 (0.8) +0.5 (1.1) +3.5 (0.8)
TRIGLYCERIDES, %  
Baseline Mean (SD) 119.0 (39.3) 117.5 (40.3) 114.6 (37.1) -3.9 -14.3
LS Mean Change (SE) +9.1 (2.3) +5.2 (3.1) -5.2 (2.2)
FASTING GLUCOSE, mg/dL  
Baseline Mean (SD) 93.1 (8.7) 93.9 (9.2) 93.0 (9.5) -1.2 -2.5
LS Mean Change (SE) +1.9 (0.5) +0.8 (0.7) -0.6 (0.5)
WAIST CIRCUMFERENCE, cm  
Baseline Mean (SD) 120.5 (14.0) 121.5 (15.2) 120.0 (14.7) -2.5§ -7.8§
LS Mean Change (SE) -3.1 (0.5) -5.6 (0.6) -10.9 (0.5)

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

Study design1

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  • At the beginning of the study, the average weight and BMI of patients was 256 pounds and 42 kg/m2, respectively (patients' BMI ranged from 35 to 70)

Study 1 Equip. Study design.

  • 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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