Treatment-emergent adverse events from the head-to-head study1
Treatment-emergent adverse events ≥5% in either trial group at any time during the double-blind treatment period1*
| QULIPTA 60 mg QD(n=273) | Topiramate†(n=267) | |
|---|---|---|
| PARESTHESIA | 5.1% | 41.2% |
| NAUSEA | 19.8% | 16.5% |
| FATIGUE | 15.4% | 14.2% |
| NASOPHARYNGITIS | 11.0% | 12.7% |
| DIZZINESS | 7.7% | 10.5% |
| DECREASED APPETITE | 12.5% | 10.1% |
| DISTURBANCE IN ATTENTION | 7.0% | 9.7% |
| HYPOESTHESIA | 0.7% | 5.6% |
| CONSTIPATION | 9.9% | 4.9% |
Patients experienced similar weight decreases between QULIPTA and topiramate at the end of the double-blind treatment period2‡:
In the overall safety population§ the mean change from baseline weight for patients were¶:
- QULIPTA 60 mg (n=270):
-3.3 lb from baseline 157.8 lb - Topiramate (n=262):
-4.3 lb from baseline 159 lb
88.8% of patients on topiramate (237/267) and 76.9% of patients on QULIPTA (210/273) experienced treatment-emergent adverse events1*
*Based on the safety population (N=540) which included all subjects who received at least 1 dose of study treatment during the double-blind treatment period.1
†Topiramate dosing: 25 mg starting daily dose was titrated up to the highest tolerated daily dose of 50 mg, 75 mg, or 100 mg.3
‡The end of double-blind treatment period is defined as the scheduled subsequent visit after a subject stops taking the study drug within the double-blind treatment period.2
§Includes subjects in the safety population with non-missing baseline weight value and post-baseline weight value at the end of the double-blind treatment period.2
¶These measurements were converted from kilograms to pounds. For QULIPTA, the baseline weight was 71.6 kg with a reduction of -1.5 kg. For topiramate, the baseline weight was 72.1 kg with a reduction of -1.9 kg.2
HEAD-TO-HEAD WEIGHT SAFETY DATA
Patients experienced similar weight decreases between QULIPTA and topiramate2
| OVERALL SAFETY POPULATIONMEAN BMI: 25.6 kg/m2 | ||
|---|---|---|
| QULIPTA 60 mg | TOPIRAMATE | |
| PERCENTAGE of patients with ≥5% WEIGHT DECREASE anytime during the double-blind treatment period* |
28% (75/270) |
29% (76/262) |
| CHANGE IN WEIGHT (lb) from baseline in patients with ≥5% WEIGHT DECREASE at the end of the double-blind treatment period* |
-11.6 lb Baseline: 159.5 lb† |
-12.4 lb Baseline: 159.1 lb† |
NOTE: 5.6% of QULIPTA patients compared to 4.6% of topiramate patients experienced a ≥5% weight gain at any time during the DB treatment period.4
*The end of the double-blind treatment period is defined as the scheduled subsequent visit after a subject stops taking the study drug within the double-blind treatment period.2
†Baseline weight measurements were converted from kilograms to pounds. Patients on QULIPTA who experienced at least 5% weight decrease had a baseline weight of 72.4 kg with a reduction of -5.3 kg. Patients on topiramate who experienced at least 5% weight decrease had a baseline weight of 72.2 kg with a reduction of -5.6 kg.2
study design
