02/06/2023
Results from the 6-month, multicenter, randomized, double-blind Phase 3 BpCompare trial were published today in Hypertension, demonstrating comparable efficacy but improved tolerability of Brand X versus amlodipine.
Trial Design
This non-inferiority trial enrolled 806 men and women aged 18-75 with stage 1 or 2 hypertension across 93 sites in the US and EU.
Participants were randomized 1:1 to receive once daily treatment with either Brand X 20mg or amlodipine 5mg for 6 months, with uptitration if needed.
Efficacy Outcomes
After 6 months, patients in the Brand X arm experienced a mean reduction from baseline in systolic BP of 12.1 mmHg, compared to 12.7 mmHg in the amlodipine arm.
The mean difference of 0.6 mmHg between groups with 95% CI of -0.3 to 1.5 mmHg was within the predefined non-inferiority margin of 4 mmHg.
Similar non-inferior reductions were seen in diastolic BP between groups. On average, 74% of patients achieved BP control under 140/90 mmHg on either Brand X or amlodipine.
Safety Results
The incidence of overall adverse events was significantly lower in the Brand X group at 48% compared to 58% in the amlodipine group over 6 months.
Specifically, headaches occurred in 9.2% of Brand X patients vs 19.7% on amlodipine. Rates of dizziness (6.3% vs 12.1%), fatigue (4.2% vs 6.7%), and lower extremity edema (2.1% vs 7.9%) were also lower with Brand X.
Discontinuations due to adverse events were 8.3% for Brand X versus 13.9% for amlodipine. Both treatments demonstrated comparable laboratory, vital sign, and ECG safety.
Conclusions
“While equally effective for lowering blood pressure, Brand X provides superior tolerability with lower rates of adverse effects compared to amlodipine,” said lead author Dr. James Able.
According to the researchers, this improved safety profile may make Brand X a more suitable first-line treatment option for hypertension.