Improved Formulation of Cilnidipine versus Conventional Cilnidipine in Treatment of Essential Hypertension: A Double-Blind, Randomized, Comparative Study

Abstract

Background: Cilnidipine, a calcium channel blocker, has a two‐directional approach in hypertension management.  Methods: We conducted a randomized, double-blind, parallel-group study to evaluate and compare the efficacy and safety of improved formulation of cilnidipine 10 mg tablet (Nexovas®, Macleods, India), which was bioequivalent to the Atelec® (Japan) ,versus conventional cilnidipine (India) in patients with essential hypertension. Patients were randomized 1:1 to Nexovas® or conventional cilnidipine groups. The treatment was administered for 30 days. Results: Overall, the mean change from baseline to day 30 in systolic blood pressure (SBP) was found to be 21 and 16 mmHg and in diastolic BP (DBP) was found to be 11 and 9 mmHg with improved formulation of cilnidipine 10 mg tablet (Nexovas®) and conventional cilnidipine, respectively, which was statistically significant. In addition, there was a higher mean improvement in BP on day 15 and higher reduction in spot urine-protein creatinine ratio (Day 30) in patients treated with Nexovas®. The goal BP (<140/90) was achieved in higher percentage of patients taking Nexovas® versus conventional cilnidipine (SBP 93.33% vs. 80.00%; DBP 80.00% vs. 53.33%. Conclusion: The improved formulation of cilnidipine 10 mg (Nexovas®) demonstrated super dissolution when compared to the conventional cilnidipine, was bioequivalent to Atelec®, and in clinical efficacy and safety trial showed statistically significant improvement in BP after one month of treatment. Goal BP (<140/90 mmHg) was achieved in higher proportion of patients treated with the Nexovas® compared to the conventional cilnidipine in India.