A Randomized Open-Label Parallel-Group Study Comparing the Efficacy and Safety of Cilnidipine and Amlodipine in Hypertensive Adults.

BACKGROUND: Cilnidipine, an upcoming anti-hypertensive drug, is a combined L- and N-type calcium channel blocker. It is proposed to be more efficacious and safer due to its two-pronged approach in treating hypertension.

METHODS: The study was a randomized open-label parallel-group study, conducted in the Department of General Medicine, Sri Ramachandra Medical College Hospital, Chennai, during the period September 2014 to May 2015. 50 patients were randomized to the amlodipine group and 50 to the cilnidipine group. The blood pressure, pulse rate and adverse effects were monitored in each patient over 12 weeks. The difference in the Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP) and Heart Rate(HR) before and after treatment within each group, and between the two groups were analyzed using paired and unpaired t tests respectively. The adverse effects reported in each group were analyzed using Chi-square test.

RESULTS: There was no statistically significant difference in the reduction of SBP and DBP between the two groups (p>0.05). The HR however, showed an increase of 1.07/min in the amlodipine group and decreased by 1.16/min in the cilnidipine group. The patients in the cilnidipine group experienced significantly less adverse effects such as pedal edema and palpitations when compared to those in the amlodipine group (p<0.05).

CONCLUSIONS: Cilnidipine therapy is an effective and safe alternative in the treatment of essential hypertension. It can be used as a first line antihypertensive drug since its efficacy is comparable to that of amlodipine with a better safety profile than amlodipine.