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About 30% of the Indian population suffers from hypertension, which is one of the leading contributing factors towards chronic kidney disease (CKD) in the country. Amongst the various antihypertensive drugs (AHDs), a novel fourth generation calcium channel blocker (CCB) – Cilnidipine, has emerged as a promising molecule in India and most south-east Asian countries, for its significant benefits in terms of efficacy & side effect profile over conventional CCBs.
Cilnidipine has a novel mode of action of blocking both the L&N calcium channels and hence it not only provides optimal BP control, but also possesses reno-protective properties.
Several randomized clinical trials conclude that Cilnidipine has reno-protective benefits in hypertensive patients, with multiple modes of action on the kidneys, reducing proteinuria and retarding the decline in eGFR. However, there is a lack of real-world Indian data on the effectiveness & side effect profile of Cilnidipine.
This single-center, retrospective study was conducted with an objective to assess the effectiveness and safety of Cilnidipine in Indian hypertensive patients with albuminuria, from electronic medical records (EMR) of the Nephrology department of a multi-specialty hospital in India.
The EMR data of adult patients who were diagnosed with essential hypertension and were prescribed cilnidipine was retrospectively analyzed. The index date when the patient was initiated on Cilnidipine [10mg/20 mg BID] was considered as the baseline visit. Patients were classified based on the total number of antihypertensive (AHD) drugs prescribed along with cilnidipine. Data was collected and analyzed at the baseline visit and then at 6 months, 12 months and 24 months. Primary end point was the change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline. Reduction of albuminuria and overall safety were secondary end points. The data was statistically analyzed using repeated measures ANOVA.
Data of 151 patients was included in the study analysis. The mean age, height, weight and BMI were 55.8±1.0 years, 1.64 ± 0.003 meters, 66.8 ± 0.9 Kgs and 24.6 ± 0.3 kg/m2 respectively.
Out of the 151 patients, 114 patients were prescribed Cilnidipine + 1 AHD and 37 were prescribed Cilnidipine + 2 AHDs.
The mean ± SEM [95% confidence interval (CI)] change in the cilnidipine + 1 AHD group at 24-months follow-up was SBP [14.4 ± 1.0, (12.0, 16.8) P < 0.001] mm Hg and DBP [8.5 ± 0.7 (6.8 to 10.2) P < 0.001] mm Hg, while the change in cilnidipine + 2 AHD group at 24-months follow-up was SBP [13.6 ± 1.7 (9.5 to 17.7), P < 0.001] mmHg and DBP [5.2 ± 1.3 (2.1 to 8.3), P < 0.001] mmHg.
The mean reduction in albuminuria was [36.2 ± 3.8 (27.2 to 45.2)] mg/dl and [73.6 ± 13.4 (40.7 to 106.4)] mg/dl in the Cilnidipine + 1 AHD and Cilnidipine + 2 AHD groups respectively (p<0.001).
The addition of Cilnidipine to the overall treatment regimen was well tolerated by the patients.
Addition of the novel, reno-protective CCB, Cilnidipine, to existing AHD regimens during routine clinical practice, significantly reduced the blood pressure and albuminuria and was well tolerated in Indian hypertensive patients.