Introduction:
About 36% of the Indian population suffers from hypertension, with many patients having uncontrolled blood pressure [BP] despite treatment. Calcium Channel Blockers [CCB] are widely prescribed in India and Southeast Asia, either as monotherapy or in combination with other AHDs, and have proven efficacy and safety. Cilnidipine, a novel CCB, has shown promising results in controlled trials in Southeast Asia, but there is no real-world Indian data available.
Methods:
This single-centre, retrospective study used EMR data from adult patients with essential hypertension, with or without diabetes, who started cilnidipine between 2018 and 2021. Patients were followed for at least 2 years. The baseline visit was the date of cilnidipine initiation (10/20mg). Patients were categorized by the number of AHDs prescribed after starting cilnidipine. Data was collected at baseline, 6 months, 12 months, and 24 months. The primary endpoint was the change in systolic (SBP) and diastolic (DBP) blood pressure from baseline. Secondary endpoints included proteinuria reduction and change in heart rate.
Results:
Among the 200 included patients, mean age, weight, height and BMI were 55.1 ± 0.9 years, 67.3 ± 0.8 kg, 1.6 ± 0.003 m and 25 ± 0.2 respectively. The mean SBP and DBP was 155.0 ± 0.5 mm Hg and 82.3 ± 0.4 mm Hg at baseline, 144.9 ± 0.5 mm Hg and 78.1 ± 0.3 mm Hg at 6 months, and 138.7 ± 0.6 mm Hg and 75.7 ± 0.4 mm Hg at 24 months (P<0.001). Out of 200 patients, 164 were prescribed the novel CCB [cilnidipine] along with 1AHD and 36 were taking cilnidipine along with 2 AHDs. The mean±SEM (95% CI) change in SBP was 17 ± 0.8 mm Hg (P<0.001) and DBP was 6.6 ± 0.5 mm Hg (P<0.001) at 24 months. Mean (95% CI) reduction in urinary albumin excretion was 52.0 ± 4.3 mg/dl and 76.9 ± 14.2 mg/dl in cilnidipine + 1 AHD and cilnidipine + 2 AHD groups, respectively at 24 months. The mean (95% CI) change in heart rate was 5.9 ± 0.5 bpm at 6 months, 6.3 ± 0.5 bpm at 12 months, and 6.5 ± 0.5 bpm at 24 months in patients on cilnidipine + 1AHD. Similarly, the mean (95% CI) change in heart rate was 12.3 ± 1.3 bpm at 6 months, 9.1 ± 1.2 bpm at 12 months, and 9.9 ± 1.2 bpm at 24 months in patients taking cilnidipine + 2AHD.
Conclusions:
Novel CCB Cilnidipine, added to existing drug regimens during routine clinical practice significantly reduces BP, heart rate and proteinuria in Indian hypertensive patients. The current study is one of the first real-world studies in India to assess the impact of cilnidipine on patients with essential hypertension using EMR data.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process.