A Comparative Study to Evaluate the Safety and Efficacy of Cilnidipine versus Amlodipine in Newly Diagnosed Essential Hypertensive Patients at a Tertiary Health Care Centre of Uttar Pradesh

Abstract

Introduction: Hypertension remains a major modifiable determinant of cardiovascular, cerebrovascular and renal morbidity, and sustained pharmacological therapy is frequently required to achieve adequate blood-pressure control. Amlodipine is an established long-acting L-type calcium-channel blocker, whereas cilnidipine inhibits both L- and N-type calcium channels and may provide additional attenuation of sympathetic activity. Comparative assessment of their antihypertensive efficacy and tolerability is clinically relevant, particularly because peripheral edema and other treatment-related adverse effects may influence long-term adherence.

Aim: To compare the safety and efficacy of cilnidipine versus amlodipine in newly diagnosed essential hypertensive patients.

Methodology: This prospective, randomized, open-label comparative clinical study was conducted in the Department of Pharmacology and Therapeutics in collaboration with the Department of Medicine, Baba Raghav Das Medical College, Gorakhpur, Uttar Pradesh, from September 2024 to September 2025. A total of 180 newly diagnosed Stage 1 or Stage 2 essential hypertensive patients were allocated in a 1:1 ratio by simple randomization. Ninety received cilnidipine 10 mg once daily and 90 received amlodipine 5 mg once daily. Clinical assessment was performed at baseline and at 1, 3, 6, 9 and 12 months. Blood pressure, heart rate, treatment compliance and adverse events were evaluated during follow-up.

Results: The treatment groups were comparable at baseline. Among participants completing 12-month follow-up, mean SBP reduction was −22.3 ± 10.1 mmHg with cilnidipine and −23.1 ± 9.8 mmHg with amlodipine (p=0.611), while DBP reduction was −14.3 ± 6.2 and −13.5 ± 6.0 mmHg, respectively (p=0.407). At 12 months, SBP was 130.4 ± 4.8 versus 130.1 ± 4.6 mmHg (p=0.686), while DBP was 81.5 ± 2.7 versus 82.8 ± 2.8 mmHg (p=0.003). Pedal edema occurred in 5.6% versus 16.7% (p=0.018). Overall adverse events occurred in 15.6% versus 26.7% (p=0.068), and drug-related events in 12.2% versus 23.3% (p=0.051). Heart-rate reduction was greater with cilnidipine (−5.9 ± 4.1 vs −0.8 ± 3.8 bpm; p<0.001).

Conclusion: Both agents provided substantial antihypertensive efficacy. Cilnidipine demonstrated a favourable tolerability and heart-rate profile, with a significantly lower frequency of pedal edema, while systolic blood-pressure reduction was similar between treatments.