Comparative Evaluation of Pedal Edema and Albuminuria Associated with Amlodipine and Cilnidipine in Hypertensive Patients: A Randomized Controlled Study

Abstract

Background: Alcium channel blockers are widely prescribed for the management of hypertension; however, adverse effects such as pedal edema and albuminuria may compromise treatment adherence and long-term outcomes. Cilnidipine, a newer dual L/N-type calcium channel blocker, has been reported to produce fewer vascular adverse effects compared with amlodipine. This study aimed to compare the safety profile and clinical complications associated with amlodipine and cilnidipine in hypertensive patients. Methods: This open-label randomized controlled study was conducted at the Department of Pharmacology and Therapeutics, Rajshahi Medical College, Bangladesh, from January to December 2021. Sixty patients with mild-to-moderate hypertension were randomly allocated into two equal groups. Group A received amlodipine (5–10 mg/day), while Group B received cilnidipine (10–20 mg/day) for three months. Demographic and clinical data were collected using a semi-structured questionnaire. The primary outcomes were the occurrence of pedal edema and albuminuria. Statistical analyses were performed using SPSS version 24, with p<0.05 considered statistically significant. Results: The baseline demographic characteristics were comparable between the two groups. Pedal edema occurred significantly more frequently in the amlodipine group than in the cilnidipine group (20.0% vs. 3.3%; p=0.041). Albuminuria was also more common among patients receiving amlodipine (23.3% vs. 6.7%), although the difference did not reach statistical significance (p=0.073). Conclusion: Cilnidipine demonstrated a more favorable safety profile than amlodipine, particularly regarding the lower incidence of pedal edema. These findings suggest that cilnidipine may be a better-tolerated alternative for the management of hypertension.