Evaluation of Safety and Tolerability of Amlodipine and Cilnidipine - A Comparative Study
Journal Title: Scholars Journal of Applied Medical Sciences - Year 2016, Vol 4, Issue 8
Abstract
Abstract: Amlodipine and Cilnidipine are found equally efficacious in terms of blood pressure control but very few studies have been conducted on safety and tolerability profile of both the drugs except regarding ankle oedema. Cilnidipine has a slow-onset but the long-lasting antihypertensive action action like Amlodipine. It had get approval in June 2007 and introduced in the market and claimed to be superior over Amlodipine. The aim of this study is to assessment of safety and tolerability of both calcium antagonists i. e Amlodipine and Cilnidipine. The Objectives are to evaluate the incidence of adverse drug reactions of Amlodipine and Cilnidipine and to compare the incidence of ADRs between Amlodipine and Cilnidipine. Patients with hypertension (n= 326) meeting the inclusion and exclusion criteria, reporting in the department of medicine between December 14 to November 15 for their treatment were enrolled in the study. The enrolled patients were then divided as (1) Hypertensive patient - the study group received Cilnidipine and control group receiving Amlodipine. (2) Hypertensive with controlled diabetic patients are also grouped separately as study or control group receiving Cilnidipine or Amlodipine respectively. All patients were examined periodically at 1, 3, 6, and 12 months intervals. Dose of Amlodipine andCilnidipine were titrated according to their BP goal. We exclude the data of drop out participants, those who withdraw consentand any protocol violation like those patients for whom additional anti hypertensive were added other than ARB or ACEI for inadequate BP control.After exclusion of dropouts, the study was continued in 258 participants. All values were expressed as means ± SEM (n = 6 in each group). The comparison between Amlodipine and Cilnidipine in both diabetic as well as non diabetic hypertensive patients was done by Fischer exact test. Significance is set at P ≤ 0.05. It is evident from the present study that incidence of ankle edema, palpitations and weight gain was significantly more in Amlodipine than cilnidipine. Incidence of other adverse drug reactions were noted to be more frequent in Amlodipine treated patients but no significant difference was found. It can be concluded that Cilnidipine has a better tolerability profile than Amlodipine, though having equal potency in equivalent doses as the incidence of ADRs were more associated with Amlodipine than Cilnidipine in both diabetic and non diabetic hypertensive patients. Keywords:Amlodipine, Cilnidipine, Safety, Tolerability, Adverse drug reactions (ADR), Ankle oedema.
Authors and Affiliations
Dr. Manjushree Mohanty, Dr. Krishna Padarabinda Tripathy, Dr. Sougata Srakar, Dr. Vartika Srivastava
Keywords
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