실니디핀의 안전성 및 유효성 평가를 위한 시판 후 조사

Abstract

Objective: In order to investigate the safety and efficacy of cilnidipine among Korean patients with hypertension in primary care setting, an observational study was carried out.

Methods: A total of 560 patients with hypertension were enrolled by 15 family physicians from March 2002 to September 2003. To ascertain the safety and efficacy, patients were followed up regularly at the intervals of 4, 12 and 24 weeks. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events throughout the course of treatment. We defined controlled blood pressure as less than 140 mmHg systolic and 90 mmHg diastolic at 24 weeks from the beginning of treatment.

Results: Of the 560 patients, five hundred and three were evaluated for safety and 498 for efficacy assessment. A total of 57 adverse events were reported in 45 patients (9.0%). Most frequently reported adverse event (AE) was flushing (3.4%) and followed by headache (2.6%), dizziness (1.0%), palpitation (0.6%), and indigestion (0.6%). Incidence of AE in women with cilnidipine was 15.8% which was significantly higher than that (5.8%) of men (p<0.05). AEs were assessed as mild in 43.8%, moderate in 50.9%, and severe in 5.3%. Thirty patients (6.0%) discontinued cilnidipine as a direct result of AEs. They were divided into two groups: a controlled (56.6%) group and an uncontrolled (43.4%) group. Factors associated with the controlled group were new user (OR 1.7, 95%CI 1.1-2.6), low score of stress (OR 1.7, 95%CI 1.1-2.6), and stage 1 hypertension (OR 1.9, 95%CI 1.4-2.7).

Conclusion: Cilnidipine was well tolerated, and the factors associated with good efficacy were new user, low score of stress, and stage 1 hypertension.