PS-P07-3: EFFICACY AND SAFETY OF NIFEDIPINE GASTROINTESTINAL THERAPEUTIC SYSTEM VERSUS RAMIPRIL IN CHINESE AND EUROPEAN PATIENTS WITH HYPERTENSION

Abstract

Objective: In a post-hoc analysis of a multinational, randomized trial, we investigated whether the efficacy and safety of nifedipine gastrointestinal therapeutic system (GITS) and ramipril differed between Chinese and European patients with hypertension. Method: Previously treated (2-week washout) and untreated patients with hypertension were randomly assigned to treatment with nifedipine GITS 30 mg or ramipril 10 mg for 12 months, if they had elevated clinic (≧ 140/90 mmHg) and daytime (≧ 135/85 mmHg) ambulatory systolic/diastolic blood pressure (BP) and standard deviation of home (> 7 mmHg) and daytime systolic BP (> 12 mmHg). BP was measured at each of the clinic visits at baseline and during follow-up. Ambulatory and 7-day home BP monitoring were performed at baseline and 10 weeks and 12 months of follow-up. Results: The 67 Chinese and 101 European patients significantly differed in age (50.9 vs. 54.6 years), body mass index (24.5 vs. 27.0 kg/m2), clinic diastolic BP (87.9 vs. 92.5 mmHg), clinic heart rate (75.0 vs. 70.8 beats/minute) and nighttime diastolic BP (79.3 vs. 75.9 mmHg). However, within each ethnicity, patients were comparable between the nifedipine GITS and ramipril groups (P≧ 0.05). In both Chinese and European patients, BP was similarly reduced in the nifedipine GITS and ramipril groups, except that daytime systolic/diastolic BP reductions were 7.4/4.1 mmHg greater in the ramipril than nifedipine GITS group in Chinese (P = 0.02). The safety profile significantly (P for drug*ethnicity interaction ≦ 0.046) differed between the Chinese and European patients for the incidence of all adverse events (lower on nifedipine GITS in Chinese), ankle edema (higher on nifedipine GITS in Europeans) and dry cough (higher on ramipril in Chinese). Conclusion: In the Chinese and European patients with hypertension, nifedipine GITS and ramipril had similar BP lowering efficacy, but different safety profile and tolerability.