Runlin Gao, Junren Zhu, Guozhang Liu, Weizhong Zhang, Tingjie Zhang, Ningling Sun, Landen Harald
Fuwai Cardiovascular Institute and Hospital, Beijing, China.
Clin Drug Investig. 2007;27(8):565-72. doi: 10.2165/00044011-200727080-00005.
This post-marketing surveillance study assessed the efficacy, safety and tolerability of treatment with nifedipine GITS (gastrointestinal therapeutic system) in hypertensive patients with different risk profiles under normal daily practice conditions in China.
A total of 7395 patients were included in 564 outpatient clinics. Patients received 30mg or 60mg of nifedipine GITS, which could be up- and down-titrated if necessary. Efficacy, safety and tolerability data were collected at up to three follow-up visits. Patient documentation was completed using standardised and barcoded case report forms. Descriptive and explorative analyses of the data were performed.
At endpoint, 93% of patients were receiving 30mg of nifedipine GITS and 7% were taking 60mg of nifedipine GITS. The mean observation period was 9 +/- 7 weeks. At endpoint, the mean BP reduction was 27.7/14.8mm Hg; 43% of patients had a systolic BP <140mm Hg, and 58% had a diastolic BP <90mm Hg. BP control as recommended by international guidelines was achieved in 43.5% of all patients. A total of 3163 patients (42.8%) received additional antihypertensive medication, of which ACE inhibitors were most commonly used (40.7%), followed by beta-adrenoceptor antagonists (25.8%).Twenty-nine patients (0.4%) experienced a total of 39 adverse events. Subjective physicians' assessments of efficacy, tolerability and patient acceptance of nifedipine GITS treatment returned ratings of 'very good' and 'good' in 91-95% of each category.
Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 7395 Chinese patients under normal daily practice conditions. The results confirm the findings and experience of previously performed clinical studies.
本上市后监测研究评估了在中国正常日常实践条件下，硝苯地平胃肠道治疗系统（GITS）治疗不同风险特征高血压患者的疗效、安全性和耐受性。
共有7395例患者纳入564家门诊诊所。患者接受30mg或60mg硝苯地平GITS治疗，必要时可上调或下调剂量。在最多三次随访中收集疗效、安全性和耐受性数据。使用标准化和带有条形码的病例报告表完成患者记录。对数据进行描述性和探索性分析。
在终点时，93%的患者接受30mg硝苯地平GITS治疗，7%的患者服用60mg硝苯地平GITS。平均观察期为9±7周。在终点时，平均血压降低27.7/14.8mmHg；43%的患者收缩压<140mmHg，58%的患者舒张压<90mmHg。所有患者中有43.5%达到国际指南推荐的血压控制。共有3163例患者（42.8%）接受了额外的抗高血压药物治疗，其中最常用的是血管紧张素转换酶抑制剂（40.7%），其次是β肾上腺素能受体拮抗剂（25.8%）。29例患者（0.4%）共经历39次不良事件。医生对硝苯地平GITS治疗的疗效、耐受性和患者接受度的主观评估在各类别中91-95%的评价为“非常好”和“好”。
在正常日常实践条件下，硝苯地平GITS被证明对7395例中国高血压患者的治疗有效且耐受性良好。结果证实了先前进行的临床研究的发现和经验。
