|Efficacy and safety of nifedipine GITS in Asians with hypertension - Results of a post-marketing surveillance study in China|
|Gao Runlin; Zhu Junren; Liu Guozhang; Zhang Weizhong; Zhang Tingjie; Sun Ningling; Landen, Harald|
|刊名||CLINICAL DRUG INVESTIGATION|
|WOS标题词||Science & Technology|
|类目[WOS]||Pharmacology & Pharmacy|
|研究领域[WOS]||Pharmacology & Pharmacy|
|关键词[WOS]||TO-MODERATE HYPERTENSION ; CALCIUM-CHANNEL BLOCKER ; BLOOD-PRESSURE ; MANAGEMENT ; PROGRESSION ; GUIDELINES ; MORBIDITY ; MORTALITY ; RELEASE ; SOCIETY|
Objective: 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.
Methods: 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.
Results: 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 anti hypertensive medication, of which ACE inhibitors were most commonly used (40.7%), followed by P-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.
Conclusions: 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.
|作者单位||1.Zhongshan Hosp, Shanghai, Peoples R China|
2.Ruijin Hosp, Shanghai Inst Hypertens, Shanghai, Peoples R China
3.Chengdu First Municipal Hosp, Chengdu, Peoples R China
4.Beijing Univ, Peoples Hosp, Beijing 100871, Peoples R China
5.Bayer Vital GmbH, Bayer HealthCare, PMS Management, D-51368 Leverkusen, Germany
6.Fuwai Cardiovasc Inst & Hosp, Beijing, Peoples R China
|Gao Runlin,Zhu Junren,Liu Guozhang,et al. Efficacy and safety of nifedipine GITS in Asians with hypertension - Results of a post-marketing surveillance study in China[J]. CLINICAL DRUG INVESTIGATION,2007,27(8):565-572.|
|APA||Gao Runlin.,Zhu Junren.,Liu Guozhang.,Zhang Weizhong.,Zhang Tingjie.,...&Landen, Harald.(2007).Efficacy and safety of nifedipine GITS in Asians with hypertension - Results of a post-marketing surveillance study in China.CLINICAL DRUG INVESTIGATION,27(8),565-572.|
|MLA||Gao Runlin,et al."Efficacy and safety of nifedipine GITS in Asians with hypertension - Results of a post-marketing surveillance study in China".CLINICAL DRUG INVESTIGATION 27.8(2007):565-572.|