美托洛尔与氨氯地平固定剂量复方制剂在印度原发性高血压患者中的疗效和耐受性

Efficacy and tolerability of fixed dose combination of metoprolol and amlodipine in Indian patients with essential hypertension.

作者信息

Rao N Srinivasa, Oomman Abraham, Bindumathi P L, Sharma Vikram, Rao Satish, Moodahadu Latha Subramanya, Patnaik Ashis, Kumar B R Naveen

机构信息

Department of General Medicine, Osmania General Hospital and Medical College, Hyderabad, Andhra Pradesh, India.

Department of Cardiology, Apollo Hospital, Chennai, Tamil Nadu, India.

出版信息

J Midlife Health. 2013 Jul;4(3):160-6. doi: 10.4103/0976-7800.119000.

DOI:10.4103/0976-7800.119000

PMID:24672188

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3952407/

Abstract

BACKGROUND

This open-labeled, post-marketing study was conducted to assess the efficacy and tolerability of fixed dose combination of amlodipine and metoprolol extended release capsules in mild to moderate hypertension in adult Indian patients.

MATERIALS AND METHODS

Of 101 enrolled patients, 64 drug naïve patients were treated with regimen A (amlodipine 5 mg + metoprolol 25 mg) and those with prior history of hypertension (n = 37) were treated with regimen B (amlodipine 5 mg + metoprolol 50 mg) for 8 weeks. Treatment response was assessed at week 4 and 8. Dose up titration to regimen B was carried out for those who failed to achieve the target blood pressure (BP) at week 4 in regimen A and additional antihypertensives were added to those in regimen B. Safety laboratory tests were performed at baseline and end of study.

RESULTS

Mean age (±SD) of patients was 53.36 (±11.26) years and body weight (±SD) 63.40 (10.03) kg. Ninety five patients (94.06%) were only hypertensive and 6 (5.94%) had hypertension with history of coronary artery disease; mean duration (±SD) of hypertension was 42.50 (48.07) months. At baseline, patients had a mean (±SD) systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 154.98 (±7.76) mmHg and 95.55 (±5.70) mmHg respectively. There was a statistically significant (P < 0.001) reduction of 12.16% and 14.69% in SBP, 11.49% and 14.65% in DBP at week 4 and week 8 respectively, compared to baseline. Normalization of overall BP was achieved in 49.49% and 70.71% patients at week 4 and 8, respectively. Peripheral edema was reported in 2.97% (3/101) patients.

CONCLUSION

This combination was safe, efficacious, and well-tolerated in study population.

摘要

背景

本开放性上市后研究旨在评估氨氯地平与美托洛尔缓释胶囊固定剂量组合对成年印度轻度至中度高血压患者的疗效和耐受性。

材料与方法

101名入组患者中，64名初治患者接受方案A（氨氯地平5mg + 美托洛尔25mg）治疗，有高血压病史的患者（n = 37）接受方案B（氨氯地平5mg + 美托洛尔50mg）治疗，为期8周。在第4周和第8周评估治疗反应。对在方案A第4周未达到目标血压（BP）的患者进行剂量上调至方案B，对方案B中的患者加用其他降压药。在基线和研究结束时进行安全性实验室检查。

结果

患者的平均年龄（±标准差）为53.36（±11.26）岁，体重（±标准差）为63.40（10.03）kg。95名患者（94.06%）仅患有高血压，6名（5.94%）患有高血压并伴有冠状动脉疾病史；高血压的平均病程（±标准差）为42.50（48.07）个月。基线时，患者的平均（±标准差）收缩压（SBP）和舒张压（DBP）分别为154.98（±7.76）mmHg和95.55（±5.70）mmHg。与基线相比，第4周和第8周时SBP分别有12.16%和14.69%的统计学显著降低（P < 0.001），DBP分别有11.49%和14.65%的降低。第4周和第8周时分别有49.49%和70.71%的患者血压恢复正常。2.97%（3/101）的患者报告有外周水肿。