Motaweih Ahmed K, Usova Elena, Hussain Wajid, Dello Ziad, Schmidt Birgit, Petri Thomas
Cardiovascular Medicine Department, Faculty of Medicine, Azhar University, Giza, Egypt.
Clinical Hospital 122, Saint Petersburg, Russia.
BMC Cardiovasc Disord. 2015 May 9;15:35. doi: 10.1186/s12872-015-0037-x.
Observational studies can provide important information on the efficacy and safety of antihypertensive agents in the real-life clinical setting. AdADOSE was a large observational study to assess the effectiveness of nifedipine GITS in combination with other antihypertensive agent(s). The study was also the first to examine the role of combination therapy with nifedipine GITS in the Middle East, Pakistan and Russia, regions that are associated with particularly high cardiovascular risk.
AdADOSE was a 12-week, international, multicenter, prospective, observational study. Patients with hypertension (ie, blood pressure [BP] >140/90 mm Hg, or >130/80 mm Hg in patients at high or very high cardiovascular risk) received once-daily nifedipine GITS (30, 60 or 90 mg) in combination with another antihypertensive or as add-on to existing therapy. The primary study endpoint was the proportion of patients who achieved the target BP of <140/90 mm Hg (or <130/80 mm Hg for those at high or very high cardiovascular risk). Study outcomes are reported by descriptive statistics.
The study enrolled 4497 patients (n = 4477, safety population; n = 3430, efficacy population). Baseline mean systolic/diastolic BP (SBP/DBP) was 166.4/99.7 mm Hg; 85.2 % of patients had received prior antihypertensive treatment, and 90.6 % had ≥ 1 concomitant diseases. Following combination treatment with nifedipine GITS, target BP was achieved by 64.8% of patients without concomitant diseases, and by 56.5%, 32.3% and 22.6% with 1, 2-3 and >3 concomitant diseases, respectively. The proportion of patients achieving target BP was 51.5% in previously untreated and 33.7% in previously treated patients. Nifedipine GITS combination treatment provided mean SBP/DBP changes of -36.1/-18.8 mm Hg in all patients, -40.2/-21.5 mm Hg in previously untreated patients, and -35.6/-18.4 mm Hg in previously treated patients, with similar BP reductions irrespective of the number of concomitant diseases. Drug-related adverse events (AEs) were reported in 2.6% patients. There were no serious AEs and only 0.8% of patients discontinued due to drug-related AEs.
Combination therapy with nifedipine GITS in a real-life observational setting was highly effective in reducing SBP/DBP in a range of hypertensive patients, with low rates of treatment-related AEs.
at ClinicalTrials.gov registration number NCT01118286 .
观察性研究能够在实际临床环境中提供有关抗高血压药物疗效和安全性的重要信息。AdADOSE是一项大型观察性研究，旨在评估硝苯地平控释片与其他抗高血压药物联合使用的有效性。该研究也是首次在中东、巴基斯坦和俄罗斯等心血管风险特别高的地区，探讨硝苯地平控释片联合治疗的作用。
AdADOSE是一项为期12周的国际多中心前瞻性观察性研究。高血压患者（即血压[BP]>140/90 mmHg，或心血管风险高或非常高的患者BP>130/80 mmHg）每天服用一次硝苯地平控释片（30、60或90 mg），与另一种抗高血压药物联合使用，或作为现有治疗的附加治疗。主要研究终点是达到目标血压<140/90 mmHg（或心血管风险高或非常高的患者<130/80 mmHg）的患者比例。研究结果通过描述性统计报告。
该研究共纳入4497例患者（n = 4477，安全人群；n = 3430，疗效人群）。基线平均收缩压/舒张压（SBP/DBP）为166.4/99.7 mmHg；85.2%的患者曾接受过抗高血压治疗，90.6%的患者有≥1种合并症。硝苯地平控释片联合治疗后，无合并症的患者中64.8%达到目标血压，有1种、2 - 3种和>3种合并症的患者分别为56.5%、32.3%和22.6%。未接受过治疗的患者中达到目标血压的比例为51.5%，接受过治疗的患者中为33.7%。硝苯地平控释片联合治疗使所有患者的平均SBP/DBP分别降低-36.1/-18.8 mmHg，未接受过治疗的患者降低-40.2/-21.5 mmHg，接受过治疗的患者降低-35.6/-18.4 mmHg无论合并症数量多少，血压降低情况相似。2.6%的患者报告了与药物相关的不良事件（AE）。没有严重不良事件，只有0.8%的患者因药物相关不良事件停药。
在实际观察环境中，硝苯地平控释片联合治疗在降低一系列高血压患者的SBP/DBP方面非常有效，与治疗相关的不良事件发生率较低。
在ClinicalTrials.gov注册，注册号为NCT01118286 。
Zotero 插件
