The Safety Of Azilsartan Medoxomil For Essential Hypertension: A Meta-Analysis

【 Objective 】 This study was to compare the safety in patients with hypertension receiving azilsartan medoxomil as monotherapy or other antihypertensive agents.【 Methods 】 The Cochrane library, PubMed, Web of Science, Embase, Chinese National Knowledge Infrastructure, China Biology Medicine disc, Wanfang and VIP Data were searched from the beginning of the records through September 2015. Eligible studies were prospective randomised controlled trials of azilsartan(including azilsartan medoxomil) vs. any control therapy.Data of articles finally included were extracted by two physicians, The pooled risk of serious adverse effects, clinical adverse reactions, laboratory were computed and expressed as odds ratios(ORs) for azilsartan medoxomil 40 mg and 80 mg and relative to any antihypertensive monotherapy. The pooled risk was assessed by RCTs(randomized controlled trials) evaluation index recommended by the Cochrane collaboration first 5.1.0 version of evaluation manual. Mean difference(MD) and the 95% confidence interval(95%CI) express the merger statistics statistical indicators, odds ratio(OR) and 95%CI express the merger statistics statistical indicators of categorical data. According to Cochrane handbook standard, heterogeneity test is based on I2 and P values. If I2 ≤50% and P≥0.1, there is no heterogeneity among studies included, then fixed effect model is used to meta analysis; If I2 >50% and P<0.1, there is heterogeneity among studies included, it need further analysis to find the sources of heterogeneity or make a subgroup analysis.Finally the statistical effect quantities were accurately imported and analyzed by Revman 5.2software.【Results】6 RCTs(randomized controlled trials) encompasses 5093 patients were included. The results of this analysis showed that difference in total adverse effects, serious adverse effects and adverse leading to discontinuous have no statistical significance between azilsartan medoxomil 40 mg and the controlled group(respectively: [OR=1.00, 95%CI(0.89, 1.14)]; [OR=0.93,95%CI(0.54,1.60)]; [OR=0.83, 95%CI(0.50,1.36)]; P>0.05). such as azilsartan medoxomil 80 mg and control group(respectively: [OR=1.03, 95%CI(0.90,1.18)]; [OR=1.19, 95% CI(0.70,2.03)];[OR=1.14, 95%CI(0.77,1.67)]; P > 0.05). However, compared with control group, dizziness,urinary tract infection and potassium ≥6.0 mmol/L were more frequent on azilsartan medoxomil40 mg(respectively: [OR=1.44, 95%CI(1.01,2.06)]; P=0.04; [OR=1.82, 95%CI(1.10,3.01)];P=0.02; [OR=5.88, 95%CI(1.53,22.59)]; P=0.01).【 Conclusion 】 Total adverse effects and serious adverse effects were similar in azilsartan medoxomil group and controlled group in patients with hypertension. Demonstrate strength is not strong because of less literature report on laboratory indexes, such as blood potassium, sodium,urea nitrogen. Clinical trial which has a large sample and long follow-up time is need to be designed to inquire into the effect on the biochemical indexes.