Strongman Helen, Korhonen Pasi, Williams Rachael, Bahmanyar Shahram, Hoti Fabian, Christopher Solomon, Majak Maila, Kool-Houweling Leanne, Linder Marie, Dolin Paul, Heintjes Edith M
Clinical Practice Research Datalink, London, UK.
EPID Research, Espoo, Finland.
BMJ Open Diabetes Res Care. 2017 May 29;5(1):e000364. doi: 10.1136/bmjdrc-2016-000364. eCollection 2017.
Estimate and compare the risk of mortality in patients whose antidiabetic therapy is modified to include pioglitazone compared with an alternative antidiabetic medication at the same stage of disease progression.
Retrospective cohort study.
Pooled analysis of clinical data collected from primary and/or secondary care settings in four European countries: Finland, The Netherlands, Sweden and the UK .
56 337 patients with type 2 diabetes mellitus first prescribed pioglitazone between 2000 and 2011, and 56 337 patients never prescribed pioglitazone matched by treatment stage, history of diabetes, diabetes complications and cardiovascular disease, and year of cohort entry using exact and propensity score matching. Patients were followed-up for a mean of 2.90 (SD 2.21) and 2.83 (SD 2.37) years in the pioglitazone-exposed and non-pioglitazone-exposed groups, respectively.
All-cause mortality ascertained from clinical or registry data. Mortality was a planned secondary outcome in a study primarily studying the association of pioglitazone use with bladder cancer risk.
The crude overall mortality rate per 10 000 patient years was 206 (95% CI 199 to 213) in the pioglitazone-exposed group and 448 (95% CI 438 to 458) in the non-pioglitazone-exposed group. The crude HR comparing pioglitazone to alternative antidiabetic exposure was 0.46 (95% CI 0.45 to 0.48). This reduced in magnitude to 0.67 (95% CI 0.64 to 0.70) following further adjustment for matching variables, propensity scores, age, gender and time-dependent variables representing use of alternative antidiabetic drugs.
In this large observational cohort study of patients with type 2 diabetes, pioglitazone exposure was associated with a statistically significant decrease in the risk of all-cause mortality across four European countries. Results should be interpreted with caution due to the potential for residual confounding.
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
评估并比较在疾病进展的同一阶段，抗糖尿病治疗方案改为包含吡格列酮的患者与使用其他抗糖尿病药物的患者的死亡风险。
回顾性队列研究。
对从芬兰、荷兰、瑞典和英国这四个欧洲国家的初级和/或二级医疗保健机构收集的临床数据进行汇总分析。
2000年至2011年间首次开具吡格列酮处方的56337例2型糖尿病患者，以及56337例从未开具过吡格列酮处方的患者，通过治疗阶段、糖尿病病史、糖尿病并发症和心血管疾病以及队列进入年份进行精确匹配和倾向得分匹配。吡格列酮暴露组和非吡格列酮暴露组患者的随访时间分别平均为2.90（标准差2.21）年和2.83（标准差2.37）年。
根据临床或登记数据确定全因死亡率。在一项主要研究吡格列酮使用与膀胱癌风险关联的研究中，死亡率是一个计划中的次要结局。
吡格列酮暴露组每10000患者年的粗全因死亡率为206（95%可信区间199至213），非吡格列酮暴露组为448（95%可信区间438至458）。吡格列酮与其他抗糖尿病药物暴露相比的粗风险比为0.46（95%可信区间0.45至0.48）。在进一步调整匹配变量、倾向得分、年龄、性别以及代表使用其他抗糖尿病药物的时间依赖性变量后，该风险比降至0.67（95%可信区间0.64至0.70）。
在这项针对2型糖尿病患者的大型观察性队列研究中，在四个欧洲国家，吡格列酮暴露与全因死亡率风险的统计学显著降低相关。由于存在残余混杂的可能性，结果应谨慎解释。
欧洲药物流行病学和药物警戒中心网络。
