Wertz Debra A, Chang Chun-Lan, Sarawate Chaitanya A, Willey Vincent J, Cziraky Mark J, Bohn Rhonda L
HealthCore, Inc., 800 Delaware Ave., 5th Floor, Wilmington, DE 19801, USA.
Circ Cardiovasc Qual Outcomes. 2010 Sep;3(5):538-45. doi: 10.1161/CIRCOUTCOMES.109.911461. Epub 2010 Aug 24.
This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population.
Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had <1 year continuous eligibility preindex or a preindex insulin claim. Primary outcome measure was time to composite event of AMI, AHF or death among pioglitazone- and rosiglitazone-treated patients. The National Death Index database was accessed to obtain date of death for patients who died during the study period. Propensity score matching was used to control for potential confounders. The Cox proportional hazards model was used to evaluate effects of exposure to rosiglitazone and pioglitazone on time to event. A total of 36 628 patients (58% male; mean age, 54 years) were identified. Of the rosiglitazone-treated patients, 602 (4.16%) had an AMI, AHF, or death compared with 599 (4.14%) propensity score-matched pioglitazone-treated patients. No significant difference was observed between matched groups for risk of composite event (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15; P=0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death.
In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score-matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.
本研究直接比较了在管理式医疗人群中，接受吡格列酮和罗格列酮治疗的患者发生急性心肌梗死（AMI）、急性心力衰竭（AHF）或全因死亡的风险。
纳入2001年1月1日至2005年12月12日期间开始新使用罗格列酮或吡格列酮的18岁及以上患者。罗格列酮或吡格列酮首次药房配药日期定义为索引日期。如果患者在索引日期前连续资格不足1年或有索引前胰岛素配药记录，则被排除。主要结局指标是吡格列酮和罗格列酮治疗患者发生AMI、AHF或死亡的复合事件时间。通过访问国家死亡指数数据库获取研究期间死亡患者的死亡日期。采用倾向评分匹配法控制潜在混杂因素。使用Cox比例风险模型评估罗格列酮和吡格列酮暴露对事件发生时间的影响。共识别出36628例患者（58%为男性；平均年龄54岁）。在罗格列酮治疗的患者中，602例（4.16%）发生了AMI、AHF或死亡，而倾向评分匹配的吡格列酮治疗患者为599例（4.14%）。从索引日期随访至研究期末、入组状态终止或诊断为AMI/AHF/死亡时，匹配组之间复合事件风险无显著差异（风险比，1.03；95%置信区间，0.91至1.15；P = 0.666）。
在这项回顾性队列研究中，直接比较了罗格列酮和吡格列酮与包含死亡率数据的倾向评分匹配人群，未发现AMI、AHF或死亡风险存在显著差异。
