Cohort Study of Pioglitazone and Cancer Incidence in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 236,507
- 主要终点
- Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone
研究概览
简要总结
The purpose of this study was to evaluate whether treatment with pioglitazone is associated with risk of incident cancer at the 10 most common sites in a cohort of participants with recognized diabetes.
详细描述
The study enroll a large population of approximately 252467 participants. The study would analyze association of cancer and pioglitazone in 2 cohorts based on the usage of pioglitazone. Participants in were originally planned to be followed-up from January 1, 1997 to December 31, 2005. Based on the discussion with advisory board, it was recommended to increase the study population and duration of follow-up. The follow-up period was extended to June 30, 2012 for the study.
This multi-center trial was conducted in the United States of America. The overall time to participate in this study was approximately 15.5 years. Participants were followed-up from January 1, 1997 up to June 30, 2012 for the assessment of cancer risk associated with pioglitazone use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has been in the KPNC diabetes registry Diabetes Mellitus (DM) registry, aged 40 years or older and are members of KPNC as of January 1, 1997, or
- •has been in the DM registry, reached aged 40 years between January 1, 1997 and June 30, 2005 and are KPNC members on their 40th birthday, or
- •has joined KPNC after January 1, 1997, aged 40 years or older when they are identified by the DM registry between January 1, 1997 and June 30, 2005.
排除标准
- •Age less than (<) 40 years during study period.
- •No KPNC medication benefits at the time of entry into the cohort (baseline) or gap in medication benefit greater than equal to (>=) 4 months that started in the first 4 months after entering in the cohort.
- •Gap in KPNC membership >= 4 months that started in the first 4 months after entering in the cohort.
- •Participant with a diagnosis of Human immunodeficiency virus (HIV).
- •Participants with evidence of selected surgeries for some cancer sites.
- •All prevalent cancers at baseline, that is, all participants ever diagnosed with cancer other than non-melanoma skin cancer.
研究组 & 干预措施
Ever User of Pioglitazone
Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone
时间窗: 15 years 5 months
The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.
Number of 10 Most Common Cancers Associated Cases
时间窗: 15 years 5 months
Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.
次要结局
- Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone(15 years 5 months)
- Number of 10 Most Common Cancer Cases By Dose of Pioglitazone(15 years 5 months)
- Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone(15 years 5 months)
- Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone(15 years 5 months)
- Number of 10 Most Common Cancer Cases by Duration of Pioglitazone(15 years 5 months)
- Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone(15 years 5 months)