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.
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.
Study Type
OBSERVATIONAL
Enrollment
236,507
Participants with diabetes who were members of the KPNC registry, and had received at least 2 prescriptions for pioglitazone within a 6-month period were followed up to 15.5 years (1997-2012) in this observational study 1.
Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone
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.
Time frame: 15 years 5 months
Number of 10 Most Common Cancers Associated Cases
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.
Time frame: 15 years 5 months
Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone
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 time since first use of pioglitazone. The various times since initiation include \<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. 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.
Time frame: 15 years 5 months
Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone
Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as \<12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 15 years 5 months
Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone
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 duration of pioglitazone. The duration of pioglitazone was categorized as \<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. 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.
Time frame: 15 years 5 months
Number of 10 Most Common Cancer Cases by Duration of Pioglitazone
The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as \<12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.
Time frame: 15 years 5 months
Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone
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 dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (\>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. 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.
Time frame: 15 years 5 months
Number of 10 Most Common Cancer Cases By Dose of Pioglitazone
The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and \>=50001 mg.
Time frame: 15 years 5 months