Dataset Information

A prospective stratified case-cohort study on statins and multiple adverse events in Japan.

ABSTRACT:

Purpose

To assess the association between statins and diverse adverse events in Japanese population.

Methods

New users of statin who started statin after 6-month period of non-use were identified in 68 hospitals between January 2008 and July 2010. In addition to the random sample subcohort, we selected additional subcohort members to make the stratified sample subcohort have at least one patient in all subgroups stratified by each combination of statin and hospital. By abstraction from medical records, detailed information was obtained for all potential cases and pre-selected subcohort members. The event review committee consisting of 3 specialists judged whether possible cases met the definition of one of the adverse events of interest, and for adjudicated cases the committee further judged whether statin was a certain, probable or possible cause of the occurrence of the event. Adjusted for covariates including age, gender, status of "switcher", use of high daily dose and comorbidities at baseline, hazard ratio (HR) was estimated by the Cox proportional hazards model with Barlow's weighting method. Data were also analyzed by the method proposed by Breslow in 2009.

Results

A total of 6,877 new users of a statin were identified (median age: 66 years; males: 52%). The hazard ratios of increase in serum creatinine for atorvastatin and fluvastatin have wide confidence intervals, but both of the point estimates were around 2.5. Estimates of hazard ratios by the method of Barlow (1999) were similar to those by the method of Breslow (2009).

Conclusions

Use of statin was not associated with a significant increased risk for renal, liver and muscle events. However, the hazard ratio of increase in serum creatinine tended to be high with atorvastatin and fluvastatin to require further studies.

SUBMITTER: Ooba N

PROVIDER: S-EPMC4014577 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

A prospective stratified case-cohort study on statins and multiple adverse events in Japan.

Ooba Nobuhiro N Sato Tsugumichi T Wakana Akira A Orii Takao T Kitamura Masaki M Kokan Akira A Kurata Hideaki H Shimodozono Yoshihiro Y Matsui Kenichi K Yoshida Hiroshi H Yamaguchi Takuhiro T Kageyama Shigeru S Kubota Kiyoshi K

PloS one 20140508 5

<h4>Purpose</h4>To assess the association between statins and diverse adverse events in Japanese population.<h4>Methods</h4>New users of statin who started statin after 6-month period of non-use were identified in 68 hospitals between January 2008 and July 2010. In addition to the random sample subcohort, we selected additional subcohort members to make the stratified sample subcohort have at least one patient in all subgroups stratified by each combination of statin and hospital. By abstraction ...[more]

PMID: 24810427

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Dataset Information

A prospective stratified case-cohort study on statins and multiple adverse events in Japan.

Purpose

Methods

Results

Conclusions

Publications

A prospective stratified case-cohort study on statins and multiple adverse events in Japan.

Similar Datasets

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