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Pioglitazone and cause-specific risk of mortality in patients with type 2 diabetes: extended analysis from a European multidatabase cohort study
  1. Helen Strongman1,
  2. Solomon Christopher2,
  3. Maila Majak2,
  4. Rachael Williams1,
  5. Shahram Bahmanyar3,
  6. Marie Linder3,
  7. Edith M Heintjes4,
  8. Dimitri Bennett5,
  9. Pasi Korhonen2,6,
  10. Fabian Hoti6
  1. 1 Clinical Practice Research Datalink (CPRD), London, UK
  2. 2 EPID Research, Helsinki, Finland
  3. 3 Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden
  4. 4 PHARMO Institute, Utrecht, The Netherlands
  5. 5 Department of Pharmacoepidemiology, Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA
  6. 6 EPID Research, Espoo, Finland
  1. Correspondence to Dr Fabian Hoti; fabian.hoti{at}epidresearch.com

Footnotes

  • Contributors All authors planned and designed this post-hoc analysis. SC, MM, ML, RW and HS performed the data management and data analysis, and all authors interpreted the data. All authors drafted the manuscript, revised the paper critically for important intellectual content and approved the final version of the manuscript. PK supervised the analysis and is the guarantor.

  • Funding Takeda Develop­ment Centre Europe Ltd.

  • Competing interests PK, FH, SC and MM are employed by EPID Research, EMH is employed by PHARMO Institute, RW and HS are employed by CPRD, and ML and SB are employed by Karolinska Institute. EPID Research, PHARMO Institute, CPRD and the Centre for Pharmacoepidemiology (CPE) at Karolinska Institute perform commissioned pharmacoepidemiological studies and thus their employees have been and currently are working in collaboration with several pharmaceutical companies (including Takeda). DB is employed by Takeda Pharmaceutical Company Limited.

  • Ethics approval In Finland, the study protocol was approved by the Ethical Review Board of the Hjelt Institute, University of Helsinki Medical Faculty (Dnro 96/13/00/2013). The research permission numbers to use the data were obtained from Statistics Finland (Dnro TK/53-373-13), National Institute for Health and Welfare (Dnro THL/634/5.05.00/2016), Social Insurance Institute (Dnro Kela 25/522/2013), Population Register Centre (Dnro 726/410/13). In Sweden, the study was approved by the Regional Ethical Review Board at Karolinska Institute in Stockholm, Sweden. DNR: 2011/82-31/3, 2011/752-323 and 2013/347-32. In the UK, the study protocol was reviewed and approved by the Independent Scientific Advisory Committee (ISAC) which considers and provides advice to the Medicines and Healthcare products Regulatory Agency on research projects which propose the use of data obtained from the CPRD (ISAC protocol numbers 13_044 and 14_065). In the Netherlands, the PHARMO compliance committee approved use of the PHARMO Database Network for the study and confirmed no ethics approval was needed.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Criteria and process for sharing the analytical country specific datasets and meta-analysis dataset for third parties are defined in the study protocol available at the ENCePP E-Register of Studies.

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Footnotes

  • Contributors All authors planned and designed this post-hoc analysis. SC, MM, ML, RW and HS performed the data management and data analysis, and all authors interpreted the data. All authors drafted the manuscript, revised the paper critically for important intellectual content and approved the final version of the manuscript. PK supervised the analysis and is the guarantor.

  • Funding Takeda Develop­ment Centre Europe Ltd.

  • Competing interests PK, FH, SC and MM are employed by EPID Research, EMH is employed by PHARMO Institute, RW and HS are employed by CPRD, and ML and SB are employed by Karolinska Institute. EPID Research, PHARMO Institute, CPRD and the Centre for Pharmacoepidemiology (CPE) at Karolinska Institute perform commissioned pharmacoepidemiological studies and thus their employees have been and currently are working in collaboration with several pharmaceutical companies (including Takeda). DB is employed by Takeda Pharmaceutical Company Limited.

  • Ethics approval In Finland, the study protocol was approved by the Ethical Review Board of the Hjelt Institute, University of Helsinki Medical Faculty (Dnro 96/13/00/2013). The research permission numbers to use the data were obtained from Statistics Finland (Dnro TK/53-373-13), National Institute for Health and Welfare (Dnro THL/634/5.05.00/2016), Social Insurance Institute (Dnro Kela 25/522/2013), Population Register Centre (Dnro 726/410/13). In Sweden, the study was approved by the Regional Ethical Review Board at Karolinska Institute in Stockholm, Sweden. DNR: 2011/82-31/3, 2011/752-323 and 2013/347-32. In the UK, the study protocol was reviewed and approved by the Independent Scientific Advisory Committee (ISAC) which considers and provides advice to the Medicines and Healthcare products Regulatory Agency on research projects which propose the use of data obtained from the CPRD (ISAC protocol numbers 13_044 and 14_065). In the Netherlands, the PHARMO compliance committee approved use of the PHARMO Database Network for the study and confirmed no ethics approval was needed.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Criteria and process for sharing the analytical country specific datasets and meta-analysis dataset for third parties are defined in the study protocol available at the ENCePP E-Register of Studies.

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