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• Re:Statin trial and cardiovascular outcome
  P Ruokoniemi
  Published on: 23 November 2015
• Statin trial and cardiovascular outcome
  Reeta Devi
  Published on: 23 November 2015

• Published on: 23 November 2015

  Re:Statin trial and cardiovascular outcome

  • P Ruokoniemi

  We thank our colleagues Reeta Devi and Maulana Azad for their comment and welcome the discussion on the representativeness of clinical statin trials for real-world diabetes care.

  The health system in Finland has universal coverage, i.e. all persons (regardless of their socioeconomic status) have access to free care and subsidized prescription drugs. Finnish register system is also exceptional, because it has legi...

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  We thank our colleagues Reeta Devi and Maulana Azad for their comment and welcome the discussion on the representativeness of clinical statin trials for real-world diabetes care.

  The health system in Finland has universal coverage, i.e. all persons (regardless of their socioeconomic status) have access to free care and subsidized prescription drugs. Finnish register system is also exceptional, because it has legislative cover of total population since the 1960s and records can be deterministically linked using the personal identification codes. Our data captures all individuals with diabetes identifiable from the Finnish nationwide administrative registers, i.e. all who have purchased anti-diabetic medications or have had hospital visit with recorded diabetes diagnosis. We acknowledge that people with undiagnosed diabetes or treated with diet only in outpatient primary care may remain unidentified, but our data represent the closest thing to the unselected real-world population of statin initiators (among medically treated diabetes) that is feasible to obtain.

  Our goal for presenting outcome data after statin initiation was simply to depict the level of event rates among real-world patients in comparison with trial populations. These rates are affected by the baseline cardiovascular risk of statin initiators and effects of statins consumed by them during the follow-up. In other words, these rates are descriptive facts for the studied real-world population, but must not in any circumstances to be interpreted as results on statin effectiveness in the real world.

  Our study aimed to investigate whether there is a significant selection between trial populations and real-world population. We have recently also published more detailed data on the use of statins among people with newly diagnosed diabetes (Vehko et al. 2013). In conclusion, we believe that these kinds of results on real-world populations are a step towards the understanding of patterns of statin usage, and will eventually help the clinicians and policy makers to promote more rational statin use in diabetes, but we agree that more research on the actual benefits and harms of statins in different population groups is required.

  On behalf of all authors, P Ruokoniemi, MD, Corresponding author

  Additional references: Vehko T, Sund R, Arffman M, Manderbacka K, Ilanne-Parikka P, Keskimaki I. Monitoring the use of lipid-lowering medication among persons with newly diagnosed diabetes: a nationwide register-based study. BMJ Open. 2013 Nov 4;3(11):e003414. doi: 10.1136/bmjopen-2013-003414. PubMed PMID: 24189078; PubMed Central PMCID: PMC3822306.

  Conflict of Interest:

  Please refer to the original article.

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  Conflict of Interest:
  None declared.

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• Published on: 23 November 2015

  Statin trial and cardiovascular outcome

  • Reeta Devi, Assistant Professor,
  • Other Contributors:
    • Mongjam Meghachandra Singh, Bimla Kapoor

  Dear Editor,

  The present study has shown under representation of statin users in the population with real diabetes mellitus patients. It has tried to capture data from the available registries which may not depict a true picture of the real patients of diabetes mellitus. As highlighted by the authors, many of the cases may be unreported and may not be taking medications. Such cases were excluded from the study....

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  Dear Editor,

  The present study has shown under representation of statin users in the population with real diabetes mellitus patients. It has tried to capture data from the available registries which may not depict a true picture of the real patients of diabetes mellitus. As highlighted by the authors, many of the cases may be unreported and may not be taking medications. Such cases were excluded from the study. One of the major factors that may affect the study results is the use of different doses of statin in the estimation of association with cardiovascular outcomes. Varying doses may make the results in comparable across different age groups, sex and also socioeconomic variables which are not discussed in the study.

  In addition, the controversy over the use of statin in diabetes mellitus is still unresolved. Studies mention about the role of statin initiating diabetes mellitus in the long term causes much concern to the use of statin for preventing cardiovascular diseases. There is a need to revisit the recommendations on the use of statin for prevention of cardiovascular events.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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