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While the findings of this study will give some support to the notion that it is reasonable to stop drugs that are designed to have long term benefit the the limitations of this study are really quite significant.
Therefore their assertion that the positive results reported would be heralded as a breakthrough need to be tempered with the criticism of trying to actually show convincingly that there is no difference in mortality / cardiovascular outcomes when the study population only number 384 patients for less than a year. Studies on new diabetic drugs being undertaken to check on their effect on CVD outcomes typically need patient numbers in excess of 10,000.
The predicted CVD event rate for this study would have needed to be massive for any difference to be statistically significant. Sadly the study seems underpowered to show any difference.
This is not to say I disagree with the notion that drugs which may be reducing quality of life should be considered for discontinuation but I would not rely on this study to reassure me that the drugs being stopped can be stopped with no potential adverse event in Cardiovascular outcomes.
Competing interests:
Principal investigator in a number of cardiovascular outcome studies
Re: Terminally ill patients could benefit from stopping statins, study says
While the findings of this study will give some support to the notion that it is reasonable to stop drugs that are designed to have long term benefit the the limitations of this study are really quite significant.
Therefore their assertion that the positive results reported would be heralded as a breakthrough need to be tempered with the criticism of trying to actually show convincingly that there is no difference in mortality / cardiovascular outcomes when the study population only number 384 patients for less than a year. Studies on new diabetic drugs being undertaken to check on their effect on CVD outcomes typically need patient numbers in excess of 10,000.
The predicted CVD event rate for this study would have needed to be massive for any difference to be statistically significant. Sadly the study seems underpowered to show any difference.
This is not to say I disagree with the notion that drugs which may be reducing quality of life should be considered for discontinuation but I would not rely on this study to reassure me that the drugs being stopped can be stopped with no potential adverse event in Cardiovascular outcomes.
Competing interests: Principal investigator in a number of cardiovascular outcome studies