Abstract
A strong controversy has emerged about the reality of safety and efficacy of statins as stated by company-sponsored reports. However, physicians need credible data to make medical decisions, in particular about the benefit/harm balance of any prescription. This study aimed to test the validity of data on the company-sponsored statin trial by comparing them over time and then comparing statins with each other. Around the years 2005/2006, new stricter Regulations were introduced in the conduct and publication of randomized controlled trials (RCTs). This would imply that RCTs were less reliable before 2006 than they were later on. To evaluate this, we first reviewed RCTs testing the efficacy of statins versus placebo in preventing cardiovascular complications and published after 2006. Our systematic review thereby identified four major RCTs, all testingrosuvastatin. They unambiguously showed that rosuvastatin is not effective in secondary prevention, while the results are highly debatable in primary prevention. Because of the striking clinical heterogeneity and the inconsistency of the published data in certain RCTs, meta-analysis was not feasible. We then examined the most recent RCTs comparing statins to each other: all showed that no statin is more effective than any other, including rosuvastatin. Furthermore, recent RCTs clearly indicate that intense cholesterol-lowering (including those with statins) does not protect high-risk patients any better than less-intense statin regimens. As for specific patient subgroups, statins appear ineffective in chronic heart failure and chronic kidney failure patients. We also conducted a MEDLINE search to identify all the RCTs testing a statin against a placebo in diabetic patients, and we found that once secondary analyses and subgroup analyses are excluded, statins do not appear to protect diabetics. As for the safety of statin treatment – a major issue for medical doctors – it is quite worrisome to realize that it took 30 years to bring to light the triggering effect of statins on new-onset diabetes, manifestly reflecting a high level of bias in reporting harmful outcomes in commercial trials, as has been admitted by the recent confession of prominent experts in statin treatment. In conclusion, this review strongly suggests that statins are not effective for cardiovascular prevention. The studies published before 2005/2006 were probably flawed, and this concerned in particular the safety issue. A complete reassessment is mandatory. Until then, physicians should be aware that the present claims about the efficacy and safety of statins are not evidence based.
Highlights
There is a growing controversy affecting several drugs about their efficacy and safety, triggered by increasing signs of altered validity of numerous companysponsored trials
The only statin that has been tested after the implementation of the New Regulations is rosuvastatin that was tested in four randomized controlled trials (RCTs) (Figure 1 and Table 1):
The CORONA trial, wherein patients were all survivors of a prior acute myocardial infarction (AMI) – with various degrees of cardiac dysfunction – and at high risk of AMI recurrence and cardiac death [52];
Summary
There is a growing controversy affecting several drugs about their efficacy and safety, triggered by increasing signs of altered validity of numerous companysponsored trials. The 5-year battle needed to access the raw trial data led to a reversed picture of the drugs: benefits had been overestimated and harms under-reported in the company-sponsored trial reports [1, 2]. The benefit/harm balance was not in favor of the drugs; this is a critical issue for physicians, in particular when they are in charge of fragile patients. One probable cause of the failure is that none of the trials was independent of the drug’s manufacturers. Several experts conclude that the “Tamiflu story” may suggest that the entire ecosystem of drug evaluation and regulation could be flawed [3, 4]
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