Coronary Heart Disease and Statins Controversy (Part IV) – Blog Post by Asrar Qureshi
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Continued
from Previous……
Questions about Results of Randomized
Clinical Trials (RCTs)
Most
information, and excerpts, for this part has been taken from the published
article Rabaeus M et al. Recent Flaws in Evidence-Based Medicine: Statin
Effects in Primary Prevention and Consequences of Suspending the Treatment. J
Controversies Biomed Res 2017;3(1):1–10. 1
Statin
therapy is being promoted by the pharmaceutical companies as a protection against
ischemic heart disease (IHD) complications. It therefore stands to reason that
the statins should decrease cardiovascular as well as all-cause mortality, and
possibly should increase life expectancy. However, the true effects of statin
therapy on IHD complications and mortality, as presented in RCTs are under
intense controversy. The controversy is particularly intense around the effects
on primary prevention and consequences of discontinuation.
Primary
prevention means that if a person is taking statin, she/he would possibly be prevented
from developing heart disease. Consequences of discontinuation would possibly be
seen in a patient already taking statins.
The
number of dissenting and contesting voices is growing. It is openly being questioned
whether the physicians, scientists and patients have been misled by the way the
results of clinical trials have been presented.
The authors
comment. “On April 2, 2016,
investigators of the Heart Outcomes Prevention Evaluation (HOPE)-3 trial
reported the main results of a randomized double-blinded trial testing the
effects of rosuvastatin (10 mg per day against placebo) on the risk of
cardiovascular complications. The authors concluded that cholesterol lowering
with rosuvastatin “resulted in a significantly lower risk of cardiovascular
events than placebo in an intermediate-risk, ethnically diverse population
without cardiovascular disease”. The associated editorial concluded that HOPE-3
“adds to the evidence supporting statin use for primary prevention” (7).
With all due respect, we think
these statements should be seriously questioned. As recently underlined, the
claims about efficacy (supposed to be high) and toxicity (supposed to be low)
of statins are essentially based on RCTs published before 2005, which can be
seriously criticized. Recent RCTs (published after 2005) are still equivocal,
suggesting that even after 2005 basic methods of evidence-based medicine were
still not fully and systematically respected (1).
There are several ways of (intentionally or not) flawing RCT data, for
instance, by not fully describing the raw data and/or only reporting partial
data extracted from large database. Also, as the clinical files of randomized
patients are quite easily accessible via Internet, unblinding is, although
unproven, probably frequent. In consequence, health authorities are more and
more precautious, and investigators are obliged to release increasing amounts of
data, often performed in the form of “online supplementary materials.” Careful
examination of all these released materials can provide information on the way
the RCTs are conducted and analyzed. What about HOPE-3, the latest reported
statin RCTs?
References.
Continued……
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