Re: Dangers of rosuvastatin known before and after FDA approval

From: Zee (zwalanga_at_yahoo.com)
Date: 06/26/04 

Date: 25 Jun 2004 17:40:13 -0700

zwalanga@yahoo.com (Zee) wrote in message news:<e5f4a9c2.0406241411.473986f9@posting.google.com>...

In the interests of fairness, I post this. I have the pdf for Wolfe's
article. If you want it you know how to get it. Zee

THE LANCET • Published online June 25, 2004 •

http://image.thelancet.com/extras/04cor6147web.pdf
Safety and efficacy of rosuvastatin

In response to the letter from Public
Citizen (June 26, p 2189),1 rosuvastatin
(Crestor) is a highly efficacious
3-hydroxy-3-methylglutaryl coenzyme
A (HMG-CoA) reductase inhibitor
(statin) with a safety profile comparable
to those of other marketed statins.
AstraZeneca's ongoing review of postmarketed
safety data as well as a recent
review of data by health authorities
worldwide, including the US Food and
Drug Administration, supports this
conclusion.
Because patients' safety is of
paramount importance to AstraZeneca,
rosuvastatin was the most extensively
studied statin ever submitted for
regulatory review. To date, regulatory
authorities in more than 60 countries
worldwide have approved rosuvastatin
on the basis of the excellent benefit-risk
profile, and over 2 million patients have
now been treated with rosuvastatin.
Since rosuvastatin is the statin
delivering the greatest reduction in LDL
cholesterol (with the advantage of a
significant increase in HDL
cholesterol), more than 80% of patients
can reach their LDL cholesterol goal on
the usual start dose of rosuvastatin 10
mg. For the small number of patients
with particularly severe hypercholesterolaemia
who are inadequately
treated with current monotherapies,
titration to rosuvastatin 40 mg offers a
therapeutic option.
Rhabdomyolysis is seen with all
statins and is observed rarely across the
full dose range. With continued
marketed experience of rosuvastatin, the
reporting rate of rhabdomyolysis has
remained very rare by the Council for
International Organizations of Medical
Sciences' definition (<0·01%) and is
consistent with the rates for all currently
marketed statins. Rare cases of fatal
rhabdomyolysis have been reported with
all other statins, but cerivastatin was
unusual in that it was associated with 31
fatal reports of rhabdomyolysis on a
background of nearly 10 million
prescriptions. For rosuvastatin, there
have been no cases to date of fatal
rhabdomyolysis, directly or indirectly
related to the drug, on a background of
over 5 million prescriptions.
Despite Public Citizen's claims to the
contrary, rosuvastatin 10–40 mg is well
tolerated from the renal perspective. In
the clinical trial programme, proteinuria
was seen in a small number of patients
receiving rosuvastatin, comparator
statins, and placebo. This finding was
thoroughly assessed for rosuvastatin and
found to be transient, often resolved on
continued treatment, and was not
predictive of acute or progressive renal
disease. Indeed, a recent publication
reported that renal function in more
than 10 000 patients treated with
rosuvastatin for up to 3·8 years was
maintained or tended to improve
slightly.2
AstraZeneca is surprised that
The Lancet has decided to publish a
letter containing inappropriate data
comparisons that only serve to cause
undue alarm for patients whose
dyslipidaemia is currently being
successfully treated with rosuvastatin. In
fact, this letter, which is a rehash of
misinformation presented by Public
Citizen in the past, includes reference to
a non-marketed dose (80 mg) and is
highly speculative.
In summary, rosuvastatin has an
excellent benefit-risk profile compared
with the other marketed statins, having
better efficacy in lowering LDL
cholesterol and raising HDL cholesterol
and a safety profile comparable to those
of the other marketed statins.
Gunnar O Olsson
gunnar.o.olsson@astrazeneca.com
AstraZeneca, Pepparedsleden 1,
431 83 Mölndal, Sweden
1 Wolfe SM. Dangers of rosuvastatin identified
before and after FDA approval. Lancet 2004;
363: 2189–90.
2 Vidt DG, Cressman MD, Harris S, Pears JS,
Hutchinson HG. Rosuvastatin-induced arrest
in progression of renal disease. Cardiology
2004; 102: 52–60.

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