JAMA publish results of Statins cause cancer.

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JAMA 1996 Jan 3;275(1):55-60Related Articles, Links

 

Comment in:

JAMA. 1996 Jan 3;275(1):67-9.

JAMA. 1996 May 15;275(19):1479-80; discussion 1481-2.

JAMA. 1996 May 15;275(19):1479; discussion 1481-2.

JAMA. 1996 May 15;275(19):1480-1; discussion 1481-2

JAMA. 1996 May 15;275(19):1480; discussion 1481-2.

JAMA. 1996 May 15;275(19):1480; discussion 1481-2.

JAMA. 1996 May 15;275(19):1481-2.

 

Carcinogenicity of lipid-lowering drugs.

 

Newman TB, Hulley SB.

 

Department of Laboratory Medicine, School of Medicine, University of California,

San Francisco, USA.

 

OBJECTIVE--To review the findings and implications of studies of rodent

carcinogenicity of lipid-lowering drugs. DATA SOURCES--Summaries of

carcinogenicity studies published in the 1992 and 1994 Physicians' Desk

Reference (PDR), additional information obtained from the US Food and Drug

Administration, and published articles identified by computer searching,

bibliographies, and consultation with experts. STUDY SAMPLE--We tabulated rodent

carcinogenicity data from the 1994 PDR for all drugs listed as " hypolipidemics. "

For comparison, we selected a stratified random sample of antihypertensive

drugs. We also reviewed methods and interpretation of carcinogenicity studies in

rodents and results of clinical trials in humans. DATA SYNTHESIS--All members of

the two most popular classes of lipid-lowering drugs (the fibrates and the

statins) cause cancer in rodents, in some cases at levels of animal exposure

close to those prescribed to humans. In contrast, few of the antihypertensive

drugs have been found to be carcinogenic in rodents. Evidence of carcinogenicity

of lipid-lowering drugs from clinical trials in humans is inconclusive because

of inconsistent results and insufficient duration of follow-up.

CONCLUSIONS--Extrapolation of this evidence of carcinogenesis from rodents to

humans is an uncertain process. Longer-term clinical trials and careful

postmarketing surveillance during the next several decades are needed to

determine whether cholesterol-lowering drugs cause cancer in humans. In the

meantime, the results of experiments in animals and humans suggest that

lipid-lowering drug treatment, especially with the fibrates and statins, should

be avoided except in patients at high short-term risk of coronary heart disease.

 

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