Statin 藥物大規模看英國資料庫，食道癌變少?肝功能和myopathy是本來就知道的，但acute renal failure，cataract本來未知

Unintended Effects of Statin Drugs

Kidney failure and cataracts were associated significantly with statin use.

Statins lower risk for adverse cardiovascular events, especially in high-risk patients. In this large prospective U.K. cohort study, investigators sought to quantify unintended effects of these widely used drugs.

Of the more than 2 million study participants (age range, 30–84), about 225,000 were new statin users: 160,000 were prescribed simvastatin, 50,000 received atorvastatin, and 15,000 received pravastatin, rosuvastatin, or fluvastatin. Statin use was associated significantly with lower risk for esophageal cancer and higher risks for liver dysfunction (alanine transaminase levels 3x upper limit of normal), myopathy (clinical diagnosis or creatinine kinase level 4x upper limit of normal), acute kidney failure, and cataracts; liver dysfunction and acute kidney failure were dose-dependent. Adverse effects for individual statins were similar, except for liver dysfunction, in which risk was highest for fluvastatin. All excess risks persisted during treatment and returned to normal after drug cessation. Statin use was not associated with risk for osteoporotic fracture, venous thromboembolism, dementia, Parkinson disease, rheumatoid arthritis, or cancers (stomach, lung, breast, colon, kidney, and prostate cancers or melanoma).

Comment: Most clinicians are familiar with statin-associated liver dysfunction and myopathy. The results of this study suggest that clinicians should be familiar with and monitor for two more possible statin-associated adverse effects: acute kidney failure and cataracts. In addition, with the exception of esophageal cancer risk, the results are consistent with those of a prior meta-analysis, in which researchers found no association between statin use and cancer risk (JW Cardiol Mar 9 2006).

— Paul S. Mueller, MD, MPH, FACP

Published in Journal Watch General Medicine June 15, 2010

Citation(s):

Hippisley-Cox J and Coupland C. Unintended effects of statins in men and women in England and Wales: Population based cohort study using the QResearch database. BMJ 2010 May 20; 340:c2197. (http://dx.doi.org/10.1136/bmj.c2197)

• Original article (Subscription may be required)
• Medline abstract (Free)

什麼是已知的?

Meta-analyses suggest that statins reduce the risk of cardiovascular disease, particularly in
high risk patients
Although meta-analyses provide valuable information on effectiveness they tend to lack
representative samples, duration of follow-up, or power to assess unintended effects
Information on the unintended effects of statins in representative primary care populations is
lacking although statins are prescribed in large volumes for long periods

WHAT THIS STUDY ADDS?

Individual statins were not significantly associated with risk of Parkinson’s disease,
rheumatoid arthritis, venous thromboembolism, dementia, osteoporotic fracture, and
several common cancers
The risk of oesophageal cancer was reduced but for liver dysfunction, acute renal failure,
myopathy, and cataract it was increased
Adverse effects were similar across the statin types for each outcome except liver dysfunction
where fluvastatin was associated with the highest risks

acute renal failure 很詭異：

The increased risk of acute renal failure was apparent
within the first year of starting treatment (adjusted
hazard ratios 1.54 (1.09 to 2.17) for women and 1.67
(1.26 to 2.21) for men), and persisted for the first five
years of treatment. The risk remained increased during
the first year of stopping treatment and then returned
to normal 1-3 years after stopping treatment: adjusted
hazard ratios 1.23 (0.69 to 2.20) for women and 1.57
(0.95 to 2.60) for men.

https://docs.google.com/fileview?id=0B278nGJMQBk7YzQ0ZjhiZTEtOTFmNC00NzE2LTk0NWItNDE2OTNiYmI1YWIy&hl=en