Statin drugs are one of the most frequently prescribed medications.  Millions of Americans take these drugs to lower cholesterol levels.

Despite the belief that because they lower cholesterol levels, and provides protection against cardiovascular disease, a new study discovered they have very real, and very significant risks, and a not appropriate or safe, for everyone.  The new study found that statin drugs actually  the risk of having a certain type of stroke, caused by bleeding in the brain if you've already had one before. In fact, it increased the risk of a second stroke by  22 percent among patients who took cholesterol lowering drugs compared with 14 percent in those who did not.

There are two reasons why this might happen: the drugs may either lower your cholesterol too much, to the point that it increases your risk of brain bleeding, or they may affect clotting factors in your blood, increasing the bleeding risk.

While the benefits of statins for reducing the risk of heart disease and stroke appear to be well established, widespread use of statin therapy remains controversial, according to background information in the article. "A particular group of patients for whom the advisability of statin use is unclear are those at high risk for intracerebral hemorrhage," (a stroke caused by bleeding within the brain).  The authors added,  "The reason for added concern is the increased incidence of intracerebral hemorrhage observed among subjects randomized to statin therapy in a clinical trial of secondary stroke prevention."

"Because intracerebral hemorrhage sufferers commonly have co-morbid [co-occurring] cardiovascular risk factors that would otherwise warrant cholesterol-lowering medication, it is important to weigh the risks and benefits of statin therapy in this population," write M. Brandon Westover, M.D., Ph.D., of Massachusetts General Hospital and Harvard Medical School, Boston, and colleagues. The researchers used a Markov decision model to evaluate these benefits and risks.

Due to the results of earlier research, simulated patients were assigned to states that correspond to disease risk and could then experience any combination of events which may lead to the increased risk of stroke or heart disease, change in quality of life or death.

"Our analysis indicates that in settings of high recurrent intracerebral hemorrhage risk, avoiding statin therapy may be preferred," the authors write. "For lobar intracerebral hemorrhage [bleeding in the cerebrum] in particular, which has a substantially higher recurrence rate than does deep intracerebral hemorrhage, statin therapy is predicted to increase the baseline annual probability of recurrence from approximately 14 percent to approximately 22 percent, offsetting the cardiovascular benefits for both primary and secondary cardiovascular prevention."

In the case of deep intracerebral hemorrhage, a type of stroke due to bleeding deep within the brain that has a lower risk of recurrence, the benefits and risks of statin use were more evenly balanced. "Consequently, the optimal treatment option may vary with specific circumstances," the authors write.

The mechanism by which statins might increase the risk of hemorrhagic stroke are unknown, the authors note. The association may be due to an increased risk of brain bleeding among those with lower cholesterol levels, or potential anti-clotting properties of statins.

"In summary, mathematical decision analysis of the available data suggests that, because of the high risk of recurrent intracerebral hemorrhage in survivors of prior hemorrhagic stroke, even a small amplification of this risk by use of statins suffices to recommend that they should be avoided after intracerebral hemorrhage," the authors conclude. "In the absence of data from a randomized clinical trial (ideally comparing various agents and doses), the current model provides some guidance for clinicians facing this difficult decision."

Editorial: Do No Harm With Statin Treatment

"The question prompting the decision analysis model reported by Westover et al epitomizes a common conundrum faced by clinicians -- the need to make a therapeutic decision for a given patient in the absence of guidance from specific, high-quality clinical trial data," writes Larry B. Goldstein, M.D., of Duke University and Durham VA Medical Center, Durham, N.C.

"In this case, exploratory data from two clinical trials (Heart Protection Study and SPARCL) suggest, but do not prove, a statin-associated increased risk of brain hemorrhage that may reduce the overall benefit of treatment in patients with a history of cerebrovascular disease."

The available data are "generally consistent with the conclusion of the decision analysis -- the risk of statin therapy likely outweighs any potential benefit in patients with (at least recent) brain hemorrhage and should generally be avoided in this setting."

Dr. Goldstein writes. "Until and unless there are data to the contrary, or warranted by specific clinical circumstances, the use of statins in patients with hemorrhagic stroke should be guided by the maxim of nonmaleficence -- Primum non nocere."

Statins  Protection Against Heart Attacks Question

Originally, statin drugs were prescribed for secondary prevention, meaning the prevention of a second heart attack or stroke if you'd already suffered one and had clear signs of heart disease.

However, with the 2008 publication of the Jupiter Study, in the New England Journal of Medicine the results prompted doctors to prescribe these drugs for to a majority of for primary prevention, and supposedly help lower those with certain risk factors of heart disease -- although otherwise healthy -- from having a heart attack or stroke in the first place.

The study claimed that statin drugs could lower the risk of heart attack by 54 percent, the risk of death from all causes by 20 percent,  the risk of needing angioplasty or bypass surgery by 46 percent, and the risk of stroke by 48 percent.

The study was funded by the maker of the drug Crestor, Astra-Zeneca.

Findings contradicted

In 2010, three reports  were published in the Archives of Internal Medicine, that contradicted and refuted the claims of the Jupiter study.

One of these studies, Cholesterol lowering, cardiovascular diseases and the rosuvastin-JUPITER controversy: a critical reappraisal,  carefully reviewed the methods and the results of the JUPITER trial and concluded that the trial was flawed. The authors wrote,  “The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.”

In part 3 we’ll take a look at other harmful side effects of these drugs.

Sources:

http://archneur.ama-assn.org/cgi/content/full/archneurol.2010.356

M. Brandon Westover; Matt T. Bianchi; Mark H. Eckman; Steven M. Greenberg. Statin Use Following Intracerebral Hemorrhage: A Decision Analysis. Archives of Neurology, 2011; DOI: 10.1001/archneurol.2010.356

Larry B. Goldstein. Statins After Intracerebral Hemorrhage: To Treat or Not to Treat. Archives of Neurology, 2011; DOI: 10.1001/archneurol.2010.349

http://www.nejm.org/doi/full/10.1056/NEJMoa0807646#t=articleTop

http://www.ncbi.nlm.nih.gov/pubmed/20585068

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