A study revealed that cholesterol lowering drugs called statins — including the popular drug, Lipitor — may cause painful side effects in millions of Americans who take them each year. According to the study, about 10 percent of people in the U.S. suffer muscle pain, weakness or cramping when taking a statin. This equates to about three to four million Americans. Because of the severe pain, many patients stopped therapy, putting them at increased risk of heart attack and stroke. Even when patients reported the problem, many doctors ignored the claims because of lack of evidence. Some researchers said the pain was largely psychological. But, the new study published in JAMA at the beginning of April confirmed that these patients have a condition known as "statin intolerance." "We've confirmed that this is a problem and it's real," lead study author Dr. Steve Nissen said. Nissen and colleagues studied data from the study that included about 500 people. Some patients received Pfizer's Lipitor (atorvastatin), while others received a placebo. The study found "muscle symptoms occurred in 209 of 491 (42.6%) while taking atorvastatin (Lipitor) but not while taking placebo." In phase two of the trial, researchers tried alternative treatments for lowering cholesterol using new type of drug called evolocumab, a medication that belongs to the PCSK9 inhibitor class. These drugs work differently from statins and do not cause the same muscle effects. In the study, evolocumab decreased LDL-C (bad cholesterol) more than Lipitor. The new drugs offer hope to people suffering from high cholesterol that cannot tolerate statins, but PCSK9 inhibitors have yet to acquire FDA approval and treatment could cost from $10,000 to $15,000 a year. While these findings confirmed the statin intolerance, researchers pointed out that the study involved a relatively small group and more study is needed.
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