New Study Implicates Statins in Heart Failure.
November 30, 2004.
Since the early nineties–several years after statin drugs were introduced in 1987–the incidence of congestive heart failure (CHF) has risen sharply. CHF, in fact, is the fastest growing cardiovascular disorder in the United States(1).
Each year, around 400,000 new cases of CHF are diagnosed in America, and approximately half of these patients will die within five years. Sadly, there is no cure for CHF short of a heart transplant.
Although the causes of this CHF epidemic are unknown, statin-induced CoQl0 deficiency has been posited as a possible contributing factor.
New study: 20mg of Lipitor daily produced diastolic cardiac abnormalities in patients who were otherwise free of heart disease.
In the latest issue of the American Journal of Cardiology, Peter Langsjoen, a leading authority on statin-induced CoQ10 depletion, and his colleagues present evidence that supports this contention.
Langsjoen and his team studied 14 patients free of heart disease who were about to begin atorvastatin therapy. All of the patients met the National Cholesterol Education Program’s recommendations for initiating
pharmacologic therapy. The decision to initiate therapy was made by the
patients’ primary physician. Potential subjects were excluded if they were younger than 50 years old, had a history of heart failure or previous myocardial infarctions, had unstable angina pectoris, or other evidence of impaired cardiac function.
Plasma CoQ10 and echocardiograms were performed at baseline, and at the
conclusion of the study. After the baseline echocardiogram, patients were started on 20 mg of atorvastatin (Lipitor) per day for 3 to 6 months.
Ten of the 14 patients (71%) developed abnormalities in the heart’s
diastolic phase (when the heart muscle fills with blood). Diastolic
dysfunction is a major cause of congestive heart failure in older people.
Of the 10 patients who had worsening of LV diastolic function, 9 were
supplemented with 300 mg/day of Coenzyme Q10 (100 mg orally 3 times daily) for an additional 3 months while continuing to take atorvastatin.
Eight of these 9 patients (89%) had reversal of one or markers of diastolic abnormality, four patients (44%) had reversal of all three of the diastolic parameters employed, while one patient had no change in the parameters
Interestingly, these improvements were seen even though CoQ10 levels
decreased in 5 patients, remained the same in 4 patients, and increased in 5 patients during atorvastatin therapy.
Of the 9 patients who were supplemented with CoQ10, seven had significant increases in their blood levels of CoQ10, and one had no change (the remaining patient did not have follow-up CoQ10 blood levels drawn).
In light of these results, the researchers stated that, “Because baseline levels of CoQ10 do not predict dysfunction, routine concomitant CoQ10 administration, especially in patients at risk, seems prudent.”(2).
Statins: the next Vioxx?
Yesterday (November 29, 2004) Langsjoen and Julian M. Whitaker, M.D, issued DRUG CRISIS LOOMS LARGER THAN “VIOXX & REG;”
The release explains how Whitaker petitioned FDA on May 24, 2002 to change the warning labels on statin drugs to alert consumers to the fact that they deplete CoQ10 levels in the blood, placing millions at risk of myopathies, including cardiomyopathy (heart failure).
The FDA did nothing in response.
Whitaker has now filed a second petition with FDA, notifying the agency of “Health Canada’s insistence on use of the warning and demanding that FDA do the same without delay.”
Langsjoen and Whittaker believe that the FDA’s inaction and the recently revised National Cholesterol Education Program (NCEP) guidelines, which markedly increase the number of people eligible for statin therapy, have dramatically increased the risk of myopathies, “threatening a national health crisis.”
To read the press release, click
1. National Heart, Lung, and Blood Institute, National Institutes of Health
Data Fact Sheet. Congestive Heart Failure in the United States: A New
Epidemic. Available online: http://www.medhelp.org/NIHlib/GF-241.html
2. Silver MA, et al. Effect of Atorvastatin on Left Ventricular Diastolic
Function and Ability of Coenzyme Q10 to Reverse That Dysfunction. American
Journal of Cardiology, 2004; 94: 1306-1310.
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