Everybody's takin' a brand new pill, now.
Come on baby, do the Statin Shuffle.
Get loss of muscle function, you'll feel real ill, now.
Come on baby, do the Statin Shuffle.
You're losin' your balance like you've drunk too much,
You're feet and legs are hurtin' and you need a crutch,
Come on, come on, do the Statin Shuffle with me.

CHORUS
You need CoEnzyme Q ten,
Come on baby, go buy, and now
You gotta tell your doctor how, woah oh.

My bigger older brother got his mem'ry impaired.
Come on baby, do the Statin Shuffle.
And little younger sister, now she needs a wheel chair.
Come on baby, do the Statin Shuffle.
My mother and my father died of heart attack,
And they were takin' statin drugs by the pack.
Come on, come on, do the Statin Shuffle with me.

CHORUS
You need CoEnzyme Q ten,
Come on baby, go buy, and now
You gotta tell your doctor how, woah oh.

The drug corporation's makin' lots of money,
Come on baby, do the Statin Shuffle.
While cells inside your body get really runny,
Come on baby, do the Statin Shuffle.
When liver levels rise they just change the drugs,
It's still a deadly statin that your doctor plugs.
Come on, come on, do the Statin Shuffle with me.

CHORUS
You need CoEnzyme Q ten,
Come on baby, go buy, and now
You gotta tell your doctor how, woah oh.

You wanna get better? The cure is known, now.
Come on baby, do the Statin Shuffle.
All you gotta do is get ubiquinone, now.
Come on baby, do the Statin Shuffle.
Tell this to your family and tell your friends,
'Cause it's the kind of thing on which your life depends.
Come on, come on, do the Statin Shuffle with me.

CHORUS
You need CoEnzyme Q ten,
Come on baby, go buy, and now
Go tell your doctor. Woah oh oh
Come on, go buy,
And tell your doctor. Woah oh oh

(Song fades out)

See: Petition by Dr. Julian M. Whitaker, M.D. and a review of pertinent human and animal data. http://www.fda.gov/ohrms/dockets/dailys/02/May02/052902/02p-0244-cp00001-01-vol1.pdf

Dr. Whitaker is demanding, that ALL companies that produce statin drugs put a label on their product telling people that they MUST take 100-200 mg of CoQ10 with the statin drug. When these pharmaceutical companies peddle their products to doctors, and to patients via television ads, "Ask your doctor about this drug (Lipitor, Zocor, Pravachol and so forth)" they could and should throw in the information about CoQ10 with no loss to their profits. The point is, they DO NOT do this. Why not? Perhaps because by not mentioning it, everyone makes money as the patient suffers with new problems? What else can anyone think after seeing the PATENT below showing that as earlier than January 1989, at least one pharmaceutical company KNEW the harm that statins could do to the body and KNEW the necessity of taking CoQ10 with such powerful and dangerous drugs? What else can anyone think?  What is anyone supposed to think?  

Statins definitely do lower LDL cholesterol.  And high LDL cholesterol is "associated with" heart attack.  But if you deplete CoEnzyme Q10 you will be at SUPER high risk for heart attack - and Statin drugs deplete this CoQ10!  And by the way, not all doctors (especially those not affiliated with any pharmaceutical company) agree that LDL cholesterol is a cause of heart attack.  Quite a few do not agree on this issue.   See here or here or here. Just do a search for Statins, "Truth About Statins" or "CoEnzyme Q10" and you can unearth a ton of information, much of it from or quoted from medical journals. 

Merck, a large pharmaceutical company, actually patented (4,933,165) a combination of statin and CQ10 in a pill but they never put it on the market.  See their Patent or see below (in case it vanishes from the patent site).

Given the marketing shenanigans (getting a legal patent to prevent others from marketing such a pill) of these scoundrels it is just the thing to do to protect their business with disease. This clearly shows that Merck KNEW about CoQ10 and KNEW what statin drugs really did. Is this not "reckless endangerment" or even murder? It's clearly criminal.

Pharmaceutical Companies and Disease - see HERE.

Here is the information from the actual patent, it is here in case it somehow, via clout of pharmaceutical companies, vanishes into thin air:

United States Patent: 4,933,165

A pharmaceutical composition and method of counteracting HMG-CoA reductase inhibitor-associated myopathy is disclosed. The method comprises the adjunct administration of an effective amount of a HMG-CoA reductase inhibitor and an effective amount of Coenzyme Q.sub.10.

Current U.S. Class:	424/94.1; 514/415; 514/460; 514/510; 514/689; 514/922
Intern'l Class:	A61K 031/405; A61K 031/35; A61K 031/21; A61K 031/12
Field of Search: 424/10,510 514/415,690,460,922,689

BACKGROUND OF THE INVENTION

Coenzyme Q.sub.10 (2,3-dimethoxy-5-methyl-6-decaprenyl-1,4-benzoquinone) is a redox component in the respiratory chain and is found in all cells having mitochondria. It is thus an essential co-factor in the generation of metabolic energy and is particularly important in muscle function. For example, Folkers et al., Proc. Natl. Acad. Sci., 82: 901 (1985) have measured the levels of Coenzyme Q.sub.10 (CoQ.sub.10) in endomyocardial biopsy samples taken from patients with varying stages of cardiomyopathy. Folkers et al. states that these data show decreasing tissue levels of CoQ.sub.10 with increasing severity of the symptoms of cardiac disease. Folkers et al., Proc. Natl. Acad. Sci., 82: 4513 (1985) in a double-blind study have reported improved cardiac output for some patients upon receiving an oral administration of CoQ.sub.10.

HMG-CoA reductase inhibitors represent a new class of cholesterol-lowering drugs. Relatively low doses of these drugs effectively reduce plasma cholesterol levels. These drugs are believed to function by inhibiting the chemical transformation HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. A branch of the mevalonate cholesterol biosynthetic pathway in mammalian cells leads to the formation of CoQ.sub.10. [reviewed by Brown and Goldstein J. Lipid Res., 21, 505 (1980)]. Furthermore high levels of lovastatin can reduce CoQ.sub.10 in the liver (MK-803 NDA report) and compactin reduces LDL-bound CoQ.sub.10 at doses employed in humans [H. Mabuchi et al, N. E. J. Med., 478 (August 1981].

The Physician's Desk Reference, 42d Ed., 1366 (1988) states that myalgia has been associated with lovastatin therapy. Tobert, N. E. J. Med., 48 (Jan. 7, 1988) states that in a very small number of patients (0.5 percent) myopathy appeared to be associated with lovastatin therapy. Concomitant therapy with immunosuppressant drugs, including cyclosporine, with gemfibrozil or niacin or a combination, appears to increase the risk of myopathy. (J. A. Tobert, Am. J. Cardiol. 1988, 62: 28J-34J). The myopathy is reversible upon discontinuance of lovastatin therapy.

Although cholesterol-lowering therapy through the use of HMG-CoA reductase inhibitors is generally free of side reactions, it would be of considerable benefit to counteract the myopathy observed in a small percent of patients. Since CoQ.sub.10 is of benefit in congestive heart failure patients the combination with HMG-CoA reductase inhibitors should be of value in such patients who also have the added risk of high cholesterol levels.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a method of counteracting HMG-CoA reductase inhibitor-associated myopathy in a patient receiving HMG-CoA reductase therapy which comprises the adjunct administration of an effective amount of an HMG-CoA reductase inhibitor and an effective amount of Coenzyme Q.sub.10. Included within the scope of the present invention is the treatment of those patients receiving HMG-CoA reductase therapy and who are also taking immunosuppressant drugs, gemfibrozil or niacin.

The HMG-CoA reductase inhibitor employed may be lovastatin, simvastatin, pravastatin, XU-62-320 (Sodium-3,5-dihydroxy-7-[3-(4-fluorophenyl)-1(methylethyl)-1H-Indole-2yl]- hept-6-enoate) or any other member of the class of compounds that inhibit HMG-CoA reductase. The preparation of lovastatin (U.S. Pat. No. 4,231,938), simvastatin (U.S. Pat. No. 4,444,784) and pravastatin (U.S. Pat. No. 4,346,227) have been described in the patent literature. The preparation of XU-62-320 is described in WIPO Pat. No. WO84/02131, published June 7, 1984. These methods of preparation are hereby incorporated by reference.

Coenzyme Q.sub.10 is manufactured by the Kanegafuchi Chemical Industry Co., Ltd. and is widely available.

In its application to the counteraction of myopathy the present invention is accordingly to be understood as providing for the avoidance of myopathy where this may otherwise occur as well as the amelioration of myopathy. The term counteracting is accordingly to be understood as connecting both a precautionary or prophylactic as well as curvative or treatmental function.

In accordance with the method of the present invention, an HMG-CoA reductase inhibitor and CoQ.sub.10 can be administered separately at different times during the course of therapy or concomitantly in divided or single combination forms. Thus treatment with CoQ.sub.10 can commence prior to, subsequent to or concurrent with the commencement of HMG-CoA reductase treatment. The present invention is to be understood as embracing all such regimes of treatment and the term "adjunct administration" is to be interpreted accordingly.

The compounds of the instant invention may be administered orally or parenterally in the form of a capsule, a tablet, an injectable preparation or the like. The general amounts of HMG-CoA reductase inhibitor will be of the same or similar order to that employed in HMG-CoA reductase therapy. In general, satisfactory results are obtained by administration of 0.10 to 80 mg/day of the HMG-CoA reductase inhibitor in a single or divided dose. Doses of CoQ.sub.10 may vary from 25 mg to 1 g day in a single or divided dose. Tablets or capsules may also be administered which contain both compounds in the dosage ranges indicated.

EXAMPLE 1

As a specific embodiment of a composition of this invention, 20 mg of lovastatin and 35 mg of Coenzyme Q.sub.10 are formulated with sufficient finely-divided lactose to provide a total amount of 580 to 590 mg to fill a size 0 hard-gelatin capsule. Optionally added are a excipient such as finely divided cellulose, a disintegrant such as Explotat and a lubricant such as magnesium stearate.

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