Financially speaking, cholesterol-lowering statin drugs are hugely successful for pharmaceutical companies. Pfizer Pharmaceuticals had worldwide sales of $12.7 billion in 2007 of atorvastatin (Lipitor). Now Pfizer has launched an aggressive marketing campaign to convince doctors and patients that an 80-mg dose of Lipitor offers better protection against cardiovascular disease (CVD) than the usual 10mg dose.

Yet to me, the big question is not whether people need this higher dose—it's whether people need statins at all.

Pfizer's push is based on a study that the company sponsored, published in The Journal of the American Medical Association, to compare dosages and gauge the safety of reducing LDL "bad" cholesterol below the currently recommended maximum of 130 milligrams per deciliter (mg dl). Participants included 10,001 CVD patients whose LDL was less than 130 mg/dl. For eight weeks, one group took 80 mg daily of Lipitor and the other took 10 mg daily. Findings…

  • Average LDL fell to 77 mg/dl in the high-dose group...versus 101 mg/dl in the low-dose group.
  • Over the five-year study period, there were 126 CVD-related deaths in the high-dose group...versus 155 in the low-dose group.
  • The high-dose group had 2.2% fewer nonfatal cardiovascular events than the low-dose group.

The study results are interesting-but are they reason enough to put millions of people on statin megadoses? The answer must take into account statins' possible side effects—muscle pain, muscle damage, fatigue, weakness, and potentially fatal liver and kidney damage. In the Pfizer study…

  • Among high-dose patients, 8.1% had side effects...versus 5.8% in the low-dose group.
  • In the high-dose group, 7.2% of participants quit taking Lipitor because of side effects.. versus 5.3% of low-dose patients.
  • Among high-dose users, 1.2% had elevated enzymes indicative of liver inflammation and/or injury...versus 0.2% of low-dose users.

Given the risks, I think statins are hugely overprescribed. Most people can reduce cholesterol with diet, exercise and supplements of niacin (vitamin B-3)...Sytrinol (a brand-name Vitamin E and citrus extract formula). guggul (a plant resin)...red yeast rice...and/or fish oil.

Furthermore, as a marker for CVD risk, cholesterol may be less significant than elevated levels of C-reactive protein and Interleukin 6, blood markers of plaque-promoting inflammation...homocysteine, an amino acid that is toxic in excess.. lipoprotein a, which transports artery-clogging LDL and apolipoprotein b, a major component of LDL. Another important marker is a reduced level of apolipoprotein a, the major constituent of HDL "good" cholesterol.

My opinion: Long-term statin use usually is appropriate only for people with LDL above 200 mg/dl and total cholesterol above 350 mg/dl who do not respond to natural therapies. Short-term statin use (about one year) may be beneficial after a heart attack to reduce inflammation. In such cases, the question of dosage remains. Best: If it is absolutely necessary to take a statin, use a "start low, go slow" approach. The 10-mg dose may be effective for you—and if not, your doctor can increase it gradually to determine your optimal dose.

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