Don’t let the left hand know what right is doing – Joe Tex
On February 28, 2012, the FDA announced a warning that all statin drugs – the best known are Lipitor and Crestor – could raise blood sugar, aggravate Type II diabetes, and create cognitive impairment. Two FDA doctors issued contradictory statements about this warning. Mary Parks, M.D. authored the warning to apply to all drugs in the class. Amy Egan, M.D. was interviewed for Medscape, and stated that different statins had different levels of risk. Her interview reflected the data that pravastatin, which has been in use since 1988 (and is now generic which is why you don’t see it advertised), is significantly safer than its more famous peers.
Politics and medicine have always made uncomfortable bedfellows. Think of C. Everett Koop, MD arguing with the Reagan administration about the existence of the HIV/AIDS epidemic. The science of lowering cholesterol is straightforward. Cholesterol, and its sub-fractions, are factors in reducing heart disease, but only in about one third of heart disease cases. The statin drugs reduce LDL, but in the long run, their anti-inflammatory effects may be more important. The politics is also straightforward – Lipitor and Crestor are multi-billion dollar drugs, and have been accorded kid-glove treatment when it comes to reporting of side effects. Political observers don’t think it is entirely coincidental that Lipitor’s side effects have become more public as it loses its patent protection and earning potential. The London School of Tropical Hygiene reported on statin side effects ten years ago (10% patient drop out in year one, 20% drop out in year two), but the FDA somehow maintained a tin ear.
So while all the statins can have the same side-effects, pravastatin has always had the fewest. Pravastatin has better pharmacokinetics than other statins. Pravastatin is water soluble, and is excreted through the kidneys quickly. Fat soluble drugs penetrate muscle and brain to a much greater degree, and stay in the body much longer, which can lead to somewhat lower cholesterols, but unfortunately greater side effects. Pravastatin, being rapidly excreted from the body, allows the cholesterol enzyme system time to recover. Lipitor is fat-soluble and is associated with a higher incidence of muscle pain and cognitive dysfunction. Crestor, though water soluble, has a half-life of almost a day, so the cholesterol enzyme system has no chance to recover, and has the higher incidence of diabetic dysfunction.
More important, pravastatin is an effective drug. In the West of Scotland Coronary Prevention Study (WOSCOPS, NEJM, 1991), pravastatin was compared against all existing therapies and shown to be the only one with significant benefit. Followed up 10 years after the study ended, the pravastatin group had a 24%, decreased risk of death from coronary disease and a decreased rate of death from all causes excluding coronary disease. 30% of patients taking pravastatin had reductions in blood sugar and hemoglobin A-1 C as well. In comparison, in the JUPITER trial (Justification for the Use of Statins In Primary prevention Intervention Trial), patients taking Crestor had a 0.59% advantage in coronary survival – when total mortality was added in ( 31 more people in the Crestor group died from other causes), the resulting is zero net benefit, and 20% of patients had blood sugar elevations. In epidemiologic circles, we don’t get excited about drugs that don’t change death rates. In comparison to the other drugs in the class, pravastatin had the lowest incidence of muscle pain.
One should take this FDA warning with a large grain of salt. The underlying problem in atherosclerosis is inflammation of the artery wall. With Integrative medicine, we seek to decrease is inflammation through application of all interventions that have scientific backing. Diet, exercise, pharmaceuticals, vitamins, and supplements allow us to attack the cycle of inflammation at multiple points. Small doses of Omega-3 fish oil, cold milled flaxseed, aspirin, low carbohydrate diets, Vitamin D and niacin, when used with small doses of pravastatin, create an anti-inflammatory environment that protects artery walls as well as other organs.
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fish oil. I subscribe to a service called Consumer Lab, which tests vitamins, supplements and herbs for purity and potency. They have not found any traces of mercury or heavy metals in fish oil for years. Chia is good source of Omega oil and fiber, but fish oil and flax seed are still my preference for nutritional supplementation. Should contrary data appear, I’ll be certain to add it to my letters.