Q:Everyday, I read in the paper about how cholesterol lowering drugs have now definitely been shown to save lives. My doctor is pressing me to take pravastatin because my cholesterol is slightly elevated, based on new medical evidence, he says. Is it

As you may know, in 1994, the Scandinavian Simvastatin Survival Study appeared to vindicate cholesterol lowering drugs, at least among those with a heart condition and high cholesterol levels. After five and a half years, the group given cholesterol drugs had a 42 per cent lower rate of fatal heart attacks and a one third reduction in heart disease over those given the placebo (The Lancet, 1994; 344: 1383-9).

Hard at the heels of the 4S study was the West of Scotland Coronary Prevention Study (WOSCOPS), which claimed to show that with healthy men who had high levels of cholesterol but no history of heart disease, pravastatin, another “statin” cholesterol lowering drug, could prevent heart attacks by a third (New Engl J Med, 1995; 333: 1301-7).

Other studies, including one reviewing a number of studies together, concluded that pravastatin could reduce the rate of heart attacks by at least 60 per cent and slow hardening of the arteries (Circulation, 1995; 92: 2419-25; also J Am Coll Cardiol, 1995: 26: 1133-9).

Although there were many important differences between the trials, the effect on the rank and file in medicine was galvanic. The WOSCOP study was widely interpreted to mean that otherwise healthy men with high cholesterol levels could take cholesterol drugs and reduce their chances of dying by nearly a third. All patients with higher cholesterol levels, of whatever age or sex, were being placed on cholesterol lowering drugs for life (The Lancet, 1996; 347; 1267-8).

One hospital in Dundee, which maintained statistics about the level of cholesterol drug prescribing before and after the publications of the 4S study, found a striking increase both in the percentage of patients whose cholesterol was being measured (by a third) and in the percentage of patients being prescribed drugs (by nearly eight times) (The Lancet, 1996; 347: 551-2).

Many of those receiving the drugs were elderly or female, even though the drugs hadn’t really been studied in either category of patient. In fact, though the 4S study showed limited benefit of cholesterol drugs for women, and women weren’t even included in WOSCOPS, more than half of all cholesterol patients receiving drugs in America now are women (The Lancet, 1996; 347: 1389-90).

In the WOSCOPS study, the deaths from heart disease in the group not taking the drug was higher than in the general population closer to the average deaths in people 10 years older suggesting that those in the control group happened to be more ill than usual. Furthermore, although pravastatin did reduce cholesterol and the number of heart attacks or deaths from heart attacks in the in WOSCOPS, it did not significantly save lives from other coronary disease or any other cause. A review of all the studies with pravastatin also didn’t show that a reduction in heart attacks translated into a significant number of lives being saved. Any improvements in the death rate, other than from heart attacks, were not considered “statistically significant” (Journal Watch, 1995; 15 (24): 190 and 15 (23): 181-2). And even if you tally in the survival statistics from heart attacks, overall survival over five years in the WOSCOPS trial was only increased from 96 to 97 per cent. In the 4S trial, survival over six years was only increased from 87.7 to 91.3 per cent (Drs Nilesh J Samani and David P De Bono, correspondence, New Eng J Med, 1996; 334 (20): 1333-4). In our view, many people with no history of heart attack may be put on cholesterol lowering drugs indefinitely for a extremely minimal gain.

The other problem with a cholesterol drug “prescription for life” is that there is a great deal we still don’t know about this category of drugs. Patients are being counselled to take statins up until the time they die, even though the benefits of these drugs have not been tested in the elderly. In fact other research shows that a higher cholesterol level is less of a risk factor (or possibly even irrelevant) after the age of 55. And of course we don’t know what effect these drugs have on you if you take them over many years.

Dr Thomas Newman of the University of California at San Francisco, who has written extensively on US medical policy concerning cholesterol, has examined epidemiological data suggesting that these drugs are less beneficial to women, the elderly and younger men (in both the big cholesterol studies, the subjects were all middle aged men) (Journal Watch, 1996; 16 (10): 83-4). There may even be slightly increased rate of death among women on cholesterol lowering drugs (New Eng J Med, 1996: 334 (20): 1334).

But in any case, doctors don’t agree about whether women should lower their cholesterol. Earlier evidence has shown that women’s risks of developing a heart condition aren’t lessened even if their cholesterol levels are lowered through diet, and there is no evidence linking high cholesterol levels in women with heart conditions in later life (J Amer Med Association, 1995; 274 (14): 1152-8).

Some researchers also have noted that slightly more people died from all causes in the 4S study. Although this number wasn’t considered significant, we need more study of the drugs to figure out if cholesterol lowering drugs could be responsible for increasing deaths from other causes (The Lancet, 1995, 346: 1440-1).

So far, we do know that a low blood cholesterol concentration can cause hemorrhagic stroke (BMJ, 1994; 308: 373-9).

There are dietary measures which have been shown to reverse heart disease, but they are more complex than those which simply lower fat. To determine whether comprehensive lifestyle changes might affect coronary atherosclerosis, a group of patients embarked on a low fat vegetarian diet, stopped smoking, trained in stress management and engaged in a moderate exercise. They were compared with another group with similar clogged arteries who did not undergo the special lifestyle modifications. After a year, the vegetarian group’s coronary arteries had widened by 3 per cent, while the control group’s had narrowed by 4 per cent. In all, 82 per cent of the experimental group had shown improvement, demonstrating that a comprehensive lifestyle change could reverse even severe coronary atherosclerosis without drugs after only one year (The Lancet, 1990; 336 (8708): 129-33). A more recent study measuring coronary arteries with special CAT scanning showed that disease was halted or reversed in 99 per cent of patients over five years (J Am Med Assoc, 1995; 274: 894-901).

In another study, patients given a cholesterol lowering diet alone also were able to reverse coronary artery disease nearly as much as those given a diet and drugs (The Lancet, March 7, 1992). And women runners were found to have higher levels of high density lipoprotein (HDL-the “good” cholesterol needed by our bodies which appears to protect against heart disease), the more they exercised (New Eng J Med, 1996; 334 (20): 1298-1303). Giving up smoking, which appears to exacerbate the vascular abnormalities of people with high blood cholesterol, is possibly one of the most meaningful lifestyle changes you can make (Circulation, 1996; 93: 1346-53).

Nevertheless, there is some question about which low fat diets are appropriate. Some very low fat diets can change some of the levels of HDL cholesterol or result in low levels of essential fatty acids, which have been associated with an increased risk of heart attack (J Am Med Assoc, 1996; 275 (18): 1402-3).

Even the two heart doctors who performed the vegetarian diet studies disagree over whether patients should be strict vegetarians or have a high or low carbohydrate diet (J Amer Med Assoc, 1996; 275 (18): 1402-3).

Your best best is to follow the diet recommended by Harald Gaier on p 12, which is designed to reverse atherosclerosis of all varieties, and not simply erectile dysfunction.

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Written by What Doctors Don't Tell You

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