|[Part 1, Part 2, Part 3]|
BySally Fallon and Mary G. Enig, PhD
Originallyprinted at WestonA. Price
Honolulu Hearth Program (2001)
This report, part of an ongoing study, looked at cholesterol loweringin the elderly. Researchers compared changes in cholesterol concentrationsover 20 years with all-cause mortality.34 To quote:
"Our data accords with previous findings of increased mortalityin elderly people with low serum cholesterol, and show that long-termpersistence of low cholesterol concentration actually increasesrisk of death. Thus, the earlier that patients start to have lowercholesterol concentrations, the greater the risk of death ...The most striking findings were related to changes in cholesterolbetween examination three (1971-74) and examination four (1991-93).
There are few studies that have cholesterol concentrations fromthe same patients at both middle age and old age. Although ourresults lend support to previous findings that low serum cholesterolimparts a poor outlook when compared with higher concentrationsof cholesterol in elderly people, our data also suggest that thoseindividuals with a low serum cholesterol maintained over a 20-yearperiod will have the worst outlook for all-cause mortality [emphasisours]."
The MIRACL study looked at the effects of a high dose of Lipitoron 3,086 patients in the hospital after angina or nonfatal MI andfollowed them for 16 weeks.35 According to the abstract: "Forpatients with acute coronary syndrome, lipid-lowering therapy withatorvastatin, 80 mg/day, reduced recurrent ischemic events in thefirst 16 weeks, mostly recurrent symptomatic ischemia requiringrehospitalization." What the abstract did not mention was thatthere was no change in death rate compared to controls and no significantchange in re-infarction rate or need for resuscitation from cardiacarrest. The only change was a significant drop in chest pain requiringrehospitalization.
ALLHAT (Antihypertensive and Lipid-Lowering Treatment to PreventHeart Attack Trial), the largest North American cholesterol-loweringtrial ever and the largest trial in the world using Lipitor, showedmortality of the treatment group and controls after three or sixyears was identical.36
Researchers used data from more than 10,000 participants and followedthem over a period of four years, comparing the use of a statindrug to "usual care," namely maintaining proper body weight,no smoking, regular exercise, etc., in treating subjects with moderatelyhigh levels of LDL cholesterol. Of the 5170 subjects in the groupthat received statin drugs, 28 percent lowered their LDL cholesterolsignificantly. And of the 5,185 usual-care subjects, about 11 percenthad a similar drop in LDL. But both groups showed the same ratesof death, heart attack and heart disease.
Heart Protection Study (2002)
Carried out at Oxford University,37 this study received widespreadpress coverage; researchers claimed "massive benefits"from cholesterol-lowering,38 leading one commentator to predictthat statin drugs were "the new aspirin."39 But as Dr.Ravnskov points out,40 the benefits were far from massive. Thosewho took simvastatin had an 87.1 percent survival rate after fiveyears compared to an 85.4 percent survival rate for the controlsand these results were independent of the amount of cholesterollowering. The authors of the Heart Protection Study never publishedcumulative mortality data, even though they received many requeststo do so and even though they received funding and carried out astudy to look at cumulative data.
According to the authors, providing year-by-year mortality datawould be an "inappropriate" way of publishing their studyresults.41
PROSPER (Prospective Study of Pravastatin in the Elderly at Risk)studied the effect of pravastatin compared to placebo in two olderpopulations of patients of which 56 percent were primary preventioncases (no past or symptomatic cardiovascular disease) and 44 percentwere secondary prevention cases (past or symptomatic cardiovasculardisease).42
Pravastatin did not reduce total myocardial infarction or totalstroke in the primary prevention population but did so in the secondary.However, measures of overall health impact in the combined populations,total mortality and total serious adverse events were unchangedby pravastatin as compared to the placebo and those in the treatmentgroup had increased cancer. In other words: not one life saved.
Japanese Lipid Intervention Trial was a six-year study of 47,294patients treated with the same dose of simvastatin.43 Patients weregrouped by the amount of cholesterol lowering. Some patient hadno reduction in LDL levels, some had a moderate fall in LDL andsome had very large LDL reductions. The results: no correlationbetween the amount of LDL lowering and death rate at five years.Those with LDL cholesterol lower than 80 had a death rate of justover 3.5 at five years; those whose LDL was over 200 had a deathrate of just over 3.5 at five years.
In a meta-analysis of 44 trials involving almost 10,000 patients,the death rate was identical at 1 percent of patients in each ofthe three groups--those taking atorvastatin (Lipitor), those takingother statins and those taking nothing.44 Furthermore, 65 percentof those on treatment versus 45 percent of the controls experiencedan adverse event. Researchers claimed that the incidence of adverseeffects was the same in all three groups, but 3 percent of the atorvastatin-treatedpatients and 4 percent of those receiving other statins withdrewdue to treatment-associated adverse events, compared with 1 percentof patients on the placebo.
Statins and Plaque (2003)
A study published in the American Journal of Cardiology casts seriousdoubts on the commonly held belief that lowering your LDL-cholesterol,the so-called bad cholesterol, is the most effective way to reducedarterial plaque.45 Researchers at Beth Israel Medical Center inNew York City examined the coronary plaque buildup in 182 subjectswho took statin drugs to lower cholesterol levels. One group ofsubjects used the drug aggressively (more than 80 mg per day) whilethe balance of the subjects took less than 80 mg per day.
Using electron beam tomography, the researchers measured plaquein all of the subjects before and after a study period of more thanone year. The subjects were generally successful in lowering theircholesterol, but in the end there was no statistical differencein the two groups in the progression of arterial calcified plaque.On average, subjects in both groups showed a 9.2 percent increasein plaque buildup.
Statins and Women (2003)
No study has shown a significant reduction in mortality in womentreated with statins. The University of British Columbia TherapeuticsInitiative came to the same conclusion, with the finding that statinsoffer no benefit to women for prevention of heart disease.46 Yetin February 2004, Circulation published an article in which morethan 20 organizations endorsed cardiovascular disease preventionguidelines for women with several mentions of "preferably astatin."47
ASCOT-LLA (Anglo-Scandinavian Cardiac Outcomes Trial -- Lipid LoweringArm) was designed to assess the benefits of atorvastatin (Lipitor)versus a placebo in patients who had high blood pressure with averageor lower-than-average cholesterol concentrations and at least threeother cardiovascular risk factors.48 The trial was originally plannedfor five years but was stopped after a median follow-up of 3.3 yearsbecause of a significant reduction in cardiac events. Lipitor didreduce total myocardial infarction and total stroke; however, totalmortality was not significantly reduced. In fact, women were worseoff with treatment. The trial report stated that total serious adverseevents "did not differ between patients assigned atorvastatinor placebo," but did not supply the actual numbers of seriousevents.
Cholesterol Levels in Dialysis Patients(2004)
In a study of dialysis patients, those with higher cholesterollevels had lower mortality than those with low cholesterol.49 Yetthe authors claimed that the "inverse association of totalcholesterol level with mortality in dialysis patients is likelydue to the cholesterol-lowering effect of systemic inflammationand malnutrition, not to a protective effect of high cholesterolconcentrations." Keeping an eye on further funding opportunities,the authors concluded: "These findings support treatment ofhypercholesterolemia in this population."
Stay tuned for Part IV in the next issue of the newsletter.
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