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Statin Therapy Cuts Coronary Mortality By 24% in Elderly
‘There is clearly no justification now’ for withholding statins from the elderly.

CHICAGO — Three years of pravastatin reduced coronary deaths by 24% in the first large trial to examine statin therapy's effects specifically in the elderly.

“We believe that PROSPER [the Prospective Study of Pravastatin in the Elderly at Risk trial] is good news for senior citizens. There is clearly no justification now for withholding statin therapy from the elderly,” principal investigator Dr. James Shepherd said at the annual scientific sessions of the American Heart Association.

PROSPER randomized 5,804 Scots, Irish, and Belgians aged 70-82 years to 40 mg/day of pravastatin or placebo for 3.2 years. More than half were women; mean age at baseline was 75 years. It was a high-risk population: half had known vascular disease; the rest were at elevated risk because of diabetes, hypertension, smoking, or other major risk factors.

Pravastatin lowered LDL cholesterol by 34%. The primary study outcome—a composite of coronary death, nonfatal MI, and fatal or nonfatal stroke—occurred in 14.1% of the pravastatin group and in 16.2% of controls, for a 15% reduction in relative risk among statin-treated patients.

This benefit was essentially due to reductions in coronary heart disease death and nonfatal MI, which were cut by 19%. Stroke risk was unaffected, probably because of the relatively short treatment period. Prior statin trials in middle-aged patients have shown stroke prevention, but not until after 5-6 years, noted Dr. Shepherd, professor and head of the department of pathologic biochemistry at the University of Glasgow (Scotland). But transient ischemic attacks were reduced by 25% in PROSPER, he added.

Cognitive function was an eagerly anticipated secondary end point in PROSPER. The participants had to have good cognitive function at baseline, based on a Mini-Mental Status Exam score above 24. The hope was that pravastatin would slow the typical age-related decline in cognitive function, as has been suggested by several nonrandomized observational studies involving middle-aged patients on statins. But pravastatin showed no effect on cognition, just as simvastatin had no impact upon cognitive decline in the earlier 20,536-patient Heart Protection Study.

“It might be better to look at the use of antihypertensives in the elderly to prevent cognitive decline,” Dr. Shepherd said.

Bone mineral density data are still being analyzed by the PROSPER team. Prior studies have suggested that statins may have a salutary effect in this key area.

PROSPER's import lies in the fact that the number of people aged 65 or older will double to 300 million worldwide in the next 30 years. Today in Europe, only 2% of 80-year-olds who would benefit from statin therapy actually receive it, he continued.

New cancer cases were 25% more common in the pravastatin arm. Dr. Shepherd attributed this to chance, since the number of new cases in the first year of PROSPER was the same as in later years.

Abnormal liver function tests occurred no more frequently in the pravastatin arm, nor did drug-drug interactions, even though PROSPER participants were on an average of 3.6 other medications.

Discussant Dr. Stephen P. Fortmann said that based upon PROSPER, physicians would need to treat 30 elderly patients with pravastatin for 5 years in order to prevent a single major end point, a figure that he deemed “quite acceptable.”

He is unsure that PROSPER will change U.S. clinical practice greatly, since he suspects that many physicians have extrapolated from earlier landmark trials in middle-aged patients and are already prescribing statins for the elderly.

As for the increase in cancer, Dr. Fortmann agreed that this finding was probably due to chance, given the “remarkable track record of safety with the statins, one of the best-studied classes of medications that we have.”

“Still, it does bear further watching. After all, this was the first statin trial in this age group,” noted Dr. Fortmann, the C.F. Rehnborg Professor of Preventive Medicine at Stanford (Calif.) University.

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