By Dennis Thompson
People 65 and older treated with pravastatin (Pravachol) as part of a major clinical trial had about the same risk of death as people in a placebo group, according to the results. They also appeared to suffer strokes and heart attacks at about the same rate.
"Our study shows there may not be any benefit for taking a statin therapy for primary prevention for people who are over the age of 65," said Dr. Benjamin Han.
Statins might even pose a risk to people 75 and older, added Han, an assistant professor of medicine and population health at New York University School of Medicine.
"There was some suggestion the statin group had a little bit higher mortality than the placebo group" at that age, Han said. But, this result was not statistically significant, he noted.
Experts from the American Heart Association and Mount Sinai Hospital in New York City urged doctors and patients to take these findings with a grain of salt.
"The only merit to the study is that it raises questions that haven't been adequately answered," said Dr. Robert Eckel, an AHA spokesman. "This is not the kind of evidence that should influence guidelines about statin therapy in adults 65 and older," said Eckel, chair of atherosclerosis at the University of Colorado School of Medicine.
For the study, Han and his colleagues analyzed data from a clinical trial conducted from 1994 to 2002, called the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT).
Most statin studies have focused on middle-aged people, so there's little known about the effect of these medications on seniors, Han said.
With an aging population, the question keeps coming up, "Should you be on a statin medication even if you don't have a history of cardiovascular disease?" Han said. "Will this help you in the long run?"
From the antihypertensive trial data, the researchers drew a sample that included almost 3,000 adults 65 and older with high blood pressure, but no plaque buildup in the arteries that would occur due to high cholesterol.
About half of those adults took pravastatin while half received usual care.
The researchers found no health benefit from pravastatin in these older patients. In fact, more deaths occurred in the pravastatin group than in the usual care group -- 141 versus 130 among adults 65 to 74, and 92 versus 65 among adults 75 and older.
The side effects of statins, which include muscle pains and fatigue, might weigh more heavily on older people, Han said.
"Anything that can affect their physical function, anything that can affect their ability to do activities on a daily basis, puts them at a higher risk for further decline and a higher risk for mortality," Han said.
Dr. Robert Rosenson is director of cardiometabolic disorders at the Icahn School of Medicine at Mount Sinai. He said the new study is flawed because its conclusions rely on data from a very small number of patients. For example, the analysis of people 75 and older included only 375 people taking pravastatin and 351 in the control group.
"That's such a small number to detect difference in events, let alone mortality when you're dealing with a low-potency statin," Rosenson said.
Because of this, the effects noted in the study often aren't backed up by the statistics, he said.
"From a fundamental statistical standpoint, I think they're far overstating their conclusion," Rosenson said.
Rosenson also criticized the research team for choosing the ALLHAT-LLT clinical trial as source of their data.
"If you wanted to make the point that statins don't help older people and may harm them, then that would be the study you would pick to show that the hypothesis is going to fail," Rosenson said.
Eckel said he is "somewhat underwhelmed" by the study.
"There are so many limitations to this paper, and the authors, to their credit, list most if not all of them," Eckel said.
The U.S. National Institutes of Health funded the study. The results were published May 22 in JAMA Internal Medicine.