FRIDAY, April 2 (HealthDay News) -- When the U.S. Food and Drug Administration in February approved the use of the cholesterol-lowering statin drug Crestor for some people with normal cholesterol levels, cardiologist Dr. Steven E. Nissen cheered the decision.
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"You have to go with the scientific evidence," said Nissen, who is chairman of cardiovascular medicine at the Cleveland Clinic. "A clinical trial was done and there was a substantial reduction in morbidity and mortality in people treated with this drug."
But Dr. Mark A. Hlatky, a professor of health research and policy and medicine at Stanford University, has expressed doubts about the FDA move. He worries that more people will rely on a pill rather than diet and exercise to cut their heart risk, and also points to studies linking statins such as Crestor to muscle troubles and even diabetes.
"I haven't seen anything that changes my mind about that," Hlatky said.
So, will millions of healthy Americans soon join the millions of less-than-healthy people who already take these blockbuster drugs?
The FDA's Feb. 9 approval of expanded use of rosuvastatin (Crestor) was based on results of the JUPITER study, which involved more than 18,000 people and was financed by the drug's maker, AstraZeneca. People in the trial who took the drug for an average of 1.9 years had a 44% lower risk of heart attack, stroke and other cardiovascular problems compared to those who took a placebo -- results so outstanding that the trial was cut short. Based on JUPITER, an FDA advisory committee voted 12 to 4 in December to approve widened use of the drug.
The people in the trial included men over 50 and women over 60 with normal or near-normal cholesterol levels. However, these individuals did have high levels of C-reactive protein, a marker of inflammation that has also been linked to cardiovascular problems. They also had at least one other heart risk factor, such as obesity or high blood pressure.
For that specific group, Crestor makes sense, Nissen said. "Over a five-year period of time, you prevent one death or minor stroke for every 25 people treated," he noted.
Whether or not others with normal cholesterol should take Crestor or another statin remains unclear. "Not everyone with normal cholesterol should be treated," Nissen said. "You should give it to people with a high enough risk."
And he added that the results applied only to Crestor. Other popular statins include Lipitor, Pravachol and Zocor, as well as some generic versions.
Those statins might not produce the same benefits, Nissen said. "Statins differ from each other in terms of potency," Nissen said. Crestor, which is available only in a more expensive brand-name form, is toward the top of the list in terms of potency, he noted, while generic drugs such as simvastatin (Zocor) and pravastatin (Pravachol) have much less powerful effects.
"For patients who need a lot of cholesterol reduction, I use the most powerful drug," Nissen said. "If I can get a patient there with a generic drug, of course I use a generic drug."
But Hlatky has his doubts about the advisability of widening statins' reach. He said he's reluctant to have people at cardiovascular risk pop a pill rather than change the lifestyle factors that put them in trouble in the first place.
"My view has always been that you start with the basics and do the simple things first before you go to drugs," Hlatky said. "Lots of people are not doing the sensible things. They're not eating the right diet, they're not exercising, they're still smoking. Most of the people in the JUPITER trial were smack in the middle of that group."
So Hlatky says he might still prescribe a statin for someone in that group, "but I would have an informed conversation about the long-term risks and benefits and what you need to do to reduce the risks."
"It is so much easier to prescribe a drug than to change behavior, and that is my worry," Hlatky said. "We're heading down that road. Cardiovascular risk prevention is moving in the wrong direction."
He's also worried about exposing more people to the rare but still possible side effects that come with statins. The drugs can cause myalgia -- severe muscle pain -- and a recent study published in the British journal The Lancet found a 9% increase in diabetes incidence among people taking statins.
But Nissen believes the benefits of expanded use of Crestor outweigh possible risks. The study that found an increased incidence of diabetes did not find that it was accompanied by any increase in cardiovascular problems and deaths, he noted.
"The is one example where the FDA got it exactly right," Nissen said.
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SOURCES: Steven E. Nissen, M.D., chairman, cardiovascular medicine, Cleveland Clinic, Cleveland; Mark A. Hlatky, M.D., professor, health research policy and medicine, Stanford University, Stanford, Calif.