Use Of Cholesterol Drugs By Patients Without High Cholesterol Level.
When the US Food and Drug Administration in February 2010 approved the use of the cholesterol-lowering statin remedy Crestor for some populace with regular cholesterol levels, cardiologist Dr Steven E Nissen cheered the decision. "You have to go with the ordered evidence," said Nissen, who is chairman of cardiovascular pharmaceutical at the Cleveland Clinic. "A clinical trial was done and there was a substantial reduction in morbidity and mortality in clan treated with this drug".
But Dr Mark A Hlatky, a professor of condition research and policy and medicine at Stanford University, has expressed doubts about the FDA move. He worries that more citizenry 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 take offence at about that".
So, will millions of fine fettle Americans soon join the millions of less-than-healthy society 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 affected more than 18000 people and was financed by the drug's maker, AstraZeneca. People in the distress who took the drug for an average of 1,9 years had a 44 percent further risk of heart attack, stroke and other cardiovascular problems compared to those who took a placebo - results so choice that the trial was cut short. Based on JUPITER, an FDA warning committee voted 12 to 4 in December to approve widened use of the drug.
The ancestors in the trial included men over 50 and women over 60 with normal or near-normal cholesterol levels. However, these individuals did have exorbitant levels of C-reactive protein, a marker of inflammation that has also been linked to cardiovascular problems. They also had at least one other nerve risk factor, such as obesity or high blood pressure.
For that definite group, Crestor makes sense. "Over a five-year period of time, you abort one death or minor stroke for every 25 people treated". Whether or not others with normal cholesterol should fasten on Crestor or another statin remains unclear. "Not everyone with normal cholesterol should be treated. You should give it to multitude with a high enough risk".
And he added that the results applied only to Crestor. Other average statins include Lipitor, Pravachol and Zocor, as well as some generic versions. Those statins might not assemble the same benefits. "Statins differ from each other in terms of potency". Crestor, which is available only in a more expensive brand-name form, is toward the vertex of the list in terms of potency while generic drugs such as simvastatin (Zocor) and pravastatin (Pravachol) have much less high effects.
"For patients who need a lot of cholesterol reduction, I use the most powerful drug. If I can get a perseverant 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 indisposed to have commonality at cardiovascular risk pop a pill rather than change the lifestyle factors that put them in trouble in the first place.
"My cityscape has always been that you start with the basics and do the simple things first before you go to drugs. Lots of people are not doing the cognizable things. They're not eating the right diet, they're not exercising, they're still smoking. Most of the plebeians 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 knowledgeable conversation about the long-term risks and benefits and what you distress to do to reduce the risks. It is so much easier to prescribe a drug than to change behavior, and that is my worry. We're heading down that road. Cardiovascular jeopardize prevention is moving in the wrong direction".
He's also worried about exposing more forebears to the rare but still possible side effects that come with statins. The drugs can cause myalgia - fierce muscle pain - and a recent study published in the British journal The Lancet found a 9 percent proliferation in diabetes incidence among people taking statins.
But Nissen believes the benefits of expanded use of Crestor preponderate possible risks. The study that found an increased extent of diabetes did not find that it was accompanied by any increase in cardiovascular problems and deaths revitol. "The is one case where the FDA got it exactly right".
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