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 antidepressant Crestor for some rank and file with natural cholesterol levels, cardiologist Dr Steven E Nissen cheered the decision. "You have to go with the precise evidence," said Nissen, who is chairman of cardiovascular pharmaceutical at the Cleveland Clinic prescription. "A clinical plague was done and there was a great reduction in morbidity and mortality in settle treated with this drug".
But Dr Mark A Hlatky, a professor of salubriousness inquire into and policy and medicine at Stanford University, has expressed doubts about the FDA move. He worries that more kith and kin will rely on a drag 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 opinion about that".
So, will millions of fit Americans soon participate with the millions of less-than-healthy mobile vulgus who already take these blockbuster drugs? The FDA's Feb 9 acceptance of expanded use of rosuvastatin (Crestor) was based on results of the JUPITER study, which confusing more than 18000 people and was financed by the drug's maker, AstraZeneca. People in the side who took the drug for an run-of-the-mill of 1,9 years had a 44 percent lower risk of guts attack, stroke and other cardiovascular problems compared to those who took a placebo - results so receivable that the trial was cut short. Based on JUPITER, an FDA consultive committee voted 12 to 4 in December to second widened use of the drug.
The kinsmen in the trial included men over 50 and women over 60 with rational or near-normal cholesterol levels. However, these individuals did have high levels of C-reactive protein, a marker of infection that has also been linked to cardiovascular problems. They also had at least one other core risk factor, such as embonpoint or high blood pressure.
For that specific group, Crestor makes sense. "Over a five-year years of time, you avoid one death or minor stroke for every 25 people treated". Whether or not others with well-adjusted cholesterol should take Crestor or another statin remains unclear. "Not person with normal cholesterol should be treated. You should give it to bodies with a high enough risk".
And he added that the results applied only to Crestor. Other stylish statins include Lipitor, Pravachol and Zocor, as well as some generic versions. Those statins might not reveal the same benefits. "Statins be dissimilar from each other in terms of potency". Crestor, which is accessible only in a more expensive brand-name form, is toward the top of the list in terms of potency while generic drugs such as simvastatin (Zocor) and pravastatin (Pravachol) have much less energetic effects.
"For patients who constraint a lot of cholesterol reduction, I use the most effectual drug. If I can get a patient there with a generic drug, of orbit I use a generic drug". But Hlatky has his doubts about the advisability of widening statins' reach. He said he's careful to have public at cardiovascular risk pop a remedy rather than change the lifestyle factors that put them in trouble in the first place.
"My sentiment has always been that you start with the basics and do the simple things first before you go to drugs. Lots of persons are not doing the sensible things. They're not eating the make up for diet, they're not exercising, they're still smoking. Most of the the crowd in the JUPITER trial were smack in the middle of that group".
So Hlatky says he might still require a statin for someone in that group, "but I would have an versed conversation about the long-term risks and benefits and what you essential to do to reduce the risks. It is so much easier to prescribe a drug than to variety 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 individuals to the rare but still possible side effects that come with statins. The drugs can cause myalgia - primitive muscle pain - and a fresh study published in the British journal The Lancet found a 9 percent spread in diabetes incidence to each people taking statins.
But Nissen believes the benefits of expanded use of Crestor tip the scales possible risks. The study that found an increased amount of diabetes did not find that it was accompanied by any increase in cardiovascular problems and deaths worldplusmed.net. "The is one benchmark where the FDA got it exactly right".
No comments:
Post a Comment