Use Of Cholesterol Drugs By Patients Without High Cholesterol Level
20/11/2013 10:01
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 tranquillizer Crestor for some ladies and gentlemen with rational cholesterol levels, cardiologist Dr Steven E Nissen cheered the decision. "You have to go with the methodical evidence," said Nissen, who is chairman of cardiovascular panacea at the Cleveland Clinic. "A clinical trial was done and there was a substantial reduction in morbidity and mortality in relatives treated with this drug".
But Dr Mark A Hlatky, a professor of constitution research and policy and medicine at Stanford University, has expressed doubts about the FDA move. He worries that more clan 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 wish about that," Hlatky said.
So, will millions of wholesome Americans soon join the millions of less-than-healthy community who already take these blockbuster drugs? The FDA's Feb 9 agreement of expanded use of rosuvastatin (Crestor) was based on results of the JUPITER study, which involved more than 18000 males and females 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 percent condescend risk of heart attack, stroke and other cardiovascular problems compared to those who took a placebo - results so smashing that the trial was cut short. Based on JUPITER, an FDA prediction committee voted 12 to 4 in December to approve widened use of the drug.
The tribe in the trial included men over 50 and women over 60 with normal or near-normal cholesterol levels. However, these individuals did have grave levels of C-reactive protein, a marker of infection that has also been linked to cardiovascular problems. They also had at least one other heart risk factor, such as obesity or elated blood pressure.
For that specific group, Crestor makes sense, Nissen said. "Over a five-year stretch of time, you prevent one death or minor stroke for every 25 people treated," he noted. Whether or not others with well-adjusted cholesterol should take Crestor or another statin remains unclear. "Not all with normal cholesterol should be treated," Nissen said. "You should give it to people with a exhilarated 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 provide the same benefits, Nissen said. "Statins quarrel from each other in terms of potency," Nissen said. Crestor, which is available only in a more expensive brand-name form, is toward the zenith of the list in terms of potency, he noted, while generic drugs such as simvastatin (Zocor) and pravastatin (Pravachol) have much less authoritative effects.
"For patients who need a lot of cholesterol reduction, I use the most stalwart 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 loath to have individuals at cardiovascular risk pop a pill rather than change the lifestyle factors that put them in skin in the first place.
"My view has always been that you start with the basics and do the simple things essential before you go to drugs," Hlatky said. "Lots of people are not doing the sensible things. They're not eating the front diet, they're not exercising, they're still smoking. Most of the people in the JUPITER trial were smack in the halfway of that group".
So Hlatky says he might still prescribe a statin for someone in that group, "but I would have an in the know conversation about the long-term risks and benefits and what you need to do to reduce the risks. It is so much easier to specify a drug than to change behavior, and that is my worry," Hlatky said. "We're heading down that road. Cardiovascular endanger prevention is moving in the wrong direction".
He's also worried about exposing more people to the choice but still possible side effects that come with statins. The drugs can cause myalgia - severe muscle misery - 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 surpass possible risks. The study that found an increased number of diabetes did not find that it was accompanied by any increase in cardiovascular problems and deaths, he noted try vimax. "The is one criterion where the FDA got it exactly right," Nissen said.
When the US Food and Drug Administration in February 2010 approved the use of the cholesterol-lowering statin tranquillizer Crestor for some ladies and gentlemen with rational cholesterol levels, cardiologist Dr Steven E Nissen cheered the decision. "You have to go with the methodical evidence," said Nissen, who is chairman of cardiovascular panacea at the Cleveland Clinic. "A clinical trial was done and there was a substantial reduction in morbidity and mortality in relatives treated with this drug".
But Dr Mark A Hlatky, a professor of constitution research and policy and medicine at Stanford University, has expressed doubts about the FDA move. He worries that more clan 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 wish about that," Hlatky said.
So, will millions of wholesome Americans soon join the millions of less-than-healthy community who already take these blockbuster drugs? The FDA's Feb 9 agreement of expanded use of rosuvastatin (Crestor) was based on results of the JUPITER study, which involved more than 18000 males and females 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 percent condescend risk of heart attack, stroke and other cardiovascular problems compared to those who took a placebo - results so smashing that the trial was cut short. Based on JUPITER, an FDA prediction committee voted 12 to 4 in December to approve widened use of the drug.
The tribe in the trial included men over 50 and women over 60 with normal or near-normal cholesterol levels. However, these individuals did have grave levels of C-reactive protein, a marker of infection that has also been linked to cardiovascular problems. They also had at least one other heart risk factor, such as obesity or elated blood pressure.
For that specific group, Crestor makes sense, Nissen said. "Over a five-year stretch of time, you prevent one death or minor stroke for every 25 people treated," he noted. Whether or not others with well-adjusted cholesterol should take Crestor or another statin remains unclear. "Not all with normal cholesterol should be treated," Nissen said. "You should give it to people with a exhilarated 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 provide the same benefits, Nissen said. "Statins quarrel from each other in terms of potency," Nissen said. Crestor, which is available only in a more expensive brand-name form, is toward the zenith of the list in terms of potency, he noted, while generic drugs such as simvastatin (Zocor) and pravastatin (Pravachol) have much less authoritative effects.
"For patients who need a lot of cholesterol reduction, I use the most stalwart 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 loath to have individuals at cardiovascular risk pop a pill rather than change the lifestyle factors that put them in skin in the first place.
"My view has always been that you start with the basics and do the simple things essential before you go to drugs," Hlatky said. "Lots of people are not doing the sensible things. They're not eating the front diet, they're not exercising, they're still smoking. Most of the people in the JUPITER trial were smack in the halfway of that group".
So Hlatky says he might still prescribe a statin for someone in that group, "but I would have an in the know conversation about the long-term risks and benefits and what you need to do to reduce the risks. It is so much easier to specify a drug than to change behavior, and that is my worry," Hlatky said. "We're heading down that road. Cardiovascular endanger prevention is moving in the wrong direction".
He's also worried about exposing more people to the choice but still possible side effects that come with statins. The drugs can cause myalgia - severe muscle misery - 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 surpass possible risks. The study that found an increased number of diabetes did not find that it was accompanied by any increase in cardiovascular problems and deaths, he noted try vimax. "The is one criterion where the FDA got it exactly right," Nissen said.