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 Re: Statins could reduce the risk of heart attacks and strokes for everyone (Re: Mohamed Omer)
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Central City woman part of Crestor trials
By Harold Reutter
The Grand Island Independent
Posted Nov 16, 2008 @ 12:06 AM
GRAND ISLAND — The JUPITER trial made medical headlines on Nov. 9 when it was reported that the medical program was being ended early because the results were so positive
The report said that even people with low cholesterol dramatically lowered their chances of dying or have a heart attack if they took rosuvastatin, which is sold under the brand name Crestor, according to The Associated Press
While the results were announced to an American Heart Association conference in New Orleans on Nov. 9, Evelyn Robinson of Central City knew eight months ago that a medical trial had gone so well that it was being ended early
That's because Robinson was one of the thousands of people in 26 countries who were part of the trial, which was nicknamed JUPITER for Justification for the Use of Statins in Primary Prevention: Intervention Trial Evaluating Rosuvastatin
Robinson said her physician is Dr. David Colan of Grand Island. She said Colan's office contacted her more than two years ago to see whether she was interested in participating in the drug trial
Robinson said the medical office then sent her written information to review before she made a final decision on whether to participate
She said she normally only visits Colan's office for an annual checkup or whenever she's ill.
As part of the trial, she made more frequent trips between Central City and Grand Island to have blood samples drawn
Whenever she had blood drawn before entering the trial, Robinson said, she usually had one vial drawn by a phlebotomist. During the drug trial, that increased to three vials of blood. But she said that never caused her discomfort or concern
"They did a good job of vampiring me," she joked
Robinson said she was willing to enter the trial because she viewed the blood tests as a good way to have her health monitored at no expense. She also hoped the trial might help people with medical problems
The Associated Press reported that more than 17,800 people in the United States and 25 other countries participated in the trial.
Forty percent of the participants were women, which was significant because many previous statin studies have included few women, the AP story said. One-fourth of trial participants were black or Hispanic
AP also reported the following information:
Trial guidelines mandated that men had to be 50 or older, with women in the study needing to be 60 or older
Participants also were supposed to have low LDL cholesterol, below 130, and a high level of C-reactive protein or CRP
The study was undertaken because half of all heart attacks occur in people with normal or low cholesterol
As a result, medical researchers wanted to see whether high CRP levels might be a risk factor in causing heart attacks. CRP is a measure of inflammation
Participants in the drug trial received either a placebo or Crestor. Neither participants nor their doctors knew who was taking what
The study was originally supposed to run five years, but it was ended after 1.9 years because of the positive results
AP reported that "Crestor reduced a combined measure -- heart attacks, strokes, heart-related deaths or hospitalizations, or the need for artery-opening surgery -- by 44 percent."
Dr. Paul Ridker of Harvard-affiliate Brigham and Women's Hospital in Boston led the study. Ridker reported that the study revealed that heart attack risk was reduced by 54 percent, stroke by 48 percent, and the chance of needing bypass surgery or angioplasty by 46 percent
Those were the results that caused the trial to be ended early
But as with all medical studies, the results come with caveats, which The Associated Press also listed
Ridker is a co-inventor of the patent of the test for high CRP levels. Also, British-based AstraZeneca PLC, the maker of Crestor, paid for the study. Ridker and other authors of the study have consulted for AstraZeneca, as well as other statin makers
Study results were published in the New England Journal of Medicine
AP also reported a number of other caveats or cautions. It said more people in the Crestor group saw blood-sugar levels rise or were newly diagnosed with diabetes
The story also quoted Dr. Sidney Wolfe, who has campaigned against Crestor in the past, as saying Crestor has the highest rate among statins of a rare, but serious, muscle problem
Saying the good benefits are unlikely to accrue specifically to Crestor, Wolfe raised the question of whether there are safer and less expensive ways to get the same benefits. AP reported that Crestor costs $3.45 per day versus less than $1 per day for generic statins
AP reported that if 7.4 million people -- the estimated number of Americans with normal or low cholesterol but high levels of CRP -- took Crestor, it would cost $9 billion per year to prevent about 30,000 heart attacks, strokes or deaths
AP quoted Dr. Thomas Pearson of the University of Rochester School of Medicine and Dentistry as saying that is a high price tag, unless a person comes from a family with a history of heart disease or other heart disease risk factors
AP said researchers did not know whether the benefits seen in the study are because of reduced CRP levels or lower cholesterol, because Crestor did both things
Nevertheless, AP quoted Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute, as saying that the JUPITER trial, as well as two other government-sponsored studies, "provide the strongest evidence to date" for testing CRP levels and adding it to traditional risk measures
For her part, Robinson was not aware of all the debate caused by the study. But she said she was happy to be part of a study that might help others
"I told Peggy (Klein, a nurse at Internal Medical Associates in Grand Island) that I would be in another study," she said
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Mohamed Omer
فيس بوك
تويتر
انستقرام
يوتيوب
بنتيريست