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Heart Disease
Crestor Statin Controversy: Results of Major Statin Trial are Biased and Flawed
Date: 23/07/10
Almost two years ago, when the results of JUPITER (Justification for the Use of Statins in Primary Prevention) were released singing the praises of cholesterol-lowering statins, the Daily Health was one of the first to call its results into question.
Along with the fact that there are nearly 900 clinical trials citing the adverse side effects of statins, we also questioned the fact that JUPITER was funded by the manufacturers of Crestor (the popular statin drug used in the trial), AstraZeneca...
Two years later and the medical mainstream have finally caught onto our way of thinking...
A bit of background
JUPITER, a two year study, involved 18,000 patients and was designed to see if Crestor reduced heart attacks and strokes in patients with high inflammation in the blood stream, but with low-to-normal cholesterol levels.
The trial ended early when a provisional analysis showed a 44 per cent reduction in the risk factors... The logic probably was that with results that positive, why continue the study?
Back then, the final published results showed that statin (Crestor) use reduced heart attacks by 54 per cent, strokes by 48 per cent and the need for a bypass by 46 per cent, compared with a placebo...
Now, according to an article in the Archives of Internal Medicine, researchers who took a second look at the findings of JUPITER say that the results are flawed.
From the same hymn-sheet
Dr. Michel de Lorgeril, of Joseph Fourier University and the National Centre of Scientific Research in Grenoble, France, argues that there are major discrepancies between the reductions in non-fatal stroke and heart attacks reported by JUPITER and the results of numerous other research trials...
According to de Lorgeril, the JUPITER results are clinically inconsistent and should not be used to change medical practice or clinical guidelines.
Just as we did two years ago, de Lorgeril and his team also question AstraZeneca’s involvement in the trial. In their article, the researchers point out that 9 of the 14 researchers in the JUPITER trial have financial relationships with AstraZeneca...
Dr. de Lorgeril also cited the early termination of JUPITER as one of several methodological problems with the trial.
In many clinical trials, there are pre-specified early stopping points which are clearly described in the trial protocol. However, this was not the case in the published description of JUPITER’s protocol...
This leaves the question: which endpoint was used to define the rules for stopping, or which level of benefits was required to justify early termination?
It also makes one wonder if, along with a vested interest and financial incentives, the JUPITER researchers ran the trial until they had the outcome they were looking for...
To date JUPITER stands alone in its finding of showing a significant benefit of statin use in patients with no history of coronary heart disease (CHD).
Based on their review, Dr. de Lorgeril says that the time has come for a critical reappraisal of cholesterol-lowering statin treatments in the prevention of CHD. He added that the emphasis on statin use for the prevention of CHD takes the attention away from the proven benefits of adopting a healthy lifestyle, including regular physical activity, not smoking, and a Mediterranean-style diet.
Insult to injury
In the same issue of the Archives of Internal Medicine, another article supports Dr. de Lorgeril’s take on the Jupiter findings.
A meta-analysis - reviewing 11 randomized clinical trials to see if statins cut death rates among intermediate and high- risk patients with no history of CHD - found no evidence that statins are associated with a reduced risk of death among those at risk.
The study, involving a total of 65,229 patients, was led by Dr. Kausik Ray of the University of Cambridge. Dr. Ray concluded that due consideration is needed in applying statin therapy in lower-risk primary prevention populations.
However, based on the findings we’d argue that this applies to high-risk patients too!
This, along with the dangerous side effects of statins, like muscle problems, anaemia, sexual dysfunction, pancreas or liver dysfunction, and cataracts, puts a massive question mark over any potential benefits of using.
Heart Disease Related Reading:
Crestor : The Super Strong Statin Drug
Cholesterol: Why the Medical Mainstream Have the Wrong End of the Stick
Cholesterol – Your Doctor’s Advice Could be Damaging Your Health...
Mainstream Medicine Finally Catches on to the Risks of Taking a Daily Aspirin
HOT TOPICS:
Prelox - New Erectile Dysfunction Treatment To Enhance Sex Life
Green Tea May Protect Against Breast Cancer
Prevent Arthritis and Promote Healthy Joints With Omega-3 Fatty Acids
Sources:
Cholesterol-Busting Statins: Study Raises New Concerns, published online 29.06.10, abcnews.go.com
Report Examines Whether Statins Prevent Death in High-Risk Individuals Without Heart Disease, published online 04.07.10, sciencedaily.com
Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy, published 28.06.2010, Arch Intern Med
Back to topAlong with the fact that there are nearly 900 clinical trials citing the adverse side effects of statins, we also questioned the fact that JUPITER was funded by the manufacturers of Crestor (the popular statin drug used in the trial), AstraZeneca...
Two years later and the medical mainstream have finally caught onto our way of thinking...
A bit of background
JUPITER, a two year study, involved 18,000 patients and was designed to see if Crestor reduced heart attacks and strokes in patients with high inflammation in the blood stream, but with low-to-normal cholesterol levels.
The trial ended early when a provisional analysis showed a 44 per cent reduction in the risk factors... The logic probably was that with results that positive, why continue the study?
Back then, the final published results showed that statin (Crestor) use reduced heart attacks by 54 per cent, strokes by 48 per cent and the need for a bypass by 46 per cent, compared with a placebo...
Now, according to an article in the Archives of Internal Medicine, researchers who took a second look at the findings of JUPITER say that the results are flawed.
From the same hymn-sheet
Dr. Michel de Lorgeril, of Joseph Fourier University and the National Centre of Scientific Research in Grenoble, France, argues that there are major discrepancies between the reductions in non-fatal stroke and heart attacks reported by JUPITER and the results of numerous other research trials...
According to de Lorgeril, the JUPITER results are clinically inconsistent and should not be used to change medical practice or clinical guidelines.
Just as we did two years ago, de Lorgeril and his team also question AstraZeneca’s involvement in the trial. In their article, the researchers point out that 9 of the 14 researchers in the JUPITER trial have financial relationships with AstraZeneca...
Dr. de Lorgeril also cited the early termination of JUPITER as one of several methodological problems with the trial.
In many clinical trials, there are pre-specified early stopping points which are clearly described in the trial protocol. However, this was not the case in the published description of JUPITER’s protocol...
This leaves the question: which endpoint was used to define the rules for stopping, or which level of benefits was required to justify early termination?
It also makes one wonder if, along with a vested interest and financial incentives, the JUPITER researchers ran the trial until they had the outcome they were looking for...
To date JUPITER stands alone in its finding of showing a significant benefit of statin use in patients with no history of coronary heart disease (CHD).
Based on their review, Dr. de Lorgeril says that the time has come for a critical reappraisal of cholesterol-lowering statin treatments in the prevention of CHD. He added that the emphasis on statin use for the prevention of CHD takes the attention away from the proven benefits of adopting a healthy lifestyle, including regular physical activity, not smoking, and a Mediterranean-style diet.
Insult to injury
In the same issue of the Archives of Internal Medicine, another article supports Dr. de Lorgeril’s take on the Jupiter findings.
A meta-analysis - reviewing 11 randomized clinical trials to see if statins cut death rates among intermediate and high- risk patients with no history of CHD - found no evidence that statins are associated with a reduced risk of death among those at risk.
The study, involving a total of 65,229 patients, was led by Dr. Kausik Ray of the University of Cambridge. Dr. Ray concluded that due consideration is needed in applying statin therapy in lower-risk primary prevention populations.
However, based on the findings we’d argue that this applies to high-risk patients too!
This, along with the dangerous side effects of statins, like muscle problems, anaemia, sexual dysfunction, pancreas or liver dysfunction, and cataracts, puts a massive question mark over any potential benefits of using.
Heart Disease Related Reading:
Crestor : The Super Strong Statin Drug
Cholesterol: Why the Medical Mainstream Have the Wrong End of the Stick
Cholesterol – Your Doctor’s Advice Could be Damaging Your Health...
Mainstream Medicine Finally Catches on to the Risks of Taking a Daily Aspirin
HOT TOPICS:
Prelox - New Erectile Dysfunction Treatment To Enhance Sex Life
Green Tea May Protect Against Breast Cancer
Prevent Arthritis and Promote Healthy Joints With Omega-3 Fatty Acids
Sources:
Cholesterol-Busting Statins: Study Raises New Concerns, published online 29.06.10, abcnews.go.com
Report Examines Whether Statins Prevent Death in High-Risk Individuals Without Heart Disease, published online 04.07.10, sciencedaily.com
Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy, published 28.06.2010, Arch Intern Med
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