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People with Diabetes (PWD) are 70% more likely to have liver disease.
Diabetes Diary: http://www.facebook.com/pages/CHI-Creating-Health-Institute/46249556606
Diabetes increases Parkinson's risk http://care.diabetesjournals.org/cgi/content/long/34/4/910I hope you are connecting the dots...
Predictors of New-Onset Diabetes in Patients Treated With Atorvastatin
Results From 3 Large Randomized Clinical Trials
David D. Waters, MD ,Jennifer E. Ho, MD ,David A. DeMicco, DPharm ,Andrei Breazna, PhD ,Benoit J. Arsenault, PhD ,Chuan-Chuan Wun, PhD ,John J. Kastelein, MD, PhD ,Helen Colhoun, MD, PhD andPhilip Barter, MD, PhD Division of Cardiology, San Francisco General Hospital, and the University of California at San Francisco, San Francisco, California
Pfizer, Inc., New York, New York
Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
Department of Public Health, University of Dundee, Dundee, Scotland
Heart Research Institute, Sydney, Australia
Manuscript received July 28, 2010; revised manuscript received October 4, 2010, accepted October 11, 2010.
* Reprint requests and correspondence: Dr. David D. Waters, Division of Cardiology, San Francisco General Hospital, 1001 Potrero Avenue, San Francisco, California 94114 (Email:dwaters@medsfgh.ucsf.edu).
Objectives: We sought to examine the incidence and clinical predictors of new-onset type 2 diabetes mellitus (T2DM) within 3 large randomized trials with atorvastatin.
Background: Statin therapy might modestly increase the risk of new-onset T2DM.
Methods: We used a standard definition of diabetes and excluded patients with prevalent diabetes at baseline. We identified baseline predictors of new-onset T2DM and compared the event rates inpatients with and without new-onset T2DM.
Results: In the TNT (Treating to New Targets) trial, 351 of 3,798 patients randomized to 80 mg of atorvastatin and 308 of 3,797 randomized to 10 mg developed new-onset T2DM (9.24% vs. 8.11%, adjusted hazard ratio [HR]: 1.10, 95% confidence interval [CI]: 0.94 to 1.29, p = 0.226). In the IDEAL (Incremental Decrease in End Points Through Aggressive Lipid Lowering) trial, 239 of 3,737 patients randomized to atorvastatin 80 mg/day and 208 of 3,724 patients randomized to simvastatin 20 mg/day developed new-onset T2DM (6.40% vs. 5.59%, adjusted HR: 1.19, 95% CI: 0.98 to 1.43, p = 0.072). In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, new-onset T2DM developed in 166 of 1,905 patients randomized to atorvastatin 80 mg/day and in 115 of 1,898 patients in the placebo group (8.71% vs. 6.06%, adjusted HR: 1.37, 95% CI: 1.08 to 1.75, p = 0.011). In each of the 3 trials, baseline fasting blood glucose, body mass index, hypertension, and fasting triglycerides were independent predictors of new-onset T2DM. Across the 3 trials, major cardiovascular events occurred in 11.3% of patients with and 10.8% of patients without new-onset T2DM (adjusted HR: 1.02, 95% CI: 0.77 to 1.35, p = 0.69).
Conclusions: High-dose atorvastatin treatment compared with placebo in the SPARCL trial is associated with a slightly increased risk of new-onset T2DM. Baseline fasting glucose level and features of the metabolic syndrome are predictive of new-onset T2DM across the 3 trials.
Statins and All-Cause Mortality in High-Risk Primary PreventionA Meta-analysis of 11 Randomized Controlled Trials Involving 65 229 Participants
Kausik K. Ray, MD, MPhil, FACC, FESC ;Sreenivasa Rao Kondapally Seshasai, MD, MPhil;
Sebhat Erqou, MD, MPhil, PhD ;Peter Sever, PhD, FRCP, FESC ;J. Wouter Jukema, MD, PhD ;
Ian Ford, PhD ;Naveed Sattar, FRCPath
Arch Intern Med. 2010;170(12):1024-1031.
Background Statins have been shown to reduce the risk of all-cause mortality among individuals with clinical history of coronary heart disease. However, it remains uncertain whether statins have similar mortality benefit in a high-risk primary prevention setting. Notably, all systematic reviews to date included trials that in part incorporated participants with prior cardiovascular disease (CVD) at baseline. Our objective was to reliably determine if statin therapy reduces all-cause mortality among intermediate to high-risk individuals without a history of CVD.
Data Sources Trials were identified through computerized literature searches of MEDLINE and Cochrane databases (January 1970-May 2009) using terms related to statins, clinical trials, and cardiovascular end points and through bibliographies of retrieved studies.
Study Selection Prospective, randomized controlled trials of statin therapy performed in individuals free from CVD at baseline and that reported details, or could supply data, on all-cause mortality.
Data Extraction Relevant data including the number of patients randomized, mean duration of follow-up, and the number of incident deaths were obtained from the principal publication or by correspondence with the investigators.
Data Synthesis Data were combined from 11 studies and effect estimates were pooled using a random-effects model meta-analysis, with heterogeneity assessed with the I2 statistic. Data were available on 65 229 participants followed for approximately 244 000 person-years, during which 2793 deaths occurred. The use of statins in this high-risk primary prevention setting was not associated with a statistically significant reduction (risk ratio, 0.91; 95% confidence interval, 0.83-1.01) in the risk of all-cause mortality. There was no statistical evidence of heterogeneity among studies (I2 = 23%; 95% confidence interval, 0%-61% [P = .23]).
Conclusion This literature-based meta-analysis did not find evidence for the benefit of statin therapy on all-cause mortality in a high-risk primary prevention set-up.
WASHINGTON (AFP) – Cholesterol-lowering statin medications, miracle drugs for those suffering from heart disease, may be over-prescribed as a preventative measure for healthy adults, a new study said Tuesday.
The study by cardiologists at Johns Hopkins University found that, among healthy adults, only those with measurable buildup of artery-hardening calcium would significantly benefit from the treatment.
"Our results tell us that only those with calcium buildup in their arteries have a clear benefit from statin therapy," the study's lead investigator Michael Blaha said in a statement.
"Those who are otherwise healthy and have no significant calcification should, with their physician, focus on aggressive lifestyle improvements instead of early initiation of statin medications," he added.
The statin class of pharmaceuticals, including the popular cholesterol-lowering drugs Lipitor and Crestor, lowers cholesterol by blocking an enzyme in the liver.
The six-year study found that 75 percent of all heart attacks, strokes or heart-related deaths occurred in the 25 percent of participants who had the highest calcium buildup in their blood vessels.
The 47 percent of participants who had no detectable levels of calcium buildup meanwhile suffered just five percent of heart disease-related events, meaning the statin therapy would have offered little protection.
"It certainly is not the case that all adults should be taking (statin therapy) to prevent heart attack and stroke, because half are at negligible risk of a sudden coronary event in the next five to 10 years," Blaha said.
Roger Blumenthal, another Johns Hopkins researcher who carried out the study, said the drugs "should not be approached like diet and exercise as a broadly based solution for preventing coronary heart disease."
"These are lifelong medications with potential, although rare, side effects, and physicians should only consider their use for those patients at greatest risk, especially those with high coronary calcium scores."
He added that as many as five percent of people on statins develop serious side effects, such as muscle pain, while one in 255 will develop diabetes.
The study of 950 healthy and ethnically diverse men and women was unveiled on Tuesday at an American Heart Association conference in Chicago.
The report is the latest in a series of studies questioning the widespread prescription of preventative heart medication for otherwise healthy adults.
A US meta-analysis of 11 studies published in June had already revealed that statin treatments do not reduce the death rate among patients with high cholesterol but no history of heart disease.
The two studies contrast the results of a 2008 clinical trial known as "JUPITER," which found that a daily does of 20 milligrams of Crestor, a statin treatment marketed by the British pharmaceutical giant AstraZeneca, halved the number of potentially fatal coronary blockages in 18,000 adults.
All of the adults in the JUPITER study had high levels of C-reactive protein (CRP), believed by some to predict coronary disease.
But BlahaCRP, which he said offered no predictive value.
Coronary heart disease remains the leading cause of death in the United States, responsible for one in five deaths among adults.
Posted in: statins
HOLON, Israel, July 7 (UPI) -- Vitamin C, vitamin E, co-enzyme Q10 and selenium supplement had beneficial effects for those with cardiovascular risk factors, researchers in Israel said.
Reuven Zimlichman and colleagues at the Wolfson Medical Center in Israel said the study involved 70 patients from the center's hypertension clinic.
"Antioxidant supplementation significantly increased large and small artery elasticity in patients with multiple cardiovascular risk factors," Zimlichman said in a statement. "This beneficial vascular effect was associated with an improvement in glucose and lipid metabolism as well as significant decrease in blood pressure."
The research team randomized the 70 patients to receive either antioxidants or placebo capsules for six months.
The study, published in the journal Nutrition Metabolism, found that at the three-month and six-month mark, patients in the antioxidant group had more elastic arteries -- a measure of cardiovascular health -- better blood sugar and better cholesterol profiles.
READ IT HERE FIRST: THE IMPORTANT ISSUES FACING YOU IN HEALTH CARE AT NATURAL HEALTH NEWS DAYS, AND OFTEN WEEKS OR MONTHS, AHEAD OF THE SITES THAT HAVE BEEN COPYING OUR WORK FOR MORE THAN 10 YEARS...Liptor and other statin drugs already have a record of serious side effects and other problesm related to increased risk of demthia and cancer as well as liver and kidney failure.
Pfizer gets EU approval for kids' cholesterol drug
By LINDA A. JOHNSON, AP Business Writer Tue Jul 6, 2010TRENTON, N.J. – The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides, a type of blood fat, Pfizer said Tuesday.
The approval includes children whose high blood fats are due to an inherited disease that causes extremely high cholesterol levels, familial hypercholesterolemia.
New York-based Pfizer Inc. won U.S. approval for Lipitor use in children 10 to 17 with that condition in 2002.
Lipitor is the world's top-selling drug, with 2009 sales of about $13 billion, but its U.S. patent expires at the end of November 2011. Pfizer, the world's biggest drugmaker, will quickly lose most Lipitor revenue once generic competition hits, so the company has been trying to boost sales where possible before then.
Pfizer said last fall that it plans to apply for a six-month extension of its patent in European countries, after doing studies of Lipitor in youngsters.
As in the United States, the European Union allows drug makers to seek an additional six months of patent protection for medications if they test them in children, who generally are excluded from the drug studies performed to win approval for a new medication.
Pfizer already won such an extension for its crucial U.S. patent on Lipitor.
For blockbuster drugs, those extensions can easily bring hundreds of millions of dollars in additional revenue. Normally, they are for drugs that are widely used by different age groups.
Until recently, cholesterol drugs have been primarily taken by adults with heart disease, but their use has expanded to younger patients as more obese, sedentary teenagers and adolescents develop heart disease and diabetes.
Lipitor is approved to lower risk of heart attack and stroke, but can cause dangerous muscle pain or weakness, and it cannot be taken by patients with liver problems or by nursing or pregnant women.
A statin taken by millions of Britons may increase risk of a condition which can lead to fatal kidney failure at high doses, a drug watchdog has warned.
By Rebecca Smith, Medical Editor, 20 Mar 2010
Simvastatin is taken by around three million people in order to lower their cholesterol and reduce the risk of having a heart attack.
However an analysis of clinical trial data in America has found that high doses can cause muscle damage and a rare condition which induces kidney problems and may be fatal.
Patients were told not to stop taking simvastatin but advised to talk to their doctor if they have concerns.
The American medicines regulator, the Food and Drug Administration, has issued a warning to patients to be alert to signs of problems when taking the 80mg daily dose of simvastatin. It has also listed drugs that should not be prescribed to those on high doses of statins.
Muscle aches and damage are a known side effect of all statins but the risks are generally considered to be outweighed by the benefit in reducing the risk of a heart attack.
The FDA found that patients on the 80mg dose were more likely to develop a severe form of muscle damage called myopathy, compared with those on the lower 20mg dose.
Over six years, 52 of the 6,031 patients taking 80 mg doses developed myopathy compared with one person out of the 6,033 taking 20mg.
And 11 patients taking the 80 mg dose developed rhabdomyolysis, the most serious form of myopathy which can lead to kidney failure and death, where as none of those on the 20mg dose developed the condition.
The majority of patients in Britain taking simvastatin are on the 20mg and 40mg dose.
The FDA said patients experiencing muscle pain, tenderness or weakness, urine that is dark or red-coloured, or unexplained tiredness, should contact their doctor.
The UK drugs regulator said the side effects are known about and included in patient information with the medication.
A spokesman for the Medicines and Healthcare products Regulatory Agency said: "The 80 mg per day dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications.
"Myalgia (complaints of muscle aches) is a common side effect of statins, including simvastatin. It is recognised that very rarely statins can cause more serious muscle damage (myopathy) which in some cases may be life-threatening.
"There are comprehensive warnings in the product information for prescribers and in the Patient Information Leaflet.
"These warnings advise that the risk of muscle injury is greater: at higher doses of simvastatin; when used in combination with certain other medicines including amiodarone (a medicine used for an irregular heart beat) and other medicines that are recognised to increase the risk of myopathy; and in certain patient groups including those who are more than 70 years old, those with kidney or thyroid problems, those who consume large amounts of alcohol, and those with a history of previous muscle problems during treatment with statins or other lipid lowering drugs.
"As with all marketed medicines the safety of simvastatin is kept under continuous review by the MHRA."
Ellen Mason, Senior Cardiac Nurse at the British Heart Foundation (BHF) said: “Simvastatin remains a widely used and well researched drug, which has been around for many years and serious muscle damage is rare.
"It is considered a safe drug for many people in the UK to take. The benefits of statins in lowering cholesterol levels and reducing the risk of a heart attack are clear.
“Only a small number of people with very high levels of cholesterol would need to take the maximum dose of simvastatin. Any concerned patients who are taking the highest prescribed dose and experience muscle weakness or pain should speak to their GP.”
I'd like to stick to Cupid and chocolate this month a lot more than spending the remaining days of February listening to PSAs like the one from Women in Government. Researchers Document the Dangers of Statins Byron Richards, CCN
A new scientific review of the dangers of statin medications is the first official paper to shed light on what I have been saying for years. It reviews 900 studies on the adverse effects of statins. It shows beyond any doubt that statins are potent disrupters of normal energy production by cells – meaning that the drugs are anti-life. It is technically not possible to have a drug that is anti-energy have any value in long term use. Yet, the statin machine rolls on, killing and injuring countless Americans.
The study is the first to connect the mitochondrial statin dots, a revelation that proves beyond any doubt that statins are too dangerous to consume for almost anyone. Serious side effects include loss of muscle function, cognitive loss, neuropathy, pancreatic and hepatic dysfunction, and sexual dysfunction. These side effects are worse in people with genetic susceptibility, in combination with other drugs, or in the presence of other energy related problems such as thyroid disease.
Side effects are worse with age and the new data clearly demonstrates that the risks for any person over the age of 70 far outweigh the benefits – even for patients with heart disease. This study lends further support to my observation that 450,000 new cases of heart failure per year are likely due to widespread statin use in older Americans.
Of course, you haven’t seen this information on the front page of any Big Pharma sponsored media.
Statins reduce cardiovascular disease in healthy people, and why this study is a poke in the eye for the cholesterol hypothesis
By Dr John Briffa On November 10, 2008
It’s been going this way for a while: even healthy people should be on the cholesterol-reducing drugs known as statins. That, in a nutshell, is the verdict of a study published over the weekend which found that even in people deemed to be at low risk of cardiovascular disease, treatment with rosuvastatin (Crestor) at a dose of 20 mg per day almost halved the risk of ‘vascular events’ (such as heart attack, stroke, and death from these conditions) in middle-aged and elderly men and women. Overall risk of death was down too in those taking the rosuvastatin, to the tune of 20 per cent. Average length of treatment was a shade under two years.
These results look impressive, but it does need to be borne in mind that the study population were essentially healthy. And, because of this, the risk of things like heart attacks and strokes is generally low in this population. Just to put this in perspective, the risk of vascular events was 2.2 per cent in the group taking the statin, but 2.8 per cent in those on placebo. In other words, what is known as the absolute risk reduction (as opposed to the relative risk reduction) was a little over half a percent.
It is perhaps also worth reflecting on the fact that treatment with rosuvastatin was associated, compared with placebo, with a significantly increased risk of developing diabetes. Curiously, the authors of the study say this effect could “reflect the play of chance.” In other words, even though there was a statistically significant enhanced risk of diabetes in those taking the statin, it may have nothing to do with the statin, and everything to do with bad luck. Curiously, the authors are not similarly circumspect about the positive effects of statins seen in this study.
But the reason for writing about this study is not so much to put the results in this context, but more to explore what these results say about the widely accepted context that cholesterol causes cardiovascular disease. On the face of it, this study strengthens this concept. But I’m not so sure.
You see this study was done in individuals whose cholesterol levels were not deemed to be risky. Individuals had to have LDL cholesterol levels of less than 130 mg/L (3.37 mmol/L) to qualify. However, to qualify for the study individuals did have to have elevated levels of a substance known as C-reactive protein (CRP). CRP is a marker for inflammation in the body, and inflammation is believed to be a key underlying process in the development of cardiovascular conditions such as heart disease and stroke.
Significant benefits were seen individuals who had elevated CRP levels, but no other major risk factors for cardiovascular disease (and LDL cholesterol levels of 100 mg/L or less). This inevitably throws up the possibility that in this study, the benefits of rosuvastatin came, at least in part, through its ability to reduce CRP levels. CRP levels actually dropped by 37 per cent on average in this study.
Cholesterol levels dropped too (LDL levels actually halved), but as the authors point out, the clinical benefit associated with this was much larger than expected. This finding also adds weight to the idea that rosuvastatin’s benefits may have been less to do with bringing cholesterol levels down, and more to do with an anti-inflammatory and/or other actions.
Previously on this site I have cited a 2006 review of the evidence regarding the relationship between cholesterol and cardiovascular outcomes such as heart attacks and strokes [2]. Having reviewed a broad range of available evidence, the authors of this review stated that: ‘…no clinical trial subgroup analyses or valid cohort case control analyses suggesting that the degree to which LDL cholesterol responds to statin independently predicts the cardiovascular risk reduction.” In other words, there is no robust relationship between cholesterol levels and degree of risk of cardiovascular disease.
This is not the only review that has found this. In another from the same year, researchers reviewed 13 studies in which statins were used in individuals who had suffered from ‘acute coronary syndrome’ (i.e. heart attack and angina). Statin therapy was found to reduce risk of cardiovascular disease, but this was independent of LDL cholesterol reduction. The authors concluded that there is no significant evidence that reduction in LDL cholesterol level explains the clinical benefits seen with statin therapy on cardiovascular disease risk [3].
And what of studies that have assessed the relationship between CRP and cardiovascular outcomes? The lead author of the recent NEJM paper was also the lead author of a paper published in 2005 that assessed data from another large statin study (the so-called ‘PROVE-IT’ study) [4]. The study concluded: “Patients who have low CRP levels after statin therapy have better clinical outcomes than those with higher CRP levels, regardless of the resultant level of LDL cholesterol.”
From the same year, comes another study in which the relationship between LDL cholesterol and CRP levels and development of the process which narrows the coronary blood vessels in heart disease (atherosclerosis) in individuals treated with a statin. Atherosclerosis actually regressed in patients with the greatest reduction in CRP levels, but not in those with the greatest reduction in LDL cholesterol levels [5].
Another way of unpicking the role of cholesterol in health would be to go beyond statins, and look at the effectiveness of other cholesterol reducing drugs or strategies on overall risk of death. This latest study, and others (particularly in those at high risk of cardiovascular disease) found statin therapy is associated with a reduced risk of death. A review from 2005 assessing the impact of cholesterol reducing therapy on overall mortality. Here are the results:
Statins – statistically significant reduction in risk of overall mortality
Fibrates – NO statistically significant reduction in risk of overall mortality
Resins – NO statistically significant reduction in risk of overall mortality
Niacin – NO statistically significant reduction in risk of overall mortality
Diet – NO statistically significant reduction in risk of overall mortality
Some people argue that the failure of other cholesterol-reducing strategies is because they don’t reduce cholesterol enough. I suppose that’s one potential explanation. Here’s another: cholesterol reduction doesn’t have broad benefits for health.
References:
1. [1] Ridker PM, et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. New England Journal of Medicine. Epub 9th November 2008.
2. Hayward RA, et al. Narrative review: lack of evidence for recommended low-density lipoprotein treatment targets: a solvable problem. Ann Int Med 2006;145:520-530
3. Hulten E, et al. The effect of early, intensive statin therapy on acute coronary syndrome: a meta-analysis of randomized controlled trials. Archives of Internal Medicine. 2008;166:1814-1821
4. Ridker PM, et al. C-reactive protein levels and outcomes after statin therapy. New Engl J Med 2005;352:20-8.
5. Nissen SE, et al. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med 2005;352: 29-38
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Article printed from Dr Briffa’s Blog: http://www.drbriffa.com
URL to article: http://www.drbriffa.com/blog/2008/11/10/statins-reduce-cardiovascular-disease-in-health-people-and-why-this-study-is-a-poke-in-the-eye-for-the-cholesterol-hypothesis/
URLs in this post:
[1] Ridker PM, et al. Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. New England Journal of Medicine. Epub 9th November 2008.: http://content.nejm.org/cgi/content/full/NEJMoa0807646
Study: Wider cholesterol drug use may save lives
By MARILYNN MARCHIONE, AP Medical Writer Marilynn Marchione, Ap Medical Writer
Sun Nov 9, 9:44 am ET
NEW ORLEANS – People with low cholesterol and no big risk for heart disease dramatically lowered their chances of dying or having a heart attack if they took the cholesterol pill Crestor, a large study found.
The results, reported Sunday at an American Heart Association conference, were hailed as a watershed event in heart disease prevention. Doctors said the study might lead as many as 7 million more Americans to consider taking cholesterol-lowering statin drugs, sold as Crestor, Lipitor, Zocor or in generic form.
"This takes prevention to a whole new level, because it applies to patients who we now wouldn't have any evidence to treat," said Dr. W. Douglas Weaver, a Detroit cardiologist and president of the American College of Cardiology.
The study also gives the best evidence yet for using a new test to identify people who may need treatment, according to a statement from Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute. The new research will be considered by experts reviewing current guidelines.
However, some doctors urged caution. Crestor gave clear benefit in the study, but so few heart attacks and deaths occurred among these low-risk people that treating everyone like them in the United States could cost up to $9 billion a year — "a difficult sell," one expert said.
About 120 people would have to take Crestor for two years to prevent a single heart attack, stroke or death, said Stanford University cardiologist Dr. Mark Hlatky. He wrote an editorial accompanying the study published online by the New England Journal of Medicine.
"Everybody likes the idea of prevention. We need to slow down and ask how many people are we going to be treating with drugs for the rest of their lives to prevent heart disease, versus a lot of other things we're not doing" to improve health, Hlatky said.
Statins are the world's top-selling drugs. Until this study, all but Crestor have already been shown to cut the risk of heart attacks and death in people with high LDL, or bad cholesterol.
But half of all heart attacks occur in people with normal or low cholesterol, so doctors have been testing other ways to predict who is at risk.
One is high-sensitivity C-reactive protein, or CRP for short. It is a measure of inflammation, which can mean clogged arteries as well as less serious problems, such as an infection or injury. Doctors check CRP with a blood test that costs about $80 to have done.
A co-inventor on a patent of the test, Dr. Paul Ridker of Harvard-affiliated Brigham and Women's Hospital in Boston, led the new study. It involved 17,802 people with high CRP and low LDL cholesterol (below 130) in the U.S. and 25 other countries.
One-fourth were black or Hispanic, and 40 percent were women — important because previous statin studies have included few women. Men had to be 50 or older; women, 60 or older. None had a history of heart problems or diabetes.
They were randomly assigned to take dummy pills or Crestor, the strongest statin on the market, made by British-based AstraZeneca PLC. Neither participants nor their doctors knew who was taking what.
The study was supposed to last five years but was stopped in March, after about two years, when independent monitors saw that those taking Crestor were faring better than the others.
Full results were announced Sunday. Crestor reduced a combined measure — heart attacks, strokes, heart-related deaths or hospitalizations, or the need for an artery-opening procedure — by 44 percent.
"We reduced the risk of a heart attack by 54 percent, the risk of a stroke by 48 percent and the chance of needing bypass surgery or angioplasty by 46 percent," Ridker said.
Looked at another way, there were 136 heart-related problems per year for every 10,000 people taking dummy pills versus 77 for those on Crestor.
Remarkably, every single subgroup benefited from the drug.
"If you're skinny it worked, if you're heavy it worked. If you lived here or there, if you smoked, it worked," Ridker said.
AstraZeneca paid for the study, and Ridker and other authors have consulted for the company and other statin makers.
One concern: More people in the Crestor group saw blood-sugar levels rise or were newly diagnosed with diabetes.
Crestor also has the highest rate among statins of a rare but serious muscle problem, so there are probably safer and cheaper ways to get the same benefits, said Dr. Sidney Wolfe of the consumer group Public Citizen.
"It is highly unlikely that (the benefits are) specific to Crestor," said Wolfe, who has campaigned against the drug in the past.
Crestor costs $3.45 a day versus less than a dollar for generic drugs.
Drs. James Stein and Jon Keevil of the University of Wisconsin-Madison used federal health statistics to project that 7.4 million Americans, or more than 4 percent of the adult population, are like the people in this study.
Treating them all with Crestor would cost $9 billion a year and prevent about 30,000 heart attacks, strokes or deaths, they calculate.
"That's pretty costly. This would be a very difficult sell" unless a person also had family history or other heart disease risk factors, said Dr. Thomas Pearson of the University of Rochester School of Medicine and Dentistry.
Pearson was co-chairman of a joint government-heart association panel that wrote current guidelines for using CRP tests to guide treatment.
Researchers do not know whether the benefits seen in the study were due to reducing CRP or cholesterol, since Crestor did both.
This study and two other government-sponsored ones reported on Sunday "provide the strongest evidence to date" for testing C-reactive protein, and adding it to traditional risk measures could identify millions more people who would benefit from treatment, Nabel's statement says.
U.S. Crestor prescriptions totaled $420 million in the third quarter of this year, up 23 percent from a year earlier. In the rest of the world, third quarter sales were $520 million, up 33 percent.
Sales have been rising even though two statins — Zocor and Pravachol — are now available in generic form.
On the Net:
New England Journal: http://www.nejm.org
Heart conference: http://www.americanheart.org
Government: http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhatIs.html
By Dr John Briffa
October 24, 2008
Cholesterol-reducing drugs known as statins are hugely popular and highly profitable. It’s a shame, then, that they aren’t very effective. I say this because while they have been shown to reduce the risk of cardiovascular events such as heart attacks, they do not reduce the overall risk of death when essentially healthy individuals are being treated. This was the conclusion of an analysis of 8 studies which had been performed using individuals with no previous diagnosis of cardiovascular disease [1]. This analysis also revealed that for one individual to be protected from a cardiovascular event (heart attack or stroke) over a 5-year period, 67 people would need to be treated.
Other evidence analysing the effectiveness of the national treatment guidelines in the USA, Canada, the UK and New Zealand has revealed the so-called ‘number needed to treat’ (NNT) varies from 108-198 [2]. These startlingly high NNTs have caused some to question whether statins are really the wonder drugs some would have us believe them to be.
But wait, it gets worse. Because the limited ‘benefits’ of statins seems to be confined mainly to men. The research has found that even in women with diagnosed cardiovascular disease and/or history of heart attack or stroke, statins do not reduce overall risk of death. And in healthy women, they don’t reduce the risk of cardiovascular events (heart attacks and strokes) either. The crashing failure of statins in women was fully elucidated in an analysis from British GP Malcolm Kendrick in the BMJ last year [3].
The singular failure of statin drugs to help women was highlighted this week in the British Medical Journal [4]. In a news piece, our attention was brought to an analysis from a professor of law and a professor of clinical epidemiology in the USA. The paper focuses on the most widely prescribed statin of all - atorvastatin (Lipitor) [5]. It looks at the evidence for the effectiveness of this drug in treating essentially women with no history of cardiovascular disease. In line with previous evidence on statins, there was no significant benefit to be found.
But the authors of this analysis go further by questioning the fact that when Lipitor is promoted and advertised, there’s plenty of talk about the fact that it reduces the risk of heart attacks, but no mention of it’s stunning lack of success with regard in women. They accuse Lipitor’s manufacturers of a lack of candour here, and also ask questions of the Food and Drug Administration (FDA) in the USA. At a bare minimum, they say, the FDA should be using its muscle to protect people against misleading marketing. They also suggest that women who have paid out of their pockets as a result of false promises should be compensated for the money they’ve effectively wasted.
The authors conclude: Our findings indicate that each year reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.
According to the BMJ new piece, Pfizer have responded to the article in the form of a statement, which I can’t locate on the web. In this statement, Pfizer claims that “Cardiovascular disease is a major cause of death in women as well as men and it ultimately kills as many women as men. However, onset of disease is delayed by some 10-15 years in women compared to men; thus the National Institutes for Health (NIH) ATP III guidelines define age as a risk factor in women at age 55, compared to age 45 for men. In addition, the AHA CVD Guidelines for Women were updated in 2007 and recommend that healthcare professionals should focus on women’s lifetime heart disease risk, not just short-term risk.”
Let this not distract us from the fact, I say, that statins have not been shown to benefit essentially healthy women. And let’s not forget either that for each person that benefits from taking statins, many, many others don’t.
References:
1. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007;369:168-169
2. Manuel DG, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modeling study. BMJ 2006;332:1419
3. Kenrick M. Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No. BMJ 2007;334:983
4. Dobson R. Atorvastatin advertising misled over benefits for women, study claims. BMJ 2008;337:a2209
5. Eisenberg T, et al. Statins and Adverse Cardiovascular Events in Moderate-Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims. Journal of Empirical Legal Studies. Published Online: Sep 5 2008
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Article from: http://www.drbriffa.com/blog/2008/10/24/should-women-who-have-paid-for-statins-be-given-their-money-back/