New strategy cuts heart attacks, strokes
By Stephen Smith
Globe Staff
Boston researchers reported this morning that they have developed a strategy that dramatically reduces the risk of heart attacks, strokes, and even death among older adults who don't have the traditional warning signs of perilously clogged arteries.
Using a test they pioneered, scientists from Brigham and Women's Hospital screened patients for evidence of cardiovascular disease missed by conventional cholesterol tests and then gave them preventive doses of a type of drug known as a statin.
The result: Heart attacks and strokes were cut by roughly 50 percent among patients who received the pill as part of a sprawling medical study that spanned 26 countries and included nearly 18,000 people. And the patients who received the medication rosuvastatin, marketed under the brand name Crestor, suffered only one side effect potentially linked to
the pill, according to the study, which was paid for by the drug's maker, AstraZeneca.
A half-dozen specialists not involved in the research predicted that the findings, presented in New Orleans at an American Heart Association convention that attracts thousands of cardiologists, will spawn a seismic shift in heart disease prevention. Describing the study as a landmark, the doctors said millions of patients who previously would not have been
considered candidates for statins now appear destined to receive some form of the medication widely used to lower cholesterol.
"The extent of reduction in death, heart attacks, and stroke is larger than we've seen in any trial I can remember," said Dr. Steven Nissen, a prominent Cleveland Clinic cardiologist. "I don't know how you get much bigger than that."
The National Heart, Lung, and Blood Institute will take the findings into "strong consideration" as it revises guidelines on preventing and treating heart disease next year, said Dr. Elizabeth Nabel, the agency's director. That could translate into widespread use of the Brigham test among men over 50 and women over 60 -- and more prescriptions for drugs.
Still, a cardiovascular researcher at Stanford University sounded a cautionary note about rushing to prescribe statins -- already the top-selling drugs in America -- to millions of additional patients.
Scientists need to better identify those patients who stand to gain the most from a medication designed to prevent, not treat, an illness, because all drugs carry medical risks and financial costs, warned Stanford's Dr. Mark A. Hlatky, who penned a critical editorial published online with the study in The New England Journal of Medicine.
"You and I have all seen drugs that everybody thought were wonderful and safe, but after a few years you say, 'Uh-oh,' " he said. "The reason I'm cautious about this is because of that history."
Every year, nearly 900,000 Americans die from cardiovascular disease, the nation's number one killer. But half of people who suffer heart attacks or strokes had no warning signs -- no previous episodes of chest pain and no elevated levels of bad cholesterol, which gums up arteries.
"And that's what this study is all about," said Dr. Paul Ridker, the Brigham specialist who presided over the research. "It's about the guy who goes running and does not come back, and the doctor and the spouse are shocked because this is someone who was thin and seemingly in good health and with a good cholesterol level."
So Ridker years ago invented a blood test to identify some of these people by detecting C-reactive protein -- or CRP -- a measurement of inflammation in arteries that can be a sign that patients are prone to catastrophic blood clots. Because the Brigham holds patents on the high-sensitivity CRP test, both the hospital and Ridker stand to profit handsomely from royalties if it becomes as common as cholesterol screening.
Some doctors have been reluctant, however, to use the test, which typically costs under $100 and is sometimes covered by insurance.
"We've known that CRP has been an indicator of risk, but never had the data to suggest that once you've identified patients with the risk factor, if you were to treat them, would it make a difference?" said Dr. W. Douglas Weaver, president of the American College of Cardiology Ridker's study was crafted to answer that question.
People were eligible to participate if they had a high CRP result but healthy cholesterol readings. Patients are generally advised to keep their total cholesterol levels below 200; more specifically, a reading lower than 130 is recommended for the bad form of cholesterol, known as LDL.
The study participants, on average, were 66 years old and overweight, but not obese.
Half received a 20 milligram dose of rosuvastatin each day while the others received a placebo. The study was supposed to last for five years, but a board monitoring the safety of the trial stopped it early -- because the results were so overwhelmingly positive.
LDL cholesterol and CRP levels plunged, and patients who received the drug suffered considerably fewer health emergencies, with 31 heart attacks and 33 strokes, compared with 68 heart attacks and 64 strokes among people who took the placebo. Deaths also fell, by 20 percent.
"They said, 'Dr. Ridker, we think it's unethical to continue giving anyone in your trial placebo,' " the Brigham doctor recalled. "We were just stunned by the result."
The only indication of a serious side effect was that patients taking the medication were more likely to be diagnosed with diabetes, a known problem of statins.
Statins -- with $18.4 billion in US sales in 2007, according to IMS Health -- have generated their fair share of criticism. Some doctors complained the drugs had not been tested thoroughly in women, and others were concerned that side effects were underreported by pharmaceutical companies.
Dr. Gregg Fonarow, a heart specialist at the University of California, Los Angeles, said that because of the sheer size of the study and the significant percentages of women, African-Americans, and
Hispanics included, lingering concerns about statins should be silenced.
"This really changes everything," said Fonarow, who was not involved in the study but has received consulting and other payments from statin makers. Now, he said, when doctors encounter patients in their 50s, 60s, or
older, they should "make sure there are absolutely no risk factors present and no elevation of CRP before deciding it's safe for that person to leave without a statin prescription."
Specialists said it was unclear how many additional patients would be eligible to receive statins if the findings from the Brigham study were widely implemented, with Ridker estimating at least 6 million Americans while other specialists forecast tens of millions. Worldwide, 13 million patients already take rosuvastatin; in his editorial, Hlatky pegged the
monthly cost at about $100.
By one standard measurement used to evaluate whether it makes sense to give a drug to big groups of people, rosuvastatin fared quite well. The researchers found that 25 people would need to take the statin for five years to prevent one serious cardiovascular episode.
"As expensive as this might be to give this drug to all these people, it might still save money if you take into account" costs associated with the complications of heart attacks and strokes, said Dr. James E. Muller, chief executive of a Burlington biotech company called InfraReDx that makes a system to detect fatty deposits embedded in arteries.
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This is ridiculous. Another "win" for big PHARMA when all people need to do is stay at a normal weight and stop eating processed fats. It's what you don't put in your body that will save your life, not the ingestion of something your body doesn't need, drugs.
This is interesting
Some good news for the pharma business.
Impressive study. Dr. Ridker should be congratulated for having the foresight to gain an intellectual property patent on CRP, as well as for gathering the funding to put together such a large, industry sponsored trial. He will undoubtedly make a large fortune.
However, it should be noted that he, nor anyone else alive today, did not "invent" CRP, discover it, or as of yet, figure out what its role is in inflammatory or cardiovascular disease. CRP was discovered >70 years ago in the blood of patients with pneumococcal pneumonia. It was subsequently found to be an independent marker of cardiovascular risk.
So, to be frank, someone took a molecule that someone else discovered, patented a blood test for it, and gave a bunch of people a drug (also discovered by someone else) which is known to reduce the risk of heart attacks. Clever-but many of us are still waiting for the science. A little humility is in order, one would think.
I'm worried about conflict of interests affecting the results. AstraZeneca sponsors a study that finds that Crestor works really well. Obviously, selling massive amounts of the drug would result in massive profits for the company. The doctors who designed the new tests may have conflicts of interest as well. I hope the Obama administration implements new oversight rules for these kinds of studies.
Interesting, I didn't know statins had the side effect of DM? I bet we are going to see alot more CRP drawn.
Of course it was sponsored by a drug company. With corporate profits falling, what better time to put everyone on a statin for prevention. Want to lower your risk? Eat well, cut out vices and exercise.
Point #1 ;"Crestor, suffered only one side effect potentially linked to
the pill, according to the study, which was paid for by the drug's maker, AstraZeneca."
Point # 2; "Statins -- with $18.4 billion in US sales in 2007, according to IMS Health -- have generated their fair share of criticism. Some doctors complained the drugs had not been tested thoroughly in women, and others were concerned that side effects were underreported by pharmaceutical companies."
All you need to know; another" unbiased" study by a pharmaceutical company with a vested financial interest in the results. Anyone remember the issues with Vioxx?!
Certainly argues for the efficacy of CRP assessment at least once q five years. Also a good example of preventative health research done well.
A good follow up article to this would talk about past "wonderdrugs" that went bad, and look at the patterns of hoopla that accompanied the initial great findings of the drugs, but then talk about the surprise adverse side effects, number of deaths, and unforeseen medical costs, that were associated with revising the usefulness or even pulling these drugs from the market after they had been used widely for several years.
Shame on the Brigham for letting themselves be used by big Pharma. The need stricter ethical guidelines.
Traditional opinions about cholesterol are INCORRECT.
Old women with high levels of cholesterol live the LONGEST.
People with high cholesterol do NOT have higher rates of heart attack.
People with lower cholesterol do NOT have lower rates of heart attack.
Don't believe me? Do the research! Start first with finding out what plaque really is and where it is really located. Hint. Cells in the artery walls expand with too much calcium when cells are damaged by extra free radicals. Cholesterol trys to patch the leaks but damaged cells not repaired until extra free radicals are removed.
Good. Now get it off of the front page until independent research verifies the results.
I wonder if it's time to make raw clinical data "open source," just like software?
Having spent many of my 26 professional years in big pharma, maybe they could release the raw data for analysis by the general public. Sure, they own the data and they paid millions to obtain it. But maybe independent analysis might be necessary. After all, didn't a pathology technician up in Minnesota determine that fen-fen (or however you spell it) was damaging to heart valves? She saw a recurring pattern of damage under the microscope, and from there, she reviewed patient records. Isn't the Framingham Heart Study data public access?
Companies design studies and FDA reviews them before implementation. Data is analyzed and summarized by the company's statistician, and then reviewed and
approved/non-approved by FDA. Companies don't fund studies they expect to fail - they are not benevolent. Pfizer had 800 million into a combination statin product designed to remove plaque before terminating the study. I saw a key exec's face after Pfizer d/c the study - I'm sure he asked to have that data reviewed in many different ways before making the decision.
Dr. Ridker - you are to be commended for your efforts. But if it was your money you were spending, would you fund the study? Would other scientists reach the same conclusions? Transparency is the new buzz-word - let us ordinary people see and analyze the raw data. Maybe we'll find another indication you overlooked.
apapproved
The potenetial health benefits demonstrated in this work for people with healthy cholesterol levels but high leves of CRP appear to be impressive. I hope the success of this treatment will encourage public health institutions to invest further into this line of work. The massive potential profits will all but ensure that BigPharma will continue to push for data on CRP and cardiovascular health. In the future, I hope we will see the real physiology that explains why statins work so well in people with high levels of CRP. In time, that line of investigation will no doubt lead to even better treatments with less side effects.
If inflamation in the circulation system is considered a cause of clots, what treatment , besides cortisone,has long term proof of reducing it?
Low cholesterol is also implicated in increased stroke risk, arterial wall stiffening, and thickening.
Medicine should get off the market band wagon and pay more attention to patient care.
A constant barrage of medical text bites and medical sound bites benefits who?
Yup Ridiculous.. Run eat right.. dont take drugs..
Big Pharma at it again.. probably not even a new drug.. more of a mee too drug..
Dont believe the hype
Since when is causation of diabetes "a known problem of statins?"
Dad check this out
are statins the only treatment for high levels of CRP? The article just assumes, following the Drug Industry, that Statins are the sole answer.
Ah, Kayla: your ignorance is telling. Some people are genetically predisposed to CVD, regardless of how they exercise or diet. Statins and other drugs improve their survival rate, in addition to watching their weight and getting exercise.
Let me guess: I'll bet you worry more about greenhouse gases and greyhounds, right? Get a clue, Kayla: you so desperately need one.
I am quite excited about this. For the last 4 years my CRP has been in the 7 range. Every physician adivsed that it is an indicator of inflammation and that there were no recommendations as to treatment. Stress tests have been unremarkable and a cardiac scan revealed scant amount of calcium. Finally, I found a cardiologist who not only started me on Crestor, but Plavix, as I have a significant family history and will do serial CRPs.
Thank you, Dr. Ridker!!!
Don't be so quick to judge people with high cholesterol as fat slobs who don't watch their diet and don't exercise. I do both and was still unable to lower mine. I was put on a statin and am grateful for this extra layer of protection. That said, it is also crucial to remember that this does not give one license to be less vigilant with regard to diet and exercise.
These studies make me ill. They dont answer the real questions, they just point to medication for prevention.
Why is it, in 1900s through 1920s when our society ingested more whole milk, real butter and eggs etc did we only see 3 to 5 thousands heart disease deaths per year and now with all of our "medical advances" and removal of saturated fats from our diet do we continue to see increased incidences and mortality rates.
Every year or two they have a new study that adjusts the new "danger level" of cholesterol down so that people who were considered health a year or two ago,
should now begin a preventitive dose of some statin/lipid controlling drug.
Why were we 100 times less likely as a nation to have issues with heart disease
when we were doing everything we are now being told not to do? People deserve better when it comes to health information then what we get. It is disgusting how this information is controlled. Talk to me about prevention, about appropriate food production and consumption.
We have the best emergency / acute illness care in the world, but the greed that has forced us into this culture of "medicine as prevention" is truly disturbing. Cancer and Heart Disease were non issues for thousands of years up until as
little as 80 years ago. Why is the question that should be studied and reported on. And how to empower people to manage their own health through intelligent choices is what we should be seeing "ground breaking" articles in our local media.
People deserve to trust "authorities" in fields as important as health. Good health is the building block of everything in our society - the masses deserve to honest information not drug company run studies.
Kayla...shut the hell up nobody wants to hear what you have to say
what I find a little weird is the title of this article "Boston Researchers........" The researchers are from Brigham and Women's but there is something insecure about the title- as if Boston isn't really on the map. Maybe I am nitpicking but the Globe has a odd way of framing articles....
Its not simply about diet and exercise for everyone. Genetics are a big player in this. I watch what I eat, have a BMI of 25, run 35 miles a week and my latest LDL was 160! I could become a vegetarian I guess, and lower my LDL to 150, but when genetics are involved statins are the only answer! Statins are one of the few drugs that the pharm industry has done right.
It goes without saying that diet and exercise are important, but the main point is that C-RP is another factor that must be considered along with Cholesterol to properly diagnose heart disease.
Nice to hear from all the doctors and cardiovascular experts here telling everyone exactly how to prevent heart attacks. Just think, all I have to do is listen to whatever comment any Joe Blow posts online and I'll live to be 100.
Almost every major drug or device study is sponsored in part by the pharamaceutical industry. These are multimillion dollars that take a great deal of resources otherwise not possible without their monatary support. That being said I am confident that the study mentioned was performed in an unbiased fashion with incredible institutional (and FDA) oversight. I can guarante that AZ had no access to the results or played roll in it's analysis.
This is an interesting study born out of knowledge and belief that inflammation plays a major role in CV events which can be decreased with a statin. CRP is nonspecific market for inflammation that is followed in many other diseases. It will be interesting to see over the next few year as further studie better eliciate accurate cost analysis and and greater mortality data.
For those who are cynical about this study because people only need to eat reasonably and get some exercise are missing the point. The research seems to be aimed at reducing the incidence of heart attacks and strokes among those who do not exhibit the common warning signs such as overweight/obesity, high cholesterol, or metabolic syndrome.
While I am wary of "Big Pharm" almost as much as I am about Big Tobacco in terms of its lust for profits, I am also pretty sure that if we could reduce those unexpected heart attack and strokes through more effective diagnostics and preventative pharmacology, it will saves lives and save medical treatment dollars as well.
Lipitor has had more studies done on it (over 200) than any other drug in history. They find that statins besides heart disease prevent a bunch of other diseases, such as prostrate cancer and alzheimer. Medical researchers call statins the miracle drug and some refer to it as the rich man's aspirin.
i have been taking statins and i have no side effects and my cholesterol has been cut down to .3.0 which i believe is very good
I would like to know when the folks on this posting are going to wake up and look down the road abit. I do not care if Big Pharma makes billions and invests that money in new drug discovery. New drugs perhaps drugs safer and better than statins can be discovered. Why should anyone carry so much anger for Big Pharma when so many new and effective drugs have been discovered and tested in the last 25 years. Without those huge profits, there will less new drug discovery and fewer therapeutic alternatives. Criticism of big Pharma profits should be less of a concern then the Wall Street greed that has devastated all of us. The one industry sector that has real innovation associated with real life issues is trashed by the American public--over and over again. Worried about your children's future? You better be because if the Government has it way, your children will only get generics made in China. Better think twice about your position on Big Pharma-it may not be perfect but it does invent.
By the way, the anti-inflammatory effects of statins on arterial walls has been suspected and to some known for years.
Everybody should take a big step back before embracing these results. While the relative risk reduction looks very impressive, the absolute risk reduction is miniscule - less than 1%. That means in order to prevent one event per year, 100 people would have to take the pill. Doesn't sound so good, does it? And that's not even taking into consideration the possibility of increased side effects.
Considering that Dr. Ridker holds that patent for measuring CRP levels, can anybody really think that he is an unbiased observer. Also, don't necessarily believe any of the gushing comments from the so-called experts. Many of them are hired guns by the drug companies.
"...Because the Brigham holds patents on the high-sensitivity CRP test, both the hospital and Ridker stand to profit handsomely from royalties if it becomes as common as cholesterol screening..."
um, unbiased study? slow day for the globe i see.
This article is ridiculous propoganda and would be funny if it were not believed by the majority of the population. Big Pharma is the new Big Tobacco. Same amoral tactics and strategies. Sad. The entire process and the FDA need to be revamped. My friends who are doctors often freely reveal the soft money that finds its way to them and they are not heavyweight in Medicine. Those is positions that can influence public perception and government/FDA processees are being overtly bribed or unwittingly manipulated. Eat, workout and live right.
Very high levels of cholesterol (above 250 mg/dL) and high levels of CRP are probably indicators of unhealthy inflammation in the body. However this does not mean that one should use a drug to reduce these inflammation markers. An infectious disease is often diagnosed by an elevated white blood-cell count, because white blood cells are a defensive mechanism of the body against infection. No one would recommend that we fight infection with a drug that artificially reduces white blood cells. Why do we use a drug to reduce cholesterol artificially, even though cholesterol is a defensive mechanism of the body to fight inflammation?
Another study that shows NO SUPPORT the cholesterol theory of CAD. You can add this to the MOUNTAINS of other evience against this fraudulent hypothesis developed by Ancel Keys in 1953.
CAD is a disease of INFLAMMATION.
This blogger might want to review your comment before posting it.
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