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Are statins overprescribed for low-risk patients?

January 26, 2011 By: Nadia Category: Cholesterol, HealthCare, Medicine Advice, Medtipster, Prescription News

www.Medtipster.com Source: Boston Globe – 1.24.2011

It’s a common scenario: A 60-year-old woman is told she has high cholesterol but has no other risk factors for heart disease like high blood pressure, diabetes, or a smoking habit. Should she take a statin to lower her cholesterol?

Many doctors say, why not? But a review study by the Cochrane Collaboration, a nonprofit research organization, suggests otherwise. The review, which analyzed 14 trials involving the use of statins to prevent heart disease in low-risk patients, found only “limited evidence” that the drugs provide significant benefits, especially in women, and urged that “caution should be taken when prescribing statins” to prevent heart disease.

The cholesterol-lowering drugs – which include atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) – have clearly been shown to reduce heart attacks, strokes, and deaths in higher risk patients such as those with diabetes or established heart disease. And they have minimal side effects.

In fact, the American Heart Association recommends that low-risk patients with high cholesterol consider taking a statin if lifestyle changes, such as increased exercise or weight loss, don’t work to bring cholesterol levels down.

But the Cochrane review study – written by British researchers – calls that practice into question, highlighting “shortcomings” in studies that found clear benefits in anyone who took statins to lower high cholesterol levels.

“The potential adverse effects of statins among people at low risk of [cardiovascular disease] CVD are poorly reported and unclear,” the authors wrote.

Other experts, though, disagree. “I think they make grand pronouncements that are wrong,” says Dr. Chris Cannon, a cardiologist at Brigham and Women’s Hospital who participated in another recent review study of statin use in low-risk patients published in the November issue of Lancet. (Cannon has accepted research grants from statin manufacturers and served on an advisory board for Bristol-Myers Squibb, which makes the statin Pravachol.)

The Lancet study found that high-risk and low-risk patients who take statins to lower their cholesterol can reduce their risk of having a heart attack, stroke, or heart procedure by 25 percent.

In absolute risk terms, statin users who don’t have heart disease would lower their yearly risk of having heart complications from 1.8 percent to 1.4 percent. Those who have already been diagnosed with heart disease would lower their yearly risk from 5.6 percent to 4.5 percent – and those with type 2 diabetes from about 5 percent to about 4 percent.

The lower your heart disease risk, the smaller the benefits you’ll receive from statins. That means the risk of side effects will play a greater role in determining whether you should take the drug. The Cochrane report found that statins didn’t increase the risk of cancer and posed a small risk of rhabdomyolysis, a serious condition involving the breakdown of muscles.

The biggest side effect, severe muscle soreness, occurs in about 3 to 5 percent of users, though some research indicates the incidence may be higher in women and for those who take higher doses or more potent statins.

Medicine is the best medicine; help patients keep taking it

December 07, 2010 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: Boston Globe, 12.3.2010

Patients who don’t take their medications are a well-documented problem in medicine. If doctors are to spot patients who might stop complying with prescriptions, it’s vital to have a fuller understanding of why and how it happens.

As many as 40 to 60 percent of those with chronic conditions like high blood pressure, heart failure, or diabetes don’t take their medicines regularly. The reasons vary – some patients never fill their prescriptions; others feel better and stop their drug regimens; in still other cases, side effects or the burden of too many pills discourage patients from refilling their prescriptions. Whatever the motive, failing to take needed drugs leads to worse health and higher spending, as patients land in the hospital for preventable conditions that cost the health care system hundreds of millions of dollars a year.

But a new study this month in the Annals of Internal Medicine, by researchers at Brigham and Women’s Hospital and Harvard Medical School, shines the spotlight on another contributor: Patients not picking up prescriptions that have already been filled.

The analysis, funded by CVS Caremark, looked at over 10 million prescriptions filled over a 3-month span in 2008 and found that 3.3 percent were never picked up. The number seems small, but translates to 110 million abandoned prescriptions per year in the United States. It costs a pharmacy an estimated $5 to $10 to prepare, then return to the shelves, an unclaimed medication, so the authors estimate the problem could be costing more than $500 million a year. CVS Caremark has a clear interest in bringing that number down – but so do patients and doctors.

The problem could worsen as technology evolves: Prescriptions sent electronically were 65 percent more likely to be left behind, probably because they bypass the step of having the patients hand- deliver a slip to the pharmacist. As electronic prescribing continues to take hold nationwide, insurers should be vigilant that prescription fill rates may reflect compliance less accurately than with traditional prescriptions.

Not surprisingly, prescriptions with $40 to $50 copays were the most likely to be abandoned. According to William Shrank, the study’s main author, this means that during economically hard times “even insured patients are experiencing sticker shock, and walking away from the pharmacy, without filling essential medications.”

Doctors are unlikely to know their patients’ copays for drugs, but taking the time to talk about drug costs would help them identify those who might never pick up their prescriptions. Down the road, those extra minutes of chat time at the office become multiple dollars saved at the hospital bedside.

The myth of the perfect drug

June 28, 2010 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News

www.Medtipster.com Source: The Boston Globe – Christoph Westphal, 6/28/2010

If we focus too much on side effects, we might forfeit important new medications

WHEN IT comes to prescription drugs, patients expect benefits but appear intolerant of risks. What would happen in a world that accepts no risks in its pharmaceuticals? We would have very empty medicine cabinets.

Every June, 200 biotech and pharmaceutical CEOs gather in Boston. This year, the deputy commissioner of the Food and Drug Administration spoke to the group on the evolving risk-benefit analysis regarding prescription drugs. Much of the ensuing dialogue with the CEOs centered on society’s changing views of drug benefits and risks.

The first “wonder drug,” aspirin, was synthesized by Bayer in 1897 and marketed in 1899. This extremely rapid path from initial experiments to market is impossible to imagine in today’s world. Now, aspirin has some wonderful properties – it reduces inflammation, prevents blood from clotting, lowers fever, and lessens pain. Millions of Americans take aspirin every year, without a doctor’s prescription. However, side effects kill roughly 10 out of 100,000 men taking aspirin. In fact, it is possible that aspirin would not be approved today by the FDA, so dramatic is the shift in society’s risk-benefit views regarding pharmaceutical products.

That shift spelled the doom a few years ago of another drug with significant benefit, but some risk, namely Vioxx. Merck had shown beneficial effects of Vioxx in severe arthritis in thousands of patients, and the drug was approved. After Vioxx reached the market, however, the risk of death from heart attack, estimated by independent academics to be on the order of 20 to 30 out of 100,000 patients taking the drug, led Merck to remove Vioxx from the market. There are likely patients with severe arthritis who would accept the risk of side effects, in order to benefit from this effective medicine. But these patients no longer are able to make their own risk-benefit calculations. Instead, society has determined on their behalf that this therapeutic option should no longer be available to them.

How dangerous, in comparison to taking aspirin or Vioxx, is driving a car? According to the National Safety Council, the risk of dying in a car accident during one year is about 155 out of 100,000. The death rate of car usage actually appears a good deal higher than the likelihood of death caused by taking Vioxx or aspirin. Nevertheless, no one is arguing that cars should be taken off the market. Instead, society has decided that the benefits of cars outweigh their risks.

As society has shifted to a view that medications should have virtually no risks, the inevitable effect has been to reduce the flow of important new drugs. It is certainly fair to rigorously test any new medication prior to approval. In addition, any new drugs should be monitored for safety and efficacy after they have reached the market.

But society must be careful to weigh the benefits of effective new drugs for diseases that until now have been poorly treated, versus the added risks of the new medications. If we focus too much on the risks of drugs, and do not balance those risks against the benefits, fewer drugs will be approved and reach patients in need. That is a risk in and of itself.

On your next drive, remember that it may be riskier to get in your car than to take the drug Vioxx, which was shown to be highly beneficial to patients with severe arthritis, but has been removed from the market.

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