[Press release] Taking statins to lower cholesterol? New guidelines

From the 4 February 2014 Mayo Clinic Press Release

ROCHESTER, Minn. — Feb. 4, 2014 — Clinicians and patients should use shared decision-making to select individualized treatments based on the new guidelines to prevent cardiovascular disease, according to a commentary by three Mayo Clinic physicians published in this week’s Journal of the American Medical Association.

Journalists:  Sound bites with Dr. Montori are available in the downloads.

Shared decision-making is a collaborative process that allows patients and their clinicians to make health care decisions together, taking into account the best scientific evidence available, as well as the patient’s values and preferences.

In 2013, the American College of Cardiology and the American Heart Association issued new cholesterol guidelines, replacing previous guidelines that had been in place for more than a decade. The new guidelines recommend that caregivers prescribe statins to healthy patients if their 10-year cardiovascular risk is 7.5 percent or higher.

“The new cholesterol guidelines are a major improvement from the old ones, which lacked scientific rigor,” says primary author Victor Montori, M.D., Mayo Clinic endocrinologist and lead researcher in the Knowledge and Evaluation Research Unit. “The new guidelines are based upon calculating a patient’s 10-year cardiovascular risk and prescribing proven cholesterol-lowering drugs — statins — if that risk is high.”

However, Dr. Montori cautions that the risk threshold established by the guideline panel is somewhat arbitrary. Instead he recommends that patients and their clinicians use a decision-making tool to discuss the risks and benefits of treatment with statins.

“Rather than routinely prescribing statins to the millions of adults who have at least a 7.5 percent risk of having a heart attack or stroke within 10 years, there is an opportunity for clinicians and patients to discuss the potential benefits, harm and burdens of statins in order to arrive at a choice that reflects the existing research and the values and context of each patient,” he says.

“We’re creating a much more sophisticated, patient-centered practice of medicine in which we move the decision-making from the scientist to the patient who is going to experience the consequences of these treatments and the burdens of these interventions,” Dr. Montori explains. “Decision-making tools can democratize this approach and put it in the hands of millions of Americans who have their own goals front and center in the decision-making process.”

Additional authors of the commentary include Henry Ting, M.D., and Juan Pablo Brito Campana, M.B.B.S., both of Mayo Clinic.

 

Experts Question Whether Preventive Drugs Are Value For Money

[For an overview of Cochrane Reviews, click here]

From the 19 April Medical News Today article

Experts today challenge the view that popular drugs to prevent disease – like statins and antihypertensives to prevent heart disease andstroke, or bisphosphonates to prevent fractures – represent value for money.

In a paper published on bmj.com[full text] today, Teppo Järvinen and colleagues argue that the benefits seen when these drugs are tested in clinical trials may not apply in the real world.

They argue that value for money in real life clinical practice is likely to be much lower than in a clinical trial, where patients are carefully selected and receive special attention from dedicated staff. “This gap between the ideal and clinical circumstances raises the question of how well our most widely used preventive drugs work in real life,” they write. ….

…although there are claims that important preventive drugs such as statins, antihypertensives, and bisphosphonates are cost effective, there are no valid data on the effectiveness, and particularly the cost effectiveness, in usual clinical care,” they say.

Despite this dearth of data, they point out that the majority of clinical guidelines and recommendations for preventive drug therapy rest on these claims.

The authors argue that before claims on cost effectiveness can be used to guide treatment policies and practices, it should be adequately proven by testing in a real-world setting. …

Related Articles

• Clinical Trials: Crafting the Label (biostrategics.wordpress.com)
• Prescriptions – Good or Bad? (georgevanantwerp.com)
• Regulatory requirements: differences or similarities between FDA and EMA? (sopwriting.wordpress.com)
• Generics Dominate Scripts in 2010
        In 2010, generics captured 78% of the total market share for prescriptions, up from 63% in 2006
• Dietary Calcium And Supplements Recommended Instead Of Bone-Building Meds (Medical News Today, May 3, 2011)
• Statins and bone drugs ‘not cost effective’ (telegraph.co.uk)