Two articles: Osteoporosis drug Fosamax linked to heart problem

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Public release date:

28-Apr-2008http://www.eurekalert.org/pub_releases/2008-04/ghcc-odf042408.php

Contact:

hughes.r@...

Group Health ative Center for Health Studies

Osteoporosis drug Fosamax linked to heart problem

Finding from Group Health and University of Washington study

SEATTLE—Women who have used Fosamax are nearly twice as likely to

develop the most common kind of chronically irregular heartbeat (atrial

fibrillation) than are those who have never used it, according to

research from Group Health and the University of Washington published in

the April 28 Archives of Internal Medicine.

Merck markets Fosamax, the most widely used drug treatment for the

bone-thinning disease osteoporosis, explained study leader

Heckbert, MD, PhD, MPH, a professor of epidemiology and scientific

investigator in the Cardiovascular Health Research Unit at the

University of Washington. The Food and Drug Administration (FDA)

approved the first generic versions (called alendronate) in February.

“We studied more than 700 female Group Health patients whose atrial

fibrillation was first detected during a three-year period,” said Dr.

Heckbert. She and her colleagues compared those women to over 900

randomly selected female Group Health members matched on age and high

blood pressure to serve as controls.

“Having ever used alendronate was associated with an 86 percent higher

risk of newly detected atrial fibrillation compared with never having

used the drug,” said Dr. Heckbert, who is also an affiliate investigator

at the Group Health Center for Health Studies.

Osteoporosis mostly affects older women and can set the stage for

fractures that can impair the quality of their lives, said Dr. Heckbert.

“Careful judgment is required to weigh the risks and benefits of any

medication for any individual patient,” she added. “For most women at

high risk of fracture, alendronate’s benefit of reducing fractures will

outweigh the risk of atrial fibrillation.”

However, said Dr. Heckbert, “women who are at high risk of fractures but

also have risk factors for atrial fibrillation—such as heart failure,

diabetes, or coronary disease—might want to discuss alternatives to

alendronate with their health care providers.” Other medications that

can lower the risk of fractures include estrogen, she said. But the

Women’s Health Initiative, on which she has also served as an

investigator, showed other heart risks from hormone therapy combining

estrogen with progesterone.

The National Heart, Lung, and Blood Institute funds Dr. Heckbert’s

Atrial Fibrillation Study, which collects data on all Group Health

patients as they are first diagnosed with atrial fibrillation. The study

aims to find new factors that raise the risk of developing this

quivering of the heart’s upper chambers (atria).

About one in 100 people—and nearly nine in 100 people over age 80—have

atrial fibrillation, said Dr. Heckbert. In many cases, atrial

fibrillation has no symptoms, and it isn’t necessarily life threatening.

But it can cause palpitations, fainting, fatigue, or congestive heart

failure.

Atrial fibrillation can also make blood pool—and sometimes clot—in the

atria, said Dr. Heckbert. When parts of clots break off and leave the

atria, they can lead to embolic strokes, as happens in over 70,000

Americans a year. That’s why atrial fibrillation is often treated with

the anticoagulant warfarin. Other results from her study have suggested

that maintaining a healthy body weight may help protect people from

atrial fibrillation.

“This study will help medical teams better inform their patients about

the risks associated with Fosamax, helping us make the best treatment

decisions for managing osteoporosis,” commented Himes Fordyce,

MD, a Group Health family practitioner. “Now with this increased

understanding of potential irregular heartbeats, both physicians and

their patients should be alert to any problems, report them immediately,

and treat them appropriately.”

###

Group Health Center for Health Studies

Founded in 1947, Group Health is a Seattle-based, consumer-governed,

nonprofit health care system that coordinates care and coverage. For 25

years, the Group Health Center for Health Studies has conducted research

on preventing, diagnosing, and treating major health problems.

Government and private research grants provide its main funding.

Please visit the virtual newsroom on our Web site, www.ghc.org under

“Newsroom.”

============================================

Public release date: 28-Apr-2008

http://www.eurekalert.org/pub_releases/2008-04/jaaj-odm042408.php

Contact:

JAMA and Archives Journals

Osteoporosis drug may be associated with irregular heartbeat

Alendronate, a medication used to prevent fractures in women with

osteoporosis, may be associated with an increased risk of atrial

fibrillation, a type of abnormal heart rhythm, according to a report in

the April 28 issue of Archives of Internal Medicine, one of the

JAMA/Archives journals.

Other recent studies have reported atrial fibrillation as an unexpected

adverse effect of bisphosphonates, a class of drugs that includes

alendronate and other medications that affect the body’s calcium levels,

according to background information in the article. Atrial fibrillation

occurs when the atria, the smaller upper chambers of the heart, begin to

beat irregularly and rapidly.

R. Heckbert, M.D., Ph.D., of the University of Washington and

Group Health, Seattle, and colleagues studied 719 women with confirmed

atrial fibrillation that began between 2001 and 2004 and 966 control

women who were the same age but did not have atrial fibrillation.

More patients with atrial fibrillation than control patients had ever

used alendronate (47 or 6.5 percent vs. 40 or 4.1 percent). After

adjusting for other risk factors, having taken alendronate was

associated with a higher risk of atrial fibrillation compared with never

having taken any bisphosphonate. The researchers estimate that

approximately 3 percent of new atrial fibrillation cases in this

population may be attributed to alendronate use.

Bisphosphonates may disrupt the function of regulatory proteins, trigger

inflammation and cause small decreases in blood calcium and phosphate

levels, any of which could affect the chambers of the heart known as

atria and therefore alter the heartbeat, the authors note. “More

information is needed about whether bisphosphonates could have effects

on atrial tissue in the long term through these or other mechanisms that

favor the initiation or persistence of atrial fibrillation,” they write.

“In conclusion, all drugs have benefits and adverse effects,” the

authors continue. “When new information becomes available about a

previously unrecognized benefit or adverse effect, physicians and

patients must reweigh the current knowledge about benefits and risks in

making treatment decisions for each patient. The benefits of fracture

prevention in patients at high risk for fracture will generally outweigh

the possible risks of atrial fibrillation. However, it is important to

carefully weigh the benefits against the possible risk of atrial

fibrillation in women who have only modestly increased fracture risk and

in women who have risk factors for atrial fibrillation, such as diabetes

mellitus, coronary disease or heart failure.”

(Arch Intern Med. 2008;168[8]:826-831. Available pre-embargo to the

media at www.jamamedia.org.)

Editor’s Note: This study was supported by grants from the National

Heart, Lung and Blood Institute. Co-author Dr. Cummings has received

research support from Amgen, Novartis, Lilly, Pfizer and Zelos and

consulting fees and honoraria from Amgen, Novartis, Lilly, Zelos, Merck

and P & G-Aventis. Please see the article for additional information,

including other authors, author contributions and affiliations,

financial disclosures, funding and support, etc.

Editorial: Risks and Benefits of Medications Must Be Balanced

“The decision to treat an individual patient with a given medication for

a specific condition should be made with consideration of the risks

associated with no treatment and of the benefits, risks and adverse

effects of each therapy,” write Jane A. Cauley, Dr.P.H., and e E.

Ensrud, M.D., M.P.H, of the University of Pittsburgh, in an accompanying

editorial.

“It is often overwhelming for patients to fully understand the overall

risks and benefits associated with different therapies,” they continue.

“Some researchers have suggested that a more quantitative presentation

of risks and benefits in terms of absolute risk reduction, relative risk

reduction or the numbers needed to treat will improve patient

understanding and facilitate shared decisions.

“Future research should evaluate the effectiveness of such strategies in

presenting risks and benefits of therapies on patient understanding,

compliance and risk of health outcomes,” they conclude.

(Arch Intern Med. 2008;168[8]:793-795. Available pre-embargo to the

media at www.jamamedia.org.)

Editor’s Note: Dr. Cauley has received research support from Merck &

Co., Eli Lilly & Co., Pfizer Pharmaceuticals and Novartis

Pharmaceuticals; has received consulting fees from Eli Lilly & Co. and

Novartis Pharmaceuticals; and is on the speaker’s bureau for Merck & Co.

Inc. Please see the article for additional information, including author

contributions and affiliations, financial disclosures, funding and

support, etc.

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