Medical research finds link between bisphosphonates, irregular heartbeat
WINSTON-SALEM, N.C. New research at Wake Forest University School of Medicine released Monday evaluated the link between a common class of drugs used to prevent bone fractures in osteoporosis patients and the development of irregular heartbeat.
Researchers found that bisphosphonate use was associated with a significant increase in the incidence of “serious” heart rhythm disturbances, classified by hospitalization, disability or death resulting from the condition. However, when they included “non-serious” cases in their analysis, they found no overall increased risk of atrial fibrillation.
“Our findings were discordant, with conflicting results,” stated Sonal Singh, an assistant professor of internal medicine and lead investigator for the study. “The challenge now is to figure out what it all means.”
Early studies indicated that the use of bisphosphonates might cause problems with heart rhythm, or atrial fibrillation, which increases the risk for stroke or heart attack. For the study published this month, researchers analyzed the data from previous observational studies and clinical trials to determine the link between bisphosphonate therapy and irregular heart beat.
“Some trials show there could be a potential link between the use of bisphosphonates and the development of serious heart rhythm problems, but in our study the link wasn’t conclusive,” Singh said. “So we urge that additional investigations be conducted.”
Bisphosphonates, found in prescription drugs including Boniva (ibandronate sodium), Fosomax (alendronate), Reclast (zoledronic acid) and Actonel (risedronate sodium), inhibit the breakdown of bones, which reduces the risk of fractures, especially those of the spine and hips in older patients. The first such drugs were approved for use in the mid-1990s.
In the clinical trials reviewed, medical records of more than 13,000 patients who had osteoporosis or fractures and were given bisphosphonates were compared to the records of more than 13,000 patients who received a placebo during study participation. Researchers were looking for the incidence of irregular heartbeat first, and then stroke or death caused by stroke or heart attack as a secondary outcome. The patient files reviewed were primarily of women who were treated with bisphosphonates and were generally in their early 70s, according to the study.
“We found no risk of stroke and cardiovascular mortality in the trials,” Singh said. “That was very reassuring.”
Given these results, physicians should not change they way they prescribe the drugs for the majority of patients with osteoporosis, Singh said, and patients should not stop taking them. He cautioned, however, that patients with pre-existing heart conditions and those with risk factors for rhythm disturbance should be especially vigilant for the development of atrial fibrillation, and doctors should continue to closely monitor patients at risk for atrial fibrillation who are taking bisphosphonates.
The study’s findings appear in the current issue of Drug Safety, a publication of the International Society of Pharmacovigilance covering the safe and proper use of medicines.
U.S. Department of Health & Human Services releases PSAs to encourage healthy lifestyles
WASHINGTON The U.S. Department of Health and Human Services’ Office of the Surgeon General on Monday released two public service announcements, in English, “Take the Lead” and in Spanish, “Mi Cocina,” on childhood overweight and obesity prevention.
“Early intervention against overweight and obesity is crucial,” stated acting Surgeon General Steven Galson. “This is because children learn lifelong eating and activity habits at a young age.”
Both PSAs encourage families to be physically active and eat healthy foods. The new PSAs encourage adults to adopt and maintain healthy lifestyles to improve their personal health and set an example for children to follow. More than 12.5 million children and adolescents — 17.1% of people ages 2 to 19 years — are overweight. As they grow older, overweight children and adolescents are more likely to have risk factors associated with cardiovascular disease such as high blood pressure, high cholesterol, and Type 2 diabetes.
“To ensure a healthy future for America’s children we must help kids get the recommended 60 minutes or more of daily physical activity,” Galson said. “Using family time to help children develop good habits will benefit them now and throughout their lives.”
The National Public Health Information Coalition, an independent organization dedicated to improving America’s health through public health communications, will help distribute the PSAs to health departments nationwide and promote posting the announcements to the departments’ Web sites.
The PSAs will be featured beginning Monday on Washington, D.C.’s WUSA 9 as part of its Lighten Up Campaign, a partnership between Children’s National Medical Center, Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc. and WUSA 9, that brings attention to childhood obesity. In addition, the PSAs will be highlighted by Weight Watchers on www.weightwatchers.com.
In the “Take the Lead” PSA, children emulate the adults as they exercise, make healthy food choices, and practice good hygiene. The PSA closes with a message from Galson urging everyone to take a part in leading our youth to a healthy future. He also directs the audience to the Office of the Surgeon General’s web site to receive a parent or caregiver checklist. The Spanish PSA “Mi Cocina,” takes a family approach that encourages helpful tips on healthy eating. Both PSAs reinforce the importance of adults taking the lead in setting healthy examples.
Natrol introduces probiotic
CHATSWORTH, Calif. Natrol last week announced the launch of Natrol Probiotic Intestinal-Maximum Care, a probiotic that helps protect the lining of the gastrointestinal tract and supports gut immune defense mechanisms.
“Spring travel and holidays can be stressful on the mind and body and Natrol Probiotic Intestinal-Maximum Care allows consumers to enjoy holiday meals without worry of digestive upset, and it helps immune support, which is needed during times of stress,” stated Michael Yatcilla, Natrol VP research and development. “With clinically validated probiotic strains, Natrol Probiotic Intestinal-Maximum Care is a great solution for consumers, particularly seniors, menopausal women and people with digestive sensitivities.”
The supplement supports healthy immunity, digestion, food absorption and elimination, the company stated.
The new probiotic contains IntestiBiotic, a proprietary blend of four probiotic strains to help reduce oxidative stress and promote cellular health within the digestive tract. Suggested retail for a 10-capsule package is $16.99.