News in brief - April 12, 2004

Osteoporosis drug cuts fracture risk - FDA broadens antidepressant warnings - Explanation for why viruses make asthma worse? - Most schizophrenics don't take meds, raising health care costs

Osteoporosis drug cuts fracture risk

Alendronate, a widely prescribed drug for treating osteoporosis, was found to be safe and to effectively reduce fracture risk among a group of postmenopausal women who took it continuously for 10 years, according to a study published in the March 18 New England Journal of Medicine.

Alendronate, marketed as Fosamax, was the first orally active bisphosphonate introduced in the United States for the treatment of osteoporosis. It is marketed by Merck, which also funded the study.

Henry G. Bone, MD, director of the Michigan Bone and Mineral Clinic, and colleagues began the study in 1991 as a three-year examination of 994 postmenopausal women ages 44 to 84. They continued to track 247 participants for the additional years, dividing them into groups that took 5 mg, 10 mg or 20 mg of Fosamax daily. The 20 mg group was changed to 5 mg for three years and then to a placebo for five years.

The women also received 500 mg of calcium daily and were permitted, but not required, to take vitamin D supplements.

Osteoporosis takes an enormous toll among postmenopausal women, said Gordon J. Strewler, MD, an internist at Beth Israel Deaconess Medical Center in Boston, in an accompanying article. One woman in three and one man in nine older than age 80 will sustain a hip fracture at some point, and 15% to 20% of these patients will die from complications, he wrote.

FDA broadens antidepressant warnings

The Food and Drug Administration has broadened its warnings on antidepressants to include adults as well as children and teens among those who must be carefully monitored for worsening depression and suicidal thoughts.

Patients should be watched especially closely at the beginning of therapy with any one of several antidepressants and when the dose is either increased or decreased, said the March 22 FDA public health advisory.

The drugs that are the focus of the new warning include Prozac, (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram); Wellbutrin (bupropion); Effexor (venlafaxine); Serzone (nefazodone) and Remeron (mirtazapine).

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric, according to the FDA.

If any such symptoms should worsen or newly emerge, the FDA recommends reevaluating the use of the medication. If a decision is made to stop treatment, the FDA recommends that the medication be tapered off rather than stopped abruptly.

Explanation for why viruses make asthma worse?

Viral infections may exacerbate asthma by changing the expression of the receptors in the lung surface cells, according to a paper published in the December 2003 Journal of Biological Chemistry.

The fact that viruses can worsen asthma has been long established but never fully explained.

In order to solve this puzzle, researchers at the University of Iowa, Iowa City, exposed cell models to the respiratory syncytial virus. RSV increased the number of Toll-4 receptors on the airway cells. These receptors can act as a foothold for endotoxin found in household dust and cause additional inflammation that could constrict the airways of asthmatics.

"This could explain the viral-induced asthma exacerbations seen in people with asthma," said Martha Monick, lead author and senior research assistant in the division of pulmonary, critical care and occupational medicine in the university's Dept. of Internal Medicine.

The team plans to test the hypothesis in human subjects and animal models in the future.

Most schizophrenics don't take meds, raising health care costs

A majority of patients with schizophrenia don't take their medication as they should and the patients who are not adherent cost the health care system thousands of dollars, according to a study published in the April American Journal of Psychiatry.

Researchers at the University of California, San Diego, School of Medicine analyzed Medicaid eligibility claims data from 1998-2000 for the local area. They found that 41% of those with the illness took their medication as recommended. Another 24% didn't comply at all, and 17% took some. About 19% took more than they should. These "excess fillers" were the most expensive patients costing $14,000 more than compliant patients -- mostly for hospitalizations, although the figure also included the cost of the extra medication. Those who took their medicine as directed had substantially lower hospitalization costs, although their medication costs were higher than those who took less than they should or none at all.

The researchers hope that this information will create an incentive for those paying for the care of these patients to prioritize tight control of the disorder.

"Estimating the medical costs of nonadherence might also provide an incentive for insurers to allocate resources to improve adherence in patients with schizophrenia," said Dilip Jeste, MD, senior author and professor of psychiatry and neurosciences.