CHICAGO—The antidepressant medication sertraline is an effective and well-tolerated short-term treatment for children and adolescents with major depressive disorder (MDD), according to an article in the August 27 issue of The Journal of the American Medical Association (JAMA).

According to the article, up to 3 percent of children and 8 percent of adolescents have MDD. The lifetime likelihood of having depression for youths aged 15 to 18 years old has been estimated at 14 percent to 15 percent - rates comparable with those of adults. Selective serotonin reuptake inhibitors (SSRIs) are safe, effective and well tolerated by adults, but their safety and efficacy has not been well established in depressed children and adolescents.

Karen Dineen Wagner, M.D., Ph.D., of University of Texas Medical Branch, Galveston, Texas, and colleagues studied the efficacy and safety of sertraline (an SSRI drug) compared with placebo on 376 children and adolescents with MDD aged 6 to 17 years old. The children and adolescents were participants in two multi-center randomized, double-blind, placebo-controlled trials conducted at 53 hospitals, general practice, and academic centers in the United States, India, Canada, Costa Rica and Mexico between December 1999 and May 2001. The results from these two trials were pooled for the current study.

Participants were randomly assigned to take either a flexible dosage (50 - 200 milligram per day) of sertraline (n=189) or placebo (n=187) for 10 weeks. Changes in their depression (based on the Children's Depression Rating Scale - Revised [CDRS-R scores]) were used to evaluate the effects of the drug or placebo.

The researchers found that the children and adolescents assigned to the sertraline group experienced statistically significant greater improvements in their depression compared to participants taking placebo at week 10 of treatment. Based on CDRS-R scores, 69 percent of sertraline-treated patients compared with 59 percent of placebo treated patients were considered responders. Sertraline was generally well tolerated. Seventeen sertraline-treated patients (9 percent) and 5 placebo patients (3 percent) discontinued the study because of adverse events including diarrhea, vomiting, anorexia and agitation.

CHICAGO—A lower dosage of estrogen than conventionally prescribed for hormone therapy increases bone density in older women without the adverse effects typically associated with estrogen therapy, according to an article in the August 27 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, osteoporosis is a major cause of disability and death in older women. Although estrogen therapy (a hormone therapy) has been shown to be effective in treating and preventing osteoporosis, many older women may be reluctant to take this drug because of adverse effects reported by the Women's Health Initiative. That report showed that women who took hormone therapy (as estrogen plus progesterone) for approximately 7 years had decreased risk of hip fracture, but increased risk for breast cancer, heart disease, stroke and deep vein blood clots.

Karen M. Prestwood, M.D., of the University of Connecticut Health Center, Farmington, Conn., and colleagues investigated the effects of lower doses of estrogen (approximately one quarter of the dosage used in conventional hormone therapy) on bone loss in healthy post-menopausal women.

The researchers conducted a randomized, double-blind, placebo-controlled clinical trial from July 24, 1998 through June 14, 2002 with 167 women older than 65 years old at the beginning of the study. The women were randomly assigned to receive either 0.25 milligrams per day of micronized 17beta-estradiol (n=83) or placebo (n=84). The researchers measured bone mineral density (BMD) of the hip, spine, wrist and the total body every year for 3 years. They also measured biochemical markers of bone resorption (leaching of calcium from the bones) and bone formation at the beginning of the study, at 3 months into the study and during the first and third year of treatment.

The researchers found that the average BMD increased at all the sites measured for patients taking the low-dose estrogen compared with patients taking placebo. Participants taking the low-dose estrogen had BMD increases of 2.6 percent in the femoral neck, 3.6 percent in the hip, 2.8 percent in the spine, and 1.2 percent in the total body measurement. Biochemical markers indicating bone loss were significantly decreased in participants taking the low-dose estrogen compared to the placebo group.

The researchers also found that adverse effects were similar in both the estrogen group and the placebo group.

CHICAGO—A newly developed risk score can be used for patients with new onset of atrial fibrillation to estimate their risk of stroke or death, according to an article in the August 27 issue of The Journal of the American Medical Association (JAMA).

According to background information in the article, atrial fibrillation (AF; abnormal irregular heart rhythm) is the most common cardiac rhythm disturbance, affecting more than 2 million individuals in the United States. As the population ages and the prevalence of cardiovascular disease increases, the occurrence of this arrhythmia is expected to increase. Patients with AF have a 5- to 6-fold increased risk of stroke, and numerous studies have attempted to define clinical criteria that may be used to classify patients with AF as being at low or high risk. Such risk stratification may aid in estimating prognosis and in selecting appropriate candidates for therapies such as warfarin (a blood thinner used to help prevent stroke).

Thomas J. Wang, M.D., of the Framingham Heart Study, Framingham, Mass., and colleagues derived clinical risk scores for patients with AF, focusing on 2 outcomes: stroke alone and stroke or death. The study included 868 participants of the Framingham Heart Study who had new onset AF, 705 of whom were not treated with warfarin at baseline. Risk scores for subsequent stroke (ischemic or hemorrhagic) and stroke or death were developed.

During a mean follow-up of 4.0 years free of warfarin use, stroke alone occurred in 83 participants and stroke or death occurred in 382 participants. "A risk score for stroke was derived that included the following risk predictors: advancing age, female sex, increasing systolic blood pressure, prior stroke or transient ischemic attack, and diabetes. With the risk score, 14.3 percent of the cohort had a predicted 5-year stroke rate of 7.5 percent or less (average annual rate 1.5 percent or less), and 30.6 percent of the cohort had a predicted 5-year stroke rate of 10 percent or less (average annual rate of 2 percent or less). Actual stroke rates in these low-risk groups were 1.1 and 1.5 per 100 person-years, respectively. Previous risk schemes classified 6.4 percent to 17.3 percent of subjects as low-risk, with actual stroke rates of 0.9 to 2.3 per 100 person-years," they write.

"These risk scores can be used to estimate the absolute risk of an adverse event in individuals diagnosed with AF, which may be helpful in counseling patients and in making treatment decisions," the researchers write. "Our data indicate that although AF is associated with a high overall risk of stroke or death, risk factors can be used to easily stratify patients at particularly high or low risk."

The authors add that it will be important to test the performance of this risk score in other cohorts.

PRESCRIPTION ANTI-DEPRESSANT EFFECTIVE AND SAFE FOR DEPRESSED CHILDREN AND TEENS