Adverse events associated with testosterone administration.

BACKGROUND: Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. METHODS: Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. RESULTS: A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. CONCLUSIONS: In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.)

Factors Associated with Readmission of Pediatric Patients in a Developing Nation.

OBJECTIVES: To determine the incidence of readmission in pediatric patients in a tertiary care hospital in a developing nation and to ascertain factors precipitating readmissions. METHODS: A prospective study was conducted from February 2016 through January 2017 at a tertiary care hospital. Children between 1 mo to 15 y of age were included if they were readmitted within 60 d of discharge. The risk factors for readmission were determined on the basis of medical record review and a structured questionnaire and the ascribed cause of readmission was grouped into three categories: Patient specific factors, Hospital specific factors and Unrelated/ New illness. RESULTS: The readmission rate was 3%, out of which 80.66% were found to be causally related to the index admission. Several sociodemographic characteristics i.e. lack of health information like television, lower socioeconomic status, absence of adequate breastfeeding, lower age, migrants were found to be significantly associated with readmission along with other patient specific factors like presence of cardiac disease, presence of comorbid conditions like anemia, malnutrition, and global developmental delay. The most important cause for readmission was determined as patient specific (48.66%) followed by hospital specific (38%) and unknown/unrelated factors (13.33%). CONCLUSIONS: The progression of the primary illness and social determinants of pediatric readmissions are important contributing risk factors for readmission in developing countries in pediatric patients. Multicentric studies are needed from this region of the world to include different hospital readmissions rate and to address the issue of potential preventability of pediatric readmissions.