Should Endovascular Repair Be Reimbursed for Low Risk Abdominal Aortic Aneurysm Patients? Evidence from Ontario, Canada

Background. This paper presents unpublished clinical and economic data associated with open surgical repair (OSR) in low risk (LR) patients and how it compares with EVAR and OSR in high risk (HR) patients with an AAA > 5.5 cm. Design. Data from a 1-year prospective observational study was used to compare EVAR in HR patients versus OSR in HR and LR patients. Results. Between 2003 and 2005, 140 patients were treated with EVAR and 195 with OSR (HR: 52; LR: 143). The 1-year mortality rate with EVAR was statistically lower than HR OSR patients and comparable to LR OSR patients. One-year health-related quality of life was lower in the EVAR patients compared to OSR patients. EVAR was cost-effective compared to OSR HR but not when compared to OSR LR patients. Conclusions. Despite a similar clinical effectiveness, these results suggest that, at the current price, EVAR is more expensive than open repair for low risk patients

Double blind randomized placebo-controlled trial on the effects of testosterone supplementation in elderly men with moderate to low testosterone levels: design and baseline characteristics [ISRCTN23688581]

In ageing men testosterone levels decline, while cognitive function, muscle and bone mass, sexual hair growth, libido and sexual activity decline and the risk of cardiovascular diseases increase. We set up a double-blind, randomized placebo-controlled trial to investigate the effects of testosterone supplementation on functional mobility, quality of life, body composition, cognitive function, vascular function and risk factors, and bone mineral density in older hypogonadal men. We recruited 237 men with serum testosterone levels below 13.7 nmol/L and ages 60–80 years. They were randomized to either four capsules of 40 mg testosterone undecanoate (TU) or placebo daily for 26 weeks. Primary endpoints are functional mobility and quality of life. Secondary endpoints are body composition, cognitive function, aortic stiffness and cardiovascular risk factors and bone mineral density. Effects on prostate, liver and hematological parameters will be studied with respect to safety. Measure of effect will be the difference in change from baseline visit to final visit between TU and placebo. We will study whether the effect of TU differs across subgroups of baseline waist girth (< 100 cm vs. ≥ 100 cm; testosterone level (<12 versus ≥ 12 nmol/L), age (< median versus ≥ median), and level of outcome under study (< median versus ≥ median). At baseline, mean age, BMI and testosterone levels were 67 years, 27 kg/m(2 )and 10.72 nmol/L, respectively

Serum sex hormone and plasma homocysteine levels in middle-aged and elderly men

Objective: To investigate whether circulating levels of testosterone (total, bioavailable), estradiol (total, bioavailable), and DHEA sulfate (DHEAS) are associated with fasting plasma homocysteine (tHcy) levels in middle-aged and elderly men. Design: A population-based sample of 400 independently living men between 40 and 80 years of age in a cross-sectional study. Methods: Total testosterone, sex hormone binding globulin (SHBG), and total estradiol were measured by RIA methods and bioavailable testosterone and estradiol were calculated. DHEAS was measured using an immunometric technique. Fasting homocysteine was measured by fluorescence polarization immunoassay. Anthropometric characteristics were also measured and two standardized questionnaires completed, including life-style factors and diet. Linear regression analysis adjusted for age, body mass index (BMI), creatinine clearance, and mean visceral fat was used to assess the association of endogenous sex hormones and fasting plasma homocysteine levels. Results: After adjustment for age, BMI, creatinine clearance, and mean visceral fat no statistically significant association was observed between testosterone (total, bioavailable), DHEAS, and estradiol (total, bioavailable)levels with natural log tHcy (β = - 2 × 10-3; 95% confidence intervals (CI) - 9 × 10-3; 5 × 10-3), (β= -4 × 10-3; 95%CI -18 × 10-3; 9 × 10-3), (β= 3 × 10-3; 95%CI - 6 × 10-3; 12 × 10-3), (β= -9.3 × 10-5; 95% CI - 1 × 10-3; 1 × 10-3), and (β=0.00; 95% CI - 3 × 10-3; 2 × 10-3) respectively. Additional adjustment for smoking, alcohol intake, daily physical activity, diabetes mellitus, and hypertension did not change these findings. Conclusion: The results of our study do not support a direct role for circulating sex hormone levels in the regulation of fasting plasma tHcy concentrations in middle-aged and elderly men