OBJECTIVE -This study evaluated the efficacy and safety of vardenafil treatment for erectile dysfunction (ED) in men with diabetes.RESEARCH DESIGN AND METHODS -In this prospective multicenter double-blind placebo-controlled fixed-dose parallel-group phase III trial, 452 patients with diabetes (type 1 or type 2) and ED were randomized to take 10 or 20 mg vardenafil or placebo as needed for 12 weeks. Efficacy responses were assessed by International Index of Erectile Function domain scores, rates of vaginal penetration and successful intercourse, and a global assessment question (GAQ) about erection improvement during the previous 4 weeks. RESULTS-After 12 weeks of treatment, a dose-dependent (P ϭ 0.02) improvement in erections was noted for the GAQ, with 57 and 72% of men taking 10 mg or 20 mg vardenafil, respectively, reporting improved erections, in contrast to 13% after taking placebo (P Ͻ 0.0001). For the erectile function domain, dose-dependent (P ϭ 0.03) final scores for the 10-and 20-mg dose were 17.1 and 19.0 compared with 12.6 for placebo (P Ͻ 0.0001). Both vardenafil doses significantly enhanced the rates of successful penetration (P Ͻ 0.0001) and successful intercourse (P Ͻ 0.0001) compared with placebo. Vardenafil treatment was effective in increasing intercourse success rates at all levels of baseline ED severity, at each level of plasma HbA 1c , and for type 1 and 2 diabetes. Treatment-emergent adverse events were primarily mild to moderate headache (Յ13%), flushing (Յ10%), and rhinitis (Յ10%).CONCLUSIONS -Vardenafil statistically improved erectile function and was generally well tolerated in these diabetic patients with ED. Diabetes Care 26:777-783, 2003E rectile dysfunction (ED), the consistent or recurrent inability to attain and/or maintain a penile erection sufficient for sexual performance (1), can have a significant effect on a patient's quality of life (2-4). ED is a common complication of diabetes because Ͼ50% of diabetic men develop ED within 10 years of being diagnosed with diabetes (5). The prevalence of ED increases with age, from 9% in diabetic men ages 20 -29 years to 95% in diabetic men Ͼ70 years (5), and increases with duration, poor control, and complications of diabetes (such as vascular and microvascular disease and neuropathies) (6).Diabetic men with ED tend to be less responsive to treatment perhaps because the pathogenesis of diabetes-associated ED is likely to be multifactorial (7,8). Although treatment with phosphodiesterase type 5 (PDE5) inhibitors is less effective in the diabetic patient than in the nondiabetic ED patient, the convenience of an orally formulated PDE5 inhibitor has popularized treatment in a large number of men with diabetes and ED (9,10).Vardenafil, a new PDE5 inhibitor, is more selective for PDE5 and more biochemically potent than sildenafil in in vitro and in vivo studies when tested under the same conditions (11-13). These properties suggest that vardenafil may be a highly efficacious oral treatment in the difficult-to-treat ED patients with diabetes. ...

Low-density lipoprotein cholesterol reductions of about 25% to 30% can be achieved with low-dose combination therapy with fluvastatin and cholestyramine. The addition of low-dose resin appears to produce greater overall cholesterol reduction than does a simple doubling of the fluvastatin dosage. The low-dose combination treatment was highly successful in achieving the goals of the National Cholesterol Education Program guidelines.