Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors.

Previous studies established the efficacy of once-daily tadalafil for men with erectile dysfunction. However, no trial has focused on the effects of such treatment on men without previous experience using oral phosphodiesterase type 5 inhibitors. Patients were randomized (2:1) to once-daily tadalafil 5 mg (with possible down-titration to 2.

Exenatide twice daily versus glimepiride for prevention of glycaemic deterioration in patients with type 2 diabetes with metformin failure (EUREXA): an open-label, randomised controlled trial.

Background: Glycaemic control deteriorates progressively over time in patients with type 2 diabetes. Options for treatment escalation remain controversial after failure of first-line treatment with metformin. We compared add-on exenatide with glimepiride for durability of glycaemic control in patients with type 2 diabetes inadequately controlled by metformin alone.

A randomized phase II trial of sequential gemcitabine plus vinorelbine followed by gemcitabine plus ifosfamide versus gemcitabine plus cisplatin in the treatment of chemo-naive patients with stages III and IV non-small cell lung cancer (NSCLC).

Background: Third-generation platinum-based combinations are established as first-line treatment for advanced non-small cell lung cancer (NSCLC). Non-platinum regimens could be an alternative if they show similar efficacy with better tolerability. This randomized phase II trial compared the objective tumor response rate (ORR) of sequential gemcitabine plus vinorelbine followed by gemcitabine plus ifosfamide versus gemcitabine plus cisplatin.

The effect of raloxifene after discontinuation of long-term alendronate treatment of postmenopausal osteoporosis.

Objective: The aim of this study was to compare bone mineral density (BMD) and biochemical markers of bone turnover in patients receiving long-term alendronate therapy who continued alendronate, were switched to raloxifene, or discontinued antiresorptive therapy.

Design, Patients, And Interventions: Ninety-nine ambulatory women who were diagnosed with postmenopausal osteoporosis and treated with alendronate (10 mg/d) for a mean period of 43 months were randomized to double-blind raloxifene (60 mg/d; n = 33), placebo (n = 33), or continuation of open-label alendronate (n = 33) for 12 months. Patients continued their assigned treatment in a subsequent 12-month, open-label extension phase.

Antipsychotic treatment and sexual functioning in first-time neuroleptic-treated schizophrenic patients.

The present study examined sexual functioning among first-time treated schizophrenia patients at the time that they initiated antipsychotic treatment, and again 3 and 6 months later. These first-time treated patients comprise a subgroup of 570 schizophrenia patients who were part of a cohort of 7,655 patients enrolled in the Intercontinental Schizophrenia Outpatient-Health Outcomes observational study (IC-SOHO). As part of a brief clinical assessment conducted at entry to the study, and after 3 and 6 months of antipsychotic medication, patients were asked to rate their sexual functioning, and the investigator was asked to rate the extent to which the patient had neuroleptic-related loss of libido and sexual dysfunction.

Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction.

Objective: Tadalafil (Cialis) is an inhibitor of phosphodiesterase type 5, which mediates relaxation of vascular smooth muscle in the corpus cavernosum thus facilitating erection. The purpose of this multicentre, randomized, double-blind, parallel group, placebo-controlled study was to evaluate efficacy and treatment satisfaction of on-demand Cialis in men with mild-to-severe erectile dysfunction (ED).

Methods: Following a 4-week treatment-free run in period, patients stratified into three severity groups by the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score were randomized to receive either placebo or Cialis 20 mg taken on demand over a 12-week period.

The Comparative Peripheral Anticholinergic-Like Adverse Event Profiles of Olanzapine and Risperidone.

OBJECTIVE: To test the hypothesis that reported in vitro muscarinic receptor affinity differences between olanzapine and risperidone would be reflected in peripheral solicited anticholinergic adverse event frequencies. METHOD: Data from a double-blind, randomized trial of olanzapine versus risperidone in 339 patients (age range, 18-65 years) with DSM-IV schizophrenia spectrum acute psychosis were retrospectively analyzed. Subgroups based on the median of the mean daily drug dose were constructed (olanzapine 17 mg; risperidone 6 mg).

Survival advantage associated with heterozygous factor V Leiden mutation in patients with severe sepsis and in mouse endotoxemia.

Sepsis is associated with systemic inflammation, coagulopathy, and disrupted protein C (PC) pathway function. The effect of prothrombotic polymorphism, factor V Leiden (Arg506Gln; FV Leiden), was examined in a large clinical trial (PROWESS) of severe sepsis and a mouse endotoxemia model. In PROWESS, 4.

Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: data from the PROWESS trial.

Objective: Based on the results of the PROWESS trial the European Agency for the Evaluation of Medicinal Products has recently approved drotrecogin alfa (activated) for treatment of adult patients with severe sepsis and multiple-organ failure. We report study's data on efficacy and safety in patients with multiple-organ dysfunction.

Design And Setting: Randomized, double-blind, placebo-controlled, multicenter trial in 164 medical centers.

Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial.

Objective: To assess morbidity in patients with severe sepsis managed with and without drotrecogin alfa (activated).

Design: Analysis of secondary end points in a prospective, randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (PROWESS).

Setting: A total of 164 medical institutions in 11 countries.

Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis.

Objective: To assess the cost-effectiveness of drotrecogin alfa (activated) therapy, which was recently shown to reduce mortality in severe sepsis.

Design: Estimates of effectiveness and resource use were based on data collected prospectively as part of a multicenter international trial. Estimates of hospital costs were based on a subset of the patients treated in the United States (33% of all enrolled patients).