Outcomes research and drug development.

With increasing health care cost, focus needs to be given towards value-for-money, especially in the context of innovative drugs. A multi-disciplinary approach towards drug development is important in order to demonstrate the value of innovation to physicians and patients. Input into the drug development process at various stages of clinical trials must incorporate patient-focused endpoints and analyses.

Cost-effectiveness of linezolid versus vancomycin for hospitalised patients with complicated skin and soft-tissue infections in Germany.

This study used a decision analytic model approach to evaluate the cost-effectiveness of linezolid versus vancomycin in the empirical treatment of complicated skin and soft-tissue infection (cSSTI) due to suspected methicillin-resistant Staphylococcus aureus (MRSA) from the German hospital and health care system perspective. Clinical probabilities were obtained from trial data, resource utilisation and MRSA prevalence rates were obtained through German physician interviews, and costs from published sources were applied to resource units. Outcomes included total cost/patient and cure.

Cost-effectiveness study comparing cefoperazone-sulbactam to a three-drug combination for treating intraabdominal infections in an Indian health-care setting.

Objective: This article presents the methodology and results of the pharmacoeconomic analysis of the Magnex Against Standard COmbination Therapy study comparing cefoperazone-sulbactam (Magnex) versus ceftazidime+ amikacin+metronidazole, in the treatment of intra-abdominal infections.

Methods: This prospective, open label, phase IV study was conducted at 17 study sites in India and randomized subjects to receive either cefoperazone-sulbactam or the combination. Pharmacoeconomic analysis was included as a secondary objective and conducted in the clinical efficacy-evaluable (CEE) and the successfully treated patients.

Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States.

Purpose: We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR.

Materials And Methods: This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment.

Results: Compared with the placebo group (125 patients, mean age +/- SD 55 +/- 13 years, mean years ED 3.

Association between the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship Questionnaire following treatment with sildenafil citrate for men with erectile dysfunction.

Objectives: Research is lacking on the correlation between treatment satisfaction and confidence, self-esteem, and relationships for men receiving treatment for erectile dysfunction (ED). We sought to correlate scores between the validated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index and the validated Self-Esteem And Relationship (SEAR) questionnaire following treatment with sildenafil citrate (VIAGRA).

Methods: This study was based on an open-label, flexible-dose trial of 93 sildenafil-naive patients with ED.

Linezolid reduces length of stay and duration of intravenous treatment compared with vancomycin for complicated skin and soft tissue infections due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA).

We compared the health outcomes in patients treated with linezolid or vancomycin for complicated skin and soft tissue infections (cSSTIs). This analysis is part of a randomised, open-label, multinational trial involving 1200 adult patients hospitalised with cSSTIs due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Subjects received linezolid 600 mg intravenous (i.

Economic analysis of sildenafil citrate (Viagra) add-on to treat erectile dysfunction associated with selective serotonin reuptake inhibitor use.

The objective of this study was to compare the economic cost of adding sildenafil citrate (Viagra, Pfizer Inc., New York, NY) to treat selective serotonin reuptake inhibitor (SSRI)-induced erectile dysfunction with that of discontinuing antidepressant pharmacotherapy, switching patients to another SSRI, or adding a non-SSRI. Based on our real-world experience in an academic medical center, we performed an economic analysis of a hypothetical cohort of 1000 patients taking SSRIs on a course of acute and continuation treatment recommended by the American Psychiatric Association.

Treatment responsiveness of the Self-Esteem And Relationship questionnaire in erectile dysfunction.

Objectives: To determine the treatment responsiveness of the disease-specific Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction.

Methods: The SEAR questionnaire was administered at baseline and at the end of the study in 93 patients with erectile dysfunction enrolled in a 10-week, open-label, flexible-dose (50-mg sildenafil, adjustable to 25 mg or 100 mg) trial. Changes from the baseline score were analyzed using the paired t test.