Structured Benefit-Risk Assessment Across the Product Lifecycle: Practical Considerations.

Background: Assessing the benefit-risk profile of a medicinal product is a complex but fundamental activity that sponsors and regulators must perform throughout the product's lifecycle. In order to improve the transparency and consistency of the decision-making process, regulators and sponsors alike are increasingly applying a structured approach to benefit-risk assessment. However, to our knowledge, there has been little practical guidance in the published literature regarding how to embed such a process organizationally.

The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point.

Effects of venlafaxine extended release on resilience in posttraumatic stress disorder: an item analysis of the Connor-Davidson Resilience Scale.

The aim was to evaluate the efficacy of venlafaxine extended release (ER) on characteristics of resilience, measured by the Connor-Davidson Resilience Scale, in patients with posttraumatic stress disorder (PTSD). Data were evaluated from a randomized, 6-month, international, multicenter study of adult outpatients with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition PTSD for >or=6 months, and 17-item Clinician-Administered PTSD Scale score >or=60. Patients were assigned randomly to treatment with flexible-dose venlafaxine ER (37.

Comprehensive analysis of remission (COMPARE) with venlafaxine versus SSRIs.

Background: To compare venlafaxine and selective serotonin reuptake inhibitors (SSRIs; fluoxetine, sertraline, paroxetine, fluvoxamine, and citalopram) in the treatment of depression.

Methods And Materials: Meta-analysis of 34 randomized, double-blind studies identified by a worldwide search of all research sponsored by Wyeth Pharmaceuticals through January 2007. Patients were treated with venlafaxine (n = 4191; mean dose 151 mg/day) or SSRIs (n = 3621); nine studies also included a placebo control group (n = 932).

Treatment of posttraumatic stress disorder with venlafaxine extended release: a 6-month randomized controlled trial.

Context: No large-scale posttraumatic stress disorder drug trials have been conducted to evaluate treatment effects beyond 12 weeks outside of those with selective serotonin reuptake inhibitors.

Objective: To evaluate the efficacy of venlafaxine extended release (ER), a serotonin norepinephrine reuptake inhibitor, in posttraumatic stress disorder.

Design: 6-month, double-blind, placebo-controlled trial.

Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo-controlled study.

This 12-week, double-blind, multicenter trial evaluated the efficacy of venlafaxine extended release (ER), sertraline, and placebo in adult outpatients (N = 538) with a primary diagnosis of posttraumatic stress disorder (PTSD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, symptoms for 6 months or more and 17-item Clinician-administered PTSD Scale (CAPS-SX17) score of 60 or more. Patients were randomly assigned to receive placebo or flexible doses of venlafaxine ER (37.5-300 mg/d) or sertraline (25-200 mg/d) for 12 weeks or less.

Venlafaxine extended release in the short-term treatment of depressed and anxious primary care patients with multisomatoform disorder.

Objective: This pilot study explored the efficacy and tolerability of extended-release venlafaxine (venlafaxine ER) in anxious and/or depressed patients with multisomatoform disorder (MSD).

Method: This 12-week, multicenter, randomized, double-blind study evaluated adult primary care outpatients with MSD and comorbid major depressive disorder, generalized anxiety disorder, or social anxiety disorder (DSM-IV criteria). The intent-to-treat population included 112 patients (venlafaxine ER, N = 55; placebo, N = 57).

Ziprasidone and haloperidol in the treatment of acute exacerbation of schizophrenia and schizoaffective disorder: comparison of intramuscular and oral formulations in a 6-week, randomized, blinded-assessment study.

Rationale: Conventional intramuscular (IM) antipsychotics used in managing acute exacerbation of schizophrenia are associated with side effects such as acute dystonia.

Objectives: To compare the efficacy and tolerability of sequential IM/oral ziprasidone with haloperidol in acute exacerbation of schizophrenia or schizoaffective disorder.

Methods: In a 6-week, multicenter, parallel-group, flexibly dosed study, patients were randomized to ziprasidone (IM up to 3 days, then oral 40-80 mg, b.

Efficacy and tolerability of ziprasidone versus risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder: an 8-week, double-blind, multicenter trial.

Background: More head-to-head comparisons of antipsychotics are needed to discern the relative efficacy and safety profiles of these compounds. Thus, we compared ziprasidone and risperidone in patients with acute exacerbation of schizophrenia or schizoaffective disorder.

Method: Patients with DSM-III-R acute exacerbation of schizophrenia or schizoaffective disorder were randomly assigned to double-blind ziprasidone 40 to 80 mg b.