Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension.

Introduction: High efficacy and safety of 8-week glecaprevir/pibrentasvir (G/P) therapy was seen in hepatitis C (HCV)-infected, treatment-naïve (TN), compensated cirrhosis (CC) patients in EXPEDITION-8. To provide further understanding of the efficacy of G/P treatment in HCV-infected TN patients with CC and clinical evidence of portal hypertension (PHT), this analysis focused on differences in sustained virologic response at post-treatment week 12 (SVR12) between 8-week and 12-week G/P treatment groups in patients with PHT, and on differences in safety outcomes between PHT and non-PHT groups.

Methods: Data were derived from an ad hoc subgroup analysis of the EXPEDITION-8 study for patients receiving 8 weeks of G/P therapy, and pooled patient-level data from nine clinical studies for patients receiving 12 weeks of therapy.

Efficacy and safety of the novel α₄β₂ neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study.

Rationale: α(4)β(2) Neuronal nicotinic receptors (NNRs) are implicated in the pathophysiology of attention-deficit/hyperactivity disorder (ADHD).

Objectives: This study examined the efficacy and safety of the α(4)β(2) NNR partial agonist ABT-089 versus placebo in adults with ADHD.

Methods: In this multicenter, randomized, double-blind, placebo-controlled crossover study, subjects received placebo followed by ABT-089 (2 mg once daily [QD], 5 mg QD, 15 mg QD, 40 mg QD, or 40 mg twice daily [BID]), or vice versa, in a 2 × 2 crossover design.

Recurrent ovarian cancer: use of contrast-enhanced CT and PET/CT to accurately localize tumor recurrence and to predict patients' survival.

Purpose: To compare accuracy and interobserver variability in the detection and localization of recurrent ovarian cancer with contrast material-enhanced (CE) computed tomography (CT) and positron emission tomography (PET)/CT and determine whether imaging findings can be used to predict survival.

Materials And Methods: Waiving informed consent, the institutional review board approved this HIPAA-compliant, retrospective study of 35 women (median age, 54.4 years) with histopathologically proven recurrent ovarian carcinoma who underwent CE CT and PET/CT before exploratory surgery.

Enhanced habituation and decreased anxiety by environmental enrichment and possible attenuation of these effects by chronic alpha-tocopherol (vitamin E) in aging male and female rats.

Middle-aged 330-day-old male and female hooded rats were group-housed for nearly 5 months in either standard cages, or in cages containing objects. Each cage also provided either pure water, or a solution of vitamin E (DL-alpha-tocopherol acetate) for drinking. Records were kept of averages for each cage of the rats' body weights and the volume of fluid/100g average body weight drunk.

Relationship of open acute mania treatment to blinded maintenance outcome in bipolar I disorder.

Background: Most bipolar treatment guidelines recommend that acutely effective therapy be continued as maintenance treatment, unless contraindicated. No published studies have statistically evaluated the relationship between the outcomes in maintenance treatment and the principal acute agent.

Methods: Post-hoc analysis of prophylactic results obtained during a 12-month maintenance study in recently manic patients assessed the relationship between open treatment and randomized maintenance treatment.

A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania.

Objective: The efficacy and safety of divalproex sodium extended release (divalproex ER) were evaluated in patients hospitalized for acute mania associated with bipolar I disorder, manic or mixed type (DSM-IV-TR criteria).

Method: Following screening and washout of psychotropic medications, 377 patients were randomly assigned in a 1:1 ratio to 21 days of double-blind treatment with divalproex ER (N = 192) or placebo (N = 185). Daily dosage was initiated at 25 mg/kg, increased 500 mg on day 3, and adjusted to serum valproate concentrations of 85 to 125 microg/mL.

Relationship of mania symptomatology to maintenance treatment response with divalproex, lithium, or placebo.

Euphoric and mixed (dysphoric) manic symptoms have different response patterns to divalproex and lithium in acute mania treatment, but have not been studied in relationship to maintenance treatment outcomes. We examined the impact of initial euphoric or dysphoric manic symptomatology on maintenance outcome. Randomized maintenance treatment with divalproex, lithium, or placebo was provided for 372 bipolar I patients, who met improvement criteria during open phase treatment for an index manic episode.

Clinical comparison of extended-release divalproex versus delayed-release divalproex: pooled data analyses from nine trials.

Divalproex sodium is an effective anticonvulsant, antimanic, and migraine prophylaxis agent. Recently, a new extended-release (ER) formulation of divalproex sodium has become available, which allows for once-daily dosing and provides prolonged therapeutic serum levels. Using data pooled from nine open-label trials involving 321 epilepsy and psychiatry patients, we compared the efficacy and tolerability of divalproex ER with preceding treatment with the older delayed-release (DR) formulation, based on patient reports and analysis by McNemar's test for within-subject paired data.