Overall Survival with Osimertinib in Resected -Mutated NSCLC.

Background: Among patients with resected, epidermal growth factor receptor ()-mutated, stage IB to IIIA non-small-cell lung cancer (NSCLC), adjuvant osimertinib therapy, with or without previous adjuvant chemotherapy, resulted in significantly longer disease-free survival than placebo in the ADAURA trial. We report the results of the planned final analysis of overall survival.

Methods: In this phase 3, double-blind trial, we randomly assigned eligible patients in a 1:1 ratio to receive osimertinib (80 mg once daily) or placebo until disease recurrence was observed, the trial regimen was completed (3 years), or a discontinuation criterion was met.

Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study.

Purpose: The open-label, phase III POSEIDON study evaluated tremelimumab plus durvalumab and chemotherapy (T + D + CT) and durvalumab plus chemotherapy (D + CT) versus chemotherapy alone (CT) in first-line metastatic non-small-cell lung cancer (mNSCLC).

Methods: Patients (n = 1,013) with / wild-type mNSCLC were randomly assigned (1:1:1) to tremelimumab 75 mg plus durvalumab 1,500 mg and platinum-based chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression and one additional tremelimumab dose; durvalumab plus chemotherapy for up to four 21-day cycles, followed by durvalumab once every 4 weeks until progression; or chemotherapy for up to six 21-day cycles (with or without maintenance pemetrexed; all arms). Primary end points were progression-free survival (PFS) and overall survival (OS) for D + CT versus CT.

Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study.

Introduction: In the phase II ATLANTIC study, durvalumab provided durable responses with acceptable tolerability in heavily pretreated patients with advanced NSCLC, across three independent patient cohorts defined by EGFR/ALK status and tumour PD-L1 expression. Preliminary overall survival (OS) data were encouraging. We now report final OS and updated safety data.

Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study.

Background: In the ongoing, phase 3 PACIFIC trial, durvalumab improved the primary endpoints of progression-free survival and overall survival compared with that for placebo, with similar safety, in patients with unresectable, stage III non-small-cell lung cancer. In this analysis, we aimed to evaluate one of the secondary endpoints, patient-reported outcomes (PROs).

Methods: PACIFIC is an ongoing, international, multicentre, double-blind, randomised, controlled, phase 3 trial.

Analysis of serum phosphate control and phosphate binder utilization in incident hemodialysis patients.

The purpose of this study was to conduct a retrospective analysis of serum phosphate level variability in patients new to hemodialysis (HD) and to identify patient characteristics associated with this variability. The medical records of 47,742 incident HD patients attending US outpatient dialysis centers between January 1, 2006 and March 31, 2009 were analyzed. Monthly mean serum phosphate levels determined over a 6-month evaluation period (months 4-9 after HD initiation) were assigned to one of three strata: low (<1.

Lanthanum carbonate versus placebo for management of hyperphosphatemia in patients undergoing peritoneal dialysis: a subgroup analysis of a phase 2 randomized controlled study of dialysis patients.

Background: This short-term study assessed the efficacy and safety of lanthanum carbonate in the treatment of hyperphosphatemia in dialysis patients; here, we report a prespecified subgroup analysis of patients undergoing peritoneal dialysis.

Methods: Men and women (n=39) who had received continuous ambulatory peritoneal dialysis for chronic kidney disease for 6 months or more were enrolled in eight renal medicine departments in the United Kingdom. A 2-week washout period was followed by a 4-week dose-titration phase during which patients received lanthanum carbonate titrated up to 2250 mg/day.

Lanthanum carbonate reduces urine phosphorus excretion: evidence of high-capacity phosphate binding.

The effectiveness of phosphate binders can be assessed by evaluating urinary phosphorus excretion in healthy volunteers, which indicates the ability of the phosphate binder to reduce gastrointestinal phosphate absorption. Healthy volunteers were enrolled into one of five separate randomized trials; four were open label and one double blind. Following a screening period of ≤28 days, participants received differing tablets containing lanthanum carbonate [LC, 3000 mg/day of elemental lanthanum (in one study other doses were also used)].

Results of a pilot program to improve phosphorus outcomes in hemodialysis patients.

Objective: End-stage renal disease causes dysregulation of bone and mineral metabolism, including increased serum phosphorus levels. Kidney Foundation Kidney Disease Outcome Quality Initiative 2003 guidelines recommend maintaining phosphorus levels between 3.5 and 5.

Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study.

Background: Lanthanum carbonate and sevelamer carbonate are noncalcium phosphate binders used to treat hyperphosphatemia in patients with chronic kidney disease. This is the first study to compare phosphate absorption from a standardized meal ingested with a typical clinical dose of these binders.

Study Design: Randomized open-label crossover study.

The effect of sevelamer carbonate and lanthanum carbonate on the pharmacokinetics of oral calcitriol.

Background: Lanthanum carbonate and sevelamer carbonate are non-calcium-based phosphate binders used to manage hyperphosphataemia in patients with chronic kidney disease (CKD). Patients with CKD may require intravenous or oral active vitamin D. We investigated the effects of lanthanum carbonate and sevelamer carbonate on the bioavailability of oral calcitriol.

Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study.

Objective: The primary aim of this study was to assess the efficacy of atomoxetine in improving ADHD and ODD symptoms in paediatric patients with ADHD and comorbid oppositional defiant disorder (ODD), non-responders to previous psychological intervention with parent support.

Methods: This was a multicentre, randomised, placebo-controlled trial conducted in patients aged 6-15 years, with ADHD and ODD diagnosed according to the DSM-IV criteria by a structured clinical interview (K-SADS-PL). Only subjects who are non-responders to a 6-week standardized parent training were randomised to atomoxetine (up to 1.

Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naïve Swedish children and adolescents.

Objective: The primary objective of this study was to assess the impact of atomoxetine in combination with psychoeducation, compared with placebo and psychoeducation, on health-related quality of life (HRQL) in Swedish stimulant-naïve pediatric patients with attention deficit/hyperactivity disorder (ADHD). HRQL results will be presented elsewhere. Here, psychoeducation as well as efficacy and safety of the treatment are described.

The provision and nature of ADHD services for children/adolescents in the UK: results from a nationwide survey.

The Attention Deficit Hyperactivity Disorder (ADHD) Observational Research in Europe (ADORE) project aims to describe the relationship between prescribed treatment regimen and quality of life in ADHD patients across Europe over a 2-year period. As an adjunct to the ADORE study, a survey was conducted to assess the availability and range of ADHD treatment services in the UK. A questionnaire was developed to assess service provision at 20 UK ADORE sites.

A multi-centre, randomised, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

Objective: To assess the broader efficacy (i.e., improvements in quality of life/functional outcomes) of atomoxetine compared with standard current therapy (SCT) in UK paediatric patients with ADHD and to explore clinician/parent/child perceptions of ADHD.

Cross-cultural reliability and validity of ADHD assessed by the ADHD Rating Scale in a pan-European study.

Objectives: To provide psychometric information on the Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-IV (ADHD-RS-IV) in a large population of children with ADHD.

Methods: Patients aged 6-18 years (n=1,478 in baseline analysis) were rated by 244 physicians on the ADHD-RS-IV based on a semi-structured interview with the patient's parent. Physicians additionally rated functional impairment (CGAS) and health status (CGI-S), and parents rated their child's behavioural and emotional problems (SDQ) and quality of life (CHIP-CE).

Cost-effectiveness analysis of stratified versus stepped care strategies for acute treatment of migraine: The Disability in Strategies for Care (DISC) Study.

Background: The Disability in Strategies for Care (DISC) study was the first large randomised controlled trial to compare alternative treatment strategies in the acute treatment of migraine. With 835 patients in its intention-to-treat efficacy analysis, DISC compared a stratified care strategy, where initial therapy was based on clinical need as determined by the Migraine Disability Assessment Scale (MIDAS) and two stepped care strategies (across attacks and within attacks), where first-line therapy with a simple combination analgesic was escalated, if response had been inadequate, to zolmitriptan, a migraine-specific therapy.

Objective: To report on the cost effectiveness of these three strategies from a societal perspective.