Assessing United States Patient and Dermatologist Experiences with Severe Chronic Hand Eczema.

Objective: Patients with severe chronic hand eczema often have persistent symptoms that interfere with daily activities, social functioning, and employment. Many patients are refractory to topical corticosteroids. This survey-based study was performed to characterize treatment experiences, impact on productivity, and quality of life of patients with severe chronic hand eczema; understand dermatologists' severe chronic hand eczema treatment patterns.

Systematic review and network meta-analysis of the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants among patients with nonvalvular atrial fibrillation and CHADS2 score ⩾ 2.

Background: The nonvitamin K antagonist oral anticoagulants pivotal clinical trials for stroke prevention in atrial fibrillation have important differences in trial designs and baseline patient characteristics.

Objective: We sought to evaluate the relative efficacy and safety of edoxaban versus other nonvitamin K antagonist oral anticoagulants in the management of stroke prevention in atrial fibrillation by adjusting for differences in baseline stroke risk and the length of follow-up among the four phase 3 randomized controlled trials.

Methods: We conducted a systematic literature review of randomized controlled trials evaluating the nonvitamin K antagonist oral anticoagulants for stroke prevention in atrial fibrillation and performed a network meta-analysis using data from ENGAGE AF-TIMI 48, RE-LY, ROCKET-AF, and ARISTOTLE, with warfarin as a common comparator.

Randomized controlled trials in relapsed/refractory chronic lymphocytic leukemia: a systematic review and meta-analysis.

This systematic literature review with meta-analysis was conducted on the clinical efficacy and safety of interventions used in the treatment of chronic lymphocytic leukemia (CLL). We systematically searched databases (PubMed, Cochrane Library, and Embase; 1997 to August 2, 2012), conference abstracts, bibliographic reference lists, recent reviews, and Clinicaltrials.gov.

Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology.

Overall survival (OS) is the gold standard in measuring the treatment effect of new drug therapies for cancer. However, practical factors may preclude the collection of unconfounded OS data, and surrogate endpoints are often used instead. Meta-analyses have been widely used for the validation of surrogate endpoints, specifically in oncology.

The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years.

The Osteosarcoma Surveillance Study, an ongoing 15-year surveillance study initiated in 2003, is a postmarketing commitment to the United States (US) Food and Drug Administration to evaluate a potential association between teriparatide, rhPTH(1-34), a recombinant human parathyroid hormone analog (self-injectable medication to treat osteoporosis), and development of osteosarcoma in response to a finding from preclinical (animal) studies. Incident cases of primary osteosarcoma diagnosed in adults (aged ≥40 years) on or after January 1, 2003, are identified through population-based state, regional, and comprehensive cancer center registries in the US. Information on possible prior treatment with teriparatide, on demographics, and on risk factors is ascertained by patient or proxy telephone interview after patient consent.

Single-pill vs free-equivalent combination therapies for hypertension: a meta-analysis of health care costs and adherence.

This meta-analysis compares health care resource use costs, adherence, and persistence between groups of patients taking antihypertensives as single-pill combinations (SPCs) vs free-equivalent components (FEC) based on a structured review of published studies. The search yielded 12 retrospective database studies included in analyses. The mean difference in combined total annual all-cause and hypertension-related health care costs was $1357 (95% confidence interval [CI], $778-$1935) lower in favor of SPC than FEC groups.

Meta-analysis of the association between progression-free survival and overall survival in metastatic colorectal cancer.

Purpose: The validity of progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in metastatic colorectal cancer (mCRC) trials has been studied, primarily in first-line treatment. The relationship between PFS and OS has not been well studied in later lines of treatment.

Methods: We conducted a systematic literature review of mCRC phase 2 and 3 clinical trials that reported OS and PFS (or time-to-progression [TTP]) data.

Quality-adjusted survival analysis of first-line treatment of hormone-receptor-positive HER2+ metastatic breast cancer with letrozole alone or in combination with lapatinib.

Aim: Compare first-line lapatinib plus letrozole (L + Let) versus letrozole monotherapy (Let) in hormone-receptor-positive HER2 + metastatic breast cancer, employing Q-TWiST (quality-adjusted time without symptoms and toxicity) analysis to account for differences in progression times, with offsets for the impact of adverse events during the treatment period.

Methods: The area under survival curves for each treatment group was partitioned into distinct health states of varying utility: toxicity (TOX), time without toxicity or disease progression (TWiST), and the period following disease progression until death or end of follow-up (REL). The utility-weighted sum of the mean health state durations was derived for each group.

Urgency as an Endpoint in Irritable Bowel Syndrome.

Background: The choice of endpoints is crucial for proper evaluation of agents in clinical trials of irritable bowel syndrome (IBS). In a recently published draft guidance for IBS from the United States Food and Drug Administration (FDA), urgency was not considered an appropriate primary endpoint. The FDA's position is that it is not clear how patients with diarrhea-predominant IBS (D-IBS) "define or describe urgency".

Does Timing of Colon Procedures Affect Outcomes in D-IBS Trials?

Background: Sigmoidoscopy/colonoscopy is usually performed prior to enrollment into clinical trials of irritable bowel syndrome (IBS). Two main reasons are to rule out alternative diagnoses and to ensure that colitis is not present. However, the possible impact of a recent versus remote colon procedure on symptoms in IBS trials has not been evaluated.

Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib.

Background: A phase III trial compared lapatinib plus letrozole (L + Let) with letrozole plus placebo (Let) as first-line therapy for hormone receptor (HR)(+) metastatic breast cancer (MBC) patients. The primary endpoint of progression-free survival (PFS) in patients whose tumors were human epidermal growth factor receptor (HER)-2(+) was significantly longer for L + Let than for Let (8.2 months versus 3 months; p = .

Impact of waist circumference difference on health-care cost among overweight and obese subjects: the PROCEED cohort.

Objective: To estimate the incremental effect of waist circumference (WC) on health-care costs among overweight and obese subjects after adjusting for body mass index (BMI).

Methods: A prospective study. The subjects were members of Internet panels in the United States (US) and Germany.

Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer.

Background: In a phase 3 randomized, multicenter, double-blind, placebo-controlled study, first-line therapy with lapatinib plus paclitaxel significantly improved clinical outcomes based on a pre-planned analysis of ErbB2+ metastatic breast cancer patients (GSK Study #EGF30001; ClinicalTrials.gov identifier: NCT00075270). Patients with ErbB2- or untested did not significantly benefit.

Attempts to quit smoking and relapse: factors associated with success or failure from the ATTEMPT cohort study.

Objective: To identify predictors of attempts to stop smoking and predictors of relapse.

Methods: This study included 2431 smokers from pre-existing Internet panels in the United States, United Kingdom, Canada, France, and Spain. These panel members are Internet users who have registered voluntarily and agreed to participate in various online research studies.

Predictors of health-related quality of life in sufferers with restless legs syndrome: a multi-national study.

Background And Purpose: To explore aspects of restless legs syndrome (RLS) associated with detrimental impact on health-related quality of life (HRQoL).

Patients And Methods: The RLS epidemiology, symptoms, and treatment (REST) survey included SF-36 data on adults with RLS symptoms in the USA and five European countries. Linear regression models on each SF-36 dimension score explored factors influencing HRQoL in this population.

Cancer risk in asthmatic populations.

Objective: To conduct a meta-analysis of epidemiologic studies to derive a pooled estimate of the association between asthma and cancer incidence and between allergy and cancer incidence.

Data Sources: Five cohort studies and 1 case-control study of cancer incidence in asthma, 4 studies of cancer mortality in asthma, and 3 studies of cancer incidence in allergy.

Study Selection: We searched the National Library of Medicine Gateway to identify observational studies of cancer incidence in asthma and included any case-control or cohort study of incident cancers or of cancer mortality that met the predefined inclusion criteria.

Effect of persistent moderate viremia on disease progression during HIV therapy.

Objective: Although highly active antiretroviral therapy has been shown to lower plasma HIV-1 RNA in HIV infection, many patients do not reach the target goal of undetectable viremia. We evaluated whether risk of clinical progression varies by level of viral suppression achieved.

Design: Patients in the Collaborations in HIV Outcomes Research/United States cohort who maintained stable HIV-1 RNA levels of either <400, 400 to 20,000, or >20,000 copies/mL during a run-in period of at least 6 months were studied.

Disease progression in HIV-infected patients treated with stavudine vs. zidovudine.

Background And Objectives: This prospective, observational study compared disease progression and death in HIV-1 patients treated with stavudine vs. zidovudine in the Collaborations in HIV Outcomes Research/U.S.

Three-year posttransplant graft survival in renal-transplant patients with graft function at 6 months receiving tacrolimus or cyclosporine microemulsion within a triple-drug regimen.

Background: Registry data can provide valuable information about possible treatment effects; however, pretreatment differences in patient characteristics may influence treatment assignment. Careful analysis must therefore be undertaken when evaluating treatment differences in the context of nonrandomized studies so that the impact of treatment selection bias is minimized.

Methods: A multivariable risk factor analysis of adult patients registered in the US Renal Data System who received a primary renal allograft during 1995 to 1998 was undertaken to compare 3-year graft survival using tacrolimus or Neoral with mycophenolate mofetil (MMF) and steroids.