Real-world effectiveness of anti-TNF switching in psoriatic arthritis: a systematic review of the literature.

Anti-tumor necrosis factors (Anti-TNFs) are a class of biologic disease-modifying anti-rheumatic drugs indicated for the treatment of moderate-to-severe psoriatic arthritis (PsA). Refractory patients are commonly managed by switching from one anti-TNF to another. To assess the evidence on the effectiveness of anti-TNF cycling in PsA patients, a systematic review of the literature was conducted.

Nurse workload in implementing a tight glycaemic control protocol in a UK hospital: a pilot time-in-motion study.

Aims And Objectives: The cumulative time that critical care nurses spend implementing a tight glycaemic control (TGC) protocol was estimated in a time-in-motion (TiM) study conducted in a hospital in the UK.

Background: TGC protocols were introduced to the critical care setting to reduce hyperglycaemic events in high-risk patients. The time burden to critical care nurses of implementing such protocols has not yet been studied in the UK.

A systematic review of validated methods for identifying hypersensitivity reactions other than anaphylaxis (fever, rash, and lymphadenopathy), using administrative and claims data.

Purpose: The Food and Drug Administration's Mini-Sentinel pilot program aims to conduct active surveillance to refine safety signals that emerge for marketed medical products. A key facet of this surveillance is to develop and understand the validity of algorithms for identifying health outcomes of interest from administrative and claims data. This article summarizes the process and findings of the algorithm review of hypersensitivity reactions.

A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data.

Purpose: The Food and Drug Administration's Mini-Sentinel pilot program initially aims to conduct active surveillance to refine safety signals that emerge for marketed medical products. A key facet of this surveillance is to develop and understand the validity of algorithms for identifying health outcomes of interest from administrative and claims data. This article summarizes the process and findings of the algorithm review of anaphylaxis.

A systematic review of validated methods for identifying erythema multiforme major/minor/not otherwise specified, Stevens-Johnson Syndrome, or toxic epidermal necrolysis using administrative and claims data.

Purpose: The Food and Drug Administration's (FDA) Mini-Sentinel pilot program aims to conduct active surveillance to refine safety signals that emerge for marketed medical products. A key facet of this surveillance is to develop and understand the validity of algorithms for identifying health outcomes of interest (HOIs) from administrative and claims data. This paper summarizes the process and findings of the algorithm review of erythema multiforme and related conditions.

Efficient practices associated with diagnosis, treatment and management of fibromyalgia among primary care physicians.

Objectives: To describe beliefs and practice patterns of primary care physicians (PCPs) providing fibromyalgia (FM) care, and to characterize differences between PCPs who report being able to provide timely and beneficial care versus the remaining PCPs.

Methods: A mixed-methods approach including surveys followed by semi-structured focus groups among United States-based PCPs in seven cities was used. Post hoc, a composite threshold of timely and beneficial care, defined as PCPs reports of at least one-half of their patients achieving an 'acceptable' quality of life within one to four office visits after diagnosis, was created to compare subgroups.

Prevalence of apolipoprotein E4 genotype and homozygotes (APOE e4/4) among patients diagnosed with Alzheimer's disease: a systematic review and meta-analysis.

Background: Population allele frequencies of apolipoprotein E (APOE) vary by geographic region. The purpose of this study is to summarize and evaluate published estimates for the prevalence of APOE e4 carrier status among the population diagnosed with Alzheimer's disease (AD) by geographic region and country.

Methods: A systematic review of English-language publications from January 1, 1985, through May 31, 2010, was conducted.

Apolipoprotein E ε4 prevalence in Alzheimer's disease patients varies across global populations: a systematic literature review and meta-analysis.

Background: The ε4 allele of apolipoprotein E (APOE) is associated with Alzheimer's disease (AD). However, attributable risk due to APOE4 varies by region and by race/ethnicity.

Methods: A literature review and meta-analysis were conducted to estimate the prevalence of APOE4 by geographic area among AD patients.

A multicenter pilot study to estimate the prevalence of bovine and human coagulation antibodies in the general US population.

Antibodies to bovine and human coagulation proteins have been reported to develop in some patients receiving perioperative exposure to topical bovine thrombin. To estimate the prevalence of antihuman and antibovine thrombin and factor V antibodies in the general population, this multicenter pilot study in 278 participants was undertaken. Of the participants, 88% had no detectable antibodies by enzyme-linked immunosorbent assay (ELISA).

Hypertriglyceridemia in a pediatric referral practice: experience with 300 patients.

Background: Pediatric hypertriglyceridemia is an emerging comorbidity of childhood obesity.

Methods: This study reviewed medical records retrospectively to describe the characteristics and clinical course of 300 at-risk children followed in a pediatric preventive cardiology clinic.

Results: Average baseline triglyceride (TG) level was 269 mg/dL (SD 342 mg/dL); 91% had TG levels between 150 and 399 mg/dL.

Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting System.

Purpose: To review topical bovine thrombin spontaneous adverse event (AE) reports that were forwarded to the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) between January 1986 and December 2006.

Methods: Forty-one spontaneous AE reports were summarized for reported AE profile and chronological reporting patterns. Each AE report was adjudicated by a hematologist for the topical bovine thrombin product that was given and the AE(s) that were reported.

Bovine thrombin safety reporting: an example of study design and publication bias.

Background: Bovine thrombin, a popular hemostat and sealant since 1945, has recently been subjected to clinical trial testing due to reformulations in 1998. We sought to compare adverse event rates of early observational studies with those of later interventional trials.

Methods: A MEDLINE-based literature search in publications that report safety in bovine thrombin exposed surgical patients was extracted and reviewed.

A safety review of topical bovine thrombin-induced generation of antibodies to bovine proteins.

Background: Topical bovine thrombin has been used to accelerate attainment of hemostasis in the surgical setting for >60 years, and its immunogenicity has been widely reported. Although the development of antibodies is inherent in the introduction of any non-self-therapeutic protein such as bovine-sourced thrombin, there are questions about the relationship between the presence of antibodies to constituents of the therapeutic protein preparation and the occurrence of clinically relevant adverse events (AEs).

Objective: This review examines the proposed mechanisms for the immunogenicity of topical bovine thrombin preparations and summarizes available evidence from randomized clinical trials, observational studies, and case reports to explore possible relationships between the reported immunogenicity of topical bovine thrombin and the occurrence of AEs.

Safety of multi-targeted kinase inhibitors as monotherapy treatment of cancer: a systematic review of the literature.

Purpose: To identify potential safety profiles for small molecule multi-targeted kinase inhibitors for the treatment of advanced cancer.

Methods: A systematic review was performed on published papers and meeting abstracts reporting safety outcomes in cancer patients for selected multi-kinase inhibiting small molecules with mainly anti-angiogenic activity. Specifically, we focused on single agent safety or early phase clinical development studies.

Exogenous bovine thrombin as a biomarker of exposure and outcome.

Bovine thrombin has been used for more than 60 years as a surgical hemostat and sealant. Rare postsurgical events have been attributed to antibovine thrombin immunoglobulins cross-reacting with human homologs. In a literature review of 37 papers reporting safety outcomes in surgical patients, we extracted each paper for a quantitative measurement of bovine thrombin exposure and coagulopathic outcomes.

Pregnancy outcomes in women with epilepsy: a systematic review and meta-analysis of published pregnancy registries and cohorts.

Purpose: To conduct a systematic review and meta-analysis to quantify the incidence of congenital malformations (CMs) and other pregnancy outcomes as a function of in utero anti-epileptic drug (AED) exposure.

Methods: We performed a systematic literature review to identify all published registries and cohort studies of births from pregnant women with epilepsy (WWE) that reported incidence of CMs. Overall incidences were calculated using a random effects model.

Topical bovine thrombin and adverse events: a review of the literature.

Objective: To review published evidence suggesting a link between topical bovine thrombin (TBT) and important adverse events (AEs).

Research Design And Methods: English language articles and abstracts were obtained from MEDLINE using combinations of text and MeSH terms for thrombin, bovine thrombin and their trade names. References from summary articles were also retrieved.

Risk of bleeding in surgical patients treated with topical bovine thrombin sealants: a review of the literature.

Background: One of the most anticipated, but potentially serious complications during or after surgery are bleeding events. Among the many potential factors associated with bleeding complications in surgery, the use of bovine thrombin has been anecdotally identified as a possible cause of increased bleeding risk. Most of these reports of bleeding events in association with the use of topical bovine thrombin have been limited to case reports lacking clear cause and effect relationship determination.

Systematic review to establish the safety profiles for direct and indirect inhibitors of p38 Mitogen-activated protein kinases for treatment of cancer. A systematic review of the literature.

Objective: To identify potential tolerability issues for a novel selective p38 Mitogen-activated Protein Kinases (p38MAPK) inhibitor, we performed a systematic review of published studies and abstracts reporting safety outcomes for indirect inhibitors of p38MAPK.

Methods: A systematic review was performed to identify articles and meeting abstracts published between January 1, 1990 and March 31, 2005 that reported safety outcomes in cancer patients. Study, patient, and treatment level data were summarized using descriptive statistics without meta-analyses.

Efficacy and safety of erythropoiesis-stimulating proteins in myelodysplastic syndrome: a systematic review and meta-analysis.

Objective: The objective was to assess the efficacy and safety of erythropoiesis-stimulating proteins (ESPs) in anemia of myelodysplastic syndrome (MDS).

Method: A systematic review and meta-analysis was conducted covering English-language studies published from 1980 to December 2005.

Results: Fifty-nine studies qualified: five controlled trials (n = 354), all epoetin versus control (EvC); 51 epoetin single-arm studies (n = 1,650); and three darbepoetin single-arm studies (n = 102).

Synthesis and structure-activity relationships of soluble 7-substituted 3-(3,5-dimethoxyphenyl)-1,6-naphthyridin-2-amines and related ureas as dual inhibitors of the fibroblast growth factor receptor-1 and vascular endothelial growth factor receptor-2 tyrosine kinases.

7-Substituted 3-aryl-1,6-naphthyridine-2,7-diamines and related 2-ureas are inhibitors of fibroblast growth factor receptor-1 (FGFR-1) and vascular endothelial growth factor receptor-2 (VEGFR-2). 3-(3,5-Dimethoxyphenyl) and 3-phenyl analogues were prepared from 7-acetamido-2-tert-butylureas by alkylation with benzyl omega-iodoalkyl ethers, debenzylation, and amination, followed by selective cleavage of the 7-N-acetamide. 3-(2,6-Dichlorophenyl) analogues were prepared from the 7-fluoro-2-amine by displacement with substituted alkylamines, followed by selective acylation of the resulting substituted naphthyridine-2,7-diamines with alkyl isocyanates.