Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study.

Background: Odanacatib, a cathepsin K inhibitor, reduces bone resorption while maintaining bone formation. Previous work has shown that odanacatib increases bone mineral density in postmenopausal women with low bone mass. We aimed to investigate the efficacy and safety of odanacatib to reduce fracture risk in postmenopausal women with osteoporosis.

Incidence of hypersensitivity and anaphylaxis with sugammadex.

Study Objective: To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex.

Design: Retrospective analysis.

Setting: Sugammadex clinical development program and post-marketing experience.

Continuous treatment with odanacatib for up to 8 years in postmenopausal women with low bone mineral density: a phase 2 study.

Unlabelled: The efficacy and safety of weekly oral odanacatib (ODN) 50 mg for up to 8 years were assessed in postmenopausal women with low bone mineral density (BMD). Treatment with ODN for up to 8 years resulted in continued or maintained increases in BMD at multiple sites and was well tolerated.

Introduction: ODN is a selective inhibitor of cathepsin K.

Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial.

Context: Odanacatib (ODN) is a selective cathepsin K inhibitor being developed to treat osteoporosis.

Objective: The effects of ODN were evaluated on bone mineral density (BMD), biochemical markers of bone turnover, and safety in patients previously treated with alendronate.

Design: This was a randomized, double-blind, placebo-controlled, 24-month study.

Intermittent or daily montelukast versus placebo for episodic asthma in children.

Background: No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype.

Objective: To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma.

A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma.

Background: Up to 30% of patients require hospitalization for acute asthma despite standard therapy in the emergency department. In adults, intravenous montelukast added to standard therapy significantly improved forced expiratory volume in 1 second (FEV1) and reduced hospital admissions compared with standard therapy alone.

Objective: To evaluate the efficacy of intravenous montelukast added to standard therapy in children with acute asthma.

A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma.

Background: Current treatments for acute asthma provide inadequate benefit for some patients. Intravenous montelukast may complement existent therapies.

Objective: To evaluate efficacy of intravenous montelukast as adjunctive therapy for acute asthma.

Enhancement of HIV DNA vaccine immunogenicity by the NKT cell ligand, alpha-galactosylceramide.

A number of studies have shown that the natural killer T cell (NKT) ligand alpha-galactosylceramide (alpha-GalCer) serves as an adjuvant for various vaccines, including viral vaccines, parasite vaccines and protein vaccines. In this report, we investigated the adjuvant activity of alpha-GalCer on HIV-1 DNA vaccines in mice. This is a first study to show that alpha-GalCer can enhance the immunogenicity of DNA vaccines, since co-administration of alpha-GalCer with suboptimal doses of DNA vaccines greatly enhanced antigen-specific CD4+ T-cell and CD8+ T-cell responses.

Design, construction, and characterization of a dual-promoter multigenic DNA vaccine directed against an HIV-1 subtype C/B' recombinant.

An effective vaccine against HIV-1 is generally considered the best hope for controlling the raging AIDS pandemic. As a part of our AIDS vaccine development effort, we constructed a dual-promoter plasmid capable of high-level expression of 2 independent transgenes. HIV-1 gag, pol, env, nef, and tat from a primary subtype C/B' CCR5-tropic HIV-1 were "codon" optimized, modified to eliminate known functional activity, and assembled using an overlapping polymerase chain reaction into 2 plasmids: ADVAX-I (containing env and gag) and ADVAX-II (containing pol and nef-tat).

Independent origin of mono-rifampin-resistant Mycobacterium tuberculosis in patients with AIDS.

Historically, infections caused by Mycobacterium tuberculosis have been treated simultaneously with isoniazid and rifampin. As a consequence of this combined therapy, strains resistant only to rifampin were rarely recovered. However, recently there has been an increasing number of reports describing HIV-positive patients infected with mono-rifampin-resistant M.