Cardiovascular risk factors and outcomes in early rheumatoid arthritis: a population-based study.

Objective: To assess the burden of cardiovascular disease (CVD) at and prior to diagnosis in people with early rheumatoid arthritis (RA) and subsequent CVD in these patients.

Methods: A retrospective case-control study using a large English primary care database. People with RA (n=6591) diagnosed between 2004 and 2016 (inclusive) were identified using a validated algorithm, matched 1:1 by age and gender to those without RA (n=6591) and followed for a median of 5.

Prognostic value of comorbidity indices and lung diseases in early rheumatoid arthritis: a UK population-based study.

Objectives: We assessed comorbidity burden in people with RA at diagnosis and early disease (3 years) and its association with early mortality and joint destruction. The association between lung disease and mortality in RA is not well studied; we also explored this relationship.

Methods: From a contemporary UK-based population (n = 1, 475 762) we identified a cohort with incident RA (n = 6591).

Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research.

Background/aim: Phase 1 trials with healthy volunteers are an integral step in drug development. Commentators worry about the possible exploitation of healthy volunteers because they are assumed to be disadvantaged, marginalized, and inappropriately influenced by the offer of money for research for which they do not appreciate the inherent risks. Yet there are limited data to support or refute these concerns.

Phase 1 healthy volunteer willingness to participate and enrollment preferences.

Background/aims: Healthy volunteers in phase 1 clinical trials contribute to the development of safe drugs and other biologics and accept risks and burdens without anticipated health benefits from participation. Although emerging data have shown that healthy volunteers are influenced by risk, some still worry that financial incentives lead them to take on unreasonable risk. Yet little is known about healthy volunteers' preferences and how they make choices about enrolling in research studies.

Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies.

Objective: To quantify the frequency and seriousness of adverse events in non-oncology phase I studies with healthy participants.

Design: Meta-analysis of individual, healthy volunteer level data.

Setting: Phase I studies with healthy volunteers conducted between September 2004 and March 2011 at Pfizer's three dedicated phase I testing sites in Belgium, Singapore, and the United States.

Metabolism, excretion and pharmacokinetics of [14C]crizotinib following oral administration to healthy subjects.

1. Crizotinib (XALKORI®), an oral inhibitor of anaplastic lymphoma kinase (ALK) and mesenchymal-epithelial transition factor kinase (c-Met), is currently approved for the treatment of patients with non-small cell lung cancer that is ALK-positive. 2.

Biomarker-assisted dose selection for safety and efficacy in early development of PNU-100480 for tuberculosis.

Tuberculosis is a serious global health threat for which new treatments are urgently needed. This study examined the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple ascending doses of the oxazolidinone PNU-100480 in healthy volunteers, using biomarkers for safety and efficacy. Subjects were randomly assigned to PNU-100480 or placebo (4:1) at schedules of 100, 300, or 600 mg twice daily or 1,200 mg daily for 14 days or a schedule of 600 mg twice daily for 28 days to which pyrazinamide was added on days 27 and 28.

Acute lower limb ischemia due to thrombo-embolic arterial occlusions in two previously healthy men with markedly elevated Lp(a).

Lipoprotein (a) (Lp(a)) is a well-documented risk factor for atherosclerotic cardiovascular disease. Its role in acute thrombo-embolic occlusions of peripheral arteries is not known. We describe two cases of multiple, acute, peripheral arterial occlusions in two previously healthy men with markedly elevated Lp(a).