A Phase 1 Randomized, Placebo-controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of Inactivated Streptococcus pneumoniae Whole-cell Vaccine in Adults.

Background: Broadly protective pneumococcal vaccines that are affordable for low-resource countries are needed. Streptococcus pneumoniae whole cell vaccine (wSp) is an investigational vaccine that contains killed cells from a nonencapsulated strain of S. pneumoniae (SPn) with aluminum hydroxide adjuvant.

Carotid artery intima-media thickness after raloxifene treatment.

Background: Raloxifene, a selective estrogen receptor modulator (SERM), decreases total and low-density lipoprotein cholesterol (LDL-C) in postmenopausal women and inhibits increases in intima-media thickness (IMT) in animal models. We tested whether up to 8 years exposure to raloxifene had an effect on subclinical atherosclerosis in the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the follow-up study, the 4-year Continuing Outcomes Relevant to Evista (CORE) trial.

Methods: A subsample of postmenopausal women with osteoporosis, who had completed the MORE and CORE trials and were on average 68 years of age and 19 years postmenopausal at randomization into MORE, participated in this substudy.

Safety assessment of raloxifene over eight years in a clinical trial setting.

Objective: Osteoporosis is a chronic disorder that warrants long-term therapy. If benefits are to outweigh risks, the long-term safety profiles of these therapies must be favorable. The aim of this study was to assess the safety of raloxifene over 8 years in 4011 postmenopausal women with osteoporosis in a clinical trial setting through adverse event reporting.

Vascular events in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial: incidence, patient characteristics, and effect of raloxifene.

Objective: To determine the incidence of arterial and venous thromboembolic (VTE) events, to determine the effect of raloxifene on the incidence of combined vascular (arterial and VTE) events, and to identify patient characteristics associated with these vascular events, in women participating in the MORE trial.

Design: In a post hoc analysis using MORE data, arterial, VTE, and combined vascular event rates were compared between participants receiving placebo (n = 2,576) and those receiving 60 mg/d of raloxifene (n = 2,557). Baseline characteristics were compared between those who did and did not experience an arterial event.

Effects of raloxifene and low-dose simvastatin coadministration on plasma lipids in postmenopausal women with primary hypercholesterolemia.

Abstract Raloxifene and low-dose simvastatin can each reduce low-density lipoprotein (LDL) cholesterol without affecting high-density lipoprotein (HDL) cholesterol and triglycerides. The objective of this double-blind, 12-week study is to determine whether raloxifene and simvastatin coadministration gives added benefit beyond either monotherapy in affecting fasting lipoproteins and apolipoproteins. Ninety-five postmenopausal women with moderately elevated LDL cholesterol (mean, 146 mg/dL) were randomized to placebo, raloxifene 60 mg/d, simvastatin 10 mg/d, or raloxifene 60 mg/d coadministered with simvastatin 10 mg/d.

Year-by-year analysis of cardiovascular events in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial.

Objective: To assess the effect of raloxifene 60 mg/day (RLX) on year-by-year cardiovascular (CV) events in postmenopausal women participating in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, a double-blind, placebo-controlled osteoporosis treatment trial.

Research Design And Methods: Post hoc analysis, using data from participants receiving placebo (N = 2576) or RLX 60 mg/day (N = 2557) in MORE, was performed to determine the relative risk (RR, 95% CI) of CV events in each individual trial year. Analyses were performed for the overall cohort and for women in high and low risk subsets.