Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study.

Background: Key goals in the treatment of CAP include early response to treatment and achievement of clinical stability. The US FDA recommends early response endpoints (72 hours after initiation of treatment) in clinical trials for the treatment of community-acquired bacterial pneumonia. REACH (REtrospective Study to Assess the Clinical Management of Patients With Moderate-to-Severe Complicated Skin and Soft Tissue Infections [cSSTI] or CAP in the Hospital Setting) was a retrospective observational study, providing current data on the clinical management and resource burden of CAP in real-life settings in European hospitals.

Modeling effects of SGLT-2 inhibitor dapagliflozin treatment versus standard diabetes therapy on cardiovascular and microvascular outcomes.

Aims: Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor, has been shown to lower glycated hemoglobin (HbA1c), weight, blood pressure and serum uric acid in clinical trials. Plasma lipids were also evaluated as exploratory variables. The goal of this study was to estimate the long-term cardiovascular (CV) and microvascular outcomes of dapagliflozin added to the standard of care (SOC) versus SOC using simulation methodology.

Evaluation of the efficacy and safety of bazedoxifene/conjugated estrogens for secondary outcomes including vasomotor symptoms in postmenopausal women by years since menopause in the Selective estrogens, Menopause and Response to Therapy (SMART) trials.

Background: Bazedoxifene/conjugated estrogens (BZA/CE), a novel tissue-selective estrogen complex (TSEC), has been evaluated in the Selective estrogens, Menopause And Response to Therapy (SMART) trials. Secondary outcomes from these trials were evaluated to determine whether the effects of BZA/CE are influenced by years since menopause (YSM).

Methods: SMART-1 and SMART-2 were randomized, double-blind, placebo (PBO)-controlled phase 3 trials in nonhysterectomized postmenopausal women.

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial.

Objective: The effects of bazedoxifene (BZA)/conjugated estrogens (CE) on sleep and health-related quality of life (HRQoL) were evaluated in nonhysterectomized postmenopausal women who were enrolled in a randomized, double-blind, placebo- and active-controlled phase 3 trial.

Methods: The sleep/HRQoL substudy enrolled 459 women with bothersome moderate to severe vasomotor symptoms who were randomized to BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.

Evaluation of the direct and indirect effects of bazedoxifene/conjugated estrogens on sleep disturbance using mediation modeling.

Objective: Mediation modeling was used to evaluate the direct effects of bazedoxifene (BZA)/conjugated estrogens (CE) on sleep, compared with its indirect effects via improvements in hot flushes, in postmenopausal women enrolled in the SMART (Selective estrogens, Menopause, And Response to Therapy)-2 and SMART-5 trials.

Methods: Statistical mediation modeling estimated the direct effects of BZA/CE on sleep disturbance (Medical Outcomes Study sleep scale) and its indirect effects via hot flush improvement (item 1 of the Menopause-Specific Quality of Life questionnaire). In SMART-2, a total of 318 women with moderate to severe vasomotor symptoms (VMS) received BZA 20 mg/CE 0.