Online Survey of Clinical Practice in Patients with Schizophrenia Treated with Long-Acting Injectable Aripiprazole or Paliperidone Palmitate.

BACKGROUND: To obtain real-world evidence of functional improvements during atypical long-acting injectable (aLAI) therapy in recent-onset schizophrenia, an online survey was conducted to assess the impact of aripiprazole once-monthly injectable 400 mg (AOM 400; partial D2 receptor agonist) and paliperidone palmitate once-monthly (PP1M; injectable, full D2 receptor antagonist). METHODS: Psychiatrists provided data for their 2 most recent AOM 400 patients, 2 most recent PP1M patients. Survey included 2000 patient cases (1000 AOM 400; 1000 PP1M). Eligible patients were aged 18-35 years, had been diagnosed with schizophrenia within 5 years, received AOM 400 or PP1M continuously for ≥6 months according to approved labels (mean durations: 1.6 and 1.7 years with AOM 400 and PP1M, respectively). Assessments included Global Assessment of Functioning (GAF) Scale, Personal and Social Performance Scale, Positive and Negative Syndrome Scale, and Quality of Life Scale. GAF assessments were done retrospectively and also at the time of survey. RESULTS: Baseline mean GAF scores were 43.3 and 43.8 for AOM 400 and PP1M, respectively, indicating serious symptoms/functional impairment in both groups. Mean improvements following AOM 400 and PP1M therapy were 19.7 and 16.3 points, respectively (final scores in mild functional impairment category). Other measures assessing symptoms/functionality/quality of life demonstrated the benefits of long-term aLAI therapy. CONCLUSION: Schizophrenia patients with serious functional impairment prior to current aLAI treatment showed improvements in functional outcome after AOM 400 or PP1M therapy. These results suggest functional improvements with aLAIs are apparent not only in research but also real-world settings.

Efficacy and safety of bazedoxifene in postmenopausal Latino women with osteoporosis.

OBJECTIVE: Bazedoxifene (BZA) reduces fractures and bone turnover in postmenopausal women with osteoporosis. This report evaluates safety and efficacy of BZA in Latin American women in the global trial. METHODS: In the 3-year, phase 3, randomized, double-blind trial, postmenopausal women with osteoporosis (N = 7,492) received BZA 20 or 40 mg/d, raloxifene 60 mg/d, or placebo. Outcomes included vertebral fractures, bone mineral density, bone turnover markers, and safety. This post hoc analysis included 3,036 Latin American women. RESULTS: Incidence of vertebral fractures at month 36 with BZA 20 mg, BZA 40 mg, raloxifene, and placebo was 1.87%, 1.90%, 1.43%, and 2.83%, respectively (differences not significant). Adjusted mean percentage increases in bone mineral density were 2.49%, 2.79%, 3.18%, and 1.26% for lumbar spine, and 0.40%, 0.95%, 1.11%, and -0.41% for total hip (P < 0.001 for BZA 20/40 mg vs placebo). Adjusted median percentage reductions in osteocalcin at month 12 were -43.0%, -44.1%, -46.9%, and -27.0%, and C-telopeptide were -50.7%, -53.4%, -57.6%, and -32.1% (P < 0.001 for BZA 20/40 mg vs placebo). Common adverse events included pain and flu syndrome. CONCLUSIONS: BZA significantly improved bone mineral density and reduced bone turnover, and numerically reduced fractures, compared with placebo in postmenopausal Latin American women with osteoporosis. Results were similar to the global trial.

Efficacy and tolerability of bazedoxifene in Mexican women with osteoporosis: a subgroup analysis of a randomized phase 3 trial.

OBJECTIVE: Bazedoxifene (BZA) is a selective estrogen receptor modulator that reduces fracture risk and bone turnover in postmenopausal women with osteoporosis. This analysis evaluated BZA's effects on bone mineral density (BMD) and bone turnover in Mexican women with osteoporosis from the global pivotal trial (Study Evaluating Bazedoxifene Acetate in Osteoporosis in Postmenopausal Women). METHODS: In this 3-year, phase 3, randomized, double-blind trial, healthy postmenopausal women with osteoporosis (N = 7,492) received BZA 20 or 40 mg/d, raloxifene 60 mg/d, or placebo. The subanalyses of Mexican women assessed serum concentrations of osteocalcin and collagen type 1 C-telopeptide, BMD, and tolerability with BZA 20 mg/d versus placebo. RESULTS: In the Mexican subgroup (BZA, n = 39; placebo, n = 37) at month 12, BZA 20 mg/d produced significant (P < 0.001) percentage decreases from baseline in osteocalcin (-40.5 vs -18.5) and C-telopeptide (-45.7 vs -29.4). For BZA versus placebo, percentage change in BMD from baseline to month 36 was 3.3 versus 0.64 for lumbar spine, -0.18 versus -1.8 for total hip, 0.21 versus -2.6 for femoral neck, and -0.55 versus -1.4 for femoral trochanter; differences were not statistically significant. Results were comparable to the overall study population in which differences were statistically significant. Common adverse events (≥20%) included arthralgia, back pain, gastritis, headache, influenza, and pain; none led to study withdrawal. CONCLUSIONS: In Mexican women with osteoporosis, BZA was well tolerated and seems to produce BMD changes comparable to the global phase 3 population, although differences versus placebo were not statistically significant in this smaller subgroup.