Current medical research and opinion
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Objective: To identify systemic treatment in the real-world following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDKi) among post-menopausal women with hormone receptor positive, human epidermal growth factor receptor 2 Negative (HR+/HER2-) metastatic breast cancer (mBC). Methods: Post-menopausal women with HR+/HER2- mBC were identified from MarketScan claims databases between January 1, 2012 and October 31, 2017. Eligible mBC patients who received a CDKi-based line of therapy following metastasis diagnosis were selected. ⋯ Of post-CDKi second line regimens (n = 208), 38.0% were endocrine only, 35.6% were chemotherapy-based, 14.4% were everolimus-based, 9.6% were also CDKi-based line, and 2.4% were others. After adjusting for demographic and clinical characteristics, patients transitioning from a CDKi-based line to chemotherapy (vs others) had a trend of being more likely to have recurrent rapidly progressing disease, and were significantly less likely to have the prior CDKi-based line in combination with an AI (both p < .05). Conclusions: This population-based study suggests that rapidly progressing disease, metastatic site location, age, and endocrine therapy partner may be predictive of subsequent systemic therapy regimen selection after progression on a CDKi-based line therapy in patients with HR+/HER2- mBC.
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Objective: This descriptive study examined the quality of care received by individuals with serious mental illness observed in clinical care using established Healthcare Effectiveness Data and Information Set (HEDIS) measures for individuals with serious mental illness. Methods: Administrative claims (Medicaid, Medicare, and commercial) from a national health and well-being company were used to identify adults with schizophrenia or bipolar disorder. Performance rates for five HEDIS mental health quality measures were computed. ⋯ The rates for individuals with Medicare coverage were similar or marginally higher than those reported for those with Medicaid coverage, while rates for the commercially insured population were lower than the other groups. Conclusions: Most (>65%) individuals with serious mental illness received the recommended screening and monitoring for diabetes and cardiovascular disease. Barriers to and reasons for lack of follow-up should be investigated to guide future interventions to improve follow-up after hospitalization for individuals with serious mental illness.
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Aim: The aim of study was to investigate the opportunities of local phlebectomy in the elimination of isolated pelvic-perineal reflux (PPR), as well as to determine the feasibility of endovascular embolization of the tributaries of internal iliac veins in PPR. Clinical trial no. NCT01598051. ⋯ Endovascular embolization of the tributaries of the internal iliac veins is not an essential component in the treatment of PPR. The present study has a limitation due to the absence of patients with PCS. The effectiveness of phlebectomy in the treatment of isolated PPR was studied.
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Multicenter Study
Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation.
Objective: This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Methods: Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies. Safety was assessed by treatment-emergent adverse events (AEs). ⋯ Conclusions: Plecanatide 6 mg was safe and well tolerated in patients with IBS-C treated for up to 53 weeks, with an overall safety profile similar to the 12-week IBS-C studies. Patients reported high rates of relief and satisfaction with treatment, and interest in continuing therapy. Trial registration: ClinicalTrials.gov identifier: NCT02706483.
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Objective: To compare rehospitalizations in patients with schizophrenia treated with paliperidone palmitate (PP1M) vs oral atypical antipsychotics (OAAs), with a focus on young adults (18-35 years). Methods: The Premier Healthcare database (January 2009-December 2016) was used to identify hospitalizations of adults (≥18 years) with schizophrenia treated with PP1M or OAA between September 2009 and October 2016 (index hospitalizations). Rehospitalizations were assessed at 30, 60, and 90 days after each index hospitalization in young adults and in all patients. ⋯ Similarly, when observing all patients, those receiving PP1M during an index hospitalization had 19-22% lower odds of rehospitalization within 30, 60, and 90 days compared to those receiving OAAs (all p < .001). Conclusions: Following a hospitalization for schizophrenia, PP1M treatment was associated with fewer 90-day rehospitalizations among young adults (18-35 years) relative to OAA treatment. This finding was also observed in other hospitalized adults with schizophrenia.