Current medical research and opinion
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Normalizing serum thyroid stimulating hormone (TSH) levels by lifelong treatment with levothyroxine (LT4) remains the primary goal of therapy for patients with hypothyroidism. The reference ranges for TSH are derived from populations with (supposedly) normal thyroid function. But, TSH results are affected by a number of factors including alterations in TSH levels with age, concurrent illnesses, circadian rhythm, inter- and intra-assay differences, and some commonly used medications that interfere with thyroid function or the TSH test. ⋯ However, the new LT4 formulations are associated with manifold increases in the number of self-reported adverse events. Therefore, patients with hypothyroidism as well as the clinicians managing them need to better understand the utility as well as the limitations of the widely used TSH measurement. In addition, both pharmaceutical companies and the prescribing clinician need to take greater care when patients are switched from older to newer formulations.
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Objective: To describe the cost-effectiveness of pembrolizumab plus chemotherapy (carboplatin and paclitaxel or nab-paclitaxel; P + C) in metastatic, squamous, non-small-cell lung cancer (NSCLC) patients in the US. Methods: A model comparing P + C versus C alone is developed utilizing partitioned survival analysis. Primary clinical efficacy, treatment utilization, health utility and safety data are derived from the KEYNOTE-407 trial and projected over 20 years. ⋯ Conclusions: Across all eligible patients, the addition of pembrolizumab to chemotherapy is projected to approximately double life expectancy, yielding an extension to a point not previously seen in metastatic squamous NSCLC. Overall, and within all relevant PD-L1 subgroups, use of P + C yields an ICER below $100,000/QALY, and can be a cost-effective first-line treatment for eligible metastatic squamous NSCLC patients for whom chemotherapy is currently administered. In the PD-L1 ≥ 50% subgroup, additional follow-up within trials of pembrolizumab plus chemotherapy and pembrolizumab monotherapy are needed to better define cost-effectiveness between these comparators.
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Objectives: Emergency contraception (EC) provides an opportunity to avoid an unwanted pregnancy following unprotected sexual intercourse (UPSI), failure of a regular contraceptive method, or after sexual assault. Two main methods are currently available: oral pills or the copper-T intrauterine device. In recent years there has been some debate regarding the efficacy of oral therapy in obese women. ⋯ Since the EMA review, additional evidence has been published regarding this topic. This includes PK data (which can neither support, nor deny the previously submitted meta-analyses during the Article 31 Referral procedure), or re-analyses of the previously submitted data. Conclusions: Evidence published since the EMA referral in 2014 does not change the original conclusions of the agency, which recommended that ECPs could be taken regardless of body weight or BMI, as soon as possible after UPSI.
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Objective: To examine how medical journal editors perceive changes in transparency and credibility of industry-sponsored clinical trial publications over a 5 year period (2010 to 2015). Methods: From July to September 2015, a survey link was emailed to journal editors identified from the Thomson Reuters registry. Editors ranked their perception of: a) change in transparency and credibility of industry-sponsored clinical trial publications; b) 8 "Publication Best Practices" and the impact of each on transparency; and c) the importance and adoption of the previously published "10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research". ⋯ Conclusions: The 293 editors who responded perceived an improvement in the transparency and credibility of industry-sponsored publications from 2010 to 2015. Confirmation of the importance of 9/10 recommendations by the respondents was encouraging. Yet, low adoption rates suggest that additional work is required by all stakeholders to improve best practices, transparency and credibility.
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Objective: To assess the impact of developing tardive dyskinesia (TD), both with and without other pre-existing extrapyramidal symptoms (EPS), on healthcare resource utilization (HRU) among patients with mental disorders receiving antipsychotic medications. Methods: Data on patients receiving antipsychotics who had schizophrenia, major depressive disorder or bipolar disorder were extracted from a Medicaid claims database. Separate cohorts of TD patients with and without other EPS ("TD + EPS" and "TD non-EPS") were constructed and matched to patients in a non-TD/EPS control cohort at a ∼1:5 ratio. ⋯ Difference-in-differences analyses demonstrated that development of TD was associated with a statistically significant increase of ∼15-19% in the percentage of patients with all-cause and mental-disorder-related inpatient admissions/visits. The within-cohort change from baseline to follow-up in the use of potential drugs for TD or EPS was similar between the TD cohorts and their matched controls. Conclusions: This study demonstrates a significant economic burden associated with developing TD, as captured by increased HRU including inpatient admissions and ER visits.