Current medical research and opinion
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Current evidence indicates that the pharmacokinetic profile of rivaroxaban is not significantly impacted by body weight. However, real-world data are needed to better assess the potential clinical benefits and risks associated with rivaroxaban in non-valvular atrial fibrillation (NVAF) patients with obesity. Thus, our objectives were to assess the real-world effectiveness and safety of rivaroxaban versus warfarin among NVAF patients with obesity in the US nationally representative commercially-insured population. ⋯ These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity in a commercially-insured US population.
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Paracetamol has an established place in the management of mild-to-moderate pain, but has certain limitations, including varying bioavailability, and potential hepatotoxicity if taken in overdose. Effervescent formulations may help to overcome these limitations. ⋯ Effervescent formulations of paracetamol result in faster drug absorption, and hence more rapid analgesia, than oral tablets, and offer a favorable tolerability and safety profile. The use of such formulations may therefore help to promote appropriate use of paracetamol.
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To develop a sensitive and clinically applicable risk assessment tool identifying coronavirus disease 2019 (COVID-19) patients with a high risk of mortality at hospital admission. This model would assist frontline clinicians in optimizing medical treatment with limited resources. ⋯ The OURMAPCN score is a risk assessment tool to determine the mortality rate in COVID-19 patients based on a limited number of baseline parameters. This tool can assist physicians in optimizing the clinical management of COVID-19 patients with limited hospital resources.
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To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union. ⋯ The role of RECs post approval of protocols is to protect human participants through activities such as continuing review of: (a) progress reports, (b) notifications of significant protocol amendments, (c) adverse events, (d) protocol deviations, and (e) protocol violations. Although some international guidelines such as the Declaration of Helsinki emphasize the right to monitor, RECs' predominant activity is document review. In the USA, RECs are authorized to issue approvals and terminate/suspend previously issued approvals. However, in the EU, the approach is to relegate to member states to decide the extent of legislative power they wish to give to the RECs. The REC's opinion on the end of trial report is identified as an area for further exploration.
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Objective: To identify evidence in the literature presenting the economic and humanistic (based on health state utility values [HSUVs]) burden of multiple sclerosis (MS) and report the incremental burden of secondary progressive MS (SPMS) compared with relapsing-remitting MS (RRMS). Methods: Electronic databases (Embase, MEDLINE, MEDLINE In-Process, Cochrane Library) and other relevant repositories were systematically searched from the date of inception until November 2019 for evidence on the economic burden of MS, or HSUVs in patients with MS. Data were extracted from studies investigating cost data or HSUVs for patients with SPMS compared with RRMS. ⋯ Fatigue and psychological stress (including depression) were identified as key drivers of this reduced health-related quality of life (HRQoL). Conclusions: Our findings indicate that SPMS is associated with higher costs and more substantial HRQoL decrements than RRMS. These results highlight the substantial unmet need for effective treatments that can slow disease progression in patients with SPMS, which, in turn, would reduce the rate of HRQoL deterioration and increasing healthcare costs.