Current medical research and opinion
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To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs' activities after the approval of trial protocols for clinical studies. ⋯ Post-approval follow-up activities for clinical studies by RECs is a valuable resource and means for early detection and resolution of protocol deviations and violations. However, a majority of RECs within Europe do not have active post-approval follow-up of approved protocols. The interviews revealed that resource challenges such as time, personnel, and organizational structure contribute to the lack of follow-up by RECs. Some RECs in the represented countries do not identify post-approval follow-up as part of their mandate but instead place emphasis on the culture of trust between the RECs and researchers. Current EU Regulations do not directly address the role of the REC after the approval of clinical trials.
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The extent of short-acting β2-agonist (SABA) overuse in Africa remains poorly documented. As part of the SABA use IN Asthma (SABINA) III study, we assessed SABA prescriptions/clinical outcomes in 3 African countries. ⋯ Findings from this African cohort of the SABINA III study indicate that SABA over-prescription and SABA over-the-counter purchase are common and associated with poor asthma-related outcomes. This highlights the need for healthcare providers/policymakers to align clinical practices with the latest treatment recommendations.
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Diabetes mellitus, as the most common metabolic disease, is common worldwide and represents a crucial global health concern. The purpose of this research was to investigate the related risk factors and to develop a re-amputation risk nomogram in diabetic patients who have undergone an amputation. ⋯ This novel re-amputation nomogram incorporating smoking, glycated hemoglobin A1c (HbA1c), ankle-brachial index (ABI), C-reactive protein (CRP), and smoking could be easily used to predict individual re-amputation risk prediction in diabetic foot patients who have undergone an amputation. In the future, further analysis and external testing will be needed as much as possible to reconfirm that this new Nomogram can accurately predict the risk of toe re-amputation.
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In recent years, US payers have increased usage of formulary exclusions as a means to help manage costs. Earlier this year, one of the largest pharmacy benefit managers in the country added Eliquis (apixaban), the most widely used anticoagulant, to its list of excluded medicines from its formulary, raising concerns by physicians and patients. In this commentary, we examine the potential impacts of formulary exclusion of a drug like apixaban-a treatment for patients with atrial fibrillation and venous thromboembolism to help prevent stroke and clotting events and which has been demonstrated to have a strong efficacy and safety profile. ⋯ We found that the majority of these patients remained on apixaban either through pre-emptively switching to a different Part D drug plan with apixaban coverage or applying for formulary exception. Our findings suggest that formulary exclusion did not help to achieve the goal of switching patients to less costly medications but created additional hurdles for patients to access their preferred treatment and increased patient burden. Alternative ways to manage payer costs may be needed to help avoid poor outcomes and reduce the burden placed on patients in their efforts to access life-saving medications.
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Randomized Controlled Trial Multicenter Study
Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial.
This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin. ⋯ Rapilin demonstrated non-inferior glycemic control, and matching safety and immunogenicity to NovoRapid in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks.