Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial.
Objective: DBPR108, a novel dipeptidyl-peptidase-4 inhibitor, has shown great antihyperglycemic effect in animal models. This study was to evaluate the efficacy and safety of DBPR108 monotherapy in type 2 diabetes mellitus (T2DM). Methods: This was a 12-week, double-blind, placebo-controlled phase II clinical trial. ⋯ At end of 12-week treatment, the goal of HbA1c ≤7% was achieved in 29.85, 58.82, 55.22, and 47.83% of the patients in placebo, 50, 100, and 200 mg DBPR108 groups, respectively. The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group. Conclusions: The study results support DBPR108 100 mg once daily as the primary dosing regimen for T2DM patients in phase III development program.
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Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials. Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020. Results: A total of 189 trials are included in the study. ⋯ Study design characteristics: 71% of all studies were randomized, 5% of all studies were blinded, 18% of all studies were multicenter and 76% of all studies were single center. Conclusion: Although many COVID-19 studies include randomization in their design, the lack of additional double-blind and placebo-controlled elements in their designs result in a less robust evaluation of intervention safety and efficacy. Furthermore, similar or repeated research and small sample studies that have less promise in gains of new information have possibly led to a shortage of recruitable patients and become a barrier to the completion of large multicenter clinical trial studies.
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Multicenter Study
Epidemiology, management and costs of sepsis in Spain (2008-2017): a retrospective multicentre study.
Objective: To update the profile of patients attended with sepsis in specialised care centres in Spain, to analyse in-hospital mortality, disease management and costs between 2008 and 2017. Methods: Admission records registered between 1 January 2008 and 31 December 2017 obtained from a Spanish National hospital discharge database for public and private hospitals. Centres are responsible for data codification, evaluation and confidentiality. ⋯ Mean annual direct medical costs of specialised care over the study period were €6664 and €8084 per patient in patients with sepsis without and with organ dysfunction, respectively, and €11,359 per patient in those with septic shock. Conclusions: The social and economic burden of sepsis in Spain continues to grow (incidence, total costs). Despite its general decreasing trend, CFR remains elevated, thus, patients could benefit from further research and protocol revision.
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Observational Study
Cost of cystectomy-related complications in patients with bladder cancer in the United States.
Aims: To describe healthcare utilization and cost associated with the short-term and long-term complications of cystectomy among commercially insured bladder cancer patients in the United States. Materials and methods: This retrospective, observational cohort study evaluated adults with bladder cancer receiving a transurethral resection of bladder tumor followed by a partial or radical cystectomy procedure using U. S. administrative claims from the 2005-2015 IBM MarketScan Commercial and Medicare Supplemental databases. ⋯ In the long-term period, PPPM complication-related healthcare costs were $544 [$2580] for partial cystectomy and $1619 [$7874] for radical cystectomy. Conclusions: Cystectomy-related complications, especially with radical cystectomy, present a substantial financial burden to patients and payers immediately after surgery as well as in the long term. Targeted interventions which improve clinical outcomes but reduce substantial costs associated with cystectomy for bladder cancer are needed.