Current medical research and opinion
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Multicenter Study Observational Study
Golimumab improves socio economic and health economic parameters in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Golimumab (GLM) has shown its efficacy and safety in various clinical trials. We aimed to assess the effect of GLM on socio economic and health economic parameters in daily clinical practice. ⋯ This evaluation shows improvements in socio economic and health economic parameters on GLM treatment.
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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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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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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of coenzyme A versus fenofibrate in patients with hyperlipidemia: a multicenter, double-blind, double-mimic, randomized clinical trial.
Background: We investigated the lipid-lowering efficacy and safety of coenzyme A (CoA) versus fenofibrate in Chinese patients with moderate dyslipidemia. Methods: A total of 417 subjects (aged 18-75 years) diagnosed with moderate dyslipidemia (triglyceride 2.3-6.5 mmol/L) from 13 large cardiovascular centers in China were recruited and randomly divided into a fenofibrate group (n = 207), which received 200 mg of fenofibrate orally once daily, and a CoA group (n = 210), which received 400 mg of CoA orally once a day. Blood lipoproteins, liver and renal function, creatine kinase, and blood glucose were measured at baseline, and after 4 and 8 weeks of treatment. ⋯ The incidence of side effects was significantly lower in the CoA group compared with the fenofibrate group (p < .05). Conclusions: Compared with fenofibrate, CoA has less effect on reducing plasma TG levels in subjects with moderate dyslipidemia. However, it has fewer adverse effects.
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Multicenter Study
Long-term treatment of pulmonary arterial hypertension with macitentan in Japanese patients.
Objective: Macitentan, a novel dual endothelin receptor antagonist, was approved for the treatment of pulmonary arterial hypertension (PAH) in Japan. However, long-term effects in Japanese patients of macitentan are currently unavailable. This study sought to assess the long-term efficacy and safety of macitentan in Japanese patients with PAH. ⋯ Levels of liver enzyme and hemoglobin remained unchanged throughout the study period. Conclusions: This study suggests that the long-term use of macitentan is well tolerated and effective in Japanese patients with PAH. We concluded that macitentan can be a possible approach to reduce morbidity/mortality in Japanese PAH patients.