Current medical research and opinion
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of galcanezumab in Taiwanese Patients: a post-hoc analysis of phase 3 studies in episodic and chronic migraine.
Migraine is a chronic, disabling neurological disease affecting >1 billion people worldwide. Migraine remains undertreated in Asia, including Taiwan. Galcanezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide, a peptide firmly established in the pathophysiology of migraine, with demonstrated efficacy and safety in patients with episodic or chronic migraine. Our objective was to evaluate the efficacy and safety of galcanezumab in Taiwanese patients with episodic or chronic migraine. ⋯ Galcanezumab is a promising therapeutic for the preventive treatment of migraine in the Taiwanese population.
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Randomized Controlled Trial Multicenter Study
Quality of oral anticoagulation control in Chinese patients with non-valvular atrial fibrillation: a prospective controlled study.
The sex, age, medical history, treatment, tobacco use, race risk (SAMe-TT2R2) Score; the sex, age, medical history, treatment, tobacco use, genotype combination (SAMe-TT2G2) Score; and the so-called modified SAMe-TT2R2 scores have been proposed to predict the anticoagulation quality for patients with non-valvular atrial fibrillation (NVAF). The data from a prospective controlled study is used to validate the SAMe-TT2R2 and SAMe-TT2G2 scores in Chinese NVAF patients treated with warfarin and to evaluate the association of factors with time in therapeutic range (TTR) to predict the quality of oral anticoagulation control. ⋯ A warfarin-dosing algorithm used for initial treatment of patients older than 60 helps to achieve a better quality of oral anticoagulation control, whereas concomitant torasemide can produce a negative effect. These findings provide useful information for future investigations on the quality of oral anticoagulation control in Chinese anticoagulation clinical practice.
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Randomized Controlled Trial
Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus.
Objective: To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor ertugliflozin across racial groups in patients with type 2 diabetes mellitus (T2DM). Methods: Pooled analysis of data from randomized, double-blind studies in the ertugliflozin phase III development program. Seven placebo- and comparator-controlled studies were used to assess safety (N = 4859) and three placebo-controlled studies were used to assess efficacy (N = 1544). ⋯ Conclusions: In patients with T2DM, treatment with ertugliflozin improved HbA1c, body weight and SBP across all racial subgroups. Ertugliflozin had a generally similar safety profile across racial subgroups and was generally well tolerated. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.
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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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Randomized Controlled Trial
Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.
Objective: To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Methods: Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. ⋯ Conclusion: Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.