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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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.
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Cardiac arrhythmias are the most common cardiac complication reported in pregnant women with and without structural heart disease (SHD); they are more frequent among women with SHD, such as cardiomyopathy and congenital heart disease (CHD). While older studies had indicated supraventricular tachycardia as the most common tachyarrhythmia in pregnancy, more recent data indicate an increase in the frequency of arrhythmias, with atrial fibrillation (AF) emerging as the most frequent arrhythmia in pregnancy, attributed to an increase in maternal age, cardiovascular risk factors and CHD in pregnancy. Importantly, the presence of any tachyarrhythmia during pregnancy may be associated with adverse maternal and fetal outcomes, including death. ⋯ Regarding the anticoagulation regimen in patients with AF, warfarin should be substituted with heparin during the first trimester, while direct oral anticoagulants are not indicated given the lack of data in pregnancy. Finally, for refractory arrhythmias, ablation and/or device implantation can be performed with current techniques in pregnant women, when needed, using minimal exposure to radiation. All these issues and relevant current guidelines are herein reviewed.
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Objective: Clinical guidelines recommend the use of endocrine therapy (ET) in advanced hormone receptor positive (HR+) human epidermal growth factor receptor type 2 negative (HER2-) breast cancer (BC) patients in the absence of visceral disease or ET resistance. Furthermore, studies indicate similar response and survival rates using ET or cytotoxic chemotherapy (CT). Methods: Herein, we assessed clinical characteristics, type of systemic therapy and survival rates of advanced HR + HER2-BC patients in our database. ⋯ Several patients in our institution receive CT without indication. The increase in ET usage over time can be attributed to better and faster immunohistochemical detection methods for Estrogen Receptor (ER), changes in educational and government policies, and a wider variety of ET options. Finally, clinical trials have failed to demonstrate a substantial benefit of CT over ET in this setting.