American journal of therapeutics
-
Randomized Controlled Trial Multicenter Study Comparative Study
Rationale and design of the hemodynamic, echocardiographic and neurohormonal effects of istaroxime, a novel intravenous inotropic and lusitropic agent: a randomized controlled trial in patients hospitalized with heart failure (HORIZON-HF) trial.
Current inotropes have inodilator properties and, although are frequently used in acute heart failure syndromes, do not improve outcomes, likely from reduction in systolic blood pressure and increasing in arrhythmias, causing worsened myocardial ischemia and end-organ damage. Istaroxime is a novel agent that, in animal models, has both inotropic (inhibition of the Na/K ATPase channel) and lusitropic (stimulation of sarcoplasmic reticulum calcium ATPase activity) effects. HORIZON-HF is designed to test the hypothesis that istaroxime is effective in improving central hemodynamics and left ventricular (LV) function, without lowering systolic blood pressure, increasing heart rate, and worsening renal function or myocardial necrosis. ⋯ The novel inotropic and lusitropic agent, istaroxime, was tested in acute heart failure syndromes using a comprehensive assessment of cardiovascular function in addition to hemodynamic measurements.
-
Randomized Controlled Trial Multicenter Study Comparative Study
A double-blind, controlled, multicenter, randomized study comparing the antihypertensive effectiveness and tolerance of a daily dose of two nifedipine formulations: nifedipine microgranules versus nifedipine osmotic pump.
Controlled clinical studies have clearly established the advantages of blood pressure (BP) reduction. However, optimal control of BP in the population is still not adequate. Monotherapy is ineffective in the majority of hypertensive patients, and multidrug therapy increases costs. ⋯ Target BP was reached in more than 70% of patients receiving monotherapy with either formulation. Both formulations were tolerated well.
-
Randomized Controlled Trial
Metformin plus low-dose glimeperide significantly improves Homeostasis Model Assessment for insulin resistance (HOMA(IR)) and beta-cell function (HOMA(beta-cell)) without hyperinsulinemia in patients with type 2 diabetes mellitus.
Type 2 diabetes mellitus is characterized by insulin resistance and defects in insulin secretion from pancreatic beta-cells, which have been studied by using euglycemic/hyperinsulinemic clamps. However, it is difficult to study insulin resistance and beta-cell failure by these techniques in humans. Therefore, the aim of this study was to evaluate the effect of three different antidiabetic therapeutic regimens on insulin resistance and beta-cell activity by using a mathematical model, Homeostasis Model Assessment for insulin resistance (HOMA(IR)) and beta-cell function (HOMA(beta-cell)). ⋯ Metformin plus low-dose glimepiride (plus ADA diet and physical activity) is a more effective treatment for type 2 diabetes than either metformin plus ADA diet and physical activity or ADA diet and physical activity alone. Determination of HOMA(IR) and HOMA(beta-cell) values is an inexpensive, reliable, less invasive, and less labor-intensive method than other tests to estimate insulin resistance and beta-cell function in patients with type 2 diabetes mellitus.
-
Randomized Controlled Trial Comparative Study
MK-0703 (a cyclooxygenase-2 inhibitor) in acute pain associated with dental surgery: a randomized, double-blind, placebo- and active comparator-controlled dose-ranging study.
MK-0703 is a selective cyclooxygenase-2 inhibitor investigated for the treatment of acute pain and inflammation. The purpose of this single-dose, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study was to compare MK-0703 12.5, 50, and 100 mg with ibuprofen 400 mg or placebo in patients who experienced moderate to severe pain after surgical removal of at least 2 third molars. Overall analgesic effect, duration of analgesic effect, time to onset of analgesic effect, peak analgesic effect, and tolerability were assessed over a 24-hour postdose period. ⋯ The onset of analgesic effect in the MK-0703 50 mg and 100 mg and ibuprofen 400 mg groups did not differ significantly from each other (P > 0.20). MK-0703 was generally well tolerated in single doses up to 100 mg. In summary, MK-0703 50 and 100 mg were efficacious in the treatment of postoperative dental pain and were indistinguishable from the active comparator, ibuprofen 400 mg.
-
Randomized Controlled Trial Comparative Study Clinical Trial
Benefits and risks of granisetron versus ramosetron for nausea and vomiting after breast surgery: a randomized, double-blinded, placebo-controlled trial.
Women undergoing general anesthesia for breast surgery are at particular risk of postoperative nausea and vomiting. In a randomized, double-blinded, placebo-controlled trial, 90 patients scheduled for breast surgery, aged 33-63 years, received intravenously placebo, 3 mg granisetron, or 0.3 mg ramosetron (n = 30 of each) at the end of surgical procedure. A standard general anesthetic technique and postoperative analgesia were used. ⋯ Zero to 24 hours after anesthesia, no difference in the rate of patients having emetic symptoms and the severity of nausea was observed between the granisetron and ramosetron groups. The most common reported adverse events were headache and dizziness, and there were no difference in the incidence of adverse events due to the study drug among the 3 groups. In conclusion, prophylactic therapy with ramosetron is more effective than that with granisetron for the long-term prevention of postoperative nausea and vomiting in women undergoing general anesthesia for breast surgery.