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In this clinical trial, rivaroxaban, an oral factor Xa inhibitor, was effective in the initial and continued treatment of symptomatic venous thromboembolism; it may become part of the treatment armamentarium for this common clinical problem. Acute venous thromboembolism (i.e., deep-vein thrombosis [DVT] or pulmonary embolism) is a common disorder with an annual incidence of approximately 1 or 2 cases per 1000 persons in the general population. 1 , 2 Short-term treatment is effective, with the risk of recurrent disease — the major complication — reduced from an estimated 25% to about 3% during the first 6 to 12 months of therapy. 3 The risk of recurrence remains after treatment ends and can reach 5 to 10% during the first year. 4 , 5 Standard treatment for acute venous thromboembolism is limited by the need for parenteral heparin initially, with overlapping . . .

In the treatment of patients with acute pulmonary embolism, the efficacy of rivaroxaban, a factor Xa inhibitor, was similar to that of traditional anticoagulation therapy. There was less bleeding in the group receiving rivaroxaban, which supports its use in the treatment of this condition. Pulmonary embolism is a common disease, with an estimated annual incidence of 70 cases per 100,000 population. 1 , 2 The condition usually leads to hospitalization and may recur; it can be fatal. 3 For half a century, the standard therapy for most patients with pulmonary embolism has been the administration of heparin, overlapped and followed by a vitamin K antagonist. 4 , 5 This regimen is effective but complex. 5 – 9 Recently developed oral anticoagulants that are directed against factor Xa or thrombin overcome some limitations of standard therapy, including the need for injection and for regular dose adjustments on the basis of laboratory monitoring. . . .

This trial compared the efficacy of antiplatelet therapy with prasugrel or clopidogrel in patients with non–ST-segment elevation MI or unstable angina. Although prasugrel provides more intense platelet inhibition, clinical outcomes were similar with the two drugs. Clinical-practice guidelines for patients with acute coronary syndromes consisting of unstable angina or myocardial infarction without ST-segment elevation recommend a strategy of early invasive management (angiography within 48 to 72 hours with provisional revascularization) for patients at moderate to high risk. 1 , 2 However, analyses from clinical trials and national registries have shown that many such patients are treated medically without revascularization and that such patients have poorer long-term cardiovascular outcomes than those who undergo revascularization. 3 – 6 Even though patients with acute coronary syndromes who receive only medical therapy have an increased-risk profile, they have been underrepresented in large-scale, contemporary, randomized . . .

Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding. Rivaroxaban is an orally administered direct inhibitor of factor Xa. As compared with enoxaparin, rivaroxaban was more effective in preventing venous thromboembolism after hip replacement, without a significant increase in major bleeding. Prophylactic anticoagulant therapy is standard practice after total hip or knee arthroplasty, with a minimum recommended duration of 10 days. 1 After total hip arthroplasty, extended prophylaxis for 5 weeks after surgery reduces the incidence of symptomatic and asymptomatic venous thromboembolism more effectively than does short-term prophylaxis. 2 New deep-vein thromboses have been shown to form after the discontinuation of short-term prophylaxis. 3 Several meta-analyses suggest that extended thromboprophylaxis after total hip arthroplasty leads to a reduction in symptomatic venous thromboembolic events, without increasing the risk of major bleeding. 4 – 6 These findings led to a grade 1A recommendation for extended thromboprophylaxis after total . . .

The risk of venous thromboembolism is high after total hip arthroplasty and could persist after hospital discharge. Our aim was to compare the use of rivaroxaban for extended thromboprophylaxis with short-term thromboprophylaxis with enoxaparin. 2509 patients scheduled to undergo elective total hip arthroplasty were randomly assigned, stratified according to centre, with a computer-generated randomisation code, to receive oral rivaroxaban 10 mg once daily for 31–39 days (with placebo injection for 10–14 days; n=1252), or enoxaparin 40 mg once daily subcutaneously for 10–14 days (with placebo tablet for 31–39 days; n=1257). The primary efficacy outcome was the composite of deep-vein thrombosis (symptomatic or asymptomatic detected by mandatory, bilateral venography), non-fatal pulmonary embolism, and all-cause mortality up to day 30–42. Analyses were done in the modified intention-to-treat population, which consisted of all patients who had received at least one dose of study medication, had undergone planned surgery, and had adequate assessment of thromboembolism. This study is registered at ClinicalTrials.gov, number NCT00332020. The modified intention-to-treat population for the analysis of the primary efficacy outcome consisted of 864 patients in the rivaroxaban group and 869 in the enoxaparin group. The primary outcome occurred in 17 (2·0%) patients in the rivaroxaban group, compared with 81 (9·3%) in the enoxaparin group (absolute risk reduction 7·3%, 95% CI 5·2–9·4; p<0·0001). The incidence of any on-treatment bleeding was much the same in both groups (81 [6·6%] events in 1228 patients in the rivaroxaban safety population vs 68 [5·5%] of 1229 patients in the enoxaparin safety population; p=0·25). Extended thromboprophylaxis with rivaroxaban was significantly more effective than short-term enoxaparin plus placebo for the prevention of venous thromboembolism, including symptomatic events, in patients undergoing total hip arthroplasty. Bayer HealthCare AG, Johnson & Johnson Pharmaceutical Research and Development LLC.

Patients who had received a drug-eluting stent and then dual antiplatelet therapy for 12 months were randomly assigned to 18 more months of therapy or aspirin alone. Continued therapy resulted in lower rates of stent thrombosis and major adverse cardiovascular events but more bleeding. Millions of patients worldwide undergo coronary stenting each year for the treatment of ischemic heart disease. 1 , 2 Although drug-eluting stents reduce the rate of restenosis as compared with bare-metal stents, there is concern that drug-eluting stents may be associated with a risk of stent thrombosis beyond 1 year after treatment. 3 Stent thrombosis is rare, yet it is frequently associated with myocardial infarction and may be fatal. 3 Furthermore, ischemic events, such as myocardial infarction, stroke, or death from cardiovascular causes, that are unrelated to the treated coronary lesion may also occur beyond 1 year. 4 , 5 The use of dual antiplatelet therapy . . .

In this trial, 14,264 patients with atrial fibrillation were randomly assigned to receive either rivaroxaban or warfarin. In a per-protocol, as-treated analysis, rivaroxaban was noninferior to warfarin with respect to the primary end point of stroke or systemic embolism. Atrial fibrillation is associated with an increase in the risk of ischemic stroke by a factor of four to five 1 and accounts for up to 15% of strokes in persons of all ages and 30% in persons over the age of 80 years. 2 The use of vitamin K antagonists is highly effective for stroke prevention in patients with nonvalvular atrial fibrillation and is recommended for persons at increased risk. 3 – 5 However, food and drug interactions necessitate frequent coagulation monitoring and dose adjustments, requirements that make it difficult for many patients to use such drugs in clinical practice. 6 – 8 Rivaroxaban is . . .

Aims/hypothesis The aim of this work was to evaluate the efficacy and safety of canagliflozin vs placebo and sitagliptin in patients with type 2 diabetes who were being treated with background metformin. Methods This randomised, double-blind, four-arm, parallel-group, Phase 3 study was conducted at 169 centres in 22 countries between April 2010 and August 2012. Participants ( N  = 1,284) with type 2 diabetes aged ≥18 and ≤80 years who had inadequate glycaemic control (HbA 1c ≥7.0% [53 mmol/mol] and ≤10.5% [91 mmol/mol]) on metformin therapy received canagliflozin 100 mg or 300 mg, sitagliptin 100 mg, or placebo ( n  = 368, 367, 366, 183, respectively) for a 26 week, placebo- and active-controlled period followed by a 26 week, active-controlled period (placebo group switched to sitagliptin [placebo/sitagliptin]) and were included in the modified intent-to-treat analysis set. Randomisation was performed using a computer-generated schedule; participants, study centres and the sponsor were blinded to group assignment. The primary endpoint was change from baseline in HbA 1c at week 26; secondary endpoints included changes in HbA 1c (week 52) and fasting plasma glucose (FPG), body weight, and systolic blood pressure (BP; weeks 26 and 52). Adverse events (AEs) were recorded throughout the study. Results At week 26, canagliflozin 100 mg and 300 mg reduced HbA 1c vs placebo (−0.79%, –0.94%, –0.17%, respectively; p  < 0.001). At week 52, canagliflozin 100 mg and 300 mg demonstrated non-inferiority, and canagliflozin 300 mg demonstrated statistical superiority, to sitagliptin in lowering HbA 1c (−0.73%, –0.88%,–0.73%, respectively); differences (95% CI) vs sitagliptin were 0% (−0.12, 0.12) and −0.15% (−0.27, –0.03), respectively. Canagliflozin 100 mg and 300 mg reduced body weight vs placebo (week 26: –3.7%, –4.2%, –1.2%, respectively; p  < 0.001) and sitagliptin (week 52: –3.8%, –4.2%, –1.3%, respectively; p  < 0.001). Both canagliflozin doses reduced FPG and systolic BP vs placebo (week 26) and sitagliptin (week 52) ( p  < 0.001). Overall AE and AE-related discontinuation rates were generally similar across groups, but higher with canagliflozin 100 mg. Genital mycotic infection and osmotic diuresis-related AE rates were higher with canagliflozin; few led to discontinuations. Hypoglycaemia incidence was higher with canagliflozin. Conclusions/interpretation Canagliflozin improved glycaemia and reduced body weight vs placebo (week 26) and sitagliptin (week 52) and was generally well tolerated in patients with type 2 diabetes on metformin. Clinical trial registry ClinicalTrials.gov NCT01106677 Funding This study was supported by Janssen Research & Development, LLC.

In patients with acute coronary syndromes, low doses of rivaroxaban were effective in reducing the primary end point of death from cardiovascular causes, myocardial infarction, or stroke. Rivaroxaban also reduced overall mortality, although there was more bleeding. After an acute coronary syndrome, patients remain at risk for recurrent cardiovascular events despite standard medical therapy, including long-term antiplatelet therapy with aspirin and an adenosine diphosphate–receptor inhibitor. This risk may be related in part to excess thrombin generation that persists beyond the acute presentation in such patients. 1 As a result, there has been interest in evaluating the role of oral anticoagulants after an acute coronary syndrome. Improved cardiovascular outcomes were reported for patients who were treated with the anticoagulant warfarin in addition to aspirin. 2 However, widespread use of long-term warfarin in such patients has been limited by challenges associated . . .

In acutely ill patients, 10 days of rivaroxaban was noninferior to 10 days of enoxaparin for thromboprophylaxis. Extended-duration rivaroxaban treatment (35 days) reduced the risk of venous thromboembolism. Rivaroxaban was associated with an increased risk of bleeding. Patients with active cancer, stroke, myocardial infarction, or acute exacerbations of a variety of medical conditions are at increased risk for venous thromboembolism. 1 Prolonged immobilization and risk factors such as an age older than 75 years, chronic heart failure, a history of venous thromboembolism, and obesity can increase this risk further. 2 , 3 Randomized, controlled trials involving hospitalized patients at increased risk for venous thromboembolism have shown the benefits of administering anticoagulant agents for up to 14 days, 4 – 8 and guidelines recommend the use of unfractionated heparin, low-molecular-weight heparins, or fondaparinux in such patients. 9 There is some evidence that the risk . . .