Search results for "endpoint"
showing 10 items of 437 documents
Addition of either pioglitazone or a sulfonylurea in type 2 diabetic patients inadequately controlled with metformin alone: impact on cardiovascular …
2012
Abstract Background and aims Metformin is the first-line therapy in type 2 diabetes. In patients inadequately controlled with metformin, the addition of a sulfonylurea or pioglitazone are equally plausible options to improve glycemic control. However, these drugs have profound differences in their mechanism of action, side effects, and impact on cardiovascular risk factors. A formal comparison of these two therapies in terms of cardiovascular morbidity and mortality is lacking. The TOSCA.IT study was designed to explore the effects of adding pioglitazone or a sulfonylurea on cardiovascular events in type 2 diabetic patients inadequately controlled with metformin. Methods Multicentre, random…
Similar effectiveness of dapagliflozin and GLP-1 receptor agonists concerning combined endpoints in routine clinical practice: A multicentre retrospe…
2019
Abstract Aims According to cardiovascular outcome trials, some sodium‐glucose contransporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) are recommended for secondary cardiovascular prevention in type 2 diabetes (T2D). In this real‐world study, we compared the simultaneous reductions in HbA1c, body weight and systolic blood pressure after initiation of dapagliflozin or GLP‐1RA as second or a more advanced line of therapy. Materials and methods DARWIN‐T2D was a retrospective multi‐centre study conducted at diabetes specialist clinics in Italy that compared T2D patients who initiated dapagliflozin or GLP‐1RA (exenatide once weekly or liraglutide). Data were c…
24-h efficacy and pharmacokinetics of tiotropium Respimat® 5 μg in patients with asthma
2015
Background: Once-daily tiotropium Respimat® (tioR) add-on therapy has demonstrated efficacy in patients with moderate symptomatic asthma. Aim and Objectives: To investigate whether dosing regimen (QD vs BID) affected 24-h bronchodilator efficacy and exposure of tioR. Methods: 2 randomised, double-blind, crossover trials (trial 1, NCT01152450 [placebo-controlled]; trial 2, NCT01696071); 4-week treatments of tioR 5 µg QD, 2.5 µg BID and placebo Respimat® (pboR) added to medium-dose ICS (400-800 µg budesonide or equivalent). Primary end point (Week 4): area under the curve response for FEV1 (FEV1 AUC(0-24h)) (trial 1, tioR vs pboR; trial 2, QD vs BID). Pharmacokinetic end points (steady state)…
Efficacy of tiotropium and olodaterol fixed-dose combination in patients with COPD on β-blockers
2015
Introduction: The efficacy and safety of a new once-daily (QD) fixed-dose combination (FDC) with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, was established for the treatment of COPD in the TONADO studies (NCT01431274; NCT01431287). This analysis evaluates the efficacy of the FDC in a subpopulation of patients receiving β-blockers (BBs) in these studies. Methods: Two replicate, randomised, double-blind, parallel-group, 52-week, Phase III trials assessed the efficacy and safety of T+O FDC (2.5/5 μg; 5/5 μg; Respimat ® inhaler) QD compared to the monocomponents. Key primary end point data for the combined analysis of the replicate trial…
Managed ventricular pacing vs. conventional dual-chamber pacing for elective replacements: the PreFER MVP study: clinical background, rationale, and …
2008
Udgivelsesdato: 2008-Mar AIMS: Several clinical studies have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can be detrimental. The managed ventricular pacing (MVP) algorithm is designed to give preference to spontaneous AV conduction, thus minimizing RV pacing. The clinical outcomes of MVP are being studied in several ongoing trials in patients undergoing a first device implantation, but it is unknown to what extent MVP is beneficial in patients with a history of ventricular pacing. The purpose of the Prefer for Elective Replacement MVP (PreFER MVP) study is to assess the superiority of the MVP algorithm to convention…
Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover
2020
This study investigated the efficacy and safety of pimasertib (MEK1/MEK2 inhibitor) versus dacarbazine (DTIC) in patients with untreated NRAS-mutated melanoma. Phase II, multicenter, open-label trial. Patients with unresectable, stage IIIc/IVM1 NRAS-mutated cutaneous melanoma were randomized 2:1 to pimasertib (60 mg
Epidemiology and characteristics of febrile neutropenia in oncology patients from Spanish tertiary care hospitals: PINNACLE study.
2015
Febrile neutropenia (FN) is one of the most common adverse events associated with myelosuppressive chemotherapy for cancer treatment. The objective of this study was to describe the incidence of hospitalization due to FN in Spanish tertiary care hospitals (PINNACLE study). This epidemiological, retrospective, multicenter, nationwide study involved 119 patients from oncology units of 10 Spanish tertiary care hospitals who were admitted for FN. The primary endpoint was to assess the epidemiology and characteristics of FN. The incidence of admissions due to FN in oncology patients was 2.0% (interquartile range [IQR], 1.6–3.0). In terms of fever and absolute neutrophil count (ANC), 37.0% of the…
Gonadotropin-releasing hormone agonist for the prevention of chemotherapy-induced ovarian failure in patients with lymphoma: 1-year follow-up of a pr…
2013
PURPOSE To assess the efficacy of gonadotropin-releasing hormone agonist (GnRHa) in preventing chemotherapy-induced ovarian failure in patients treated for Hodgkin or non-Hodgkin lymphoma within the setting of a multicenter, randomized, prospective trial. PATIENTS AND METHODS Patients age 18 to 45 years were randomly assigned to receive either the GnRHa triptorelin plus norethisterone (GnRHa group) or norethisterone alone (control group) concomitantly with alkylating agents containing chemotherapy. The primary end point was the premature ovarian failure (POF) rate (follicle-stimulating hormone [FSH] ≥ 40 IU/L) after 1 year of follow-up. Results Eighty-four of 129 randomly assigned patients …
Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma
2020
BackgroundWe have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.MethodsThis randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.ResultsAt a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 mont…
In the literature: April 2017
2017
The full publication in Lancet Oncology of the Stockholm III trial helps us to understand that short-course radiotherapy in patients with localised rectal cancer could also be followed by delayed surgery.1 During more than 14 years, more than 800 patients with rectal cancer not showing unresectable features were randomised in a two-arm versus three-arm study with a non-inferiority design. Patients could be randomised to short-course radiotherapy (5×5 Gy) and immediate (within a week) versus delayed (4–8 weeks) surgery. In the three-arm randomisation patients could also be allocated to a long course of concurrent chemoradiation (25×2 Gy), with surgery performed 6–8 weeks thereafter. Time to …