Search results for "Randomized"
showing 10 items of 2323 documents
Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral blood pressure after missed dose in type 2 diabet…
2016
Introduction: Combination therapy is needed to control blood pressure (BP) in a large number of hypertensive patients with diabetes mellitus. Adherence to treatment is a major clinical problem; therefore, the time duration of the antihypertensive action of a drug determines BP control when a dose is skipped. Objectives: The aim was to determine whether the fixed-dose combination of olmesartan/amlodipine provides equal efficacy and safety as the perindopril/amlodipine combination when a drug dose is missed. Methods: In this noninferiority trial with a randomized, double-blind, double-dummy parallel group, controlled design, 260 patients received either olmesartan 20-40 mg/amlodipine 5-10 mg …
Pharmacological treatment of patients with chronic critical limb ischemia: L-propionyl-carnitine enhances the short-term effects of PGE-1.
2009
Purpose. To evaluate the therapeutic effects of L-propionyl-carnitine (LPC) in patients with critical limb ischemia (CLI), as defined by the TASC guidelines. Methods. The study, double-blinded, randomised, assessed intravenous infusion of LPC 1.2 g/day in combination with PGE-1, 60 mg/day (LPC group: 37 patients), or PGE-1 only (control group: 38 patients) in a total of 75 patients suffering from CLI. Treatment duration was 20 days. We evaluated rest pain, maximum walking distance (MWD) and skin ulcer size. Results. In both groups we observed a significant reduction in pain score and ulcer size and an increase in MWD. In the patients treated with the combination, the improvement was greater…
Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial
2019
OBJECTIVE Efficacy and safety of the glucagon-like peptide 1 (GLP-1) analog oral semaglutide and the sodium–glucose cotransporter 2 inhibitor empagliflozin were compared in patients with type 2 diabetes uncontrolled on metformin. RESEARCH DESIGN AND METHODS Patients were randomized to once-daily open-label treatment with oral semaglutide 14 mg (n = 412) or empagliflozin 25 mg (n = 410) in a 52-week trial. Key end points were change from baseline to week 26 in HbA1c (primary) and body weight (confirmatory secondary). Two estimands addressed efficacy-related questions: treatment policy (regardless of trial product discontinuation or rescue medication) and trial product (on trial product with…
Assessing biomarkers in a real-world severe asthma study (ARIETTA)
2016
AbstractThe prognostic value of asthma biomarkers in routine clinical practice is not fully understood. ARIETTA (NCT02537691) is an ongoing, prospective, longitudinal, international, multicentre real-world study designed to assess the relationship between asthma biomarkers and disease-related health outcomes. The trial aims to enrol and follow for 52 weeks approximately 1200 severe asthma patients from approximately 160 sites in more than 20 countries. Severe asthmatics, treated with daily inhaled corticosteroid (≥500 μg of fluticasone propionate or equivalent) and at least 1 second controller medication are to be included. In this real-world study, patients will be treated according to the…
Pain Perception and Stabilometric Parameters in People With Chronic Low Back Pain After a Pilates Exercise Program
2016
Various exercise interventions, such as Pilates exercises and traditional physical therapy methods, are employed to decrease low back pain (LBP). Nonspecific low back pain (NSLBP) is distinct from LBP, however, as the distribution of pain is restricted to the region between the costal margin and the inferior gluteal. The aim of our randomized controlled trial was to evaluate the effects of a program of Pilates exercises on pain perception and stabilometric parameters in patients with NSLBP. Thirty-eight participants were randomly allocated, using a 1:1 scheme, to either the experimental group (EG) or control group (CG). The EG completed a 14-week program of Pilates exercises, performed thri…
Ezetimibe/simvastatin 10/20 mg versus simvastatin 40 mg in coronary heart disease patients
2010
BACKGROUND: Reducing low-density lipoprotein cholesterol (LDL-C) is the primary goal of therapy in patients with hypercholesterolemia and coronary heart disease (CHD). METHODS: This double blind placebo-controlled study enrolled patients 18 to 75 years of age with primary hypercholesterolemia and establishedCHDwhowere taking a stable daily dose of simvastatin 20 mg. Patients were randomized to ezetimibe/simvastatin 10/20 mg (eze/simva; n 5 56) or simvastatin 40 mg (simva; n 5 56) for 6 weeks. Percent change from baseline in LDL-C, total cholesterol, high-density lipoprotein cholesterol (HDL-C), and triglycerides were assessed by use of the Student t test. The percent of patients achieving L…
Effects of lipid-lowering drugs on high-density lipoprotein subclasses in healthy men-a randomized trial.
2013
Context and Objective Investigating the effects of lipid-lowering drugs on HDL subclasses has shown ambiguous results. This study assessed the effects of ezetimibe, simvastatin, and their combination on HDL subclass distribution. Design and Participants A single-center randomized parallel 3-group open-label study was performed in 72 healthy men free of cardiovascular disease with a baseline LDL-cholesterol of 111±30 mg/dl (2.9±0.8 mmol/l) and a baseline HDL-cholesterol of 64±15 mg/dl (1.7±0.4 mmol/l). They were treated with ezetimibe (10 mg/day, n = 24), simvastatin (40 mg/day, n = 24) or their combination (n = 24) for 14 days. Blood was drawn before and after the treatment period. HDL subc…
Clinical efficacy and safety of Ezetimibe on major cardiovascular endpoints: systematic review and meta-analysis of randomized controlled trials.
2015
Background Randomized clinical trials (RCTs) about Ezetimibe's efficacy on patient-oriented outcomes have given discordant results. The aim of this study was to determine the net effect of Ezetimibe and of the widely marketed combination, Ezetimibe+simvastatin, on mortality and morbidity outcomes. Methods and Findings We searched for RCT on Ezetimibe using MEDLINE, CCTR, EMBASE, ClinicalTrials.gov databases up to December 2013, Merck and Novartis online registers, and personal communications. Two authors independently selected trials fulfilling these criteria: RCTs comparing Ezetimibe±statin or another lipid-lowering drug against placebo, or against the same lipid-lowering drug at the same …
Effects of dental implant treatment on sleep quality in edentulous older people: A prospective cohort study
2020
Background Edentulism and sleep disturbances are commonly seen among older people and cause serious negative effects on their daily lives. Edentulism can induce sleep problems by changing maxillo-mandibular anatomy and surrounding soft tissues. The effect of the treatment of complete edentulism on sleep disturbances is not sufficiently understood. The purpose of this cohort study is to detect how different treatment options affect sleep quality, daytime fatigue and sleep disorder breathing in totally edentulous elderly people. Material and Methods Ninety-six individulas (50 male and 46 female) participated in this prospective cohort study. The patients were non-randomly assigned to three gr…
Economic evaluation of a guided and unguided internet-based CBT intervention for major depression: Results from a multicenter, three-armed randomized…
2017
Depression is one of the most common mental disorders and will become one of the leading causes of disability in the world. Internet-based CBT programs for depression have been classified as well established following the American Psychological Association criteria for empirically supported treatments. The aim of this study is to analyze the cost effectiveness at 12-month follow-up of the Internet-based CBT program Smiling is fun with (LITG) and without psychotherapist support (TSG) compared to usual care. The perspective used in our analysis is societal. A sample of 296 depressed patients (mean age of 43.04 years; 76% female; BDI-II mean score = 22.37) from primary care services in four Sp…