Search results for "Tolerability"
showing 10 items of 372 documents
Mesalazine for the treatment of inflammatory bowel disease
2013
Ulcerative colitis (UC) and Crohn's disease (CD) represent a chronic inflammatory condition of the bowel that often require lifelong medical therapy for the induction and maintenance of the remission. Mesalazine therapies are available both as oral delayed-release and sustained-release formulation, topical formulations and as prodrug.Available literature regarding mesalazine is extensively reviewed in this article, covering its mechanism of action, pharmaceutics and pharmacokinetics, clinical efficacy, safety and tolerability in different settings.Mesalazine has a well-established role in the management of UC. It is the treatment of choice in active and inactive mild-to-moderate UC combinin…
Fluticasone propionate/formoterol: a fixed-combination therapy with flexible dosage.
2014
International guidelines describe asthma control as the main outcome of asthma management. Prevention of symptoms, improved quality of life, and reduction of exacerbations are the main components, consequently decreasing health care costs. However, many of these objectives remain unmet in real life: several surveys show that a large proportion of asthmatic patients are not well controlled despite the efficacy of current available treatment. Several randomized controlled clinical trials indicate that combining inhaled corticosteroids and long-acting β2-agonists, by means of a single inhaler, greatly improves the management of the disease. The results of 9 multicenter phase III clinical studi…
Effects of the Combination of Candesartan plus Captopril in Elderly Patients with Anterior Myocardial Infarction
2000
Objective: To verify the feasibility, tolerability and efficacy of the combination of captopril (75 mg/day) and candesartan (8 mg/day) in early postinfarction phases of not thrombolysed and unreperfused anterior acute myocardial infarction (AMI) in elderly patients. Design and Patients: 71 patients (aged >65 years) hospitalised for anterior AMI were randomised in a double-blind manner into two groups: group A included 35 patients who received captopril 75 mg/day within 3 days of admission plus candesartan 4mg, as a first dose, and 8 mg/day successively; group B included 36 patients who received captopril 75 mg/day and placebo. 90 days after admission, patients underwent echocardiography to …
Immunochemotherapy with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) Versus Fludarabine and Cyclophosphamide (FC) Improves Response…
2008
Abstract Introduction: Previous phase II studies have suggested that a combination of FCR may increase the outcome of both untreated and relapsed CLL pts. In order to validate this concept the German CLL study group (GCLLSG) initiated a multicentre, multinational phase III trial, CLL8, to evaluate the efficacy and tolerability of FCR versus FC for the first-line treatment of pts with advanced CLL. Methods and Patients: 817 pts with good physical fitness as defined by a cumulative illness rating scale (CIRS) score (Extermann et al., JCO 1998) of up to 6 and a creatinine clearance (cr cl) □d 70 ml/min were enrolled between July 2003 and March 2006. Pts were randomly assigned to receive 6 cour…
Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic h…
2015
Summary Background Hepatitis C virus (HCV) genotype 4 accounts for about 13% of global HCV infections. Because interferon-containing treatments for genotype 4 infection have low efficacy and poor tolerability, an unmet need exists for effective all-oral regimens. We examined the efficacy and safety of an all-oral interferon-free regimen of ombitasvir, an NS5A inhibitor, and paritaprevir (ABT-450), an NS3/4A protease inhibitor dosed with ritonavir (ombitasvir plus paritaprevir plus ritonavir), given with or without ribavirin. Methods In this multicentre ongoing phase 2b, randomised, open-label combination trial (PEARL-I), patients were recruited from academic, public, and private hospitals a…
The Effects of Oregano Oil on Fungal Infections Associated with Metabolic Syndrome
2020
International audience; This study aims to compare the evolution of mycosis associated with metabolic syndrome under allopathic treatment compared to phytotherapy using oregano essential oil. The study was conducted over a period of 6 months, on a total of 72 patients diagnosed with fungal infections associated with metabolic syndrome. The patients were divided into 3 groups, depending on the administered treatment: group 1: 24 patients who received allopathic treatment; group 2: 24 patients who received oregano oil treatment; group 3: control, which did not undergo any antifungal treatment. All three groups were subjected to specific diet therapy for mycosis. The patients were initially ev…
Randomised Trial of Two Different Daily Doses of Interferon-α versus Classical Therapy in Treatment-Naïve Patients with Chronic Hepatitis C.
2018
To evaluate the efficacy and tolerability of two different daily doses of interferon-α (lymphoblastoid-IFNα-N1, Wellferon®) [IFNα] for 2 months, followed by the same dose on alternate days for up to 1 year, versus administration on alternate days for 1 year. A non-blind, randomised study of outpatients with chronic hepatitis C at five centres in Sicily, Italy. Ninety-seven consecutive treatment-naive patients [72 patients with hepatitis C virus (HCV) genotype 1b infection] with histological chronic hepatitis C were included in the study and randomised to receive IFNα subcutaneously: 5 million international units (MIU) daily for 2 months, followed by the same dose on alternate days for up to…
Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, eva…
2011
Summary Background Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft tissue defects. Aim To compare the efficacy and safety of a novel HA filler, HAE (Emervel Deep), with those of HAP (Restylane Perlane) in the treatment of severe nasolabial folds (NLF). Patients/Methods A split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive injection of HAE or HAP on their left or right NLF. Efficacy was evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Local tolerability was assessed based on subject diary during the first 3 weeks after injection. Adverse events were also evaluated. Results…
Caplacizumab prevents refractoriness and mortality in acquired thrombotic thrombocytopenic purpura: integrated analysis
2021
Abstract The efficacy and safety of caplacizumab in individuals with acquired thrombotic thrombocytopenic purpura (aTTP) have been established in the phase 2 TITAN and phase 3 HERCULES trials. Integrated analysis of data from both trials was conducted to increase statistical power for assessing treatment differences in efficacy and safety outcomes. Caplacizumab was associated with a significant reduction in the number of deaths (0 vs 4; P < .05) and a significantly lower incidence of refractory TTP (0 vs 8; P < .05) vs placebo during the treatment period. Consistent with the individual trials, treatment with caplacizumab resulted in a faster time to platelet count response (ha…
Efficacy, safety and tolerability of combined low-dose simvastatin-fenofibrate treatment in primary mixed hyperlipidaemia.
2007
In order to assess the long-term (12 months) efficacy and safety of fenofibrate administered with simvastatin in the treatment of primary mixed hyperlipidaemia, we conducted a study that compared increasing dosages of these drugs in subgroups of men and women belonging to a clinical sample of outpatients. This was an open study carried out in patients with primary mixed hyperlipidaemia (lipoprotein phenotype IIb) who needed a combined therapeutic approach because of their poor response to a single-drug regimen with an HMG-CoA reductase inhibitor (simvastatin). Thus, a fibrate (fenofibrate) was added to the therapy. The study lasted 12 months. Forty-five patients (mean age: 58.9 ± 11.3 years…