Search results for "Tolerability"

Safety and tolerability of local treatment with iloprost, a prostacyclin analogue, in patients with Peyronie's disease: a phase I study

2011

Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability

2013

Aims Mirabegron, the first β3-adrenoceptor agonist to enter clinical practice, has a different mechanism of action from antimuscarinic agents. This review presents data on the efficacy, safety, and tolerability of mirabegron in studies conducted to date. Methods All clinical data on mirabegron that are currently in the public domain are included, including some in-press manuscripts. Results In Phase III clinical trials in patients with overactive bladder (OAB), mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency,…

Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: Open-label extension of the SO…

2013

Aims To assess the long-term safety, tolerability, and efficacy of flexible-dose fesoterodine in elderly patients with OAB. Methods Patients aged ≥65 years who completed a 12-week, randomized, double-blind, placebo-controlled trial were eligible for the 12-week, open-label (OL) extension phase. Patients who received double-blind placebo started on fesoterodine 4 mg and could increase to 8 mg after 4 or 8 weeks of OL treatment, while fesoterodine-treated patients continued on their double-blind dose; only one dose escalation or de-escalation was permitted. Discontinuations and adverse events (AEs) were monitored, and patients completed 3-day bladder diaries and patient-reported outcomes at t…

Evaluation of Safety, Tolerability and Efficacy of Temsirolimus in Patients with Relapsed or Refractory Mantle Cell Lymphoma (REL/REFR MCL) in the Us…

2012

ABSTRACT Background Temsirolimus (TEMS), an mTOR-inhibitor, is approved the EU for the treatment of patients (pts) with relapsed or refractory MCL (rel/refr). A pivotal study demonstrated significantly longer progression free survival with TEMS (175mg weekly for 3 weeks followed by 75mg weekly) in rel/refr MCL pts compared to investigatoŕs choice therapy (4.8 mo vs 1.9 mo; P = .0009). To better identify safety and efficacy of TEMS in an unselected patient population during clinical routine a prospective non-interventional study with TEMS in rel/refr MCL-pts was started. Here we report on interim results of the study. Methods A registry for rel/refr MCL pts treated with TEMS was started in G…

Effectiveness of Antipsychotic Medication in the Treatment of BPD

2017

IntroductionThough prescription is off-lable, “atypical” or “second-generation” antipsychotics (SGAs) are prevalently given to borderline personality disorder (BPD) patients. They have also been the focus of research on pharmacological agents in BPD in recent years, as the previous version of the relating cochrane systematic review shows.ObjectivesWe are currently updating this cochrane systematic review on pharmacological interventions for BPD. First findings on the up-to-date evidence relating to SGAs will be presented.MethodsWe conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) according to cochrane collaboration standards. Any randomized comparisons o…

Perampanel and Visuospatial Skills in Children With Epilepsy

2021

Introduction: Perampanel (PER) is a non-competitive AMPA glutamate receptor antagonist approved for focal and generalized seizures as add-on therapy. PER does not seem to negatively affect the cognitive profile in children and adolescents, but its influence on visuospatial abilities is still to be assessed. The aim of our study was to assess visuospatial skills through a standardized neuropsychological evaluation in adolescents taking PER for 12 months.Methods: Our sample included 46 adolescents aged 12–18 years with focal and generalized drug-resistant epilepsy already in therapy with one or two antiseizure medications. Changes in visuospatial perception and memory were assessed by the Rey…

Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Artery Stenosis: Design and Rationale of a Randomized Phase II Clinical Trial

2020

AbstractPatients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor an increased risk of recurrent stroke especially within 2 weeks after the first event. In addition, the revascularization procedure itself (carotid endarterectomy [CEA] or carotid artery stenting [CAS]) is associated with both clinically apparent and silent brain infarctions, mainly caused by the embolic nature of the ruptured carotid plaque. The glycoprotein VI (GPVI) fusion protein Revacept is a highly specific antithrombotic drug without direct inhibition of systemic platelet function that might reduce periprocedural distal embolization from the vulnerable ruptured plaque located…

Do Mood Stabilizers Help in Borderline Personality Disorder?

2017

BackgroundDespite the relatively weak evidence base, individuals with borderline personality disorder are often treated with pharmacological interventions. Amongst the drugs, which have shown most promise, are mood stabilizers, which were one of the two drug classes with the most beneficial effects in a previous cochrane review though the robustness of findings was described as low (Stoffers et al., 2010). Here we present data on the latest evidence for mood stabilizers based on an updated cochrane review currently underway.MethodsA systematic review and meta-analysis of randomized controlled trials was conducted. All randomized comparisons of drug vs. placebo, drug vs. drug, or drug vs. a …

Selective RAR agonists for acne vulgaris: A narrative review.

2019

Background Acne vulgaris is a chronic disfiguring inflammatory disease of adolescents and adults affecting up to 90% of the population around the world. The sequence of etiopathogenesis in acne is not completely understood but involves abnormalities in sebum production, follicular plugging, proliferation of propionibacterium acnes, and chronic inflammation. Aims This review aims to summarize the features of the topical selective RAR agonists in treating acne vulgaris with a special emphasis on the 4th generation topical retinoid trifarotene. Methods Studies were identified by searching electronic databases (MEDLINE and PubMed) till August 2019 and reference lists of respective articles. Onl…

Cardiopulmonary exercise testing in COVID-19 patients at 3 months follow-up☆

2021

Abstract Background Long-term effects of Coronavirus Disease of 2019 (COVID-19) are of utmost relevance. We aimed to determine: 1) the functional capacity of COVID-19 survivors by cardiopulmonary exercise testing (CPET); 2) the characteristics associated with cardiopulmonary exercise testing (CPET) performance; 3) the safety and tolerability of CPET. Methods We prospectively enrolled consecutive patients with laboratory-confirmed COVID-19 from Azienda Sanitaria Locale 3, Genoa. Three months after hospital discharge a complete clinical evaluation, trans-thoracic echocardiography, CPET, pulmonary function tests, and dominant leg extension (DLE) maximal strength measurement were performed. Res…