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PubMed Journals Articles About "Phase Switching Data Support Long Term Efficacy Safety" RSS

00:34 EST 16th December 2018 | BioPortfolio

Phase Switching Data Support Long Term Efficacy Safety PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Phase Switching Data Support Long Term Efficacy Safety articles that have been published worldwide.

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We have published hundreds of Phase Switching Data Support Long Term Efficacy Safety news stories on BioPortfolio along with dozens of Phase Switching Data Support Long Term Efficacy Safety Clinical Trials and PubMed Articles about Phase Switching Data Support Long Term Efficacy Safety for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Phase Switching Data Support Long Term Efficacy Safety Companies in our database. You can also find out about relevant Phase Switching Data Support Long Term Efficacy Safety Drugs and Medications on this site too.

Showing "Phase switching data support long term efficacy safety" PubMed Articles 1–25 of 53,000+

Clinical Study Design to Assess Both Short- and Long-term Efficacy in Addition to Group Sequential Test on Safety.

In clinical studies for disorders such as rheumatoid arthritis, type 2 diabetes mellitus, multiple sclerosis, osteoporosis, etc, sometimes the developers need to address safety concerns (eg, cardiovascular risk) in the phase III development, so that a large long-term safety study is needed before registration. This article does not contain any studies with human or animal subjects performed by any of the authors. Aiming for potential regulatory approval with a single confirmatory study, the authors suggest ...


Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.

Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials ≤12 months' duration; however, long-term data are lacking.

Long-term safety and efficacy of the novel β -adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study.

To evaluate the long-term safety and efficacy of vibegron 50 mg and 100 mg, a novel β -adrenoreceptor agonist, in Japanese patients with overactive bladder.


Long-Term Efficacy and Safety of Hizentra® in Patients with Primary Immunodeficiency in Japan, Europe, and the United States: a Review of 7 Phase 3 Trials.

Many patients with primary immunodeficiency (PID) require immunoglobulin G (IgG) replacement therapy, delivered as intravenous IgG (IVIG) or subcutaneous IgG (SCIG). We aim to identify trends in efficacy and safety that would not be evident in individual studies of small patient numbers. Seven open-label, Phase 3, prospective, multicenter studies of the efficacy and safety of Hizentra® (a SCIG), conducted in Japan, Europe, and the US were summarized. Overall, 125 unique patients received 15,013 weekly infu...

Long-term tolerability, safety and efficacy of adjunctive perampanel in the open-label, dose-ascending Study 231 and extension Study 233 in Japanese patients with epilepsy.

To evaluate long-term tolerability, safety and efficacy of adjunctive perampanel in a Phase II, multicentre, open-label, dose-ascending Study 231 (NCT00849212) and its extension (Study 233; NCT00903786) in Japanese patients with refractory partial-onset seizures (POS), with/without secondarily generalised seizures.

Long-term treatment of endometriosis with dienogest: retrospective analysis of efficacy and safety in clinical practice.

Endometriosis is a debilitating disease with high recurrence rates requiring long-term management. Progestins such as dienogest are used empirically when first symptoms occur and post-surgery to reduce recurrence. This retrospective, practice-based study assessed the efficacy and safety of dienogest in women with endometriosis treated for at least 60 months.

Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase 3 Randomized Controlled Trials.

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks.

A phase 3b, multicenter, open-label extension study of the long-term safety of anagrelide in Japanese adults with essential thrombocythemia.

Cytoreductive therapy is used in high-risk essential thrombocythemia (ET) to reduce risk of thrombohemorrhagic complications. Anagrelide is an orally active, quinazolone-derived platelet-lowering agent approved for first-line treatment of high-risk ET in Japan. Long-term safety and efficacy data were collected from 53 Japanese high-risk ET patients (Study 308); 41 patients who completed Study 308 entered this phase 3b, open-label extension (Study 309; NCT01467661). Reductions in mean platelet counts occurre...

High-power and short-duration ablation for pulmonary vein isolation: Safety, efficacy, and long-term durability.

PV reconnection is often the result of catheter instability and tissue edema. High-power short-duration (HP-SD) ablation strategies have been shown to improve atrial linear continuity in acute pre-clinical models. This study compares the safety, efficacy and long-term durability of HP-SD ablation with conventional ablation.

Efficacy and safety of laxatives for chronic constipation in long-term care settings: A systematic review.

Constipation is a common disorder among long-term care (LTC) patients due to several factors. However, there are no systematic reviews investigating the use of laxatives for chronic constipation in LTC settings. This study aims to explore the safety and efficacy of laxatives in LTC patients.

Tofacitinib for the treatment of psoriasis and psoriatic arthritis.

Psoriasis and psoriatic arthritis (PsA) are inflammatory immune mediated conditions which can cause considerable disability and reduced quality of life. Management can be complex as clinical heterogeneity may lead to different treatment pathways. Tofacitinib is a novel, oral janus kinase (JAK) inhibitor with proven efficacy in rheumatoid arthritis. Areas covered: This review analyses recent studies of tofacitinib in psoriatic disease treatment. The relevant literature was identified using clinicaltrials.gov...

Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2.

To assess the long-term safety and efficacy of ixekizumab, an IL-17A antagonist, in patients with active PsA.

Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials.

To evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA).

Tofacitinib in patients with moderate to severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study.

Tofacitinib is an oral Janus kinase inhibitor. Final safety and efficacy data from an open-label extension study of tofacitinib in psoriasis are reported.

Long-term off-label dupilumab in pediatric atopic dermatitis: A case series.

Clinical trials of dupilumab have shown efficacy in treating moderate-to-severe atopic dermatitis (AD) in adult patients. While a phase 2 trial of dupilumab has shown efficacy and safety in children, the medication awaits Food and Drug Administration (FDA) approval, and off-label use is limited by dosing currently available to adults. We present this case series to describe the efficacy and safety profile of off-label dupilumab use in six pediatric patients treated by one provider in a private practice.

Switching from Originator to Biosimilar Infliximab in Paediatric Inflammatory Bowel Disease is Feasible and Uneventful.

The safety, clinical efficacy and cost-effectiveness of biosimilar infliximab in adult inflammatory bowel disease (IBD) have now been extensively shown. Limited data has been collected in the paediatric setting. We report nationwide, prospective, clinical safety and effectiveness data for patients from all three Scottish paediatric IBD (PIBD) networks switching from originator to biosimilar infliximab.Prospective clinical data was collected for 33 patients. Information was collected from electronic patient ...

Long-term comparative safety analysis of the risks associated with adding or switching to a sulfonylurea as second-line Type 2 diabetes mellitus treatment in a US Veterans Affairs population.

To examine the risks of all-cause mortality and cardiovascular events associated with adding vs switching to second-line therapies in a comparative safety study of people with Type 2 diabetes mellitus.

Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population.

In Australia, there is an unmet need for improved treatments for rheumatoid arthritis (RA). Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. To provide an overview of key study outcomes for tofacitinib in Australian patients, we analyzed the efficacy and safety of tofacitinib in the Australian subpopulation of global RA phase III and long-term extension (LTE) studies.

Efficacy and safety of macroplastique for the treatment of female stress urinary incontinence: results of an 85 patients series with an at least three years follow-up period.

to assess the long-term efficacy and safety of Macroplastique (Polydimethylsiloxane) with a minimum follow-up of 3 years.

Investigational hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) for the treatment of anaemia associated with chronic kidney disease.

In the last decade, concerns have been raised around the use of erythropoiesis stimulating agents (ESA) and intravenous iron in CKD patients, especially when given at high doses. Moreover, treatment with ESA is expensive. Areas covered: We searched PubMed for original articles, reviews and editorials having as a topic anaemia, chronic kidney disease, hypoxia inducible factor, hepcidin, iron, hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI). HIF-PHI are a new class of small molecules activati...

US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients.

To analyze the long-term safety and efficacy outcomes of patients with breast implants.

Evaluation of long-term efficacy, safety, and effect on life quality of pulsed dye laser in rosacea patients.

Rosacea is a chronic disease affecting the patients' life quality negatively. Although various laser systems are used in the rosacea treatment, studies reporting efficacy and long-term continuity of benefit of laser therapies are scarce.

Raltegravir plus abacavir/lamivudine in virologically suppressed HIV-1-infected patients: 48-week results of the KIRAL study.

Long-term combination antiretroviral therapy often results in toxicity/tolerability problems, which are one of the main reasons for switching treatment. Despite the favorable profile of raltegravir (RAL), data on its combination with abacavir/lamivudine (ABC/3TC) are scarce. Based on clinical data, we evaluated this regimen as a switching strategy.

Long-term Safety and Efficacy of Conjunctival Pedicle Graft Revision Combined With Repeated Pericardium Allograft for Exposed Glaucoma Drainage Devices.

To investigate the safety and long-term results of conjunctival pedicle graft (CPG) technique for revision of exposed glaucoma drainage device (GDD).

Efficacy and safety of a fixed-dose combination of D-norpseudoephedrine, triiodothyronine, atropine, aloin, and diazepam in obese patients
.

A fixed-dose combination (FDC) of D-norpseudoephedrine, tri-iodothyronine, atropine, aloin, and diazepam is used in Mexico for the short-term treatment of obesity; however, its efficacy and safety have been scarcely studied. The aim of this study was to analyze the efficacy and safety of this FDC in Mexican adult overweight and obese patients by a prospective, uncontrolled, multicenter, phase IV open-label study.


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