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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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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 ...
A regimen with rilpivirine (RPV), abacavir (ABC) and lamivudine (3TC) is simple and may allow the sparing of tenofovir and protease inhibitors. However, data on use of this combination as a strategy of switch are limited. Aims of the study were to assess the long-term efficacy and safety of this regimen.
Long-term, interventional, open-label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Poland and Russia who completed the global, international CHERISH trial.
Efficacy and safety of tocilizumab (TCZ), an interleukin-6 receptor inhibitor, were demonstrated in juvenile idiopathic arthritis (JIA) with polyarticular course (pJIA) in the CHERISH trial. This observational, III phase study evaluated long-term treatment of TCZ in pJIA patients was conducted by members of the Pediatric Rheumatology International Trials Organization (PRINTO) from Poland and Russia. Forty-one patients, who had completed the CHERISH core study (104 weeks), were extensionally treated with TC...
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.
Levodopa-carbidopa intestinal gel (designated as carbidopa-levodopa enteral suspension in the United States) provides stable plasma levodopa concentrations and reduces motor fluctuations in advanced Parkinson's disease patients through continuous delivery of levodopa via percutaneous endoscopic gastrojejunostomy. We report long-term safety and efficacy outcomes from an open-label phase 3 treatment program.
To study indexes of efficacy, safety and compliance for different ASA forms (Aspirin-Cardio, Cardiomagnyl, Thrombo ASS) used in stable IHD.
Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the re...
Proton pump inhibitor (PPI)-responsive eosinophilic esophagitis (EoE) is frequently observed in children, but data on long-term treatment are scarce. The objective of this study is to evaluate the long-term efficacy and safety of PPIs in children with EoE.
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.
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...
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.
Tocilizumab (TCZ) is the first humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody approved for the treatment of patients with rheumatoid arthritis (RA), Castleman's disease, polyarticular and systemic juvenile idiopathic arthritis, and, most recently, giant cell arteritis as well as for the treatment of chimeric antigen receptor T cell therapy-induced cytokine release syndrome. The global clinical development program for TCZ provides a wealth of clinical data on intravenous TCZ, and more recen...
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.
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...
To assess the long-term safety and efficacy of ixekizumab, an IL-17A antagonist, in patients with active PsA.
Tofacitinib is an oral Janus kinase inhibitor. Final safety and efficacy data from an open-label extension study of tofacitinib in psoriasis are reported.
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 ...
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.
Topical corticosteroids are the mainstay of psoriasis treatment; long-term safety concerns limit use. Combination with tazarotene may optimize efficacy, minimizing safety/tolerability concerns, In patients with moderate-to-severe plaque psoriasis treated with HP/TAZ lotion, improvement is noted within 2 weeks with few adverse effects observed after 8 weeks., HP/TAZ lotion may provide a realistic topical option for psoriasis management.
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...
To analyze the long-term safety and efficacy outcomes of patients with breast implants.
Information on the long-term safety, efficacy and durability of third-generation stentless aortic valves is lacking.
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.
To investigate the safety and long-term results of conjunctival pedicle graft (CPG) technique for revision of exposed glaucoma drainage device (GDD).
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.