530 results match your criteria observed 52-week


Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study.

Ann Rheum Dis 2021 May 13. Epub 2021 May 13.

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Objectives: To evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).

Methods: In this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52. Read More

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Temporal stability of swine movement networks in the U.S.

Prev Vet Med 2021 May 3;191:105369. Epub 2021 May 3.

Department of Veterinary Population Medicine, College of Veterinary Medicine, University of Minnesota, 1365 Gortner Avenue, St. Paul, MN, 55108, USA.

As a consequence of multi-site pig production practiced in North America, frequent and widespread animal movements create extensive networks of interaction between farms. Social network analysis (SNA) has been used to understand disease transmission risks within these complex and dynamic production ecosystems and is particularly relevant for designing risk-based surveillance and control strategies targeting highly connected farms. However, inferences from SNA and the effectiveness of targeted strategies may be influenced by temporal changes in network structure. Read More

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Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study.

Ther Adv Musculoskelet Dis 2021 20;13:1759720X211006964. Epub 2021 Apr 20.

Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People's Hospital, Xicheng District, Beijing, P.R. China.

Introduction: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).

Methods: This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients ( = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. Read More

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Motor and cognitive outcomes of cerebello-spinal stimulation in neurodegenerative ataxia.

Brain 2021 May 5. Epub 2021 May 5.

Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Cerebellar ataxias represent a heterogeneous group of disabling disorders characterized by motor and cognitive disturbances, for which no effective treatment is currently available. In this randomized, double-blind, sham-controlled trial, followed by an open-label phase, we investigated whether treatment with cerebello-spinal transcranial direct current stimulation (tDCS) could improve both motor and cognitive symptoms in patients with neurodegenerative ataxia at short and long-term. Sixty-one patients were randomized in two groups for the first controlled phase. Read More

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Education, engagement and provision of empathy by trained counselor enhances the patient satisfaction after Total Knee Arthroplasty.

J Clin Orthop Trauma 2021 Jun 23;17:191-194. Epub 2021 Mar 23.

Hoy Spirit Hospital, Andheri, India.

Background: One of the major concerns following Total Knee Arthroplasty (TKA) surgery is patient satisfaction. Hence, this study sought to assess the effect of patient education, engagement and provision of empathy delivered by trained counselor on patient satisfaction.

Methods: All the patients included in the study were randomly allocated to two groups: Patients who received counseling from trained personnel during pre-, peri- and post-TKA phase constituted group-A (n = 100) whereas patients who were advised by the surgeon before the procedure constituted group-B (n = 100). Read More

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Efficacy and Safety of Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: 52-Week Results.

Dermatol Ther (Heidelb) 2021 Apr 22. Epub 2021 Apr 22.

Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.

Introduction: Certolizumab pegol (CZP), an Fc-free, PEGylated anti-tumour necrosis factor biologic, dosed at 400 mg every 2 weeks (Q2W) and 200 mg Q2W over 16 weeks, resulted in improvements in Japanese patients with moderate to severe plaque psoriasis (PSO); no new safety signals were identified. We present 52-week efficacy and safety results.

Methods: Patients ≥ 20 years with PSO ≥ 6 months [Psoriasis Area and Severity Index (PASI) ≥ 12, body surface area ≥ 10%, Physician's Global Assessment (PGA) ≥ 3] were randomised 1:2:2 to placebo Q2W, CZP 400 mg Q2W and CZP 200 mg Q2W (400 mg weeks 0/2/4) for 16 weeks. Read More

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Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications.

Pain Med 2021 Apr 19. Epub 2021 Apr 19.

Université de Paris, Hôpital Cochin, INSERM U987, Paris, France.

Objective: To investigate efficacy of repeated application of capsaicin 179 mg cutaneous patch in non-responders to the first application.

Design: Post hoc, as-treated analysis of two prospective trials (STRIDE and PACE) with 52-week follow-up.

Blinding: Open-label. Read More

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One-year real life data of our patients with moderate-severe Crohn's disease who underwent ustekinumab therapy.

Scott Med J 2021 Apr 9:369330211008587. Epub 2021 Apr 9.

Professor of Gastroenterology, Department of Gastroenterology, Ankara City Hospital, Ankara, Turkey.

Aim: The aim of this study was to present one-year real-life data of our patients with CD who showed unresponsiveness and/or intolerance to biological agents and then received ustekinumab treatment through an early access program.

Materials And Methods: The retrospective study reviewed the 52-week clinical data of 10 patients with moderate or severe CD who underwent ustekinumab therapy.

Results: The 10 patients comprised 7 (70%) men and 3 (30%) women with a mean age of 38 ± 11. Read More

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Targeted Inactivation of Rin3 Increases Trabecular Bone Mass by Reducing Bone Resorption and Favouring Bone Formation.

Calcif Tissue Int 2021 Mar 16. Epub 2021 Mar 16.

Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK.

Common genetic variants at the RIN3 locus on chromosome 14q32 predispose to Paget's disease of bone (PDB) but the mechanisms by which they do so are unknown. Here, we analysed the skeletal phenotype of female mice with targeted inactivation of the mouse Rin3 gene (Rin3) as compared with wild-type littermates. The Rin3 mice had higher trabecular bone volume (BV/TV%) compared with wild type. Read More

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Efficacy and Safety of Dupilumab in Clinical Practice: One Year of Experience on 165 Adult Patients from a Tertiary Referral Centre.

Dermatol Ther (Heidelb) 2021 Apr 13;11(2):355-361. Epub 2021 Mar 13.

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

We have read with great interest the article by Kreeshan et al., which reported data on effectiveness and laboratory safety of dupilumab. We performed a retrospective study including 165 adult patients affected by moderate-to-severe atopic dermatitis (AD) and treated with dupilumab for at least 52 weeks. Read More

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Cardiovascular safety of mometasone/indacaterol and mometasone/indacaterol/glycopyrronium once-daily fixed-dose combinations in asthma: pooled analysis of phase 3 trials.

Respir Med 2021 Jan 27;180:106311. Epub 2021 Jan 27.

Novartis Pharma AG, Basel, Switzerland.

Objective: To evaluate cardiovascular safety of two new inhaled fixed-dose combinations for treatment of asthma: (i) the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) mometasone furoate/indacaterol acetate (MF/IND), (ii) the ICS/LABA/long-acting muscarinic antagonist (LAMA) MF/IND/glycopyrronium bromide (GLY).

Methods: Patient-level data were pooled from four randomized trials, including 52-week studies PALLADIUM (n = 2216) and IRIDIUM (n = 3092), 24-week study ARGON (n = 1426), and 12-week study QUARTZ (n = 802). Cardio-/cerebrovascular (CCV) event frequencies were examined in the following comparisons: (1) LABA effect: pooled-dose MF/IND vs. Read More

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January 2021

Topographical Response of Retinal Neovascularization to Aflibercept or Panretinal Photocoagulation in Proliferative Diabetic Retinopathy: Post Hoc Analysis of the CLARITY Randomized Clinical Trial.

JAMA Ophthalmol 2021 Mar 11. Epub 2021 Mar 11.

National Institute for Health Research Biomedical Research Centre, Moorfields Eye Hospital National Health Service Foundation Trust, London, United Kingdom.

Importance: Eyes with proliferative diabetic retinopathy have a variable response to treatment with panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor agents. The location of neovascularization (NV) is associated with outcomes (eg, patients with disc NV [NVD] have poorer visual prognosis than those with NV elsewhere [NVE]).

Objective: To investigate the distribution of NV in patients with proliferative diabetic retinopathy and the topographical response of NV to treatment with aflibercept or PRP. Read More

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Aristolochic acid I promoted clonal expansion but did not induce hepatocellular carcinoma in adult rats.

Acta Pharmacol Sin 2021 Mar 8. Epub 2021 Mar 8.

Center for Drug Safety Evaluation and Research, State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.

Aristolochic acid I (AAI) is a well-known nephrotoxic carcinogen, which is currently reported to be also associated with hepatocellular carcinoma (HCC). Whether AAI is a direct hepatocarcinogen remains controversial. In this study we investigated the association between AAI exposure and HCC in adult rats using a sensitive rat liver bioassay with several cofactors. Read More

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Exploring Telomere Dynamics in Aging Male Rat Tissues: Can Tissue-Specific Differences Contribute to Age-Associated Pathologies?

Gerontology 2021 5;67(2):233-242. Epub 2021 Mar 5.

Metabolic Research Laboratories and MRC Metabolic Diseases Unit, Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.

Introduction: Due to increasing lifespan, global aging rates are rising rapidly and age-associated diseases are increasing. To ensure that health span is concomitant with life span, a greater understanding of cellular mechanisms of aging is important.

Methods: Telomere length analysis from a wide range of tissues from weaning, young adult, and middle-aged (3, 12 and 52 week) male Wistar rats were conducted using Southern blotting. Read More

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Safety and Effectiveness of Peficitinib (ASP015K) in Patients with Rheumatoid Arthritis: Final Results (32 Months of Mean Peficitinib Treatment) From a Long-Term, Open-Label Extension Study in Japan, Korea, and Taiwan.

Rheumatol Ther 2021 Mar 3;8(1):425-442. Epub 2021 Mar 3.

Biostatistics Group, Japan-Asia Data Science, Development, Astellas Pharma Inc., Tokyo, Japan.

Introduction: This final analysis of a long-term extension (LTE) study assessed the safety, tolerability, and effectiveness of peficitinib (ASP015K), a pan-Janus kinase inhibitor, in Asian patients with rheumatoid arthritis (RA).

Methods: Patients had previously completed the 12-week phase 2b (RAJ1), or 52-week phase 3 (RAJ3 and RAJ4) peficitinib studies in Japan, Korea, and Taiwan, and received oral peficitinib 50 or 100 mg/day. Dose increase to 150 mg/day or reduction to 50 mg/day was permitted. Read More

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Long-term safety and efficacy of opicapone in Japanese Parkinson's patients with motor fluctuations.

J Neural Transm (Vienna) 2021 Mar 25;128(3):337-344. Epub 2021 Feb 25.

Department of Neurology, Juntendo University Graduate School of Medicine, Tokyo, Japan.

The double-blind part of the COMFORT-PD (COMt-inhibitor Findings from Opicapone Repeated Treatment for Parkinson's Disease) study in Japanese levodopa-treated patients with Parkinson's disease and motor fluctuations found that both opicapone 25 and 50 mg were significantly more effective than placebo. This 52-week open-label extension study evaluated the long-term safety and efficacy of opicapone 50 mg tablets in patients who completed the double-blind part of the COMFORT-PD study. Safety was monitored via adverse events, laboratory testing, and physical, cardiovascular and neurological examinations. Read More

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Long-term (52-week) efficacy and safety of dapagliflozin as an adjunct to insulin therapy in Japanese patients with type 1 diabetes: Subgroup analysis of the DEPICT-2 study.

Diabetes Obes Metab 2021 Feb 23. Epub 2021 Feb 23.

Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.

Aim: To examine the long-term efficacy and safety of dapagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor used to treat type 1 diabetes, in the Japanese subpopulation of the DEPICT-2 study.

Materials And Methods: Patients with type 1 diabetes were randomized to dapagliflozin 5 mg (n = 55), dapagliflozin 10 mg (n = 41) or placebo (n = 58) plus insulin for a 24-week, double-blind period followed by a 28-week, single-blind extension phase.

Results: From baseline to 24 weeks, dapagliflozin reduced HbA1c compared with placebo (mean change of -0. Read More

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February 2021

Real-world Safety and Efficacy of indacaterol Maleate in Patients with Chronic Obstructive Pulmonary Disease: Evidence from the Long-term Post-marketing Surveillance in Japan.

Intern Med 2021 Feb 22. Epub 2021 Feb 22.

Novartis Pharma K.K., Japan.

Objective Evidence concerning the safety and efficacy of indacaterol maleate in a real-life setting is limited. The objective of this post-marketing surveillance was to evaluate the real-life safety and efficacy of indacaterol maleate in Japanese patients with chronic obstructive pulmonary disease (COPD). Methods This was a 52-week post-marketing surveillance conducted between April 2012 and December 2018. Read More

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February 2021

Effects of biological therapies on chronic rhinosinusitis in severe asthmatic patients.

Acta Otorhinolaryngol Ital 2020 Dec;40(6):435-443

Department of Otorhinolaryngology, University of Insubria and ASST Sette Laghi, Varese, Italy.

Objective: The introduction of monoclonal antibody (mAb) therapies represents a promising treatment for refractory chronic rhinosinusitis (CRS). We assessed the effects of selected mAbs (omalizumab, mepolizumab, benralizumab) on CRS in severe asthmatic patients in a real-life setting.

Methods: A prospective observational study on severe asthmatic patients, treated with 3 different mAb (omalizumab, mepolizumab, benralizumab), and comorbid CRS was conducted. Read More

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December 2020

Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial.

Lancet 2021 02;397(10273):487-498

Icahn School of Medicine, New York, NY, USA.

Background: There is an unmet need for a treatment for psoriasis that results in complete skin clearance with a reliably quick response. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. We aimed to compare the efficacy and safety of bimekizumab with placebo and ustekinumab in patients with moderate to severe plaque psoriasis over 52 weeks. Read More

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February 2021

Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis.

Clin Pharmacol Drug Dev 2021 Mar 29;10(3):229-240. Epub 2021 Jan 29.

Pfizer Inc, Groton, Connecticut, USA.

Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We characterized tofacitinib pharmacokinetics in patients with moderate to severe UC, and the effects of covariates on variability in pharmacokinetic parameter estimates. Data were pooled from 1 8-week phase 2 and 2 8-week phase 3 induction studies, and a 52-week phase 3 maintenance study (N = 1096). Read More

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A randomized, placebo-controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in Japanese patients with type 2 diabetes and inadequate glycaemic control.

Diabetes Obes Metab 2021 Jun 17;23(6):1242-1251. Epub 2021 Feb 17.

Merck Research Laboratories, Merck & Co., Inc., Kenilworth, New Jersey, USA.

Aim: To evaluate the efficacy and safety of adding the once-weekly oral dipeptidyl peptidase-4 inhibitor omarigliptin to treatment of Japanese patients with type 2 diabetes and inadequate glycaemic control on insulin monotherapy.

Materials And Methods: In a 52-week clinical trial, Japanese patients on insulin monotherapy were randomized to once-weekly omarigliptin 25 mg (N = 123) or placebo (N = 61) for a 16-week, double-blind, placebo-controlled period. After Week 16, patients continued or switched to omarigliptin for a 36-week open-label period. Read More

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Effect of aerobic exercise on amyloid accumulation in preclinical Alzheimer's: A 1-year randomized controlled trial.

PLoS One 2021 14;16(1):e0244893. Epub 2021 Jan 14.

University of Kansas Alzheimer's Disease Center, Fairway, KS, United States of America.

Background: Our goal was to investigate the role of physical exercise to protect brain health as we age, including the potential to mitigate Alzheimer's-related pathology. We assessed the effect of 52 weeks of a supervised aerobic exercise program on amyloid accumulation, cognitive performance, and brain volume in cognitively normal older adults with elevated and sub-threshold levels of cerebral amyloid as measured by amyloid PET imaging.

Methods And Findings: This 52-week randomized controlled trial compared the effects of 150 minutes per week of aerobic exercise vs. Read More

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The Impact of Biologic Drugs on High-Density Lipoprotein Cholesterol Efflux Capacity in Rheumatoid Arthritis Patients.

J Clin Rheumatol 2020 Dec 24;Publish Ahead of Print. Epub 2020 Dec 24.

From the Rheumatology Unit, Department of Emergence Medicine and Organ Transplantations Internal Medicine Unit "C. Frugoni," Interdisciplinary Department of Medicine, University of Bari "Aldo Moro," Bari, Italy.

Background: One of the most intriguing conundrums in patients with rheumatoid arthritis (RA) is the lack of correlation between cholesterol levels and cardiovascular (CV) events, mining the reliability of plasmatic lipid levels in estimating the CV risk. High-density lipoprotein cholesterol efflux capacity (HDLc-EC) directly indicates the functional ability of HDL to scavenge cholesterol from vascular wall and may provide better information on the atherogenic risk. The aim of this study was to examine the effects of different disease-modifying antirheumatic drugs on HDLc-EC in RA. Read More

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December 2020

Dupilumab Efficacy in Patients Stratified by Baseline Treatment Intensity and Lung Function.

J Asthma Allergy 2020 16;13:701-711. Epub 2020 Dec 16.

Sanofi, Bridgewater, NJ, USA.

Purpose: The Phase 3 LIBERTY ASTHMA QUEST study in patients aged ≥12 years with uncontrolled, moderate-to-severe asthma demonstrated the efficacy and safety of dupilumab 200 mg and 300 mg every 2 weeks (q2w) vs matched placebo in the overall population. This post hoc analysis assessed dupilumab efficacy by disease severity as evidenced by baseline % predicted forced expiratory volume in 1 second (FEV) and dose of inhaled corticosteroids (ICS).

Patients And Methods: Severe asthma exacerbation rates, change from baseline in FEV, asthma control, quality of life, and fractional exhaled nitric oxide (FeNO) levels over the 52-week treatment period were assessed in patients with elevated type 2 inflammation biomarkers stratified by ICS dose and FEV% predicted at baseline. Read More

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December 2020

Bioidentical Oral 17β-Estradiol and Progesterone for the Treatment of Moderate to Severe Vasomotor Symptoms of Menopause.

Ann Pharmacother 2020 Dec 21:1060028020982611. Epub 2020 Dec 21.

Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC, USA.

Objective: To review the efficacy, safety, and available literature regarding the novel combination bioidentical product Bijuva, or 17β-estradiol/progesterone (17β-E/P), for the treatment of moderate to severe menopausal symptoms in cisgender females with an intact uterus.

Data Sources: Literature searches of both PubMed (1966 to October 2020) and Google Scholar were conducted using search terms including , and .

Study Selection And Data Extraction: All articles with studies conducted in cisgender human females and in the English language were considered for review; 18 publications were included. Read More

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December 2020

Cortical bone adaptation to a moderate level of mechanical loading in male Sost deficient mice.

Sci Rep 2020 12 18;10(1):22299. Epub 2020 Dec 18.

Research Centre, Shriners Hospital for Children-Canada, 1003 Decarie Blvd, Montreal, QC, H4A 0A9, Canada.

Loss-of-function mutations in the Sost gene lead to high bone mass phenotypes. Pharmacological inhibition of Sost/sclerostin provides a new drug strategy for treating osteoporosis. Questions remain as to how physical activity may affect bone mass under sclerostin inhibition and if that effect differs between males and females. Read More

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December 2020

Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research.

J Allergy Clin Immunol 2021 Mar 5;147(3):992-1003.e5. Epub 2020 Dec 5.

Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.

Background: Consortium for Food Allergy Research investigators previously reported 52-week outcomes from a randomized controlled trial of peanut epicutaneous immunotherapy, observing modest and statistically significant induction of desensitization, highest in children ages 4 to 11 years.

Objective: We sought to evaluate changes in efficacy, safety, and mechanistic parameters following extended open-label peanut epicutaneous immunotherapy.

Methods: Peanut-allergic participants (4-25 years) received 52 weeks of placebo (PLB), Viaskin Peanut 100 μg (VP100) or 250 μg (VP250), and then crossed over to VP250 for PLB (PLB-VP250) and VP100 (VP100-VP250) participants and continued treatment for VP250 participants (total = 130 weeks of active epicutaneous immunotherapy). Read More

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Reduced All-Cause Mortality in the ETHOS Trial of Budesonide/Glycopyrrolate/Formoterol for Chronic Obstructive Pulmonary Disease. A Randomized, Double-Blind, Multicenter, Parallel-Group Study.

Am J Respir Crit Care Med 2021 03;203(5):553-564

AstraZeneca, Durham, North Carolina.

In the phase III, 52-week ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial in chronic obstructive pulmonary disease (COPD) (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) significantly reduced all-cause mortality compared with glycopyrrolate/formoterol fumarate (GFF). However, 384 of 8,509 patients were missing vital status at Week 52 in the original analyses. To assess the robustness of the ETHOS mortality findings after additional data retrieval for patients missing Week 52 vital status in the original analyses. Read More

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Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity.

Pharmacol Res Perspect 2020 12;8(6):e00684

Astellas Pharma Europe B.V., Leiden, The Netherlands.

The aim of this investigation was to characterize and compare the pharmacokinetics (PK) of the antimuscarinic drug solifenacin in pediatric patients with overactive bladder (OAB) or neurogenic detrusor overactivity (NDO) utilizing data from three phase III trials. LION was a placebo-controlled, 12-week trial in children (5-<12 years) and adolescents (12-<18 years) with OAB. MONKEY and MARMOSET were open-label, 52-week trials in children and adolescents or younger children (6 months-<5 years), respectively, with NDO. Read More

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December 2020