910 results match your criteria 52-week safety


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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Positioning As-needed Budesonide-Formoterol for Mild Asthma: Effect of Pre-study Treatment in Pooled Analysis of SYGMA 1 and 2.

Ann Am Thorac Soc 2021 May 12. Epub 2021 May 12.

Woolcock Institute of Medical Research, University of Sydney, Dept of Respiratory Medicine, Royal Prince Alfred Hospital, Sidney, New South Wales, Australia.

Rationale: The SYGMA studies evaluated the efficacy and safety of as-needed budesonide-formoterol (BUD-FORM) in patients whose asthma was uncontrolled on as-needed inhaled short-acting bronchodilators (Subgroup 1) or controlled on inhaled corticosteroid (ICS) or leukotriene receptor antagonist (Subgroup 2).

Objective: To assess the influence of pre-study treatment in a post hoc analysis of the SYGMA studies.

Methods: In the SYGMA 1 (NCT022149199) and SYGMA 2 (NCT02224157) 52-week, double-blind, randomized, parallel-group studies, 6,735 mild asthma patients were randomized to as-needed BUD-FORM, low-dose budesonide + as-needed terbutaline (BUD maintenance), or as-needed terbutaline (SYGMA 1 only). Read More

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Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y).

Ann Rheum Dis 2021 May 6. Epub 2021 May 6.

Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.

Objectives: The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission.

Methods: COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Read More

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Ubrogepant in the Acute Management of Migraine: A Narrative Review.

J Pain Res 2021 27;14:1185-1192. Epub 2021 Apr 27.

Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.

Ubrogepant is a small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist that received Food and Drug Administration (FDA) approval for the acute treatment of migraine with and without aura in adults. The ACHIEVE I and ACHIEVE II Phase III clinical trials showed that ubrogepant was superior to placebo for pain freedom and freedom of the most bothersome migraine-associated symptom at 2 hours after medication intake. The 52-week open label extension of the Phase III trials demonstrated safety of ubrogepant. Read More

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Fluorescent light energy combined with systemic isotretinoin: A 52-week follow-up evaluating efficacy and safety in treatment of moderate-severe acne.

Clin Case Rep 2021 Apr 20;9(4):2057-2068. Epub 2021 Feb 20.

Klox Technologies Europe Dublin Ireland.

Fluorescent light energy therapy combined with low-dose isotretinoin or tetracycline show remarkable clinical effect on 12 cases of moderate-to-severe acne. Treatment was considered safe, well-tolerated, and highly efficacious. Read More

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Efficacy and Safety of As-Needed Budesonide-Formoterol in Adolescents with Mild Asthma.

J Allergy Clin Immunol Pract 2021 Apr 22. Epub 2021 Apr 22.

Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.

Background: Medication adherence is challenging for adolescents. In mild asthma, as-needed budesonide-formoterol (BUD-FORM) reduces severe exacerbations compared with as-needed short-acting beta-agonists, similar to the reduction with maintenance budesonide.

Objective: This post hoc pooled analysis of Symbicort Given as-needed in Mild Asthma (SYGMA) 1 and 2 assessed the efficacy and safety of as-needed BUD-FORM in adolescents. Read More

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Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance.

BMC Psychiatry 2021 04 22;21(1):204. Epub 2021 Apr 22.

Research Center for Child Mental Development, University of Fukui, Fukui, Japan.

Background: The purpose of this study was to evaluate the post-marketing safety and effectiveness of aripiprazole in treating irritability in pediatric patients (6-17 years) with autism spectrum disorder (ASD) in actual clinical sites of Japan.

Methods: In this post-marketing surveillance, patients were enrolled into the multicenter, prospective, non-interventional, observational study for 52 weeks, and were dosed with aripiprazole (1-15 mg/day) under daily clinical settings in Japan.

Results: In 510 patients, the continuation rate of aripiprazole treatment was 84. 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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Rationale and design of the EMPA-ELDERLY trial: a randomised, double-blind, placebo-controlled, 52-week clinical trial of the efficacy and safety of the sodium-glucose cotransporter-2 inhibitor empagliflozin in elderly Japanese patients with type 2 diabetes.

BMJ Open 2021 Apr 7;11(4):e045844. Epub 2021 Apr 7.

Yutaka Seino Distinguished Centre for Diabetes Research, Kansai Electric Power Medical Research Institute, Kobe, Japan

Introduction: Elderly people (≥65 years) with type 2 diabetes mellitus (T2DM) are becoming increasingly prevalent, notably in Japan. As cardiovascular (CV) risk increases with age and sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce CV risk, elderly patients with T2DM are increasingly likely to be prescribed these glucose-lowering drugs. There is controversy surrounding the effects of SGLT2 inhibitors on muscle mass, particularly in elderly patients for whom loss of muscle is especially undesirable; however, robust evidence on this important issue is lacking. Read More

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Tocilizumab vs placebo for the treatment of giant cell arteritis with polymyalgia rheumatica symptoms, cranial symptoms or both in a randomized trial.

Semin Arthritis Rheum 2021 Apr 18;51(2):469-476. Epub 2021 Mar 18.

Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Objective: The randomized, placebo (PBO)-controlled GiACTA trial demonstrated the efficacy and safety of tocilizumab (TCZ) in patients with giant cell arteritis (GCA). The present study evaluated the efficacy of TCZ in patients with GCA presenting with polymyalgia rheumatica (PMR) symptoms only, cranial symptoms only or both PMR and cranial symptoms in the GiACTA trial.

Methods: In GiACTA, 250 patients with GCA received either TCZ weekly or every other week plus a 26-week prednisone taper or PBO plus a 26- or 52-week prednisone taper. 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

Efficacy of Bacopa Monnieri (Brahmi) and Donepezil in Alzheimer's Disease and Mild Cognitive Impairment: A Randomized Double-Blind Parallel Phase 2b Study.

Ann Indian Acad Neurol 2020 Nov-Dec;23(6):767-773. Epub 2020 Dec 18.

Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Objectives: Alzheimer's disease (AD) is the most common cause of dementia worldwide in the older population. There is no disease-modifying therapy available for AD. The current standard of care drug therapy for AD is cholinesterase inhibitors, including donepezil. Read More

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December 2020

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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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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Efficacy and safety of vadadustat compared with darbepoetin alfa in japanese anemic patients on hemodialysis: A phase 3, multicenter, randomized, double-blind study.

Nephrol Dial Transplant 2021 Feb 26. Epub 2021 Feb 26.

Gunma University, Graduate School of Medicine, Maebashi, Gunma, Japan.

Background: Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis.

Methods: The efficacy and safety of vadadustat, compared with darbepoetin alfa, was determined in a phase 3 double-blind study in Japanese anemic patients on hemodialysis. Patients receiving erythropoiesis-stimulating agents (ESAs) were randomized and switched to either vadadustat or darbepoetin alfa for 52 weeks. Read More

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February 2021

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

Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial.

Lancet Neurol 2021 03;20(3):182-192

Neuroscience, AbbVie Inc, North Chicago, IL, USA.

Background: Progressive supranuclear palsy is a neurodegenerative disorder associated with tau protein aggregation. Tilavonemab (ABBV-8E12) is a monoclonal antibody that binds to the N-terminus of human tau. We assessed the safety and efficacy of tilavonemab for the treatment of progressive supranuclear palsy. Read More

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Certolizumab Pegol for the Treatment of Moderate to Severe Plaque Psoriasis: 16-Week Results from a Phase 2/3 Japanese Study.

Dermatol Ther (Heidelb) 2021 Apr 19;11(2):513-528. Epub 2021 Feb 19.

The Jikei University School of Medicine, Tokyo, Japan.

Introduction: Certolizumab pegol (CZP), the Fc-free, PEGylated anti-tumor necrosis factor, is approved for the treatment of moderate to severe plaque psoriasis (PSO) in Western countries and in Japan, among other indications.

Methods: We report results from the first 16 weeks of a 52-week phase 2/3 trial of CZP in Japanese patients with PSO. Patients ≥ 20 years with PSO ≥ 6 months (Psoriasis Area and Severity Index [PASI] ≥ 12, body surface area affected ≥ 10%, and Physician's Global Assessment [PGA] ≥ 3 on a 5-point scale) were randomized 2:2:1 to CZP 400 mg every 2 weeks (Q2W), CZP 200 mg Q2W (400 mg weeks 0/2/4), or placebo Q2W. Read More

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Daprodustat Compared with Epoetin Beta Pegol for Anemia in Japanese Patients Not on Dialysis: A 52-Week Randomized Open-Label Phase 3 Trial.

Am J Nephrol 2021 9;52(1):26-35. Epub 2021 Feb 9.

Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania, USA.

Background: Daprodustat is an oral agent that stimulates erythropoiesis by inhibiting the prolyl hydroxylases which mark hypoxia-inducible factor for degradation through hydroxylation. Its safety and efficacy (noninferiority) were assessed in this 52-week, open-label study.

Methods: Japanese patients not on dialysis (ND) (N = 299) with anemia of CKD (stages G3, G4, and G5) with iron parameters of ferritin >100 ng/mL or transferrin saturation >20% at screening were randomized to daprodustat or epoetin beta pegol (continuous erythropoietin receptor activator [CERA], also known as methoxy polyethylene glycol-epoetin beta). Read More

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February 2021

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

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies.

Drug Saf 2021 Apr 6;44(4):467-478. Epub 2021 Feb 6.

Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.

Introduction: Budesonide-formoterol taken as needed is an emerging treatment for mild asthma.

Objective: We used data from the SYGMA studies to assess the safety of As-needed budesonide-formoterol compared with As-needed terbutaline and compared with maintenance budesonide.

Methods: SYGMA 1 and 2 were 52-week, double-blind, parallel-group studies in patients aged ≥ 12 years with physician-assessed mild asthma. 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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Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis.

Rheumatology (Oxford) 2021 Jan 28. Epub 2021 Jan 28.

Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.

Objectives: To determine subcutaneous-tocilizumab (SC-TCZ) dosing regimens for systemic juvenile idiopathic arthritis (sJIA) and polyarticular JIA (pJIA).

Methods: In two 52-week phase 1 b trials, SC-TCZ (162 mg/dose) was administered to sJIA patients every week or every 2 weeks (every 10 days before interim analysis) and to pJIA patients every 2 weeks or every 3 weeks with body weight ≥30 kg or < 30 kg, respectively. Primary endpoints were pharmacokinetics, pharmacodynamics and safety; efficacy was exploratory. Read More

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January 2021

Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial.

Ann Rheum Dis 2021 Jan 27. Epub 2021 Jan 27.

Griffith University, Brisbane, Queensland, Australia.

Objective: To evaluate the efficacy and safety of the Janus kinase-1-preferential inhibitor filgotinib versus placebo or tumour necrosis factor-α inhibitor therapy in patients with active rheumatoid arthritis (RA) despite ongoing treatment with methotrexate (MTX).

Methods: This 52-week, multicentre, double-blind, placebo-controlled and active-controlled phase III trial evaluated once-daily oral filgotinib in patients with RA randomised 3:3:2:3 to filgotinib 200 mg (FIL200) or filgotinib 100 mg (FIL100), subcutaneous adalimumab 40 mg biweekly, or placebo (through week 24), all with stable weekly background MTX. The primary endpoint was the proportion of patients achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 12. Read More

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January 2021

Fecal Microbiota Transplantation in Chronic Pouchitis: A Randomized, Parallel, Double-Blinded Clinical Trial.

Inflamm Bowel Dis 2021 Jan 27. Epub 2021 Jan 27.

Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.

Background: In ulcerative colitis, a pouchitis is the most common long-term adverse effect after proctocolectomy and ileal pouch-anal anastomosis. Approximately 5% of patients develop chronic antibiotic-dependent or antibiotic-refractory pouchitis without any effective treatment. The aim of this trial was to investigate the efficacy and safety of fecal microbiota transplantation in the treatment of chronic pouchitis. Read More

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January 2021

Safety of switching to brexpiprazole in Japanese patients with schizophrenia: A post-hoc analysis of a long-term open-label study.

Hum Psychopharmacol 2021 Jan 26. Epub 2021 Jan 26.

Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan.

Objectives: To determine the long-term safety of switching to brexpiprazole from aripiprazole or non-aripiprazole dopamine antagonists.

Methods: Post-hoc analysis of 56-week study of Japanese outpatients with schizophrenia switched to brexpiprazole 2 mg/day over 4-week switching period with further titration (1-4 mg/day) allowed during the 52-week, open-label period. Major assessment items: total/low-density lipoprotein (LDL)-/high-density lipoprotein (HDL)-cholesterol, triglycerides, blood glucose, body weight and prolactin. Read More

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January 2021