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1.
Clin Drug Investig ; 40(3): 291, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32040760

RESUMO

Page 806, column 1, line 3: The text, which previously read.

2.
Clin Drug Investig ; 39(10): 1019, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31512163

RESUMO

The article Glucagon-Like Peptide-1 Receptor Agonists in Type 2 Diabetes: Their Use and Differential Features, written by KA Lyseng-Williamson, was originally published Online First without open access. After publication in volume 39, issue 8, pages 805-819, Springer Healthcare IME requested that the article be Open Choice to make the article an open access publication. Post-publication open access was funded by an independent educational grant from Novo Nordisk A/S . The article is forthwith distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/ ), which permits any noncommercial use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made.

3.
Clin Drug Investig ; 39(9): 915-916, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31422551

RESUMO

The original version of this article unfortunately contained some mistakes. The corrected details are provided below.

4.
Clin Drug Investig ; 39(8): 805-819, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31317516

RESUMO

Glucagon-like peptide-1 receptor analogues/agonists (GLP-1RAs) are well established as effective adjuncts to lifestyle modification in the treatment of type 2 diabetes (T2D) as monotherapy or in combination with oral glucose-lowering drugs ± insulin. The six subcutaneous GLP-1RA formulations (i.e. twice-daily exenatide, once-daily liraglutide and lixisenatide, and once-weekly dulaglutide, exenatide and semaglutide) currently available in the EU and USA have many similarities, but also some unique features and properties. By stimulating GLP-1 receptors, GLP-1RAs increase insulin secretion and suppress glucagon release in a glucose-dependent manner, thereby improving clinical and patient-reported outcomes related to glycaemic control and weight. They also have been shown to reduce, or at least not increase, the risk of major cardiovascular outcomes. GLP-1RAs are generally well tolerated, with gastrointestinal and injection-site reactions being the most troublesome drug-related adverse events, and are associated with a very low intrinsic risk of hypoglycaemia. Treatment with GLP-1RAs should be customized to meet the clinical needs and personal preferences of the individual.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Administração Oral , Glicemia/efeitos dos fármacos , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/administração & dosagem , Injeções Subcutâneas
5.
Drugs Ther Perspect ; 35(1): 46, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31186613

RESUMO

[This corrects the article DOI: 10.1007/s40267-018-0572-5.].

6.
Drugs Ther Perspect ; 35(1): 49, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31186614

RESUMO

[This corrects the article DOI: 10.1007/s40267-018-0532-0.].

7.
Drugs Ther Perspect ; 34(12): 543-553, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30546251

RESUMO

The EU indication for anakinra has been extended to include Still's disease, a serious rare inflammatory disorder of unknown aetiology that comprises adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA). As activated interleukin-1 pathways are associated with the systemic manifestations of these disorders, targeted treatment with anakinra, an interleukin-1 inhibitor, has been investigated. Across clinical and real-world studies in patients with AOSD and SJIA, treatment with anakinra achieved clinical remission/response, provided rapid and sustained improvements in systemic and laboratory manifestations, and allowed the use of corticosteroid- and disease-modifying anti-rheumatic drugs (DMARD) to be reduced or discontinued. The safety profile of anakinra in the treatment of Still's disease is consistent with that in its other approved indications.

8.
Drugs Ther Perspect ; 34(7): 300-310, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30546252

RESUMO

Macrogol 4000, a biologically inert, non-absorbable osmotic laxative, is a highly effective and well-tolerated first-line option for the treatment of the symptoms of chronic idiopathic/functional constipation in children and adults. High-molecular-weight (HMW) macrogols ± electrolytes have generally similar efficacy profiles; however, the taste of macrogol 4000 is generally preferred over that of macrogol 3350 + electrolytes. Macrogol 4000 is more effective than lactulose in improving stool frequency and consistency, and is associated with less vomiting and flatulence. Comparisons with other osmotic and bulk-forming laxatives are limited, with macrogol 4000 being at least as, or more effective than, psyllium hydrocolloid and magnesium hydroxide in treating chronic constipation. Current clinical treatment guidelines recommend the use of HMW macrogols over the use of lactulose and bulk-forming laxative in the symptomatic treatment of constipation in children and adults.

9.
Drugs Ther Perspect ; 34(8): 358-366, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30546253

RESUMO

EGb 761® (Tanakan®) is a standardized extract of Ginkgo biloba leaves that has demonstrated protective properties against neuronal and vascular damage. Overall, in randomized, placebo-controlled clinical trials and meta-analyses in adults with mild-to-moderate dementia, EGb 761® displayed positive effects, with changes from baseline in outcomes related to cognition, behaviour and global change that are generally better than those shown with placebo. EGb 761® is generally well tolerated, with no safety issues being identified during its many years of widespread use.

10.
Drugs Ther Perspect ; 34(10): 451-456, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30459507

RESUMO

Oral fostamatinib is an orally administered small molecule spleen tyrosine kinase (SYK) inhibitor approved for the treatment of adults with chronic immune thrombocytopenia (ITP) who have an inadequate response to a previous treatment. Fostamatinib has a unique mechanism of action, whereby its active metabolite targets the SYK-mediated pathway of platelet destruction. In clinical trials, fostamatinib provided durable responses in adults with chronic ITP who had not responded or had relapsed following treatment with one or more prior ITP therapies, including corticosteroids, thrombopoietin receptor agonists, rituximab, and/or splenectomy. Most patients who respond to fostamatinib maintain platelet counts of > 50 × 109/L for periods of ≥ 12 months. The most common adverse events reported with fostamatinib in clinical trials were diarrhea, hypertension, nausea, and increased transaminase levels.

11.
Drugs Ther Perspect ; 34(11): 497-506, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30459508

RESUMO

Burosumab (Crysvita®), a fully human IgG1 monoclonal antibody directed at fibroblast growth factor 23 (FGF23), is indicated for the treatment of X-linked hypophosphatemia (XLH), a condition associated with excessive FGF23 production. It directly addresses the excessive FGF23 activity in patients with XLH by binding to FGF23, and inhibiting its signaling. This leads to increased gastrointestinal phosphate absorption and renal phosphate reabsorption, thereby improving serum phosphate levels, and, ultimately, bone mineralization and the risk of bone disease. In clinical trials, subcutaneous burosumab increased serum phosphorus levels in pediatric and adult patients with XLH, as well as significantly improving the severity of rickets in children, and improving pain, stiffness, physical functioning, and fracture/pseudofracture healing in adults. Burosumab is well tolerated by children and adults with XLH, with most treatment-emergent adverse events being of mild to moderate severity.

12.
Drugs Ther Perspect ; 34(1): 8-15, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30008572

RESUMO

Pirfenidone (Esbriet®) is available as capsules containing 267 mg of pirfenidone and, more recently, as bioequivalent tablets containing 267, 534 or 801 mg of pirfenidone. Both formulations are indicated to treat idiopathic pulmonary fibrosis (IPF), with pirfenidone being shown to generally reduce the rate of decline in forced vital capacity in patients with mild to moderate IPF, while prolonging progression-free survival and reducing the risk of IPF-related and all-cause mortality. The availability of the tablet formulation reduces the daily pill burden of pirfenidone, as the recommended daily divided maintenance dose of 2403 mg/day may be administered as one 801 mg tablet three times daily instead of three 267 mg capsules three times daily. Pirfenidone is associated with gastrointestinal and skin-related events, with such events generally being manageable.

13.
Drugs ; 78(9): 941-950, 2018 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-29931594

RESUMO

Telotristat ethyl (Xermelo®), a first-in-class peripheral tryptophan hydroxylase (TPH) inhibitor, is approved to treat carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy alone. Some neuroendocrine tumours secrete serotonin (5-HT) into the blood, resulting in frequent bowel movements (BMs) and other symptoms. Telotristat ethyl inhibits TPH, thereby reducing the production of 5-HT and improving carcinoid syndrome diarrhoea. In the 12-week placebo-controlled phase of randomized trials in patients with carcinoid syndrome diarrhoea (most of whom were receiving SSA therapy), the addition of oral telotristat ethyl 250 three times daily provided significant reductions in the frequency of BMs and levels of urinary 5-hydroxyindolacetic acid (u5-HIAA; a metabolite of 5-HT) relative to placebo. Telotristat ethyl 250 mg three times daily was well tolerated, with the proportion of patients reporting at least one treatment-emergent adverse event being similar to that with placebo. With regard to adverse events of special interest, relative to placebo, telotristat ethyl had a comparable incidence of depression-related symptoms, a somewhat higher incidence of gastrointestinal (GI) disorders and a higher incidence of elevated hepatic enzyme levels.


Assuntos
Diarreia/tratamento farmacológico , Síndrome do Carcinoide Maligno/tratamento farmacológico , Fenilalanina/análogos & derivados , Pirimidinas/uso terapêutico , Triptofano Hidroxilase/antagonistas & inibidores , Interações de Medicamentos , Quimioterapia Combinada , Humanos , Fenilalanina/administração & dosagem , Fenilalanina/efeitos adversos , Fenilalanina/farmacologia , Fenilalanina/uso terapêutico , Pirimidinas/administração & dosagem , Pirimidinas/efeitos adversos , Pirimidinas/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Transdução de Sinais , Somatostatina/análogos & derivados , Somatostatina/uso terapêutico , Resultado do Tratamento
14.
Drugs Ther Perspect ; 34(12): 594, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-31186610

RESUMO

[This corrects the article DOI: 10.1007/s40267-018-0551-x.].

15.
Drugs Ther Perspect ; 34(12): 595, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-31186611

RESUMO

[This corrects the article DOI: 10.1007/s40267-018-0560-9.].

16.
Drugs Ther Perspect ; 34(8): 404, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-31186612

RESUMO

[This corrects the article DOI: 10.1007/s40267-017-0459-x.].

17.
Drugs Ther Perspect ; 34(10): 457-465, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30679901

RESUMO

Oral cabozantinib tablets (Cabometyx®) are an important option for the treatment of advanced renal cell carcinoma (RCC). Cabozantinib is an anti-angiogenic agent and potently inhibits multiple tyrosine kinases, including those implicated in the development of RCC. The previously approved indication of cabozantinib tablets (i.e. treatment of advanced RCC following prior VEGF-targeted therapy) has been extended to include the first-line treatment of advanced RCC in treatment-naïve adults with intermediate or poor risk (EU) and all patients with advanced RCC (USA). These label extensions are based on the results of a randomized, open-label phase 2 trial, in which adults with metastatic RCC of poor or intermediate risk received targeted first-line treatment with cabozantinib or standard-of-care sunitinib. Relative to sunitinib, cabozantinib significantly prolonged median progression-free survival (primary endpoint; investigator and independent assessments), and increased the objective response rate (investigator assessment). The tolerability profile of cabozantinib is comparable to those of other tyrosine kinase inhibitors, with adverse events being manageable with medical intervention, dosage reductions, treatment interruption and/or permanent discontinuation.

18.
Drugs ; 77(1): 97-106, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27988873

RESUMO

Albutrepenonacog alfa (Idelvion®), a fusion protein that genetically fuses recombinant factor IX (rFIX) with recombinant human albumin (rAlbumin), is indicated in the treatment of haemophilia B. This narrative review discusses the pharmacological properties and clinical data related to the use of this novel fusion protein, hereafter referred to as rIX-FP. The fusion of rFIX to rAlbumin prolongs the elimination half-life of rIX-FP in the circulation, allowing routine prophylaxis to be administered once every 7-14 days. In the pivotal phase 3 clinical trials in previously treated patients with moderately severe to severe haemophilia B, routine rIX-FP prophylaxis (administered once every 7 days in children, and once every 7-14 days in adolescents and adults) was associated with low annualized spontaneous, total and joint bleeding rates, and was associated with significantly fewer bleeding episodes than on-demand treatment. rIX-FP was also effective in controlling bleeding episodes when used as on-demand treatment and in maintaining haemostasis in the perioperative setting. rIX-FP was well tolerated in the clinical trials, with no reports of inhibitor development. In conclusion, rIX-FP provides an effective, well-tolerated option for the treatment and management of haemophilia B that, by virtue of its extended half-life, is less burdensome than conventional FIX products.


Assuntos
Fator IX/uso terapêutico , Hemofilia B/tratamento farmacológico , Proteínas Recombinantes de Fusão/uso terapêutico , Albumina Sérica/uso terapêutico , Humanos
19.
Drugs ; 76(7): 805-13, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27071925

RESUMO

Idebenone (Raxone(®)), a short-chain benzoquinone, is the only disease-specific drug approved to treat visual impairment in adolescents and adults with Leber's hereditary optic neuropathy (LHON), a rare genetic mitochondrial disease that causes rapid and progressive bilateral vision loss. The mechanism of action of idebenone involves its antioxidant properties and ability to act as a mitochondrial electron carrier. Idebenone overcomes mitochondrial complex I respiratory chain deficiency in patients with LHON by transferring electrons directly to mitochondrial complex III (by-passing complex I), thereby restoring cellular energy (ATP) production and re-activating inactive-but-viable retinal ganglion cells, which ultimately prevents further vision loss and promotes vision recovery. The approval of idebenone in the treatment of LHON was based on the overall data from a randomized clinical trial, a follow-up study and real-world data. Taken together, these studies provide convincing evidence that oral idebenone 900 mg/day for 24 weeks has persistent beneficial effects in preventing further vision impairment and promoting vision recovery in patients with LHON relative to the natural course of the disease. Therefore, idebenone is a valuable agent to treat visual impairment in adolescents and adults with LHON.


Assuntos
Antioxidantes/uso terapêutico , Atrofia Óptica Hereditária de Leber/tratamento farmacológico , Ubiquinona/análogos & derivados , Antioxidantes/administração & dosagem , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ubiquinona/administração & dosagem , Ubiquinona/uso terapêutico
20.
BioDrugs ; 29(6): 399-406, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26394632

RESUMO

Siltuximab (Sylvant™), an interleukin (IL)-6 chimeric immunoglobulin Gк monoclonal antibody, is a currently the only agent approved to treat human idiopathic (herpesvirus-8 negative) multicentric Castleman disease (iMCD), which is a rare lymphoproliferative disorder. iMCD is caused by dysregulated production of IL-6 in the lymph nodes, and is associated with high morbidity, and potentially fatal consequences. Siltuximab binds to human IL-6 with high affinity and specificity, thereby preventing it from binding to IL-6 receptors, and neutralizing IL-6 bioactivity. In clinical trials in patients with iMCD, siltuximab reduced levels of C-reactive protein (a biomarker for IL-6), and provided clinical responses. Relative to placebo, the addition of siltuximab to best supportive care improved tumor- and symptom-related outcomes, with patients also reporting improvements in MCD symptoms, functional status, and well-being. Siltuximab has an acceptable tolerability profile, with the majority of treatment-emergent adverse events being manageable and/or of mild severity. In the absence of a cure, siltuximab represents a significant achievement in the management of this difficult-to-treat orphan disease.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Antineoplásicos/uso terapêutico , Hiperplasia do Linfonodo Gigante/sangue , Hiperplasia do Linfonodo Gigante/tratamento farmacológico , Animais , Anticorpos Monoclonais/farmacocinética , Antineoplásicos/farmacocinética , Hiperplasia do Linfonodo Gigante/diagnóstico , Herpesvirus Humano 8/metabolismo , Humanos
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