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MeSH: benzoáty-aplikace a dávkování

23 záznamů v Medvik Filtry

Článek

Eltrombopag ve druhé linii léčby u pacienta s chronickou imunitní trombocytopenií

Genský, Miroslav
Autor Autorita Oddělení klinické hematologie, Krajská nemocnice Liberec, a. s

Acta medicinae. 2021 ; 10 (4) : 77-80.

ISSN 1805-398X
Medvik
Zdroj

Klíčová slova
eltrombopag,
MeSH
antikoagulancia aplikace a dávkování terapeutické užití MeSH
benzoáty aplikace a dávkování terapeutické užití MeSH
idiopatická trombocytopenická purpura * diagnóza farmakoterapie MeSH
lidé středního věku MeSH
lidé MeSH
receptory thrombopoetinu * agonisté MeSH
trombocytopenie diagnóza etiologie farmakoterapie MeSH
trombopoéza účinky léků MeSH
výsledek terapie MeSH
žilní trombóza diagnóza komplikace MeSH
Check Tag
lidé středního věku MeSH
lidé MeSH
mužské pohlaví MeSH
Publikační typ
kazuistiky MeSH

Článek

CFTR activity is enhanced by the novel corrector GLPG2222, given with and without ivacaftor in two randomized trials

Journal of cystic fibrosis. 2019 ; 18 (5) : 700-707. [pub] 20190503

J Cyst Fibros
ISSN 1873-5010
Medvik
Zdroj

BACKGROUND: Several treatment approaches in cystic fibrosis (CF) aim to correct CF transmembrane conductance regulator (CFTR) function; the efficacy of each approach is dependent on the mutation(s) present. A need remains for more effective treatments to correct functional deficits caused by the F508del mutation. METHODS: Two placebo-controlled, phase 2a studies evaluated GLPG2222, given orally once daily for 29 days, in subjects homozygous for F508del (FLAMINGO) or heterozygous for F508del and a gating mutation, receiving ivacaftor (ALBATROSS). The primary objective of both studies was to assess safety and tolerability. Secondary objectives included assessment of pharmacokinetics, and of the effect of GLPG2222 on sweat chloride concentrations, pulmonary function and respiratory symptoms. RESULTS: Fifty-nine and 37 subjects were enrolled into FLAMINGO and ALBATROSS, respectively. Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.2% (14/48) of subjects in FLAMINGO and 40.0% (12/30) in ALBATROSS; most were mild to moderate in severity and comprised primarily respiratory, gastrointestinal, and infection events. There were no deaths or discontinuations due to TEAEs. Dose-dependent decreases in sweat chloride concentrations were seen in GLPG2222-treated subjects (maximum decrease in FLAMINGO: -17.6 mmol/L [GLPG2222 200 mg], p < 0.0001; ALBATROSS: -7.4 mmol/L [GLPG2222 300 mg], p < 0.05). No significant effects on pulmonary function or respiratory symptoms were reported. Plasma GLPG2222 concentrations in CF subjects were consistent with previous studies in healthy volunteers and CF subjects. CONCLUSIONS: GLPG2222 was well tolerated. Sweat chloride reductions support on-target enhancement of CFTR activity in subjects with F508del mutation(s). Significant improvements in clinical endpoints were not demonstrated. Observed safety results support further evaluation of GLPG2222, including in combination with other CFTR modulators. FUNDING: Galapagos NV. Clinical trial registration numbers FLAMINGO, NCT03119649; ALBATROSS, NCT03045523.

Článek

Léčba hypertenze fixní kombinací telmisartanu a amlodipinu

Viktorová, Kateřina
Autor Autorita

Remedia. 2018 ; 28 (2) : 158-160.

ISSN 0862-8947
Medvik
Zdroj

Článek

Představují fixní lékové kombinace optimální terapii hypertenze? Odložte růžové brýle, chcete-li vidět skutečnost ve více odstínech

Kameník, Libor
Autor Autorita ORCID Interní klinika 1. LF UK a ÚVN - Vojenská fakultní nemocnice, Praha

Medicína po promoci. 2015 ; 16 (2) : 100-107.

Med. promoci
ISSN 1212-9445
Medvik
Zdroj

Kvalita terapie hypertenze významně ovlivňuje kardiovaskulární morbiditu i mortalitu. Účinná farmakoterapie znamená dosažení cílových hodnot krevního tlaku, racionální terapie navíc dosažení poklesu cílových klinických ukazatelů, tj. snížení výskytu kardiovaskulárních událostí. Optimální terapie respektuje navíc ještě kvalitu životního stylu pacienta. Jednou z hlavních příčin suboptimální kontroly hypertenze je nízká compliance a adherence pacientů k léčbě při nízké kvalitě poskytované terapie. Fixní kombinace antihypertenziv představují perspektivní strategii farmakoterapie, která zvyšuje léčebný komfort pacientů a pozitivně ovlivňuje compliance a adherenci k terapii. Léčba fixními kombinacemi je zatížena též nevýhodami, které znamenají pro určitou skupinu pacientů potenciální rizika a mohou narušit optimální kvalitu terapie. Individuální přístup k rozhodování ordinace mezi fixní nebo volnou kombinací antihypertenziv vyžaduje zvážit přítomnost dalších onemocnění a celkovou biologickou kondici pacienta.

The quality of the therapy of hypertension significantly affects cardiovascular morbidity and mortality. Effective drug therapy does mean to attain the target blood pressure. In addition, the rational therapy does mean to achieve a decline in the clinical indicators, i.e. reduction of cardiovascular events. In addition, optimal therapy respects the quality of the patient's lifestyle. One of the main causes of suboptimal control of hypertension is low compliance and adherence of patients to medication due to inadequate quality of provided therapy. Fixed combinations of antihypertensive drugs represent promising therapeutic strategy, which increases the comfort of the therapy and affects positively compliance and adherence. Treatment with fixed combinations is also burdened with some disadvantages that pose potential risks for a particular group of patients and may impair the optimal quality of this therapy. The individual decision making between fixed-dose or free-dose combination antihypertensives should be carried out with regard to the presence of other diseases and to the biological status of the patient.

Článek

Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial

Lancet. 2015 ; 386 (10004) : 1649-58. [pub] 20150728

ISSN 1474-547X
Medvik
Zdroj

BACKGROUND: The thrombopoietin receptor agonist eltrombopag has been shown to be safe, tolerable, and effective for adults with chronic immune thrombocytopenia. We aimed to investigate the safety and efficacy of eltrombopag for children with chronic immune thrombocytopenia. METHODS: PETIT2 was a two part, randomised, multicentre, placebo-controlled study done at 38 centres in 12 countries (Argentina, Czech Republic, Germany, Hong Kong, Israel, Italy, Russia, Spain, Taiwan, Thailand, UK, and USA). Paediatric patients aged 1-17 years who had chronic immune thrombocytopenia and platelet counts less than 30 × 10(9) per L were randomly assigned (2:1) to receive eltrombopag or placebo. We stratified patients by age into three cohorts (patients aged 12-17 years, 6-11 years, and 1-5 years) before randomly entering them into a 13 week, double-blind period. Randomisation was done by the GlaxoSmithKline Registration and Medication Ordering System and both patients and study personnel were masked to treatment assignments. Patients who were allocated eltrombopag received tablets (except for those aged 1-5 years who received an oral suspension formulation) once per day for 13 weeks. Starting doses for patients aged 6-17 were based on bodyweight, and ethnic origin and ranged between 50 mg/day and 25 mg/day (starting dose for patients aged 1-5 years was 1·2 mg/kg/day or 0·8 mg/kg/day for east Asian patients). Patients who completed the double-blind period entered a 24 week open-label treatment period in which all patients received eltrombopag at either the starting dose (if they were formerly on placebo) or their established dose. The primary outcome was the proportion of patients achieving platelet counts of at least 50 × 10(9) per L in the absence of rescue therapy for 6 or more weeks from weeks 5 to 12 of the double-blind period. The intention-to-treat population included in the efficacy assessment consisted of all patients who were randomly assigned to one of the treatment groups, and the safety population included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT01520909. FINDINGS: Beginning in March 15, 2012, 92 patients were enrolled, and the trial was completed on Jan 2, 2014. 63 patients were assigned to receive eltrombopag and 29 were assigned to receive placebo. In the double-blind period, three patients discontinued treatment because of adverse events: two patients in the eltrombopag group withdrew because of increased liver aminotransferases and one in the placebo group withdrew because of abdominal haemorrhage. 25 (40%) patients who received eltrombopag compared with one (3%) patient who received placebo achieved the primary outcome of platelet counts of at least 50 × 10(9) per L for 6 of the last 8 weeks of the double-blind period (odds ratio 18·0, 95% CI, 2·3-140·9; p=0·0004). Responses were similar in all cohorts (eltrombopag vs placebo: 39% vs 10% for patients aged 12-17 years, 42% vs 0% for patients aged 6-11 years, and 36% vs 0% for patients aged 1-5 years). Proportionately fewer patients who received eltrombopag (23 [37%] of 63 patients) had WHO grades 1-4 bleeding at the end of the double-blind period than did those who received placebo (16 [55%] of 29 patients); grades 2-4 bleeding were similar (three [5%] patients who received eltrombopag vs two [7%] patients who received placebo). During the 24-week open-label treatment period, 70 [80%] of 87 patients achieved platelet counts of 50 × 10(9) per L or more at least once. Adverse events that occurred more frequently with eltrombopag than with placebo included nasopharyngitis (11 [17%] patients), rhinitis (10 [16%] patients), upper respiratory tract infection (7 [11%] patients), and cough (7 [11%] patients). Serious adverse events occurred in five (8%) patients who received eltrombopag and four (14%) who received placebo. Safety was consistent between the open-label and double-blind periods. No deaths, malignancies, or thromboses occurred during the trial. INTERPRETATION: Eltrombopag, which produced a sustained platelet response in 40% of patients with chronic immune thrombocytopenia, is a suitable therapeutic option for children with chronic symptomatic immune thrombocytopenia. We identified no new safety concerns and few patients discontinued treatment because of adverse events. FUNDING: GlaxoSmithKline.