natgillin/translations-raw huggingface dataset:
The main studies conducted versus placebo were Wayoff study (tinnitus, dizziness, hearing loss) and Morgon study (tinnitus).
Glavne študije, opravljene s placebom, so bile študija Wayoff (tinitus, vrtoglavica, izguba sluha) in študija Morgon (tinitus).
However, some patients had symptoms only partially reversible after TMZ withdrawal, and the connection to TMZ in some cases of non-reversible symptoms cannot be ruled out.
Vendar pa so imeli nekateri bolniki simptome, ki so bili po umiku trimetazidina le delno reverzibilni, povezave s trimetazidinom pa v nekaterih primerih nereverzibilnih sindromov ni mogoče izključiti.
The VASCO study showed a significant difference in the effect on ergometric parameters between trimetazidine at the highest dosage (140 mg) and placebo in the group of symptomatic patients.
Študija VASCO je pokazala pomembno razliko v učinkih na ergometrične parametre med najvišjimi odmerki trimetazidina (140 mg) in placebom v skupini simptomatskih bolnikov.
• The Committee reviewed all available submitted data from clinical studies, published literature and post-marketing experience on the safety of trimetazidine containing medicinal products, in particular with regards to the Parkinson syndrome and related events.
• Odbor je pregledal vse razpoložljive predložene podatke iz kliničnih študij, objavljene literature in izkušenj iz obdobja trženja zdravila o varnosti zdravil, ki vsebujejo trimetazidin, zlasti v zvezi s sindromom parkinsonove bolezni in povezanimi dogodki.
The clinical studies supporting ophthalmic field suffer from major methodological flaws.
Klinične študije, ki podpirajo področje oftalmologije, vsebujejo velike metodološke napake.
By decreasing fatty acid oxidation at the level of 3-ketoacyl coenzyme A thiolase, it favours glucose oxidation, which improves the use of the cells' energy reserves in the event of ischaemia.
Z znižanjem oksidacije maščobnih kislin na ravni 3-ketoacil koencim A tiolaze pospeši oksidacijo glukoze, kar izboljša uporabo energetskih rezerv celice v primeru ishemije.
Furthermore, the multiplicity of comparisons was not taken into account in the statistical analyses and the criteria were not presented hierarchically, so this comparison cannot have any demonstrative value; and lastly, the Perdriel single dose electroretinographic study (versus pyridoxilate) used an injectable intravenous form of trimetazidine 20 mg that has not been authorised.
Nadalje pri statističnih analizah številne primerjave niso bile upoštevane, kriteriji pa niso bili predstavljeni hierarhično, zato taka primerjava nima nobene prikazne vrednosti; in nazadnje, v elektroretinografski študiji avtorja Perdriel z enim odmerkom (v primerjavi s piridoksilatom) je bila uporabljena intravenska oblika trimetazidina 20 mg za injiciranje, ki ni odobrena.
Most ophthalmologic trimetazidine clinical trials have been conducted with the 20 mg strength but in some studies the daily doses used (20mg and 40 mg/day) were lower than those recommended in the current marketing authorisation (60 mg or 70 mg), which is also a limit of these studies, particularly in documenting the safety at the registered dosage.
Večina oftalmoloških kliničnih preskušanj s trimetazidinom je bilo izvedenih z jakostjo 20 mg, vendar so bili v nekaterih študijah uporabljeni manjši dnevni odmerki (20 mg in 40 mg/dan) od priporočenih v trenutno odobrenem dovoljenju za promet z zdravilom (60 mg ali 70 mg), kar je tudi meja za te študije, zlasti pri dokumentiranju varnosti pri registriranem odmerku.
The Sellier study was an exercise study not primarily designed to assess clinical parameters.
Študija avtorja Sellier je bila študija vadbe, ki v primarni zasnovi ni vsebovala ocene kliničnih parametrov.
• The Committee also recommended that trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia).
• Odbor je opozoril tudi, da lahko trimetazidin povzroči ali poslabša simptome parkinsonove bolezni (tremor, akinezija, hipertonija).
Of importance the efficacy was confirmed in patients at maximal dose of metoprolol as well as in patients with recurrent angina.
Pomembno je, da je bila učinkovitost potrjena tako pri bolnikih z največjim odmerkom metoprolola kot pri bolnikih s ponavljajočo se angino pektoris.
In response to the CHMP's request regarding the re-evaluation of the risk/benefit ratio of trimetazidine (all forms and dosages) in its ophthalmologic indications, the clinical package submitted comprises of nine studies.
V odziv na zahtevek CHMP za ponovno ocenitev razmerja med tveganji in koristmi trimetazidina (vse oblike in odmerki) za oftalmološke indikacije je bil predložen paket devetih študij.
The improvement in the primary end point with trimetazidine was observed in the pooled analysis of patients receiving 35 and 70 mg twice daily and in the analysis of patients receiving either 35 mg twice daily or 70 mg twice daily.
Izboljšanje primarnega opazovanega dogodka s trimetazidinom so opazili v združeni analizi bolnikov, ki so prejemali 35 in 70 mg dvakrat na dan in v analizi bolnikov, ki so prejemali 35 mg dvakrat na dan ali 70 mg dvakrat na dan.
These data support the efficacy of trimetazidine in add-on to beta-blockers.
Ti podatki podpirajo učinkovitost trimetazidina kot dodatnega zdravila k zaviralcem receptorjev beta.
Patients with a cardiovascular profile were significantly older (mean age: 74.8 years) than those with an ophthalmological and ENT profile (70.3 years and 63.5 years, respectively).
Bolniki s kardiovaskularnim profilom so bili precej starejši (povprečna starost: 74,8 let) kot bolniki z oftalmološkim (70,3 leta) in ORL profilom (63,5 let).
Population pharmacokinetics data indicate that serious adverse events were more frequent in treated elderly patients with high trimetazidine plasma concentrations.
Populacijski farmakokinetični podatki kažejo, da so resni neželeni učinki bolj pogosti pri starejših zdravljenih bolnikih z visokimi koncentracijami trimetazidina v plazmi.
Three studies were conducted against betahistine (Haguenauer, 1980; Kluyskens, 1990; Martini, 1990) to demonstrate a clinical benefit of trimetazidine in the treatment of dizziness.
V treh študijah so zdravilo primerjali z betahistinom (Haguenauer, 1980; Kluyskens, 1990; Martini, 1990), da bi dokazali klinične koristi trimetazidina pri zdravljenju vrtoglavice.
The Committee concluded that trimetazidine is associated with the occurrence of Parkinson syndrome and related symptoms.
Odbor je zaključil, da je trimetazidin povezan s pojavom sindroma parkinsonove bolezni in povezanih simptomov.
Eight of them show inclusions of patients presenting very heterogeneous pathologies of various severities with absence of prior stratification on these pathologies, and short durations of treatment (between 2 and 6 months) while these pathologies are known to progress slowly and to require extended treatments.
Osem izmed njih vključuje bolnike z zelo heterogenimi patologijami različnih stopenj resnosti z odsotnostjo predhodne stratifikacije teh patologij in kratkim časom zdravljenja (med 2 in 6 meseci), vendar pa je znano, da te patologije napredujejo počasi in da jih je treba dolgo zdraviti.
The posthoc analysis of the study in 298 patients receiving trimetazidine in combination mainly with metoprolol is in line and it is considered useful to better assess the effect of trimetazidine in a population of patients that are often difficult to be treated with haemodynamic agents.
Post hoc analiza študije z 298 bolniki, ki so prejemali trimetazidin, v glavnem v kombinaciji z metoprololom, je skladna in koristna za boljšo oceno učinka trimetazidina pri populaciji bolnikov, ki jih je pogosto težko zdraviti s hemodinamskimi zdravili.
Dose titration in elderly patients should be exercised with caution.
Pri starejših bolnikih je treba odmerek titrirati previdno.
The aim of the Sellier study (2003) was to assess the efficacy of the combination of trimetazidine MR 70 mg/day in patients suffering from angina pectoris who were insufficiently controlled on 50 mg/day of atenolol after two months of treatment.
Cilj študije avtorja Sellier (2003) je bil oceniti učinkovitost kombinacije trimetazidina MR 70 mg/dan pri bolnikih z angino pektoris, pri katerih ni bil dosežen ustrezen nadzor z atenololom 50 mg/dan po dveh mesecih zdravljenja.
They are studies whereby the results, often presented as statistically in favour of trimetazidine, are disputable mainly for methodological reasons.
V tej študijah so rezultati pogosto predstavljeni tako, da so statistično v korist trimetazidina, vendar so sporni zaradi uporabljene metodologije.
In addition the two studies by Manchanda (1997 and 2003) and four other minor studies are considered supportive of the efficacy of trimetazidine in add-on to calcium channel blockers (CCBs).
Prav tako študiji avtorja Manchanda (1997 in 2003) in štiri druge manjše študije podpirajo učinkovitost trimetazidina kot dodatnega zdravila k zaviralcem kalcijevih kanalčkov.
Most of these studies included patients presenting very heterogeneous pathologies of various severities with absence of prior stratification on these pathologies, and of very limited duration of treatment (between 2 and 3 months) not in line with what is required by these pathologies that necessitate long term treatments.
Večina študij je vključevala bolnike, ki so imeli zelo raznolike patologije različnih stopenj resnosti z odsotnostjo predhodne stratifikacije teh patologij in z zelo omejenim trajanjem zdravljenja (med 2 in 3 meseci), kar ni bilo v skladu s tem, kar seza te patologije zahteva, saj je potrebno dolgotrajno zdravljenje.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min) the recommended dose has been added in the SmPC.
Pri bolnikih z zmerno okvaro ledvic (očistek kreatinina [30-60] ml/min) je bil v povzetek glavnih značilnosti zdravila dodan priporočeni odmerek.
The proposed multicentre, randomised, double-blind, placebo controlled long-term study in postpercutaneous coronary intervention (PCI) patients and the prospective and comparative cohort study to assess the prevalence of EPS in patients receiving trimetazidine may be adequate to solve the concerns on long-term efficacy and safety of trimetazidine.
Predlagana multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana dolgoročna študija bolnikov po perkutani koronarni intervenciji ter prospektivna in primerjalna kohortna študija za ocenitev obolevnosti za ekstrapiramidalnim sindromom pri bolnikih, ki prejemajo trimetazidin, sta morda ustrezni za razrešitev pomislekov o dolgoročni učinkovitosti in varnosti trimetazidina.
In order to show a benefit on daily episodes of angina it is important to adequately assess the baseline occurrence of angina and sublingual nitrate use and to calculate the sample size on the basis of the expected treatment effect.
Za prikaz koristi pri dnevnih epizodah angine pektoris je pomembno ustrezno oceniti izhodiščni pojav angine pektoris in uporabo podjezičnega nitrata terizračunati velikost vzorca na podlagi pričakovanega učinka zdravljenja.
The CHMP agreed that trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients.
CHMP se je strinjal, da lahko trimetazidin povzroči ali poslabša simptome parkinsonove bolezni (tremor, akinezija, hipertonija), zato so zlasti pri starejših bolnikih potrebne redne preiskave.
Results from this study did not highlight any clinical benefit of trimetazidine in comparison to the placebo to prevent the bilateralisation of choroidal neovascularisation in patients suffering from age-related macular degeneration, principal criterion of evaluation chosen to demonstrate the clinical benefit of trimetazidine 35 mg to slow the progression of age-related macular degeneration (ARMD).
Rezultati te študije niso izpostavili nobenih kliničnih koristi trimetazidina v primerjavi s placebom pri preprečevanju bilateralizacije horoidne neovaskularizacije pri bolnikih s starostno makularno degeneracijo, kar je bil načelni kriterij ovrednotenja, izbran za dokazovanje kliničnih koristi trimetazidina 35 mg pri upočasnitvi napredovanja starostne makularne degeneracije.
In response to the CHMP request regarding the re-evaluation of the risk/benefit ratio of trimetazidine (all forms and dosages) in the ENT indications, 9 clinical studies (Wayoff, 1984; Sterkers, 2001; Vitte, 2002; Haguenauer, 1980; Kluyskens, 1990; Martini, 1990; Morgon 1990; Coyas 1990 and France cochlea study, 2009 presented as support of safety since the efficacy objective was not reached) were submitted or presented as literature references.
V odgovor na zahtevek CHMP v zvezi s ponovno ocenitvijo razmerja med tveganji in koristmi za trimetazidin (vse oblike in odmerki) za indikacije ORL je bilo predloženih ali predstavljenih kot reference v literaturi 9 kliničnih študij (Wayoff, 1984; Sterkers, 2001; Vitte, 2002; Haguenauer, 1980; Kluyskens, 1990; Martini, 1990; Morgon 1990; Coyas 1990 in študija kohlee v Franciji, 2009 v podporo varnosti, saj cilj učinkovitosti ni bil dosežen).
The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
Pri pojavu motenj gibanja, kot so simptomi parkinsonove bolezni, sindrom nemirnih nog, tremorji in nestabilna hoja, je treba dokončno ukiniti uporabo trimetazidina.
It is acknowledged that extrapyramidal symptoms reported in patients receiving TMZ have a low prevalence (incidence of 0.36/100,000 PY) and are generally reversible after TMZ withdrawal.
Potrjeno je, da je obolevnost za ekstrapiramidalnimi simptomi, o katerih so poročali pri bolnikih, ki so prejemali trimetazidin, nizka (pojavnost 0,36/100.000 bolnikov/let) in da so ti na splošno po prenehanju uporabe trimetazidin reverzibilni.
The TRIMPOL-II showed that trimetazidine significantly improves exercise capacity and exerciseinduced myocardial ischemia when added to metoprolol.
Študija TRIMPOL-II je pokazala, da trimetazidin značilno izboljša vadbeno zmogljivost in miokardno ishemijo zaradi vadbe, če se ga doda metoprololu.
Recent surveys in patients with coronary artery disease have shown that most patients with angina do not receive adequate anti-anginal therapy because of haemodynamic intolerance or chronotropic incompetence.
Nedavne raziskave pri bolnikih s koronarno arterijsko boleznijo so pokazale, da večina bolnikov z angino pektoris ne prejema ustreznega zdravljenja proti njej zaradi hemodinamskega neprenašanja ali kronotropne inkompetence.
Some new potential, very rare and reversible adverse effects were highlighted during the referral procedure, including trombocytopenia, agranulocytosis and liver dysfunction and have been included in the risk management plan (RMP) and reflected in the relative sections of the SmPC.
Med napotitvenim postopkom so bili izpostavljeni nekateri novi možni, zelo redki in reverzibilni neželeni učinki, vključno s trombocitopenijo, agranulocitozo in jetrno disfunkcijo, ki so bili vključeni v načrt obvladovanja tveganja (RMP) in navedeni v ustreznih poglavjih povzetka glavnih značilnosti zdravila.
It is considered that the study is only adequate to show the efficacy of trimetazidine with reference to the primary endpoint, time to onset of angina pectoris, as no significant difference between groups could be found for the other secondary endpoints (total exercise duration, total workload and clinical endpoints).
Študija se obravnava kot ustrezna le za prikaz učinkovitosti trimetazidina glede na primarni opazovani dogodek, čas do pojava angine pektoris, saj pomembnih razlik med skupinama za druge sekundarne opazovane dogodke ni bilo mogoče ugotoviti (skupno trajanje vadbe, skupna obremenitev in klinični opazovani dogodki).
Among these nine studies, three were non-comparative studies (Guillaumat, 1982; Millara, 1988; Nowak, 2007); three were comparative studies of short duration (up to 3 months) conducted against products used at the time of these studies e.g. cinnarizine, piridoxilate which are no more considered as therapies of choice to treat or prevent retinal or glaucoma diseases by the ophthalmologists; two studies were conducted against placebo (Couderc, 1984 and Aron-Rosa, 1988).
Med temi devetimi študijami so bile tri neprimerjalne (Guillaumat, 1982; Millara, 1988; Nowak, 2007); tri so bile primerjalne s kratkim trajanjem (do 3 mesece) in izvedene s primerjanjem z zdravili, ki so se takrat uporabljala, npr. cinarizin, piridoksilat, ki za oftalmologe niso več zdravila izbire za zdravljenje ali preprečevanje bolezni retine ali glavkoma; dve študiji sta bili izvedeni s primerjanjem s placebom (Couderc, 1984 in Aron-Rosa, 1988).
Although the methodology followed by the MAH may be regarded as not totally compliant to the currently accepted standards, no major bias affecting the interpretation of study results appears evident and all analyses show a beneficial effect of trimetazidine combined with metoprolol on exercise tolerance, myocardial ischemia and clinical symptoms.
Čeprav metodologija, ki jo je imetnik dovoljenja za promet z zdravilom uporabil, ni povsem v skladu s trenutno sprejetimi standardi, ni videti večjih pristranskosti, ki bi vplivale na razlago rezultatov študije, vse analize pa kažejo na koristne učinke trimetazidina, kombiniranega z metoprololom, na prenašanje vadbe, miokardno ishemijo in klinične simptome.
The Emeriau PK study has shown high plasma concentrations of trimetazidine in old patients, receiving the usual dose of 35 mg twice daily.
Farmakokinetična študija Emeriau je pokazala visoke koncentracije trimetazidina v plazmi pri starejših bolnikih, ki so prejemali običajni odmerek 35 mg dvakrat na dan.
In a 426-patients randomised, double blind, placebo-controlled study (TRIMPOL-II), trimetazidine (60mg/day) added to metoprolol 100mg daily (50 mg b.i.d) for 12 weeks significantly improved statistically exercise tests parameters and clinical symptoms as compared to placebo: total exercise duration +20.1s, p= 0.023, total workload +0.54 METs, p=0.001, time to 1-mm ST-segment depression +33.4s, p=0.003, time to onset of angina +33.9s, p<0.001, angina attacks/week -0.73, p=0.014 and short acting nitrates consumption/week, -0.63, p=0.032, without hemodynamic changes.
V randomizirani, dvojno slepi, s placebom kontrolirani študiji s 426 bolniki (TRIMPOL-II) je trimetazidin (60 mg/dan), dodajan 100 miligramom metoprolola na dan (50 mg dvakrat na dan) za 12 tednov, v primerjavi s placebom značilno izboljšal statistične parametre testov vadbe in klinične simptome: skupno trajanje vadbe +20,1 s, p = 0,023, skupna obremenitev +0,54 METs; p = 0,001, čas do 1-mm znižanje spojnice ST +33,4 s; p = 0,003, čas do nastopa angine pektoris +33,9 s; p <0,001, napadi angine pektoris/teden -0,73; p = 0,014 in poraba kratkodelujočih nitratov/teden -0,63; p = 0,032, brez hemodinamskih sprememb.
Indeed, it is well known that patients with proven coronary artery disease who are asymptomatic may not have inducible ischemia and that in these patients anti-anginal treatments are ineffective in improving exercise capacity.
Znano je, da asimptomatski bolniki z dokazano koronarno arterijsko boleznijo morda nimajo inducibilne ishemije in da zdravljenje proti angini pektoris pri teh bolnikih nima učinka na izboljšanje vadbene zmogljivosti.
• For the indications of symptomatic treatment of tinnitus, vertigo and of visual field disturbances, the CHMP concluded that in view of the newly available safety data and very limited efficacy, the benefits no longer outweigh the risks under normal conditions of use and therefore these therapeutic indications should be removed.
• Za indikacije simptomatskega zdravljenja tinitusa, vrtoglavice in motenj vidnega polja je CHMP sklenil, da ob upoštevanju na novo razpoložljivih podatkov o varnosti in zelo omejene učinkovitosti koristi ne odtehtajo več tveganj v običajnih pogojih uporabe, zato je treba ti terapevtski indikaciji črtati.
In addition, the SmPC has to be amended to include a warning about trimetazidine induced parkinsonism, its diagnosis and management.
Poleg tega je treba povzetek glavnih značilnosti zdravila popraviti tako, da bo vsebovalo opozorilo o parkinsonizmu zaradi trimetazidina, njegovo diagnozo in zdravljenje.
For the remaining two indications of symptomatic treatment of tinnitus, vertigo and of visual field disturbances, the CHMP concluded that in view of the newly available safety data and very limited efficacy, the benefits no longer outweigh the risks under normal conditions of use and therefore these therapeutic indications should be removed.
Za preostali dve indikaciji simptomatskega zdravljenja tinitusa, vrtoglavice in motenj vidnega polja je CHMP sklenil, da ob upoštevanju na novo razpoložljivih podatkov o varnosti in zelo omejene učinkovitosti koristi ne odtehtajo več tveganj v običajnih pogojih uporabe, zato je treba ti terapevtski indikaciji črtati.
In addition, a pharmacokinetics study was agreed with the MAH to investigate the effects of renal impairment and age on the trimetazidine safety profile.
Poleg tega je bilo dogovorjeno, da imetnik dovoljenja za promet z zdravilom opravi farmakokinetično študijo, da razišče učinke okvare ledvic in starosti na varnostni profil trimetazidina.
In a 1962 patients three-month randomised, double-blinded study (VASCO study, 2011) on top of atenolol 50 mg/d, two dosages of trimetazidine (70 mg/d and 140 mg/d) were tested versus placebo.
Pri 1962 bolnikih so opravili trimesečno, randomizirano, dvojno slepo študijo (študija VASCO, 2011), v kateri so preskušali atenolol 50 mg/danskupaj z dvema odmerkoma trimetazidina (70 mg/dan in 140 mg/dan) v primerjavi s placebom.
Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected moderate due to renal impairment, or in elderly patients older than 75 years old.
Previdnost je potrebna pri predpisovanju trimetazidina bolnikom, pri katerih je pričakovana večja izpostavljenost zaradi zmerne okvare ledvic ali pri starejših bolnikih, starih več kot 75 let.
Trimetazidine (TMZ) is a metabolic agent whose aim is to protect against ischemia by increasing glucose metabolism relative to that of fatty acids.
Trimetazidin (TMZ) je presnovno zdravilo z nalogo zaščititi pred ishemijo s povečanjem presnove glukoze maščobnih kislin.
This risk has been identified in post marketing setting and in literature based on: positive dechallenge of Parkinson symptoms after the only withdrawal of TMZ, positive rechallenge, significant higher coprescription of antiparkinson drugs in TMZ group compared to control group (IMS study) and significant higher number of patients that begin antiparkinson drugs after the introduction of TMZ compared to control group (IMS study).
To tveganje je bilo opredeljeno v obdobju trženja in v literaturi na podlagi: pozitivnega okrevanja od simptomov parkinsonove bolezni po prenehanju uporabe trimetazidina, ponovitve simptomov pri ponovni uporabi, značilno višjega sočasnega predpisovanja zdravil proti parkinsonovi bolezni v skupini s trimetazidinom v primerjavi s kontrolno skupino (študija IMS) in značilno višjega števila bolnikov, ki začnejo po uvedbi trimetazidina uporabljati zdravila proti parkinsonovi bolezni v primerjavi s kontrolno skupino (študija IMS).
Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected such as with moderate renal impairment and elderly patients older than 75 years old.
Previdnost je potrebna pri predpisovanju trimetazidina bolnikom, pri katerih je pričakovana večja izpostavljenost zaradi zmerne okvare ledvic in pri starejših bolnikih, starih več kot 75 let.