natgillin/translations-raw huggingface dataset:
As stated above, RCT data are available which included sufficient number of patients and resulted in estimates of treatment effect with sufficient precision.
Kot omenjeno, so na voljo podatki iz randomiziranih nadzorovanih preskušanj, v katera je bilo vključenih dovolj bolnikov in ki so omogočila dovolj natančno oceno učinka zdravljenja.
Despite the lack of statistical power for the specific “sudden cardiac death” endpoint, the lack of substantial benefit can be concluded from this trial in a statistically valid way, as evidenced by the narrow confidence intervals.
Kljub nezadostni statistični moči glede specifičnega opazovanega dogodka „nenadna srčna smrt“ je mogoče iz preskušanja na statistično veljaven način sklepati na pomanjkanje bistvenih koristi, kar dokazujejo ozki intervali zaupanja.
The OMEGA study has several strengths compared to the GISSI-P study, e.g. administration of study drug within few days of a MI, a placebo-controlled double-blind design, optimal baseline therapy and endpoints investigated.
Študija OMEGA ima v primerjavi s študijo GISSI-P več prednosti, npr. dajanje študijskega zdravila v nekaj dneh po miokardnem infarktu, s placebom kontrolirana dvojno slepa zasnova, optimalno osnovno zdravljenje in proučevani opazovani dogodki.
The ASCEND and VITAL studies did not show an effect of omega3 fatty acids on the primary or secondary cardiovascular endpoints and, as such, were considered as negative studies.
V študijah ASCEND in VITAL niso dokazali učinka omega-3-maščobnih kislin na primarni in sekundarni srčno-žilni opazovani dogodek, zato sta šteli za negativni študiji.
However, with respect to statin therapy, CHMP concluded that subjects in this subgroup analysis were not on optimal statin therapy.
Vendar je odbor CHMP v zvezi z zdravljenjem s statini zaključil, da preskušanci v tej podskupini niso prejemali optimalnega zdravljenja s statini.
Based on the above, the CHMP reiterates that RCTs conducted in other CV risk populations are relevant in support of the efficacy (GISSI-HF although borderline and inconclusive) or lack of efficacy (ORIGIN and SU.FOL.OM3) of omega-3 fatty acids in secondary prevention of cardiovascular disease.
Glede na zgoraj navedeno odbor CHMP ponavlja, da tudi randomizirana nadzorovana preskušanja, izvedena pri drugih populacijah s srčno-žilnim tveganjem, podpirajo učinkovitost (GISSI-HF, čeprav mejen in nejasen) ali pomanjkanje učinkovitosti (ORIGIN in SU.FOL.OM3) omega-3-maščobnih kislin pri sekundarni preventivi srčno-žilnih bolezni.
Despite the lack of statistical power for the specific sudden cardiac death endpoint, the lack of substantial benefit can be concluded from this trial in a statistically valid way, as evidenced by the narrow confidence intervals.
Kljub nezadostni statistični moči glede specifičnega opazovanega dogodka nenadne srčne smrti je mogoče iz preskušanja na statistično veljaven način sklepati na pomanjkanje bistvenih koristi, kar dokazujejo ozki intervali zaupanja.
In view of all the available data, the CHMP considered that the evidence that supported the authorisation of omega-3 in secondary prevention after MI suffered from some methodological limitations and was weak.
Ob upoštevanju vseh razpoložljivih podatkov je odbor CHMP menil, da imajo dokazi, ki so podpirali odobritev omega-3-maščobnih kislin pri sekundarni preventivi po miokardnem infarktu, nekatere metodološke omejitve in niso prepričljivi.
For this, RCT data are available which included sufficient number of patients and resulted in estimates of treatment effect with sufficient precision.
Za to so na voljo podatki iz randomiziranih nadzorovanih preskušanj, v katera je bilo vključenih dovolj bolnikov in so omogočila dovolj natančno oceno učinka zdravljenja.
Therefore, these results do not support an effect in secondary prevention after MI.
Ti rezultati tako ne podpirajo učinka pri sekundarni preventivi po miokardnem infarktu.
Therefore, the CHMP considers that the validity of the meta-analyses is rather limited and that the meta-analyses can only be interpreted as being indicative, but not conclusive, with regards to potential efficacy or the lack of efficacy of omega-3 fatty acids in reducing the risk of cardiovascular events.
Odbor CHMP zato meni, da je veljavnost metaanaliz precej omejena in da jih je mogoče glede morebitne učinkovitosti ali pomanjkanja učinkovitosti omega-3-maščobnih kislin pri zmanjševanju tveganja za srčno-žilne dogodke razlagati le kot indikativne in ne kot dokončne.
• Based on the totality of the data emerging after the original approval as well as the limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary prevention after myocardial infarction at the dose of 1 g/day and, although the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
• Na podlagi vseh podatkov, ki so postali na voljo po prvotni odobritvi, in omejitev preskušanja GISSI-P je odbor CHMP zaključil, da pri odmerku 1 g/dan učinkovitost pri sekundarni preventivi po miokardnem infarktu ni dokazana, in čeprav je varnostni profil omega-3-kislinskih etilestrov ostal nespremenjen, zaključil, da razmerje med tveganji in koristmi pri tej indikaciji ni več ugodno.
The efficacy of omega-3 fatty acids in the claimed indication has also not been demonstrated by other relevant RCTs conducted in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke ), including ORIGIN, SU.FOL.OM3, ASCEND, and VITAL.
Učinkovitosti omega-3-maščobnih kislin pri navedeni indikaciji niso dokazali niti v drugih randomiziranih nadzorovanih preskušanjih, izvedenih pri drugih populacijah s srčno-žilnim tveganjem (npr. koronarna revaskularizacija, angina pektoris, ishemična možganska kap), vključno s preskušanji ORIGIN, SU.FOL.OM3, ASCEND in VITAL.
The results of the meta-analyses by Aung et al. and the recent Cochrane review, even though they include trials with products, doses and populations not exactly representing the approved secondary prevention indication, are considered relevant as all studies include patients with cardiovascular disease and therefore are supportive of lack of efficacy.
Rezultati metaanaliz, ki so jih izvedli Aung idr., ter nedavni pregled mreže Cochrane, ki so sicer vključevali preskušanja z zdravili, odmerki in populacijami, ki niso popolnoma reprezentativni za odobreno indikacijo sekundarne preventive, se štejejo za ustrezne, saj vse študije vključujejo bolnike s srčno-žilno boleznijo in torej potrjujejo pomanjkanje učinkovitosti.
• Even though the meta-analyses by Aung et al. and the recent Cochrane review includes trials with products, doses and populations not exactly representing the approved secondary prevention indication, all studies include patients with cardiovascular disease and therefore, the results are considered as supportive of lack of efficacy.
• Čeprav metaanalize, ki so jih izvedli Aung idr.,in nedavni pregled mreže Cochrane vključujejo preskušanja z zdravili, odmerki in populacijami, ki niso popolnoma reprezentativni za odobreno indikacijo sekundarne preventive, vse študije vključujejo bolnike s srčno-žilno boleznijo, zato so presodili, da rezultati potrjujejo pomanjkanje učinkovitosti.
The MAHs disagreed with the CHMP that the evidence that supported the authorisation of omega-3 in secondary prevention after MI suffered from some methodological limitations and was weak and that the efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Imetniki dovoljenj za promet z zdravili se niso strinjali z odborom CHMP, da so imeli dokazi, ki so podpirali odobritev omega-3-kislinskih etilestrov za sekundarno preventivo po miokardnem infarktu, nekatere metodološke omejitve in so bili neprepričljivi ter da učinkovitost pri tej indikaciji ni bila dokazana v poznejših in zanesljivejših kliničnih preskušanjih.
In this study, there was a relative risk reduction for one of the two the co-primary MACE endpoints of 10% with a rather poor precision (upper CI 0.99) with the second co-primary endpoint just failing to show a significant result.
V tej študiji so zabeležili 10-odstotno relativno zmanjšanje tveganja za enega od dveh soprimarnih opazovanih dogodkov MACE s precej slabo natančnostjo (zgornja meja IZ 0,99), drugi soprimarni opazovani dogodek pa ni pokazal statistično značilnega rezultata.
A meta-analysis using individual participant data (IPD), selecting patients with a history of MI and treated with the same dose as for the indication under review (1 g) would have been more appropriate.
Primernejša bi bila metaanaliza z uporabo podatkov o posameznih udeležencih in izbiro bolnikov z anamnezo miokardnega infarkta, ki so zdravljeni z enakim odmerkom kot pri obravnavani indikaciji (1 g).
The key concern of this study is that standard of care for the treatment of MI has evolved since the outcome of the GISSI-P trial in particular statin therapy, beta-blocker therapy and invasive treatment.
Ključni pomislek glede te študije je, da je standard oskrbe pri zdravljenju miokardnega infarkta od izida preskušanja GISSI-P napredoval, še zlasti v zvezi z zdravljenjem s statini, zaviralci beta in invazivnim zdravljenjem.
Therefore if omega-3 fatty acids are effective in reducing cardiovascular events after an MI, cardiovascular benefits in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke) can be anticipated.
Če torej omega-3maščobne kisline učinkovito zmanjšujejo število srčno-žilnih dogodkov po miokardnem infarktu, je srčno-žilne koristi mogoče pričakovati tudi pri drugih populacijah s srčno-žilnim tveganjem (npr. s koronarno revaskularizacijo, angino pektoris, ishemično možgansko kapjo).
Acute coronary syndrome (ACS) associated with typical coronary artery disease (atherosclerosis) is the most common cause of a MI.
Najpogostejši vzrok miokardnega infarkta je akutni koronarni sindrom (AKS), povezan s tipično koronarno arterijsko boleznijo (aterosklerozo).
The Committee, as a consequence, considers that the benefit-risk balance of Omega-3 acid ethyl esters medicinal products for oral use in secondary prevention after myocardial infarction is not favourable.
Odbor zato meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo omega-3-kislinske etilestre, za peroralno uporabo pri sekundarni preventivi po miokardnem infarktu ni ugodno.
Upon request from the MAHs, a second SAG CVS meeting was convened on 19 March 2019.
Na zahtevo imetnikov dovoljenj za promet z zdravili se je 19. marca 2019 sestala druga znanstvenosvetovalna skupina za srčno-žilna vprašanja (SAG CVS).
• The CHMP considered the totality of the data submitted for omega-3 acid ethyl esters medicinal products with regard to their use in secondary prevention after myocardial infarction.
• Odbor CHMP je upošteval vse podatke, predložene za zdravila, ki vsebujejo omega-3-kislinske etilestre, ki so se nanašali na uporabo teh zdravil pri sekundarni preventivi po miokardnem infarktu.
Although CHMP considers that the GISSI-P and the OMEGA trials are the most relevant for evaluating the effect of omega-3 containing products in the secondary prevention after MI, it is also acknowledged that RCTs (GISSI-HF, ORIGIN, SU.FOL.OM3) conducted in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke) are as well relevant, as CV disease is still considered a continuum.
Čeprav odbor CHMP meni, da sta za oceno učinka zdravil, ki vsebujejo omega-3-kislinske etilestre, pri sekundarni preventivi po miokardnem infarktu najustreznejši preskušanji GISSI-P in OMEGA, so ustrezna tudi randomizirana nadzorovana preskušanja (GISSI-HF, ORIGIN, SU.FOL.OM3), izvedena pri drugih populacijah s srčno-žilnim tveganjem (npr. koronarna revaskularizacija, angina pektoris, ishemična možganska kap), saj se srčno-žilna obolenja še vedno štejejo za kontinuum.
The MAHs have described the results from different RCTs to support the beneficial effect of omega-3 fatty acids in secondary prevention after an MI.
Imetniki dovoljenj za promet z zdravili so opisali rezultate različnih randomiziranih nadzorovanih preskušanj, ki naj bi podpirali koristne učinke omega-3-maščobnih kislin pri sekundarni preventivi po miokardnem infarktu.
Based on the totality of the data emerging after the original approval as well as the serious limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary cardiovascular prevention at the dose of 1 g/day and whereas the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
Na podlagi vseh podatkov, ki so postali na voljo po prvotni odobritvi, in resnih omejitev preskušanja GISSI-P je odbor CHMP zaključil, da učinkovitost pri sekundarni srčno-žilni preventivi v odmerku 1 g/dan ni dokazana in da razmerje med tveganji in koristmi pri tej indikaciji kljub nespremenjenemu varnostnemu profilu omega-3-maščobnih kislin ni več ugodno.
The results of RECUCE-IT study results are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Rezultati študije REDUCE-IT so omejenega pomena, saj je bil dnevni odmerek precej večji od odmerka za obravnavano indikacijo (4 g v primerjavi z 1 g), učinkovina pa ni bila mešanica EPA in DHA, temveč ikozapent etil, visokoprečiščeni etilester EPA.
In the MAHs' view, GISSI‐P represented the mainstay of evidence in favour of the use of omega-3 fatty acids in the secondary prevention after MI and it is a valid and robust study.
Po mnenju imetnikov dovoljenj za promet z zdravili je preskušanje GISSI‐P predstavljalo glavni dokaz v prid uporabe omega-3-maščobnih kislin pri sekundarni preventivi po miokardnem infarktu ter je veljavna in zanesljiva študija.
However, some experts in the SAG saw a place in therapy for omega-3containing medicinal products in secondary prevention after MI.
Vendar pa so nekateri strokovnjaki v znanstveno-svetovalni skupini prepoznali mesto v zdravljenju za zdravila, ki vsebujejo omega-3-kislinske etilestre, pri sekundarni preventivi po miokardnem infarktu.
The results of the recently published REDUCE-IT trial are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs. 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Rezultati pred kratkim objavljenega preskušanja REDUCE-IT so omejenega pomena, saj je dnevni odmerek precej presegal odmerek pri obravnavani indikaciji (4 g v primerjavi z 1 g), učinkovina pa ni bila mešanica EPA in DHA, temveč ikozapent etil, visokoprečiščeni etilester EPA.
Two of the studies (Greene5 and Macchia6) included a large number of subjects and for the latter, the documented risk reduction for all-cause mortality was 37% (RR 0.63 CI 0.56-0.72).
Odbor CHMP je pregledal rezultate treh predloženih kohortnih študij, v katere so bili vključeni preskušanci, ki so doživeli miokardni infarkt, ki so bili očitno skladni z rezultati študije GISSI-P. Dve od teh študij (Greene5 in Macchia6) sta vključevali veliko število preskušancev, pri katerih je dokumentirano zmanjšanje tveganja za umrljivost zaradi katerega koli vzroka znašalo 37 % (razmerje tveganj 0,63; IZ 0,56-0,72).
6 Macchia A, Romero M, D'Ettorre A, Tognoni G, Mariani J. Exploratory analysis on the use of statins with or without n-3 PUFA and major events in patients discharged for acute myocardial infarction: an observational retrospective study.
2016 Feb 1;117(3):340-6. 6 Macchia A, Romero M, D'Ettorre A, Tognoni G, Mariani J. Exploratory analysis on the use of statins with or without n-3 PUFA and major events in patients discharged for acute myocardial infarction: an observational retrospective study.
Therefore, the key concern that standard of care after MI has intensified since the time of the GISSI-P study, in particular statin therapy, beta-blockers and PCI, still remains.
Zato ostaja ključni pomislek, da se je od časa študije GISSI-P standard oskrbe po miokardnem infarktu izboljšal, zlasti v smislu zdravljenja s statini, zaviralci beta in perkutanim koronarnim posegom.
beneficial effect of omega-3 for secondary prevention after myocardial infarction at the dose of 1 g/day is weak.
Dokazi iz preskušanja GISSI-P, s katerimi bi podprli koristen učinek omega-3-maščobnih kislin pri sekundarni preventivi po miokardnem infarktu v odmerku 1 g/dan, torej niso prepričljivi.
Based on the results of studies available today the experts did not see a place for therapy with Omega-3 containing medicinal products at a dose of 1 g/day in the context of secondary cardiovascular prevention after MI given the considerations regarding RCTs (particularly OMEGA and GISSI-P studies), meta-analysis and retrospective cohort studies.
Na podlagi rezultatov študij, ki so na voljo danes, so izvedenci menili, da glede na ugotovitve v zvezi z randomiziranimi nadzorovanimi preskušanji (zlasti študijama OMEGA in GISSIP), metaanalizami in retrospektivnimi kohortnimi študijami zdravljenje z zdravili, ki vsebujejo omega3-kislinske etilestre v odmerku 1 g/dan, pri sekundarni srčno-žilni preventivi po miokardnem infarktu ni primerno.
In particular the GISSI-P and OMEGA trials, which were considered most relevant, have been extensively discussed by the MAHs.
Imetniki dovoljenj za promet z zdravili so zlasti podrobno razpravljali o preskušanjih GISSI-P in OMEGA, ki so ju šteli za najpomembnejši.
The OMEGA trial was a large prospective, double blind, randomized study including a population highly representative of the target population including the use of standard of care treatment.
Primarni cilj preskušanja OMEGA je bil proučiti stopnjo nenadne srčne smrti in tako preveriti enega od predvidenih mehanizmov delovanja (antiaritmično delovanje) omega-3-maščobnih kislin, ki so jih predpostavili v študiji GISSI-P. Preskušanje OMEGA je bilo obsežna prospektivna, dvojno slepa, randomizirana študija, v katero so vključili populacijo, ki je bila zelo reprezentativna za ciljno populacijo, vključno z uporabo standardnega zdravljenja.
• During the switch to this type of combination medicine and in the weeks after the switch you should measure your blood sugar levels more frequently.
• Med prehodom na tovrstno kombinirano zdravilo in v tednih po prehodu si morate krvni sladkor meriti pogosteje.
Patients and healthcare professionals are therefore advised to take extra care when using these medicines and carefully follow the recommendations given below.
Bolnikom in zdravstvenim delavcem zato svetujemo, da so pri uporabi teh zdravil posebno previdni in da skrbno upoštevajo spodaj navedena priporočila.
• Ensure that your patients are adequately informed on how to use their medicine.
• Poskrbite, da so vaši bolniki ustrezno seznanjeni s tem, kako morajo uporabljati svoje zdravilo.
These types of combination medicines are advantageous to patients since they reduce the number of injections they need to have and may help them keep to their treatment.
Tovrstna kombinirana zdravila so za bolnike ugodna, ker zmanjšujejo število potrebnih injekcij in jim pomagajo, da se držijo zdravljenja.
• If you have any questions about your treatment speak to your healthcare professional.
• Če imate kakršna koli vprašanja o zdravljenju, se posvetujte z zdravstvenim delavcem.
Before you use your medicine be clear on how many dose steps you require.
Pred uporabo zdravila morate vedeti, koliko odmernih korakov potrebujete.
However, there is a potential risk of patients receiving too little or too much of their medicine because of confusion that may arise over the way the doses are expressed for the individual components − the dose of the insulin is expressed in units while the dose of the non-insulin medicine may be expressed in other units such as mg.
Vendar pa obstaja potencialno tveganje, da bolniki prejmejo premalo ali preveč zdravila zaradi zmede, ki se lahko pojavi zaradi načina izražanja odmerkov posameznih komponent − odmerek insulina je izražen v enotah, odmerek neinsulinskega zdravila pa v drugih enotah, na primer v miligramih.
An example of a diabetes medicine that contains insulin in combination with a non-insulin active substance is Xultophy (100 units/ml insulin degludec and 3.6 mg/ml liraglutide) which was authorised in the EU on.
Primer zdravila za sladkorno bolezen, ki vsebuje insulin v kombinaciji z neinsulinsko zdravilno učinkovino, je zdravilo Xultophy (100 enot/ml insulina degludek in 3,6 mg/ml liraglutida), ki je bil v EU odobren dne.
Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors, can be found in the guidance on risk minimisation strategies for high strength and fixed combination insulin products.
Več informacij o varni uporabi teh zdravil in drugih načinih zmanjševanja morebitnih tveganj za napake pri zdravljenju je na voljo v navodilu o strategijah zmanjševanja tveganja za insulinska zdravila z veliko jakostjo in v fiksnih kombinacijah.
Always prescribe the dose of insulin and the dose of non-insulin to be injected as well as the dose frequency.
Vedno predpišite odmerek insulina in odmerek neinsulinske učinkovine, ki ju je treba injicirati, ter pogostnost odmerjanja.
• If the patient has been transferred from another pen device, highlight the differences in design between the two devices.
• Če je bolnik prej uporabljal drug peresnik, poudarite razlike v zasnovi med peresnikoma.
• One dose step contains a set number of units of insulin plus a fixed amount of the non-insulin medicine.
• En odmerni korak vsebuje določeno število enot insulina in nespremenljivo količino neinsulinskega zdravila.
In addition, healthcare professionals are encouraged to take the following precautions when storing, prescribing and dispensing diabetes medicines that contain insulin in combination with a non-insulin active substance:
Poleg tega zdravstvenim delavcem priporočamo tudi, da pri shranjevanju, prepisovanju in izdajanju zdravila za sladkorno bolezen, ki vsebujejo insulin v kombinaciji z neinsulinsko zdravilno učinkovino, upoštevajo naslednje previdnostne ukrepe:
• Your healthcare professional will explain the design and features of your pen, including how the dose counter of the pen device shows the number of dose steps to be injected.
• Zdravnik vam bo pojasnil tudi zasnovo in lastnosti peresnika, vključno s tem, kako števec odmerkov na peresniku prikazuje število odmernih korakov, ki si jih boste injicirali.
Recently, diabetes medicines that contain insulin in combination with a non-insulin active substance have been approved in the EU.
Pred kratkim so bila v EU odobrena zdravila za sladkorno bolezen, ki vsebujejo insulin v kombinaciji z neinsulinsko zdravilno učinkovino.
• Explain to your patient that the dose counter of the pen device shows the number of dose steps to be injected.
• Bolniku pojasnite, da števec odmerkov na peresniku prikazuje število odmerkov, ki si jih bo injiciral.
• Tell patients to closely monitor their blood sugar levels when starting a medicine containing insulin and a non-insulin active substance and in the weeks after.
• Bolnikom povejte, naj ob začetku zdravljenja z zdravilom, ki vsebuje insulin in neinsulinsko zdravilno učinkovino, skrbno spremljajo krvni sladkor.
• Pharmacists are encouraged to check that patients and carers are able to read the dose counter of the pen device before dispensing the medicine.
• Farmacevtom priporočamo, da pred izdajo zdravila preverijo, ali bolniki in negovalci lahko odčitajo števec odmerkov na peresniku.
EU Number Invented Name
Izmišljeno ime
Date of first authorisation: 14/04/2003 Date of last renewal: 11/03/2008
Datum pridobitve dovoljenja za promet: 14/04/2003 Datum podaljšanja dovoljenja za promet: 11/03/2008