FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 pre-filled syringe 2 pre-filled syringes 6 pre-filled syringes
Slovenian: 1 napolnjena injekcijska brizga 2 napolnjeni injekcijski brizgi 6 napolnjenih injekcijskih brizg
English: Inject Praluent once every 2 weeks (for the 75 mg or 150 mg dose), or once every 4 weeks/monthly (for the 300 mg dose).
Slovenian: Zdravilo Praluent si injicirajte vsaka 2 tedna (za 75 mg ali 150 mg odmerek) ali vsake 4 tedne/mesečno (za 300 mg odmerek).
English: The dose was up-titrated to 150 mg Q2W in 32 (16.8%) patients treated beyond 12 weeks.
Slovenian: Odmerek so povečali na 150 mg na 2 tedna pri 32 (16,8 %) bolnikih, zdravljenih več kot 12 tednov.
English: Mean baseline LDL-C was 151.5 mg/dL (3.90 mmol/L).
Slovenian: Povprečni izhodiščni h-LDL je bil 151,5 mg/dl (3,90 mmol/l).
English: How to use Praluent
Slovenian: Kako uporabljati zdravilo Praluent
English: Without Background Statin
Slovenian: Brez osnovnega zdravljenja s statinom
English: Following single-dose subcutaneous administration of 100 mg to 300 mg alirocumab, there was no meaningful difference in exposure between Japanese and Caucasian healthy subjects.
Slovenian: Med zdravimi japonskimi in belskimi preiskovanci se izpostavljenost po subkutani uporabi enkratnih odmerkov od 100 mg do 300 mg alirokumaba ni pomembno razlikovala.
English: Gender Based on a population pharmacokinetic analysis, gender has no impact on alirocumab pharmacokinetics.
Slovenian: Spol Na podlagi populacijske farmakokinetične analize spol ne vpliva na farmakokinetiko alirokumaba.
English: Patients requiring larger LDL-C reduction (>60%) may be started on 150 mg once every 2 weeks, or 300 mg once every 4 weeks (monthly), administered subcutaneously.
Slovenian: Pri bolnikih, ki potrebujejo večje znižanje h-LDL (> 60 %), je zdravljenje mogoče začeti s 150 mg subkutano enkrat na 2 tedna ali s 300 mg subkutano enkrat na 4 tedne (mesečno).
English: Local injection site reactions were reported overall at a frequency of 16.6% in the 300 mg once every 4 weeks treatment group and 7.9% in the placebo group.
Slovenian: V celoti je bila pogostnost lokalnih reakcij na mestu injiciranja v skupini s 300 mg enkrat na 4 tedne 16,6 % in v skupini s placebom 7,9 %.
English: Difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins.
Slovenian: Razlika v primerjavi s placebom je bila 24. teden statistično značilna za vse lipide/lipoproteine.
English: For pre-filled syringes Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Slovenian: Napolnjene injekcijske brizge Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Francija
English: Alirocumab significantly reduced the risk for the primary composite endpoint of the time to first occurrence of Major Adverse Cardiovascular Events (MACE-plus) consisting of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.0003).
Slovenian: Alirokumab je značilno zmanjšal tveganje za primarni sestavljeni izid - čas do prvega pojava pomembnega neželenega srčno-žilnega dogodka (MACE-plus), ki je obsegal smrt zaradi koronarne bolezni (KB), miokardni infarkt (MI) brez smrtnega izida, ishemično možgansko kap s smrtnim izidom ali brez njega, ali nestabilno angino pektoris, ki je zahtevala sprejem v bolnišnico (HR 0,85, 95 % CI: 0,78, 0,93, vrednost p = 0,0003).
English: Praluent is injected as a subcutaneous injection into the thigh, abdomen or upper arm.
Slovenian: Zdravilo Praluent je treba injicirati subkutano v stegno, trebuh ali nadlaket.
English: Major CHD event defined as: CHD death, non-fatal MI
Slovenian: Pomemben koronarni dogodek, opredeljen kot: smrt zaradi KB, MI brez smrtnega izida.
English: If additional LDL-C reduction is needed in patients treated with 75 mg once every 2 weeks or 300 mg once every 4 weeks (monthly), the dosage may be adjusted to the maximum dosage of 150 mg once every 2 weeks.
Slovenian: Če bolniki, zdravljeni s 75 mg enkrat na 2 tedna ali 300 mg enkrat na 4 tedne (mesečno), potrebujejo dodatno znižanje h-LDL, je mogoče odmerek prilagoditi do največjega odmerka 150 mg enkrat na 2 tedna.
English: Persistent ADA responses were observed in 0.7% of patients treated with alirocumab and 0.4% of patients treated with placebo.
Slovenian: Trajne odzive ADA so opazili pri 0,7 % bolnikov, ki so prejemali alirokumab, in pri 0,4 % bolnikov, ki so prejemali placebo.
English: o outer side of your upper arm
Slovenian: o zunanjo stran nadlakta
English: The solution should be clear, colourless to pale yellow.
Slovenian: Raztopina mora biti bistra, brezbarvna do bledo rumena.
English: In general, administration of alirocumab also resulted in a statistically significant greater percent reduction in total cholesterol (Total-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), and lipoprotein (a) [Lp(a)] as compared to placebo/ ezetimibe, whether or not patients were concomitantly being treated with a statin.
Slovenian: Na splošno je uporaba alirokumaba prinesla tudi statistično značilno večje znižanje celokupnega holesterola, holesterola v lipoproteinih, ki niso velike gostote (ne-h-HDL), apolipoproteina B (Apo B) in lipoproteina (a) [Lp(a)] kot placebo/ezetimib, ne glede na to, ali so bolniki sočasno jemali statin ali ne. Alirokumab je v primerjavi s placebom znižal tudi trigliceride (TG) ter zvišal holesterol v lipoproteinih velike gostote (h-HDL) in apolipoprotein A-1 (Apo A-1).
English: Follow these instructions every time you use a Praluent pen.
Slovenian: Ta navodila upoštevajte vsakič, ko uporabljate peresnik zdravila Praluent.
English: Sometimes serious allergic reactions such as hypersensitivity (difficulties breathing), nummular eczema (reddish skin spots sometimes with blisters), and hypersensitivity vasculitis (which is a specific form of a hypersensitivity reaction with symptoms such as diarrhoea, with a rash, or purple-coloured skin spots on the skin) have occurred (may affect up to 1 in 1,000 people).
Slovenian: Včasih so se pojavile resne alergijske reakcije, na primer preobčutljivost (težko dihanje), numularni ekcem (rdečkaste kožne pike, včasih z mehurji) in preobčutljivostni vaskulitis (posebna oblika preobčutljivostne reakcije, ki jo spremljajo simptomi, kot npr. driska z izpuščajem ali vijoličaste pike na koži) (pojavijo se lahko pri največ 1 od 1.000 bolnikov).
English: • By blocking PCSK9, Praluent increases the number of receptors available to help remove the “bad”
Slovenian: • Z blokiranjem PCSK9 zdravilo Praluent poveča število razpoložljivih receptorjev, tako pomaga odstraniti "slabi" holesterol in s tem zniža njegovo koncentracijo.
English: Limited data are available in patients with severe renal impairment (see section 5.2).
Slovenian: O bolnikih s hudo okvaro ledvic je podatkov malo (glejte poglavje 5.2).
English: * including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness
Slovenian: ** Vključno z eritemom/pordelostjo, srbenjem, oteklostjo, bolečinami/občutljivostjo.
English: The discontinuation rate due to injection site reactions was 0.7% in the 300 mg once every 4 weeks treatment group and 0% in the placebo group.
Slovenian: Delež prekinitev zaradi reakcij na mestu injiciranja je bil v skupini s 300 mg enkrat na 4 tedne 0,7 % in v skupini s placebom
English: Table 2: Mean Percent Change from Baseline in LDL-C and Other Lipids/ Lipoproteins in PlaceboControlled and Ezetimibe-Controlled Studies - 75 mg and/or 150 mg Q2W Dosing Regimen
Slovenian: Preglednica 2: Povprečna odstotna sprememba h-LDL in drugih lipidov/lipoproteinov v primerjavi z izhodiščem v študijah, kontroliranih s placebom ali ezetimibom - odmerna shema 75 mg in/ali 150 mg na 2 tedna
English: Nominal significance
Slovenian: f Nominalna značilnost.
English: The dose was up-titrated to 150 mg Q2W in 14 (30.4%) patients treated beyond 12 weeks.
Slovenian: Odmerek so povečali na 150 mg na 2 tedna pri 14 (30,4 %) bolnikih, zdravljenih več kot 12 tednov.
English:  If needed pinch the skin.
Slovenian:  Če je treba, stisnite kožo v gubo.
English: In the cardiovascular outcomes study (ODYSSEY OUTCOMES), injection site reactions also occurred more frequently in alirocumab-treated patients than in placebo-treated patients (3.8% alirocumab versus 2.1% placebo).
Slovenian: V študiji srčno-žilnih izidov (ODYSSEY OUTCOMES) so bile reakcije na mestu injiciranja opisane pogosteje pri bolnikih, zdravljenih z alirokumabom kot pri bolnikih, ki so prejemali placebo (3,8 % z alirokumabom in 2,1 % s placebom).
English: Non-clinical data reveal no special hazard for humans based on evaluations of safety pharmacology, and repeated dose toxicity.
Slovenian: Predklinični podatki na osnovi ocen farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: The syringe components are assembled into a single-use pre-filled pen with a blue cap and a light green activation button.
Slovenian: Elementi brizge so sestavljeni v napolnjen injekcijski peresnik za enkratno uporabo z modrim pokrovčkom in svetlo zelenim gumbom za aktiviranje.
English: Pre-filled syringe 75 mg: The syringe is equipped with a light green polypropylene plunger rod.
Slovenian: Napolnjena injekcijska brizga 75 mg: Brizga je opremljena s svetlo zelenim nosilcem bata iz polipropilena.
English: In a pool of ten placebo-controlled and active-controlled trials of patients treated with alirocumab 75 mg and/or 150 mg Q2W as well as in a separate clinical study of patients treated with alirocumab 75 mg Q2W or 300 mg every 4 weeks (including some patients with dose adjustment to 150 mg Q2W), the incidence of detecting ADA and NAb was similar to the results from the ODYSSEY OUTCOMES trial described above.
Slovenian: V kumulativni obravnavi desetih s placebom oziroma aktivno kontroliranih preskušanj pri bolnikih, zdravljenih s 75 mg in/ali 150 mg alirokumaba na 2 tedna, ter v ločeni klinični študiji bolnikov, zdravljenih s 75 mg alirokumaba na 2 tedna ali 300 mg alirokumaba na 4 tedne (vključno z nekaterimi bolniki, ki so jim odmerek prilagodili na 150 mg na 2 tedne) je bila pojavnost zaznanih ADA in NAb podobna zgoraj opisanim rezultatom preskušanja ODYSSEY OUTCOMES.
English: The pharmacokinetics of alirocumab after single subcutaneous administration of 75 mg into the abdomen, upper arm or thigh were similar.
Slovenian: Farmakokinetika alirokumaba je bila po enkratnem subkutanem injiciranju 75 mg v trebuh, nadlaket ali stegno podobna.
English: Week24 LDL-C (ITT)
Slovenian: 24. teden h‐LDL (ZNZ)
English: If you are not sure when to inject Praluent, call your doctor, pharmacist or nurse.
Slovenian: Če ste negotovi, kdaj injicirati zdravilo Praluent, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Upper respiratory tract signs and symptoms*
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora znaki in simptomi na zgornjih dihalih*
English: The pen will not work if the yellow safety cover is not depressed fully.
Slovenian: Če rumeni varnostni ščitnik ni povsem pritisnjen, peresnik ne bo deloval.
English: Unstable angina requiring hospitalization c
Slovenian: b Nestabilna angina pektoris, ki je zahtevala sprejem v bolnišnico.
English:  Push and immediately release the grey button with your thumb.
Slovenian:  S palcem pritisnite sivi gumb in ga takoj spustite.
English: Alirocumab exposure (AUC0-14d) at steady state at both the 75 and 150 mg Q2W dosing regimen was decreased by 29% and 36% in patients weighing more than 100 kg as compared to patients weighing between 50 kg and 100 kg.
Slovenian: Izpostavljenost alirokumabu (AUC0-14d) se je v stanju dinamičnega ravnovesja z obema odmernima shemama (75 in 150 mg na 2 tedna) zmanjšala za 29 % in 36 % pri bolnikih, ki so tehtali več kot 100 kg, v primerjavi s tistimi, ki so tehtali od 50 do 100 kg.
English: 1, 2, or 6 pre-filled syringes.
Slovenian: 1, 2 ali 6 napolnjenih injekcijskih brizg.
English: Non-HDL-C
Slovenian: TG h‐HDL
English: Number of patients Mean Baseline LDL-C in mg/dL (mmol/L) Week 12
Slovenian: Število bolnikov Povprečni izhodiščni h‐LDL v mg/dl (mmol/l) 12. teden h‐LDL (ZNZ)
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily, or atorvastatin 20 mg once daily (as a re-challenge arm).
Slovenian: Bolniki so prejemali ali alirokumab v odmerku 75 mg na 2 tedna ali ezetimib 10 mg enkrat na dan ali atorvastatin 20 mg enkrat na dan (kot skupina s ponovno provokacijo).
English: Pharmacokinetic/pharmacodynamic relationship(s)
Slovenian: Razmerje farmakokinetika/farmakodinamika
English: It is available in pack size of 1, 2 or 6 pre-filled syringes.
Slovenian: Na voljo je v pakiranjih z 1, 2 ali 6 napolnjenimi injekcijskimi peresniki.
English: In a phase 1 study, after administration of a single 75 mg subcutaneous dose, alirocumab pharmacokinetic profiles in subjects with mild and moderate hepatic impairment were similar as compared to subjects with normal hepatic function.
Slovenian: V študiji 1. faze je bil farmakokinetični profil alirokumaba po uporabi enkratnega subkutanega odmerka 75 mg pri preiskovancih z blago in zmerno okvaro jeter podoben kot pri preiskovancih z normalnim delovanjem jeter.
English: A multicenter, double-blind, placebo-controlled, 48 week study included 540 patients on a maximally tolerated dose of a statin, with or without other lipid-modifying therapy (308 in the alirocumab 300 mg Q4W group, 76 in the alirocumab 75 mg Q2W group, and 156 in the placebo group), and 252 patients not treated with a statin (144 in the alirocumab 300 mg Q4W group, 37 in the alirocumab 75 mg Q2W group, and 71 in the placebo group).
Slovenian: Multicentrična, dvojno slepa s placebom kontrolirana 48-tedenska študija je zajela 540 bolnikov, ki so prejemali največji tolerirani odmerek statina, z drugimi lipolitičnimi zdravili ali brez njih (309 v skupini s 300 mg alirokumaba na 4 tedne, 76 v skupini s 75 mg alirokumaba na 2 tedna in 156 v skupini s placebom), ter 252 bolnikov, ki niso prejemali statina (144 v skupini s 300 mg alirokumaba na 4 tedne, 37 v skupini s 75 mg alirokumaba na 2 tedna in 71 v skupini s placebom).
English:  Push and immediately release the green button with your thumb.
Slovenian:  S palcem pritisnite zeleni gumb in ga takoj spustite.
English: The syringe components are assembled into a single-use pre-filled pen with a blue cap and a dark grey activation button.
Slovenian: Elementi brizge so sestavljeni v napolnjen injekcijski peresnik za enkratno uporabo z modrim pokrovčkom in temno sivim gumbom za aktiviranje.
English: Difference versus ezetimibe was statistically significant at week 24 for all lipids/ lipoproteins except for TG, and Apo A-1.
Slovenian: Razlika v primerjavi z ezetimibom je bila 24. teden statistično značilna za vse lipide/lipoproteine razen za TG in Apo A-1.
English: No dose adjustment is needed for patients with mild or moderate hepatic impairment.
Slovenian: Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi.
English: Difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C, Apo B, and Lp(a).
Slovenian: Razlika v primerjavi z ezetimibom je bila 24. teden statistično značilna za h-LDL, celokupni holesterol, ne-HDL, Apo B in Lp(a).
English: A multicenter, double-blind, ezetimibe-controlled 2 year study included 707 patients categorised as very high CV risk and not at their pre-defined target LDL-C on a maximally tolerated dose of statin.
Slovenian: Ta multicentrična dvojno slepa, z ezetimibom kontrolirana 2-letna študija je zajela 707 bolnikov, ki so imeli zelo visoko KV tveganje in z največjim toleriranim odmerkom statina niso dosegli vnaprej opredeljenega ciljnega h-LDL.
English: Body weight No dose adjustment is needed in patients based on weight.
Slovenian: Telesna masa Odmerka ni treba prilagoditi glede na bolnikovo telesno maso.
English: To give the 300 mg dose, give two 150 mg injections in a row at two different injection sites.
Slovenian: Za dajanje odmerka 300 mg je treba dati dve 150-mg injekciji zapored na dve različni mesti.
English: It is available in pack size of 1, 2 or 6 pre-filled pens.
Slovenian: Na voljo je v pakiranjih z 1, 2 ali 6 napolnjenimi injekcijskimi brizgami.
English: Placebo Alirocumab
Slovenian: Alirokumab
English: Based on a population pharmacokinetic analysis, the median apparent half-life of alirocumab at steady state was 17 to 20 days in patients receiving alirocumab as monotherapy at subcutaneous doses of either 75 mg Q2W or 150 mg Q2W.
Slovenian: Na podlagi populacijske farmakokinetične analize je mediani navidezni razpolovni čas alirokumaba v stanju dinamičnega ravnovesja pri bolnikih, ki so alirokumab dobivali kot monoterapijo v subkutanih odmerkih 75 mg na 2 tedna ali 150 mg na 2 tedna, od 17 do 20 dni.
English: Mean Percent Change from Baseline in Ezetimibe-Controlled Studies On Background Statin
Slovenian: Povprečna odstotna sprememba v primerjavi z izhodiščem v študijah, kontroliranih z ezetimibom
English: General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies (see section 4.8).
Slovenian: V kliničnih študijah so bile opisane splošne alergijske reakcije, med njimi srbenje, pa tudi redke in včasih resne alergijske reakcije, kot so preobčutljivost, numularni ekcem, urtikarija in preobčutljivostni vaskulitis (glejte poglavje 4.8).
English: A multicenter, double-blind, ezetimibe-controlled, 24 week study included 103 patients with a moderate CV risk, not taking statins or other lipid-modifying therapies, and a baseline LDL-C between 100 mg/dL (2.59 mmol/L) to 190 mg/dL (4.91 mmol/L).
Slovenian: Ta multicentrična dvojno slepa, z ezetimibom kontrolirana 24-tedenska študija je zajela 103 bolnike z zmernim KV tveganjem, ki niso jemali statinov ali drugih zdravil za prilagoditev lipidov in so imeli izhodiščni h-LDL med 100 mg/dl (2,59 mmol/l) in 190 mg/dl (4,91 mmol/l).
English: LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.
Slovenian: LDLR je primarni receptor, ki odstranjuje LDL v obtoku, zato znižanje ravni LDLR zaradi PCSK9 zviša koncentracijo h-LDL v krvi.
English: Store unused syringes in the refrigerator at 2°C to 8°C.
Slovenian: Neuporabljene brizge shranjujte v hladilniku pri temperaturi od 2 do 8 °C.
English: The mean LDL-C value at baseline was 92.4 mg/dL (2.39 mmol/L).
Slovenian: Povprečni izhodiščni hLDL je bil 92,4 mg/dl (2,39 mmol/l).
English: Population pharmacokinetic analyses showed that alirocumab exposure (AUC0-14d) at steady state at both the 75 and 150 mg Q2W dosing regimen was increased by 22%-35%, and 49%-50% in patients with mild and moderate renal impairment, respectively, compared to patients with normal renal function.
Slovenian: Populacijske farmakokinetične analize so pokazale, da se je izpostavljenost alirokumabu (AUC0-14d) v stanju dinamičnega ravnovesja v primerjavi z bolniki z normalnim delovanjem ledvic z obema odmernima shemama (75 mg in 150 mg na dva tedna) pri bolnikih z blago okvaro ledvic povečala za 22 do 35 %, pri bolnikih z zmerno okvaro ledvic pa za 49 do 50 %.
English: In addition, rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in controlled clinical studies (See section 4.4).
Slovenian: Poleg tega so bile v kontroliranih kliničnih študijah opisane redke in včasih resne alergijske reakcije, na primer preobčutljivost, numularni ekcem, urtikarija in preobčutljivostni vaskulitis (glejte poglavje 4.4).
English: A third multicenter, double-blind, placebo-controlled 18-month study included 106 heFH patients on a maximally tolerated dose of statin, with or without other lipid-modifying therapies, and a baseline LDL-C ≥160 mg/dL (≥4.14 mmol/L).
Slovenian: Tretja multicentrična, dvojno slepa s placebom kontrolirana 18-mesečna študija je zajela 106 bolnikov s heFH, ki so jemali največji tolerirani odmerek statina, z drugimi zdravili za prilagoditev lipidov ali brez njih, in so imeli izhodiščni h-LDL ≥ 160 mg/dl (≥ 4,14 mmol/l).
English: Adverse reactions are presented by system organ class.
Slovenian: Neželeni učinki so prikazani po organskih sistemih.
English: Dose adjustment in the alirocumab groups to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL or ≥100 mg/dL, depending on their level of CV risk, or in patients who did not have at least a 30% reduction of LDL-C from baseline.
Slovenian: V skupinah z alirokumabom so odmerek alirokumaba 12. teden prilagodili na 150 mg na 2 tedna pri bolnikih, ki so imeli h-LDL ≥ 70 mg/dl oz. ≥ 100 mg/dl, odvisno od njihovega srčnožilnega tveganja, in pri bolnikih, ki od izhodišča niso dosegli vsaj 30-odstotnega znižanja h-LDL.
English: In patients treated beyond 12 weeks, the dose was adjusted to 150 mg Q2W in 56 (19.3%) of 290 patients in the alirocumab 300 mg Q4W arm.
Slovenian: Med bolniki, zdravljenimi več kot 12 tednov, so odmerek prilagodili na 150 mg na 2 tedna pri 56 (19,3 %) od 290 bolnikov v skupini s 300 mg alirokumaba na 4 tedne.
English: LDL-C (on treatment)
Slovenian: a h‐LDL (med zdravljenjem)
English: In pre-specified analyses of pooled phase 3 studies, treatment-emergent CV events confirmed by adjudication, consisting of coronary heart disease (CHD) death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalisation, congestive heart failure hospitalisation, and revascularisation, were reported in 110 (3.5%) patients in the alirocumab group and 53 (3.0%) patients in the control group (placebo or active control) with HR=1.08 (95% CI, 0.78 to 1.50).
Slovenian: V vnaprej opredeljenih kumulativnih analizah študij 3. faze so se med zdravljenjem nastali KV dogodki, potrjeni s presojo (ki so obsegali smrt zaradi koronarne bolezni srca, miokardni infarkt, ishemično možgansko kap, nestabilno angino pektoris, ki je zahtevala sprejem v bolnišnico, sprejem v bolnišnico zaradi kongestivnega srčnega popuščanja in revaskularizacijo), pojavili pri 110 (3,5 %) bolnikih v skupini z alirokumabom in pri 53 (3,0 %) bolnikih v kontrolni skupini (placebo ali kontrolna učinkovina); razmerje ogroženosti (ROg) = 1,08 (95 % IZ 0,78 do 1,50).
English: Major adverse cardiovascular events (“MACEplus”, i.e.: CHD death, myocardial infarction, ischemic stroke, and unstable angina requiring hospitalisation) confirmed by adjudication were reported in 52 of 3182 (1.6%) patients in the alirocumab group and 33 of 1792 (1.8%) patients in the control group (placebo or active control); HR=0.81 (95% CI, 0.52 to 1.25).
Slovenian: S presojo potrjeni hujši neželeni kardiovaskularni učinki (“MACE-plus”: smrt zaradi koronarne bolezni, miokardni infarkt, ishemična možganska kap ali nestabilna angina pektoris, ki zahteva sprejem v bolnišnico) so se pojavili pri 52 od 3182 (1,6 %) bolnikov v skupini z alirokumabom in pri 33 od 1792 (1,8 %) bolnikov v kontrolni skupini (placebo ali kontrolna učinkovina); ROg = 0,81 (95 % IZ, 0,52 do 1,25).
English: The efficacy of alirocumab was investigated in ten phase 3 trials (five placebo-controlled and five ezetimibe-controlled studies), involving 5296 randomised patients with hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, with 3188 patients randomised to alirocumab.
Slovenian: Povzetek programa kliničnih preskušanj 3. faze - odmerna shema 75 mg in/ali 150 mg na 2 tedna Učinkovitost alirokumaba so raziskali v desetih preskušanjih 3. faze (petih s placebom kontroliranih in petih z ezetimibom kontroliranih študijah), ki so zajele 5296 randomiziranih bolnikov s hiperholesterolemijo (heterozigotno familiarno ali nefamiliarno) ali mešano dislipidemijo; 3188 bolnikov je bilo randomiziranih na alirokumab.