natgillin/translations-raw huggingface dataset:
Trevaclyn anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi".
Trevaclyn is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘ combined mixed dyslipidaemia’ and ‘ primary hypercholesterolaemia’.
I Trevaclyn- tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre.
In Trevaclyn tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Den første undersøgelse, der omfattede i alt 1 613 patienter, sammenlignede virkningen af Trevaclyn med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL- kolesterol.
The first study compared the effectiveness of Trevaclyn with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Trevaclyn var effektivt til at sænke blodets indhold af LDL- kolesterol.
Trevaclyn was effective in reducing the blood levels of LDL cholesterol.
I den første undersøgelse blev indholdet af LDL- kolesterol reduceret med 19% hos patienter, der fik Trevaclyn, sammenlignet med 1% hos dem, der fik placebo.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Trevaclyn, compared with 1% in those taking placebo.
Den anden undersøgelse viste, at indholdet af LDL- kolesterol blev yderligere sænket, når Trevaclyn blev givet sammen med simvastatin (48% reduktion) sammenlignet med Trevaclyn alene (17% reduktion) eller simvastatin alene (37% reduktion).
The second study showed that the LDL cholesterol levels were further reduced when Trevaclyn was taken with simvastatin (48% reduction), compared with Trevaclyn alone (17% reduction) or simvastatin alone (37% reduction).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Trevaclyn er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Trevaclyn’ s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Trevaclyn til Merck Sharp & Dohme Ltd. den 3. juli 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Trevaclyn to Merck Sharp & Dohme Ltd. on 3 July 2008.
2/ 3 Den fuldstændige EPAR for Trevaclyn findes her.
The full EPAR for Trevaclyn can be found here.
Trevaclyn 1. 000 mg/ 20 mg tabletter med modificeret udløsning.
Trevaclyn 1000 mg/ 20 mg modified-release tablets.
Trevaclyn er indiceret til behandling af dyslipidæmi, især hos patienter med kombineret dyslipidæmi (karakteriseret ved forhøjede koncentrationer af LDL- kolesterol og triglycerider samt lavt HDL - kolesterol) og hos patienter med primær hyperkolesterolæmi (heterozygot familiær og non- familiær).
Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Trevaclyn bør anvendes sammen med HMG- CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG- CoA- reduktasehæmmere er utilstrækkelig.
Trevaclyn should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Trevaclyn kan anvendes som monoterapi hos patienter, hvor HMG- CoA- reduktasehæmmere anses for at være utilstrækkelige eller ikke tåles.
It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Diæt og anden ikke- farmakologisk behandling (f. eks. motion, vægtreduktion) bør fortsætte under behandlingen med Trevaclyn.
Diet and other non-pharmacological treatments (e. g. exercise, weight reduction) should be continued during therapy with Trevaclyn.
Hvis patienten har undladt at tage Trevaclyn i 7 eller flere på hinanden følgende dage, kan behandlingen genoptages med 1. 000 mg/ 20 mg i en uge, før dosis øges til vedligeholdelsesdosis på 2. 000 mg/ 40 mg.
If Trevaclyn is missed for 7 or more consecutive days, therapy should be resumed at the 1000 mg/ 20 mg dose for 1 week, before advancing to the maintenance dose of 2000 mg/ 40 mg.
Patienter, som skifter fra 2. 000 mg eller mere af et nicotinsyredepotpræparat, kan starte behandling med Trevaclyn med en dosis på 2. 000 mg/ 40 mg.
2 Those patients switching from 2000 mg or more of prolonged-release nicotinic acid can initiate Trevaclyn at the 2000 mg/ 40 mg dose.
Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Trevaclyn, bør starte behandling med 1. 000 mg/ 20 mg og overgå til en vedligeholdelsesdosis på 2. 000 mg/ 40 mg efter fire uger.
For patients switching from immediate-release nicotinic acid to Trevaclyn, therapy should be initiated at the 1000 mg/ 20 mg dose and advanced to the 2000 mg/ 40 mg maintenance dose after four weeks.
For at bevare egenskaberne vedrørende den modificerede udløsning må tabletterne ikke deles, brydes, knuses eller tygges, før de
To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing.
Pædiatriske patienter Trevaclyn bør ikke anvendes til pædiatriske patienter p. g. a. manglende dokumentation for sikkerhed og virkning.
Therefore, treatment is not recommended in this age group.
Patienter med lever - eller nyreinsufficiens Anvendelse af Trevaclyn er ikke undersøgt hos patienter med lever - eller nyreinsufficiens.
Use in patients with hepatic or renal insufficiency Use of Trevaclyn in patients with hepatic or renal insufficiency has not been studied.
Samtidig behandling Acetylsalicylsyre giver ikke yderligere reduktion af flushing, ud over den der opnås ved Trevaclyn.
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Trevaclyn.
4. 5).
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Trevaclyn be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Leverpåvirkning Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Trevaclyn er ikke undersøgt.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Trevaclyn has not been studied.
Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Trevaclyn, bør derfor starte med 1. 000 mg/ 20 mg.
Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1000 mg/ 20 mg dose.
Trevaclyn bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/ eller har leversygdom i anamnesen.
Trevaclyn should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Læger, som overvejer kombinationsbehandling med statiner og Trevaclyn, bør nøje overveje de mulige fordele i forhold til risikoen og bør monitorere patienterne nøje med henblik på tegn og symptomer på muskelsmerte, - ømhed eller - svaghed, især i de første måneder af behandlingen, og når doseringen af et af lægemidlerne øges.
Physicians contemplating combined therapy with statins and Trevaclyn should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Hvis muskelsmerter, - svaghed eller - kramper opstår, mens patienten er i behandling med Trevaclyn sammen med et statin, skal CK- koncentrationerne måles.
If muscle pain, weakness or cramps occur while a patient is receiving Trevaclyn with a statin, their CK levels should be measured.
Nyreinsufficiens Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Trevaclyn anvendes med forsigtighed hos patienter med nyreinsufficiens.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Trevaclyn should be used with caution in patients with renal dysfunction.
Akut koronarsyndrom Som med andre nicotinsyrepræparater bør der udvises forsigtighed, når Trevaclyn anvendes til patienter med ustabil angina eller patienter i den akutte fase af myokardieinfarkt, især når disse patienter også får vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere eller adrenerge blokkere.
4 Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Trevaclyn is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
4. 8).
Haematologic effects As with other nicotinic acid medicinal products, Trevaclyn (2000 mg/ 40 mg) was associated with small reductions in platelet count (see section 4.8).
4. 8).
Effect on uric acid As with other nicotinic acid medicinal products, Trevaclyn (2000 mg/ 40 mg) was associated with small increases in uric acid levels (see section 4.8).
Hypofosfatæmi Som med andre nicotinsyrepræparater er Trevaclyn blevet forbundet med små fald i fosfor.
Hypophosphatemia As with other nicotinic acid medicinal products, Trevaclyn was associated with small decreases in phosphorus levels.
4 Trevaclyn indeholder lactose.
Excipient Trevaclyn contains lactose.
Samtidig indtagelse af alkohol eller varme drikke kan forstærke flushing- effekten og bør derfor undgås omkring tidspunktet for indtagelse af Trevaclyn.
Simultaneous use of alcohol or hot drinks can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Trevaclyn.
4. 4).
The pharmacokinetic interaction of Trevaclyn with statins has been studied only with simvastatin (see section 4.4).
Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, anbefales det, at Trevaclyn administreres > 1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Trevaclyn be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Vitaminer eller andre ernæringstilskud med (≥ 50 mg / dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Trevaclyn.
Vitamins or other nutritional supplements containing (≥ 50 mg/ day) of nicotinic acid (or nicotinamide) have not been studied with Trevaclyn.
Forsigtighed bør udvises, når Trevaclyn administreres sammen med lægemidler, der overvejende metaboliseres af UGT2B4 eller UGT2B7, f. eks. zidovudin.
Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Trevaclyn Der foreligger ingen data for kombineret anvendelse af nicotinsyre og laropiprant til gravide.
Pregnancy Trevaclyn There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Trevaclyn Der er ikke udført undersøgelser med Trevaclyn hos diegivende dyr.
Lactation Trevaclyn No studies in lactating animals have been conducted with Trevaclyn.
Beslutning om, hvorvidt amningen eller behandlingen skal fortsætte/ ophøre, bør tages i forhold til den gavnlige virkning af amning for barnet og den gavnlige virkning af Trevaclyn for kvinden.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Trevaclyn to the woman.
4. 8 Bivirkninger I kliniske undersøgelser har mere end 2. 500 patienter fået Trevaclyn alene eller sammen med en HMG- CoA- reduktasehæmmer.
4.8 Undesirable effects In clinical trials, over 2500 patients received Trevaclyn alone or with an HMG-CoA reductase inhibitor.
6 Flushing er den mest almindelige bivirkning ved Trevaclyn.
Flushing Flushing is the most common adverse reaction of Trevaclyn.
I fire aktive eller placebo- kontrollerede kliniske undersøgelser (n=2. 548) blev der af investigator rapporteret om flushing som enten en mulig, sandsynlig eller klart behandlingsrelateret bivirkning hos 12, 3% af de patienter, der fik Trevaclyn.
In a pool of four active- or placebo-controlled clinical trials (N=2548), flushing was reported by the investigator as a possibly, probably, or definitely treatment-related adverse reaction in 12.3% of patients taking Trevaclyn.
I disse undersøgelser var procentdelen af patienter, der fik Trevaclyn, nicotinsyre (depotformuleringer, poolede) eller placebo/ simvastatin (poolet), og som stoppede behandlingen på grund af flushing - relaterede symptomer (rødme, varme, kløe og prikken i huden) henholdsvis 7, 2%, 16, 6% og 0, 4%.
In these studies, the percentage of patients taking Trevaclyn, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/ simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2%, 16.6%, and 0.4%, respectively.
Seponering på grund af andre specifikke bivirkninger var sjælden (< 1%) blandt de patienter, der tog Trevaclyn.
Discontinuations due to other specific adverse reactions among patients taking Trevaclyn were infrequent (< 1%).
Samlede bivirkninger ved Trevaclyn Nedenfor ses de kliniske bivirkninger, der ud over flushing er rapporteret af investigatorerne som muligvis, sandsynligvis eller klart relateret til Trevaclyn hos ≥ 1% af de patienter, der blev behandlet med Trevaclyn alene (n=947) eller sammen med et statin (n=1. 601) samt kliniske relevante bivirkninger (< 1%) i op til et år.
7 Overall adverse reactions with Trevaclyn In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Trevaclyn in ≥ 1% of patients treated with Trevaclyn alone (n=947) or co-administered with statin (n=1601) and clinically meaningful adverse reactions (< 1%), for up to one year are listed below.
I kontrollerede kliniske undersøgelser var incidensen af klinisk relevante stigninger i serumtransaminaser (ALAT og/ eller ASAT ≥ 3 x ULN (øvre normalgrænse) konsekutivt) 1, 0% for patienter, der blev behandlet med Trevaclyn med eller uden et statin.
In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/ or AST ≥ 3 X ULN, consecutive) was 1.0% for patients treated with Trevaclyn with or without a statin.
4. 4).
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Trevaclyn with or without a statin (see section 4.4).
7 Som med andre nicotinsyrepræparater er der i kontrollerede kliniske undersøgelser med Trevaclyn (2. 000 mg/ 40 mg) rapporteret om stigninger i fasteglucose (en gennemsnitlig stigning på ca.
As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/ dL), and uric acid (mean change from baseline of +14.7%), and reductions in platelet counts (a mean change from baseline of -14.0%) were reported in
4. 4).
8 controlled clinical studies with Trevaclyn (2000 mg/ 40 mg) (see section 4.4).
Nicotinsyrerelaterede bivirkninger Følgende nicotinsyrerelaterede bivirkninger er set i kliniske undersøgelser eller efter markedsføring med andre nicotinsyrepræparater i ukendt frekvens eller i kliniske undersøgelser med Trevaclyn (eller nicotinsyrekomponenten af Trevaclyn) hos < 1% af de behandlede patienter:
Nicotinic acid-related adverse reactions The following nicotinic acid-related adverse reactions have been seen in clinical trials or post-marketing experience with other nicotinic acid medicinal products at unknown frequency or in clinical trials with Trevaclyn (or the nicotinic acid component of Trevaclyn) in < 1% of the patients treated:
Trevaclyn I tilfælde af overdosering er det hensigtsmæssigt at anvende de sædvanlige symptomatiske og understøttende forholdsregler.
Trevaclyn In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Der er rapporteret om tilfælde af overdosering; den højeste dosis, der var taget, var 5. 000 mg/ 100 mg.
Cases of overdose have been reported; the maximum dose of Trevaclyn taken was 5000 mg/ 100 mg.
8 Trevaclyn indeholder nicotinsyre, som i terapeutiske doser er et lipidmodificerende stof, og laropiprant, der er en potent, selektiv prostaglandin D2- antagonist (PGD2) receptorsubtype 1 (DP1).
Trevaclyn contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
4. 8).
In healthy subjects receiving Trevaclyn, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Trevaclyn alone (see section 4.8).
Kliniske undersøgelser Indvirkning på lipider Trevaclyn var konsekvent effektivt på tværs af alle på forhånd specificerede patientundergrupper i henhold til race, køn, LDL- C, HDL- C og TG ved baseline, alder og diabetesstatus.
Clinical studies Effect on lipids Trevaclyn was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Patienter, der tager Trevaclyn (2. 000 mg/ 40 mg) med eller uden statin, versus placebo, havde signifikant nedsat LDL- C (- 18, 9% versus - 0, 5%), TG (- 21, 7% versus 3, 6%), LDL- C: HDL- C (- 28, 9% versus 2, 3%), non- HDL- C (- 19, 0% versus 0, 8%) apo- B (- 16, 4% versus 2, 5%), TC (- 9, 2% versus - 0, 6%), Lp( a) (- 17, 6% versus 1, 1%) og TC: HDL- C (- 21, 2% versus 1, 9%) og havde også signifikant øget HDL- C (18, 8% versus - 1, 2%) og apo- A- I (11, 2% versus 4, 3%) målt som ændring i procent i forhold til baseline.
1.1%), and TC: HDL-C (-21.2% vs.
Patienter, der fik MK524A, nicotinsyre (depotformulering) eller placebo, tog også statiner (29% atorvastatin [5- 80 mg], 54% simvastatin [10- 80 mg], 17% andre statiner [2, 5- 180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), hvoraf 9% også tog ezetimibe [10 mg].
Patients receiving Trevaclyn, nicotinic acid (prolonged-released formulation), or placebo were also taking statins (29% atorvastatin [5-80 mg], 54% simvastatin [10-80 mg], 17% other statins [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), of which 9% were also taking ezetimibe [10 mg].
I en multicenter, dobbeltblindet 12- ugers faktoriel undersøgelse reducerede Trevaclyn1. 000 mg/ 20 mg og simvastatin signifikant LDL- C (henholdsvis - 44, 2%, - 37, 4% og - 8, 2%), TG (henholdsvis - 25, 8%, - 15, 7% og - 18, 7%), TC (henholdsvis - 27, 9%, - 25, 8% og - 4, 9%), når det blev sammenlignet med simvastatin alene eller Trevaclyn 1. 000 mg/ 20 alene i 4 uger.
In a multicentre, double-blind, 12-week factorial study, Trevaclyn 1000 mg/ 20 mg co-administered with simvastatin, when compared with simvastatin alone or Trevaclyn 1000 mg/ 20 mg alone, for 4 weeks, significantly lowered LDL-C (-44.2%, -37.4%, -8.2% respectively), TG (-25.8%, -15.7%, -18.7% respectively), TC (-27.9%, -25.8%, -4.9% respectively) and significantly increased HDL-C (19.2%, 4.2%, 12.5% respectively).
HDL- C øgedes signifikant (henholdsvis 19, 2%, 4, 2% og 12, 5%).
Trevaclyn (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone or Trevaclyn (2000 mg/ 40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9%, -37.0%, -17.0% respectively), TG (-33.3%, -14.7%, -21.6% respectively), apo B
Sammenlignet med simvastatin alene eller Trevaclyn (2. 000 mg/ 40 mg) alene i 12 uger sænkede Trevaclyn (2. 000 mg/ 40 mg) sammen med simvastatin LDL- C (henholdsvis - 47, 9%, - 37, 0%, - 17, 0%), TG (henholdsvis - 33, 3%, - 14, 7%, - 21, 6%), apo B (henholdsvis - 41, 0%, - 28, 8%, - 17, 1%) og TC (henholdsvis - 29, 6%, - 24, 9%, 9, 1%) samt LDL- C: HDL- C (henholdsvis - 57, 1%, - 39, 8%, - 31, 2%), non- HDL- C (henholdsvis - 45, 8%, - 33, 4%, - 18, 1%) og TC: HDL- C (henholdsvis - 43, 0%, - 28, 0%, - 24, 9%) signifikant og øgede HDL - C signifikant (henholdsvis 27, 5%, 6, 0%, 23, 4%).
11 (-41.0%, -28.8%, -17.1% respectively), and TC (-29.6%, -24.9%, -9.1% respectively), as well as LDL-C: HDL-C (-57.1%, -39.8%, -31.2% respectively), non-HDL-C (-45.8%, -33.4%, -18.1% respectively), and TC: HDL-C (-43.0%, -28.0%, -24.9% respectively), and significantly increased HDL-C (27.5%, 6.0%, 23.4% respectively).
Yderligere analyse viste, at Trevaclyn (2. 000 mg/ 40 mg) administreret sammen med simvastatin, i sammenligning med simvastatin alene, øgede apo- A- I signifikant (henholdsvis 8, 6%, 2, 3%) og reducerede Lp( a) signifikant (henholdsvis - 19, 8%, 0, 0%).
Further analysis showed Trevaclyn (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6%, 2.3% respectively) and significantly decreased Lp(a) (-19.8%, 0.0% respectively).
Flushing I to store kliniske undersøgelser, hvor patientrapporterede flushing- symptomer blev målt, oplevede de patienter, der tog Trevaclyn, mindre flushing end de patienter, der tog nicotinsyre (depotformuleringer).
Flushing In two large clinical trials measuring patient-reported flushing symptoms, patients taking Trevaclyn experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Men hos de patienter, der blev behandlet med nicotinsyre (depotformulering) forblev hyppigheden af flushing konstant (efter uge 6).
In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Trevaclyn declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
● Trevaclyn (1. 000 mg/ 20 mg til 2. 000 mg/ 40 mg ved uge 5) ▲Nicotinsyre (depotformulering 1. 000mg to 2. 000 mg ved uge 5) ○Placebo * Inkluderer patienter med moderate, svære eller ekstreme flushing- symptomer † Øgning af dosis ved uge 5
● Trevaclyn (1000 mg/ 20 mg to 2000 mg/ 40 mg at week 5) ▲ Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5) ○ Placebo *Includes patients with moderate, severe, or extreme flushing symptoms † Dose advancement at Week 5
I den anden undersøgelse (16 uger), hvor acetylsalicylsyre var tilladt, oplevede de patienter, der fik Trevaclyn, signifikant færre dage pr. uge med moderat eller mere udbredt flushing sammenlignet med nicotinsyre (taget som depotformulering med multi- step titrering fra 500 mg til 2. 000 mg over 12 uger) (p < 0, 001).
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Trevaclyn experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2000 mg titration) (p < 0.001).
Patientkarakteristika Nyreinsufficiens Trevaclyn:
Characteristics in patients Renal insufficiency Trevaclyn:
Leverinsufficiens Trevaclyn:
Hepatic insufficiency Trevaclyn:
Børn Trevaclyn:
Paediatric Trevaclyn: