natgillin/translations-raw huggingface dataset:
Pelzont Der foreligger ingen data for kombineret anvendelse af nicotinsyre og laropiprant til gravide.
Pregnancy Pelzont There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Kombinationen er ikke testet i reproduktive toksicitetsundersøgelser.
The combination has not been tested in reproductive toxicity studies.
Nicotinsyre Der foreligger ikke tilstrækkelige data for anvendelsen af højdosis- nicotinsyre til gravide.
Nicotinic acid There are no adequate data from the use of high dose nicotinic acid in pregnant women.
Laropiprant Der foreligger ingen data for anvendelsen af laropiprant til gravide.
Laropiprant There are no data from the use of laropiprant in pregnant women.
5. 3)
Studies in animals have shown reproductive toxicity at high doses of laropiprant (see section 5.3).
Pelzont Der er ikke udført undersøgelser med Pelzont hos diegivende dyr.
Lactation Pelzont No studies in lactating animals have been conducted with Pelzont.
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 Pelzont 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 Pelzont to the woman.
Laropiprant Det er ukendt, om laropiprant udskilles i modermælk.
Laropiprant It is unknown whether laropiprant is excreted in human breast milk.
4. 8).
However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported (see section 4.8).
I kliniske undersøgelser har mere end 2. 500 patienter fået Pelzont alene eller sammen med en HMG - CoA- reduktasehæmmer.
4.8 Undesirable effects In clinical trials, over 2500 patients received Pelzont alone or with an HMG-CoA reductase inhibitor.
Bivirkningerne har normalt været milde og forbigående.
Adverse reactions have usually been mild and transient.
6 Flushing er den mest almindelige bivirkning ved Pelzont.
Flushing Flushing is the most common adverse reaction of Pelzont.
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 Pelzont.
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 Pelzont.
I disse undersøgelser var procentdelen af patienter, der fik Pelzont, 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 Pelzont, 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 Pelzont.
Discontinuations due to other specific adverse reactions among patients taking Pelzont were infrequent (< 1%).
Samlede bivirkninger ved Pelzont Nedenfor ses de kliniske bivirkninger, der ud over flushing er rapporteret af investigatorerne som muligvis, sandsynligvis eller klart relateret til Pelzont hos ≥ 1% af de patienter, der blev behandlet med Pelzont alene (n=947) eller sammen med et statin (n=1. 601) samt klinisk relevante bivirkninger (< 1%) i op til et år.
7 Overall adverse reactions with Pelzont In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Pelzont in ≥ 1% of patients treated with Pelzont alone (n=947) or co-administered with statin (n=1601) and clinically meaningful adverse reactions (< 1%), for up to one year are listed below.
Bivirkningsfrekvenserne er opstillet i henhold til følgende:
The frequencies of adverse reactions are ranked according to the following:
Meget almindelig (≥ 1/ 10), almindelig (≥ 1/ 100 til < 1/ 10), ikke almindelig (≥ 1/ 1. 000 til < 1/ 100), sjælden (≥ 1/ 10. 000 til < 1/ 1. 000), meget sjælden (< 1/ 10. 000).
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000), Very rare (< 1/ 10,000).
Systemorganklasse Undersøgelser
System organ class Investigations
Bivirkning Stigninger i ALAT og/ eller ASAT (konsekutivt, ≥ 3 x ULN), fasteglucose, urinsyre (se nedenfor).
Adverse reaction elevations in ALT and/ or AST (consecutive, ≥ 3 X ULN), fasting glucose, uric acid (see below)
Frekvens Almindelig
Frequency Common
Stigninger i CK (≥ 10 x ULN), totalt bilirubin, fald i fosfor og antal blodplader (se nedenfor).
elevations in CK (≥ 10 X ULN), total bilirubin, reductions in phosphorus and platelet counts (see below)
Nervesystemet Mave- tarmkanalen Hud og subkutane væv Vaskulære sygdomme
Nervous system disorders Gastrointestinal disorders Skin and subcutaneous tissue disorders
Svimmelhed, hovedpine, paræstesi Diarré, dyspepsi, kvalme, opkastning Erythema, pruritus, udslæt, urticaria Flushing
dizziness, headache, paraesthesia diarrhoea, dyspepsia, nausea, vomiting erythema, pruritus, rash, urticaria
Almindelig Almindelig Almindelig Meget almindelig
Common Common Common
Varmefølelse
feeling hot
Hypersensitivitetsreaktion (se nedenfor)
Hypersensitivity reaction (see below)
Angioødem, pruritus, erythema, paræstesi, bevidsthedstab, opkastning, urticaria, flushing, dyspnø, kvalme, urin - og afføringsinkontinens, koldsved, rysten, kuldegysninger, forhøjet blodtryk, hævede læber, brændende fornemmelse, medicinudslæt, artralgi, hævede ben og takykardi.
An apparent hypersensitivity reaction has been reported (< 1%) This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia.
4. 4).
Investigations Marked and persistent increases of serum transaminases have been reported infrequently (see section 4.4).
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 Pelzont 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 Pelzont 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 Pelzont with or without a statin (see section 4.4).
4. 4).
Other abnormal laboratory values reported were elevations in LDH, fasting glucose, uric acid, total bilirubin, and amylase, and reductions in phosphorus and platelet counts (see section 4.4).
7 Som med andre nicotinsyrepræparater er der i kontrollerede kliniske undersøgelser med Pelzont (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 Pelzont (2000 mg/ 40 mg) (see section 4.4).
Hos diabetikere sås en gennemsnitlig stigning af HbA1c på 0, 2% (hvor modificering af hypoglykæmisk behandling var tilladt).
In diabetic patients a median increase in HbA1c of 0.2% was observed (where modification of hypoglycaemic therapy was allowed).
Nicotinsyrerelaterede bivirkninger Følgende nicotinsyrerelaterede bivirkninger er set i kliniske undersøgelser eller efter markedsføring med andre nicotinsyrepræparater i ukendt frekvens eller i kliniske undersøgelser med Pelzont (eller nicotinsyrekomponenten af Pelzont) 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 Pelzont (or the nicotinic acid component of Pelzont) in < 1% of the patients treated:
Atrieflimren og andre hjertearytmier, palpitationer, takykardi.
Atrial fibrillation and other cardiac arrhythmias, palpitations, tachycardia.
Migræne, synkope.
Migraine, syncope.
Cystisk makulært ødem, toksisk amblyopi.
Cystoid macular oedema, toxic amblyopia.
Luftveje, thorax og mediastinum:
Respiratory, thoracic, and mediastinal disorders:
Dyspnø.
Dyspnoea.
Mavesmerter, ødem i munden, opstød, ulcus pepticum.
Abdominal pain, mouth oedema, eructation, peptic ulcer.
Acanthosis nigricans, tør hud, hyperpigmentering, makulært udslæt, svedtendens (natte - eller koldsved), vesikulært udslæt.
Acanthosis nigricans, dry skin, hyperpigmentation, macular rash, sweating (night or cold sweat), vesicular rash.
Muskelsvaghed, myalgi.
Muscular weakness, myalgia.
Nedsat glucosetolerans, urinsur gigt.
Impaired glucose tolerance, gout.
Rhinitis.
Rhinitis.
Hypotension, ortostatisk hypotension.
Hypotension, orthostatic hypotension.
Asteni, kuldegysninger, ansigtsødem, generaliseret ødem, smerter, perifert ødem.
Asthaenia, chills, face oedema, generalised oedema, pain, peripheral oedema.
Angioødem, type I- hypersensitivtet.
Angio-oedema, type I hypersensitivity.
Icterus.
Jaundice.
Pelzont I tilfælde af overdosering er det hensigtsmæssigt at anvende de sædvanlige symptomatiske og understøttende forholdsregler.
Pelzont 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 Pelzont taken was 5000 mg/ 100 mg.
Flushing, hovedpine, kløe, kvalme, svimmelhed, opkastning, diarré, epigastrisk og abdominal smerte/ ubehag samt rygsmerter.
The most commonly reported adverse reactions from the subjects who received this higher dose were consistent with a high dose of nicotinic acid and included: flushing, headache, pruritus, nausea, dizziness, vomiting, diarrhoea, epigastric and abdominal pain/ discomfort, and back pain.
Laropiprant I kontrollerede kliniske undersøgelser med raske forsøgspersoner var enkeltdoser af op til 900 mg laropiprant og multiple doser op til 450 mg én gang dagligt i 10 dage generelt veltålt.
Laropiprant During controlled clinical trials in healthy subjects, single doses of up to 900 mg laropiprant and multiple doses up to 450 mg once daily for 10 days were generally well tolerated.
5. 1).
Prolongation of collagen-induced platelet aggregation was observed in subjects taking multiple doses of 300 mg or greater (see section 5.1).
Nicotinsyre og derivater, ATC- kode:
Pharmacotherapeutic group: nicotinic acid and derivatives, ATC code:
8 Pelzont indeholder nicotinsyre, som i terapeutiske doser er et lipidmodificerende stof, og laropiprant, der er en potent, selektiv prostaglandin D2- antagonist (PGD2) receptorsubtype 1 (DP1).
Pelzont 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).
Nicotinsyre sænker koncentrationen af low- density lipoprotein kolesterol (LDL- C), totalt kolesterol (TC), very low density lipoprotein kolesterol (VLDL- C), apolipoprotein- B (apo- B, det væsentlige LDL- protein) triglycerider (TG) og lipoprotein( a) (Lp( a), en modificeret LDL- partikel) og øger koncentrationen af high- density lipoprotein kolesterol (HDL- C) og apolipoprotein- A- I (apo- A- I, den væsentlige proteinkomponent i HDL).
Nicotinic acid lowers the levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), very low density lipoprotein cholesterol (VLDL-C), apolipoprotein B (apo B, the major LDL protein), triglycerides (TG), and lipoprotein(a) (Lp(a), a modified LDL particle) and elevates the levels of high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (apo A-I, the major protein component of HDL).
Laropiprant hæmmer PGD2- medieret flushing, som er forbundet med administration af nicotinsyre.
Laropiprant suppresses PGD2 mediated flushing associated with administration of nicotinic acid.
Nicotinsyre Virkningsmekanisme De mekanismer, hvorved nicotinsyre modificerer plasmalipidprofilen, er ikke fuldstændig forstået.
Nicotinic acid Mechanism of action The mechanisms by which nicotinic acid modifies the plasma lipid profile are not fully understood.
Nicotinsyre hæmmer frigørelsen af frie fedtsyrer (FFA) fra adipøst væv, som kan bidrage til reduceret plasma LDL- C, TC, VLDL- C, apo- B, TG og Lp( a) samt forhøjet HDL- C og apo- A- I, som alle er forbundet med lavere kardiovaskulær risiko.
Nicotinic acid inhibits release of free fatty acids (FFA) from adipose tissue, which may contribute to the reduced plasma LDL-C, TC, VLDL-C, apo B, TG, and Lp(a), as well as elevated HDL-C, and apo A-I, all of which are associated with lower cardiovascular risk.
Andre forklaringer, som ikke udnævner plasma FFA - reduktioner som central drivkraft for modificering af lipidprofilen, omfatter nicotinsyremedieret hæmning af de novo- lipogenese eller esterificering af fedtsyrer til TG i leveren.
Additional explanations that do not invoke plasma FFA reduction as the central driver of lipid profile modification include nicotinic acid-mediated inhibition of de novo lipogenesis or esterification of fatty acids into TG in the liver.
Farmakodynamiske virkninger Nicotinsyre forårsager en relativ forandring i fordelingen af LDL- undergrupperne fra små, tætte (mest aterogene) LDL- partikler til større LDL- partikler.
Pharmacodynamic effects Nicotinic acid causes a relative shift in the distribution of LDL subclasses from small, dense (most atherogenic) LDL particles to larger LDL particles.
Nicotinsyre øger også HDL2- subfraktionen i højere grad end HDL3- subfraktionen og øger dermed HDL2: HDL3- ratioen, som er forbundet med nedsat kardiovalsulær risiko.
Nicotinic acid also elevates the HDL2 subfraction to a greater extent than the HDL3 subfraction, thereby increasing the HDL2: HDL3 ratio, which is associated with decreased cardiovascular disease risk.
På samme måde som LDL kan også kolesterol - og triglyceridholdige lipoproteiner, inklusive VLDL, intermediate- density lipoproteins (IDL) og rester, fremme aterosklerose.
Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis.
Der er hyppigt fundet forhøjede TG- koncentrationer i plasma i en triade med lave HDL- C- koncentrationer og små LDL - partikler og også i forbindelse med non- lipide metaboliske risikofaktorer for koronar hjertesygdom.
Elevated plasma TG levels are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD).
Coronary Drug Project, en fem - årig undersøgelse, der afsluttedes i 1975, viste, at nicotinsyre havde en statistisk signifikant positiv indvirkning på reduktionen af nonfatale, tilbagevendende myokardieinfarkter (MI) hos mænd i alderen 30- 64 år med MI i anamnesen.
The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
Selvom total mortalitet var den samme i de to grupper efter fem år, var der i en 15- årig kumulativ follow- up- undersøgelse 11% færre dødsfald i nicotinsyregruppen sammenlignet med placebokohorten.
Though total mortality was similar in the two groups at five years, in a fifteen-year cumulative follow-up there were 11% fewer deaths in the nicotinic acid group compared to the placebo cohort.
Laropiprant Virkningsmekanisme Nicotinsyreinduceret flushing er primært medieret ved frigørelse af prostaglandin D2 (PGD2) i huden.
10 Laropiprant Mechanism of action Nicotinic acid-induced flushing is mediated primarily by release of prostaglandin D2 (PGD2) in the skin.
Farmakodynamiske virkninger Laropiprant har vist sig at være effektiv til at reducere flushingsymptomer, der er induceret af nicotinsyre.
Pharmacodynamic effects Laropiprant has been shown to be effective in reducing flushing symptoms induced by nicotinic acid.
Reduktionen af flushingsymptomer (vurderet ved hjælp af patientspørgeskemaer) blev korreleret med en reduktion i nicotinsyreinduceret vasodilatation (vurderet ved hjælp af målinger af blodgennemstrømningen i huden).
The reduction in flushing symptoms (assessed by patient questionnaires) was correlated with a reduction in nicotinic acid-induced vasodilatation (assessed by measurements of skin blood flow).
4. 8).
In healthy subjects receiving Pelzont, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Pelzont alone (see section 4.8).
9 Laropiprant har også affinitet til tromboxane A2- receptoren (TP) (skønt den er væsentligt mindre potent ved TP sammenlignet med DP1).
Laropiprant also has affinity for the thromboxane A2 receptor (TP) (although it is substantially less potent at TP as compared to DP1).
4. 5).
TP plays a role in platelet function; however, therapeutic doses of laropiprant had no clinically relevant effect on bleeding time and collagen-induced platelet aggregation (see section 4.5).
Kliniske undersøgelser Indvirkning på lipider Pelzont 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 Pelzont 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 Pelzont (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.
Generelt var behandlingseffekten på alle lipidparametre imellem grupperne konsistent på tværs af alle undersøgte patientundergrupper.
4.3%) as measured by percent change from baseline.
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 Pelzont, 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].
Placebojusteret respons for LDL- C, HDL- C og TG forekom højere hos kvinder end hos mænd, og forekom højere hos ældre patienter (≥ 65 år) end hos yngre patienter (< 65 år).
The placebo-adjusted LDL-C, HDL-C and TG responses appeared greater among women compared to men and appeared greater among elderly patients (≥ 65 years) compared to younger patients (< 65 years).
I en multicenter, dobbeltblindet 12- ugers faktoriel undersøgelse reducerede Pelzont 1. 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 Pelzont 1. 000 mg/ 20 alene i 4 uger.
In a multicentre, double-blind, 12-week factorial study, Pelzont 1000 mg/ 20 mg co-administered with simvastatin, when compared with simvastatin alone or Pelzont 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%).
Pelzont (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone or Pelzont (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 (-41.0%, -28.8%, -17.1%
Sammenlignet med simvastatin alene eller Pelzont (2. 000 mg/ 40 mg) alene i 12 uger sænkede Pelzont (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 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 Pelzont (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 Pelzont (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 Pelzont, mindre flushing end de patienter, der tog nicotinsyre (depotformuleringer).
Flushing In two large clinical trials measuring patient-reported flushing symptoms, patients taking Pelzont 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 Pelzont 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).
Laropiprants flushingeffekt er ikke blevet påvist efter 24 uger.
Flushing efficacy of laropiprant has not been established past 24 weeks.
10 Figur 1.
Figure 1.
Gennemsnitligt antal dage pr. uge med moderate eller mere udbredte * flushing- symptomer i ugerne 1- 24
Average number of days per week with moderate or greater* flushing symptoms across weeks 1-24 2 Number of Days per Week