natgillin/translations-raw huggingface dataset:
Den samlede hyppighed for ophør med behandling hos sildenafilbehandlede patienter var lav (2, 9%) ved den anbefalede daglige dosis på 20 mg 3 gange dagligt og den samme som for placebo (2, 9%).
The overall frequency of discontinuation in sildenafil treated patients at the recommended daily dose of 20 mg three times a day (2.9%) was low and the same as placebo (2.9%).
131 patienter blev behandlet med placebo og epoprostenol..
7 In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with Revatio (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
For sildenafil/ epoprostenol- behandlede patienter var den samlede hyppighed for ophør med behandling på grund af bivirkninger 5, 2% sammenlignet med 10, 7% hos de placebo/ epoprostenol- behandlede patienter.
The overall frequency of discontinuations in sildenafil/ epoprostenol treated patients due to adverse events was 5.2% compared to 10.7% in the placebo/ epoprostenol treated patients.
De senest rapporterede bivirkninger, som forekommer hyppigere i sildenafil/ epoprostenol - gruppen, er blodsprængte øjne/ røde øjne, sløret syn, tilstopning af næsen, svedtendens om natten, rygsmerter og mundtørhed.
Newly reported adverse drug reactions, which occurred more frequently in the sildenafil/ epoprostenol group, were bloodshot eyes/ red eyes, blurred vision, nasal congestion, night sweats, back pain and dry mouth.
De kendte bivirkninger, som hovedpine, rødmen, smerter i ekstremiteterne og ødemer, ses hyppigere hos sildenafil/ epoprostenol- behandlede patienter sammenlignet med placebo/ epoprostenol- behandlede patienter.
The known adverse events headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/ epoprostenol treated patients compared to placebo/ epoprostenol treated patients.
I to placebo- kontrollerede studier er bivirkningerne generelt milde til moderate.
In the two-placebo controlled studies adverse events were generally mild to moderate in severity.
De mest almindeligt rapporterede bivirkninger (større eller lig med 10%) for Revatio sammenlignet med placebo er hovedpine, rødmen, dyspepsi, diarré og smerter i ekstremiteterne.
The most commonly reported adverse reactions that occurred (greater or equal to 10%) on Revatio compared to placebo were headache, flushing, dyspepsia, diarrhoea and limb pain.
Bivirkningerne er angivet efter klasse og frekvens (meget almindelig (≥1/ 10), almindelig (≥1/ 100 og < 1/ 10), ikke almindelig (≥1/ 1000 og < 1/ 100) og ikke kendt (kan ikke bestemmes ud fra tilgængelige data)).
Adverse reactions which occurred in > 1% of Revatio-treated patients and were more frequent (> 1% difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo- controlled studies in pulmonary arterial hypertension, at doses of 20, 40 or 80 mg three times a day are listed in the table below by class and frequency grouping (very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10), uncommon (≥ 1/ 1000, < 1/ 100) and not known (cannot be estimated from the available data).
MedDRA Organklasse Infektiøner og parasitære sygdomme
MedDRA System Organ Class Infections and infestations
Cellulitis, influenza, sinuitis (ikke yderligere specificeret)
Cellulitus, influenza, sinusitis not otherwise specified (NOS)
Blod - og lymfesystem
Blood and the lymphatic system disorders
Anæmi (ikke yderligere specificeret)
Anaemia NOS
Almindelig
Psychiatric disorders
Søvnløshed, angst
Common
Hovedpine
Insomnia, anxiety
Almindelig
Nervous system disorders Very Common Common
Migræne (ikke yderligere specificeret), tremor, paræstesi, brændende følelse (ikke yderligere specificeret), hypaesthesia
Headache Migraine NOS, tremor, paresthesia, burning sensation NOS, hypoaesthesia
Øjne Almindelig
Eye disorders
Retinablødning, synsforstyrrelser (ikke yderligere specificeret), sløret syn, fotofobi, chromatopsia, cyanopsia, øjenirritation, blodsprængte øjne / røde øjne
Retinal haemorrhage, visual disturbance NOS, blurred vision, photophobia, chromatopsia, cyanopsia, eye irritation, blood shot eyes/ red eyes
Uskarpt syn, dobbeltsyn, usædvanlig følelse i øjet
Visual acuity reduced, diplopia, abnormal sensation in eye
8 Øre og labyrint Almindelig Frekvens ukendt Vakulære sygdomme
Ear and labyrinth disorders Common
Vertigo Pludselig døvhed *
Vertigo
Luftveje, thorax og mediastinum Almindelig
Not known Vascular disorders
Mave- tarmkanalen
Sudden deafness*
Diarré, dyspepsi
Flushing
Almindelig
8 Respiratory, thoracic and mediastinal disorders Common
Gastritis (ikke yderligere specificeret), gastroenteritis (ikke yderligere specificeret), gastroesofageal reflukssygdom, hæmorroider. oppustet abdomen, mundtørhed
Bronchitis NOS, epistaxis, rhinitis NOS, cough, nasal congestion
Almindelig Frekvens ukendt
Very Common Common
Alopeci, erytem, svedtendens om natten Hududslæt
Diarrhoea, dyspepsia Gastritis NOS, gastroenteritis NOS, gastrooesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth
Knogler, led, muskler og bindevæv Meget almindelig
Skin and subcutaneous tissue disorders Common Not known
Ekstremitetssmerter
Alopecia, erythema, night sweats Skin rash
Almindelig
Musculoskeletal, connective tissue and bone disorders
Myalgi, rygsmerter
Very Common Common
Det reproduktive system og mammae Ikke almindelig
Limb pain Myalgia, back pain
Gynækomasti
Reproductive system and breast disorders Uncommon Not known
Frekvens ukendt Almene symptomer og reaktioner på administrationsstedet
Gynaecomastia Priapism, prolonged erection
Priapisme, forlænget erektion
General disorders and administration site conditions
* I et lille antal post- marketing- forsøg og kliniske forsøg med alle PDE- hæmmere, herunder sildenafil, er der set pludselig nedsættelse eller tab af hørelse.
* Sudden decrease or loss of hearing has been reported in a small number of post-marketing and clinical trial cases with the use of all PDE5 inhibitors, including sildenafil.
I bivirkningsovervågningen efter markedsføringen er følgende bivirkninger/ hændelser rapporteret med ukendt hyppighed hos patienter, der tager sildenafil til behandling af mandlig erektil dysfunktion (MED):
In post marketing surveillance, adverse events/ reactions that have been reported with an unknown frequency in patients taking sildenafil in the treatment of male erectile dysfunction (MED) include:
Øjensygdomme: non- arteritis anterior iskæmisk opticusneuropati (NAION), vaskulær okklusion i retina, defekt i synsfeltet.
Non-arteritic anterior ischaemic optic neuropathy (NAION), retinal vascular occlusion, visual field defect.
Ved enkeltdoser på 200 mg ses øget incidens af bivirkninger (hovedpine, rødmen, svimmelhed, dyspepsi, tilstopning af næsen, synsforstyrrelser).
At single doses of 200 mg the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
Lægemidler til erektil dysfunktion, ATC- kode:
Drugs used in erectile dysfunction, ATC code:
G04B E03.
G04B E03
Sildenafil er en potent og selektiv hæmmer af cyklisk guanosinmonophosphat (cGMP) - specifik fosfodiesterase type 5 (PDE5), enzymet der er ansvarlig for nedbrydningen af cGMP.
Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5), the enzyme that is responsible for degradation of cGMP.
In vitro undersøgelser har vist, at sildenafil er selektiv for PDE5.
Studies in vitro have shown that sildenafil is selective for PDE5.
Selektiviteten er 80 gange i forhold til PDE1 og mere end 700- gange i forhold til PDE 2, 3, 4, 7, 8, 9, 10 og 11.
There is an 80-fold selectivity over PDE1, and over 700-fold over PDE 2, 3, 4, 7, 8, 9, 10 and 11.
Især har sildenafil mere end 4. 000 gange større selektivitet for PDE5 end for PDE3, den cAMP- specifikke fosfodiesteraseisoform, som er involveret i kontrollen af hjertets kontraktilitet.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Efter kronisk dosering af 80 mg 3 gange dagligt til patienter med systemisk hypertension ses et gennemsnitlig fald fra baseline i det systoliske og diastoliske blodtryk på henholdsvis 9, 4 mmHg og 9, 1 mmHg.
After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mmHg and 9.1 mm Hg respectively.
I et klinisk studie af de hæmodynamiske virkninger efter en enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (> 70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige systoliske og diastoliske blodtryk i hvile med henholdsvis 7% og 6% sammenlignet med baseline.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Milde og forbigående ændringer i farveskelnen (blå/ grøn) ses hos visse patienter ved brug af Farnsworth- Munsell 100 skærtest 1 time efter indtagelse af 100 mg, men der ses ingen effekt 2 timer efter indtagelsen.
Mild and transient differences in colour discrimination (blue/ green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
I et lille placebo- kontrolleret studie på patienter med dokumenteret tidlig aldersbetinget makulær degeneration (n=9), sildenafil (100 mg enkeltdosis) ses der ingen signifikante ændringer i udførte synsundersøgelser (synsskarphed, farveskelnen ved simuleret trafiklys, Humphrey perimeter og fotostress).
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Effekt hos voksne patienter med pulmonal arteriel hypertension (PAH) Et randomiseret dobbelt- blindt, placebo- kontrolleret studie blev udført på 278 patienter med primær pulmonal hypertension, PAH forbundet med bindevævssygdom (CTD) og PAH efterfulgt af kirurgisk intervention af medfødte hjertelidelser.
Efficacy in adult patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease (CTD), and PAH following surgical repair of congenital heart lesions.
Placebo, sildenafil 20 mg, sildenafil 40 mg eller sildenafil 80 mg 3 gange dagligt.
Patients were randomised to one of four treatment groups: placebo, sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
Studiepopulationen bestod af 68 (25%) mænd og 209 (75%) kvinder med en gennemsnitsalder på 49 år (alder 18- 81 år) og baseline 6 minutters gangtest med en distance på mellem 100 og 450 meter inklusive (gennemsnit:
18-81 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean:
344
344 metres).
175 patienter (63%) inkluderes med diagnosen primær pulmonal hypertension, 84% (30%) med diagnosen PAH forbundet med bindevævssygdom (CTD) og 18% (7%) af patienterne med diagnosen PAH efterfulgt kirurgisk intervention af medført hjertelidelser.
175 patients (63%) included were diagnosed with primary pulmonary hypertension, 84 (30%) were diagnosed with 10 PAH associated with connective tissue disease (CTD) and 18 (7%) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
De fleste patienter var ved baseline klassificeret i WHO funktionel- klasse II (107/ 277, 39%) eller III (160/ 277, 58%) med en gennemsnitlig 6 minutters gangdistance på henholdsvis 378 meter og 326 meter ved baseline; færre patienter var i klasse I (1/ 277, 0, 4%) eller IV (9/ 277, 3%) ved baseline.
Most patients were WHO Functional Class II (107/ 277, 39%) or III (160/ 277, 58%) with a mean baseline 6 minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/ 277, 0.4%) or IV (9/ 277, 3%) at baseline.
Patienter med venstre ventrikulær uddrivningsfraktion < 45% eller venstre ventrikulær forkortningsfraktion < 0, 2% blev ikke undersøgt.
Patients with left ventricular ejection fraction < 45% or left ventricular shortening fraction < 0.2 were not studied.
Brugen af prostacyclin, prostacyclin analoger og endothelinreceptorantagonister som tillægsbehandling samt arginin– tilskud var ikke tilladt.
The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation.
Det primære endepunkt for effekt var ændring fra baseline til uge 12 for en 6 minutters gangdistance.
The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance.
En statistisk signifikant stigning i 6 minutters gangdistance blev set i alle 3 sildenafil- dosis grupper sammenlignet med placebo.
A statistically significant increase in 6-minute walk distance was observed in all 3 sildenafil dose groups compared to those on placebo.
Placebo- korrigeret stigning i gangdistance var 45 meter (p < 0, 0001), 46 meter (p < 0, 0001) og 50 meter (p < 0, 0001) for henholdsvis sildenafil 20 mg, 40 mg og 80 mg.
Placebo corrected increases in walk distance were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg respectively.
Forbedring i gangdistancen var synlig efter 4 ugers behandling, og denne virkning blev opretholdt ved uge 8 og 12.
The improvement in walk distance was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and 12.
Resultaterne var generelt konsistente i undergrupperne i henhold til baseline gangdistance, ætiologi (primær og CTD- forbundet PAH), WHO funktionel- klasse, køn, race, undersøgelsessted, middel PAP og PVRI.
Results were generally consistent in subgroups according to baseline walking distance, aetiology (primary and CTD-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Patienter på alle doser af sildenafil opnåede en statistisk signifikant reduktion i middel pulmonalt arterielt tryk (mPAP) sammenlignet med dem, der fik placebo.
Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo.
Placebo- korrigeret behandling var - 2, 7 mmHg (p=0, 04) for sildenafil 20 mg 3 gange dagligt.
The placebo-corrected treatment was – 2.7 mmHg (p=0.04) for sildenafil 20 mg three times a day.
Der var ingen tegn på forskel i effekten mellem sildenafil 20 mg og de højere doser, der blev undersøgt.
There was no evidence of a difference in effect between sildenafil 20 mg and the higher doses tested.
Den gennemsnitlige ændring fra baseline i pulmonal vaskulær modstand (PVR) var - 122 dyn. sek/ cm5, for sildenafil 20 mg 3 gange dagligt.
The mean change from baseline in pulmonary vascular resistance (PVR) was – 122 dyne. sec/ cm5 for sildenafil 20 mg three times a day.
Den procentvise reduktion i PVR (11, 2%) for sildenafil 20 mg var efter en 12 ugers periode proportionelt større end reduktionen i systemisk vaskulær modstand (SVR) (7, 2%).
The percent reduction at 12 weeks for sildenafil 20 mg in PVR (11.2%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%).
Effekt hos voksne patienter med PAH (ved anvendelse sammen med epoprostenol) Der blev udført et randomiseret, dobbelt- blindt, placebo- kontrolleret studie blev udført på 267 patienter med PAH, som blev stabiliseret på intravenøs epoprostenol.
Efficacy in adult patients with PAH (when used in combination with epoprostenol) A randomised, double-blind, placebo controlled study was conducted in 267 patients with PAH who were stabilised on intravenous epoprostenol.
PAH- patienterne inkluderede dem med primær pulmonal arteriel hypertension (212/ 267, 79%) og PAH associeret med CTD (55/ 267, 21%).
The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/ 267, 79%) and PAH associated with CTD (55/ 267, 21%).
For nogle få patienter (5/ 267, 2%) var WHO funktionel- klassen ukendt.
Most patients were WHO Functional Class II (68/ 267, 26%) or III (175/ 267, 66%); fewer patients were Class I (3/ 267, 1%) or IV (16/ 267, 6%) at baseline; for a few patients (5/ 267, 2%), the WHO Functional Class was unknown.
Patienterne blev randomiserede til placebo eller sildenafil (i en fastsat dosistitrering, som starter fra 20 mg til 40 mg og herefter 80 mg, 3 gange dagligt) anvendt i kombination med intravenøs epoprostenol.
Patients were randomised to placebo or sildenafil (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day) when used in combination with intravenous epoprostenol.
11 Det primære endepunkt for effekt var ændring fra baseline til uge 16 for en 6 minutters gangdistance.
The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance.
Der blev set en gennemsnitlig placebo- korrigeret øgning i gangdistancen på 26 meter til fordel for sildenafil (95% CI:
A mean placebo corrected increase in walk distance of 26 metres was observed in favour of sildenafil (95% CI:
Hos patienter med en gangdistance på < 325 m var behandlingseffekten 2, 3 m til placebos fordel.
For patients with a baseline walking distance ≥ 325 metres, the treatment effect was 38.4 metres in favour of sildenafil; for patients with a baseline walking distance < 325 metres, the treatment effect was 2.3 metres in favour of placebo.
Hos patienter med primær PAH var behandlingseffekten 31, 1 m sammenlignet med 7, 7 m hos patienter med PAH associeret med CTD.
For patients with primary PAH, the treatment effect was 31.1 metres compared to 7.7 metres for patients with PAH associated with CTD.
Der blev set en gennemsnitlig placebo- korrigeret behandlingseffekt på - 3, 9 mmHg til fordel for sildenafil (95% CI: - 5, 7, - 2, 1) (p=0, 00003).
A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95% CI: -5.7, -2.1) (p=0.00003).
Maksimale plasmakoncentrationer nås inden for 30- 120 minutter (gennemsnitligt 60 minutter) efter oral indgift i fastende tilstand.
Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Den gennemsnitlige absolutte orale biotilgængelighed er 41% (fra 25- 63%).
The mean absolute oral bioavailability is 41% (range 25-63%).
Efter oral indgift af 3 daglige doser af sildenafil øges AUC og Cmax proportionalt med dosis over det anbefalede dosisområde (20- 40 mg).
After oral three times a day dosing of sildenafil, AUC and Cmax increase in proportion with dose over the dose range of 20-40 mg.
Hos patienter med pulmonal arteriel hypertension er den gennemsnitlige orale biotilgængelighed for sildenafil efter 80 mg 3 gange dagligt 43% (90% CI:
In pulmonary arterial hypertension patients, the oral bioavailability of sildenafil after 80 mg three times a day was on average 43% (90% CI:
27- 60%) højere sammenlignet med de lavere doser.
27% - 60%) higher compared to the lower doses.
Det gennemsnitlige steady state fordelingsvolumen (VSS) for sildenafil er 105 l, hvilket tyder på fordeling i vævet.
The mean steady state volume of distribution (Vss) for sildenafil is 105 l, indicating distribution into the tissues.
113 ng/ ml.
After oral doses of 20 mg three times a day, the mean maximum total plasma concentration of sildenafil at steady state is approximately 113 ng/ ml.
Sildenafil og dets væsentligste cirkulerende N- desmethylmetabolit er omtrent 96% bundet til plasmaproteiner.
Sildenafil and its major circulating N- desmethyl metabolite are approximately 96% bound to plasma proteins.
50% af moderstoffet.
This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Hos patienter med pulmonal arteriel hypertension er plasmakoncentrationerne af N- desmethylmetabolitten ca.
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
72% af sildenafils efter 20 mg 3 gange dagligt (overført til et 36% bidrag til sildenafils farmakologiske effekt).
In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72% those of sildenafil after 20 mg three times a day dosing (translating into a 36% contribution to sildenafil’ s pharmacological effects).
Udskillelse:
Elimination:
Sildenafils totale clearance er 41 l/ time med en deraf følgende halveringstid på 3- 5 timer.
The total body clearance of sildenafil is 41 l/ h with a resultant terminal phase half-life of 3-5 h.
13% af indgivet oral dosis).
After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
12 Farmakokinetik hos særlige patientgrupper Ældre:
Pharmacokinetics in special patient groups Elderly:
90% højere plasmakoncentration af sildenafil og den aktive N- desmethylmetabolit, sammenlignet med yngre frivillige forsøgspersoner (18- 45 år).
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
40%.
Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.
Hos frivillige forsøgspersoner med let til moderat nedsat nyrefunktion (kreatininclearance = 30- 80 ml/ min) ændres farmakokinetikken af sildenafil ikke efter en enkelt oral dosis på 50 mg.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/ min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance < 30 ml/ min) reduceres sildenafils clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100% og 88% sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age- matched volunteers with no renal impairment.
Herudover er AUC og Cmax - værdierne for N- desmethylmetabolitten signifikant forhøjede, henholdsvis 200% og 79% hos forsøgspersoner med svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Hos frivillige forsøgspersoner med let til moderat levercirrhose (Child- Pugh klasse A og B) reduceres sildenafils clearance, hvilket giver stigninger i AUC (85%) og Cmax (47%) sammenlignet med frivillige forsøgspersoner i samme alderskategori uden nedsat leverfunktion.
12 In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.