FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP considered that it is important to emphasise that it is known from the literature that no one agent currently available is 100 % effective in the treatment of feline hypertension, and success rates of about 50 % are considered the norm.
Danish: CVMP fandt, at det er vigtigt at understrege, at det vides fra litteraturen, at ingen af de stoffer, der i øjeblikket er tilgængelige, er 100 % effektive til behandling af felin hypertension, og at helbredelsesprocenter på omkring 50 % betragtes som normen.
English: The products are currently authorised for use in dogs for the treatment of congestive heart failure (NYHA classification grade II, III and IV) due to chronic degenerative valvular heart disease or cardiomyopathy, with or without adjunct diuretic (furosemide) or cardiac glycocide (digoxin/methyldigoxin) therapy.
Danish: Produkterne er i øjeblikket godkendt til brug til hunde til behandling af kongestiv hjerteinsufficiens (NYHA-klasse II, III og IV) som følge af kronisk degenerativ hjerteklapfejl eller kardiomyopati med eller uden supplerende behandling med diuretikum (furosemid) eller hjerteglykosid (digoxin/methyldigoxin).
English: In relation to the non-specific signs such as polyuria, polydipsia etc., the CVMP opinion is that it is plausible that a correlation exists between the improvement in blood pressure measurements and the resolution of such signs.
Danish: Hvad angår de uspecifikke tegn, som f.eks. polyuri, polydipsi osv., mener CVMP, at det er plausibelt, at der er en sammenhæng mellem forbedringen i blodtryksmålingerne og reguleringen af sådanne tegn.
English: • The only prospective placebo-controlled study of feline hypertension reported that all 4 placebo cats were switched to the treatment group (amlodipine) after only 7 days (no reasons given - Snyder, 1998).
Danish: • I det eneste prospektive placebokontrollerede forsøg med felin hypertension rapporteredes det, at alle fire placebokatte blev flyttet til behandlingsgruppen (amlodipin) efter kun syv dage (der gives ingen begrundelse (Snyder, 1998)).
English: Based on the argumentation submitted, the CVMP is of the opinion that the blood pressure measuring devices used were appropriate and the data generated robust.
Danish: Med udgangspunkt i den indsendte argumentation mener CVMP, at de anvendte apparater til blodtryksmåling var passende, og at de genererede data var robuste.
English: As many of the clinical signs are non-specific, and are cardiovascular in nature, an escape therapy could be possible and more than adequate in addressing those signs.
Danish: Da mange af de kliniske tegn er uspecifikke og er af en kardiovaskulær art, ville en sikkerhedsbehandling være mulig og mere end tilstrækkelig til at afhjælpe disse tegn.
English: Sustained decreased systolic blood pressure was observed for up to 6 months and blood pressure was controlled over the 24-hour time interval between two successive administrations of Vasotop P in all cats.
Danish: Vedvarende sænket systolisk blodtryk blev observeret i op til seks måneder, og blodtrykket blev kontrolleret i intervallet på 24 timer mellem to efterfølgende doser af Vasotop P hos alle katte.
English: The MAH provided data on the Coefficient of Variation (CV) between the 5 individual measurements performed at the different study time points.
Danish: Indehaveren af markedsføringstilladelsen fremlagde data om variationskoefficienten (CV) mellem de fem individuelle målinger, der blev udført på forskellige tidspunkter i undersøgelsen.
English: The CVMP noted that better responses were obtained for the relatively non-specific clinical signs noted (e.g. polyuria, polydipsia, lethargy etc.), whilst the poorest responses were obtained for the ocular lesions (blindness, vascular tortuosity and retinal detachment).
Danish: CVMP bemærkede, at der blev opnået bedre respons for de anførte relativt uspecifikke kliniske tegn (f.eks. polyuri, polydipsi, letargi osv.), mens den dårligste respons blev opnået for okulære læsioner (blindhed, vaskulætortuositet og nethindeløsning).
English: Clinical signs like retinal haemorrhage and even polyuria-polydipsia can be quite severe and are not expected to readily respond to a placebo effect.
Danish: Kliniske tegn, som f.eks. nethindeblødning og endda polyuri/polydipsi, kan være ganske alvorlige og forventes ikke umiddelbart at respondere på en placebovirkning.
English: Almost 82 % of the included cats presented at least one clinical sign related to hypertension.
Danish: Næsten 82 % af de inkluderede katte udviste mindst ét klinisk tegn med relation til hypertension.
English: Therefore, the CVMP recommends the refusal of the variation of the Marketing Authorisations for the veterinary medicinal products referred to in Annex I.
Danish: CVMP anbefaler derfor at give afslag på ansøgningen om ændring af markedsføringstilladelserne forde i bilag I omhandlede veterinærlægemidler.
English: Literature reports were provided to support the correlation between direct blood pressure measurements and the Doppler machines used.
Danish: Rapporter fra litteraturen blev fremlagt til støtte for sammenhængen mellem direkte blodtryksmålinger og de anvendte Dopplerapparater.
English: “For the reduction of elevated systolic blood pressure (between 160 and 230 mm Hg) and the control of associated clinical signs.”
Danish: "Til reduktion af forhøjet systolisk blodtryk (mellem 160 og 230 mm Hg) og regulering af tilknyttede kliniske tegn".
English: The average systolic blood pressure in cats with or without clinical signs at inclusion were in the same range (188.2 and 195.8 mm Hg, respectively), and were not statistically different (p=0.2132).
Danish: Det gennemsnitlige systoliske blodtryk hos katte med eller uden kliniske tegn ved inklusion var i samme interval (henholdsvis 188,2 og 195,8 mm Hg) og var ikke statistisk forskelligt (p=0,2132).
English: When broken down further, 32 % of cats had one clinical sign only and the remaining 21 % of cats had two clinical signs or more.
Danish: En yderligere opdeling viser, at 32 % af kattene kun havde ét klinisk tegn, og de resterende 21 % af kattene havde to eller flere kliniske tegn.
English: The measurement error of the apparatus used for the measurement of the blood pressure of cats
Danish: Målefejl i apparat brugt til måling af kattes blodtryk
English: the CVMP concluded that the absence of a negative control group (placebo group) in the pivotal clinical field trial was considered unacceptable,
Danish: CVMP konkluderede, at manglen på en negativ kontrolgruppe (placebogruppe) i det centrale kliniske feltforsøg var uacceptabel.
English: Efficacy of Vasotop P in the treatment of arterial hypertension in cats
Danish: Virkningen af Vasotop P ved behandling af arteriel hypertension hos katte
English: • The MAH already had experience of having to abandon a placebo control group in a separate Chronic Renal Failure study, due to the unwillingness of owners to provide consent for treatment to be potentially withheld.
Danish: • Indehaveren af markedsføringstilladelsen havde allerede tidligere måttet opgive en placebokontrolgruppe i en separat undersøgelse af kronisk nyreinsufficiens på grund af ejernes manglende vilje til at give samtykke til potentiel tilbageholdelse af behandling.
English: The most frequently observed clinical signs were polyuria-polydipsia (34 %), heart murmur (28 %) and retinal detachment/haemorrhages (25 %).
Danish: De hyppigst observerede kliniske tegn var polyuri/polydipsi (34 %), hjertemislyd (28 %) og nethindeløsning/blødninger (25 %).
English: Despite a notable reduction in systolic blood pressure and a plausible link between hypertension reduction and improvement of clinical signs, there is no certainty that this effect is due to treatment without comparison to a control group.
Danish: Trods en bemærkelsesværdig reduktion i det systoliske blodtryk og en plausibel sammenhæng mellem reduktionen i hypertension og forbedringen af kliniske tegn, er der uden sammenligning med en kontrolgruppe ingen sikkerhed for, at denne virkning skyldes behandlingen.
English: The National Competent Authority of Belgium was concerned that it was not possible to conclude on the clinical efficacy of the product in reducing systemic hypertension in cats in the absence of a placebo control group in the pivotal field trials.
Danish: De nationale kompetente myndigheder i Belgien var betænkelige ved, at der ikke kunne drages nogen konklusion med hensyn til den kliniske virkning af produktet i forbindelse med nedbringelse af systemisk hypertension hos katte, eftersom der ikke var nogen placebokontrolgruppe i de centrale feltforsøg.
English: The CVMP considered that due to the low case numbers and lack of comparative statistics, the main findings from this study were more “proof of concept” than proof of definitive clinical efficacy.
Danish: På grund af det lave antal tilfælde og manglen på sammenlignende statistikker fandt CVMP, at hovedresultaterne af denne undersøgelse snarere var konceptbevis end bevis for definitiv klinisk virkning.
English: The proposed recommended therapeutic dose for this new indication is 0.125 mg ramipril/kg body weight once daily.
Danish: Den anbefalede terapeutiske dosis til denne nye indikation er 0,125 mg ramipril/kg kropsvægt en gang daglig.
English: However the issue in question was whether or not it could be ascertained that the beneficial response was truly treatment-related, rather than being due to a placebo (white coat hypertensive habituation) effect.
Danish: Det aktuelle problem var dog, om det kunne fastslås, hvorvidt den gunstige respons reelt var behandlingsrelateret og ikke skyldes en placebovirkning ("white coat hypertensive habituation" eller "konsultationshypertension").
English: The CVMP is of the opinion that hypertension-related ocular lesions (once present) are harder to resolve/reverse even if the hypertension is subsequently controlled.
Danish: CVMP er af den opfattelse, at okulære læsioner (når de forekommer) med relation til hypertension er vanskeligere at helbrede/regulere, også selv om hypertensionen efterfølgende reguleres.
English: Depending on the response to therapy, it is possible to double the dose to 0.25 mg ramipril/kg body weight per day.
Danish: Afhængigt af behandlingsrespons kan dosen fordobles til 0,25 mg ramipril/kg kropsvægt en gang daglig.
English: The MAH stated that their finding was in agreement with that reported previously by Belew
Danish: Indehaveren af markedsføringstilladelsen anførte, at deres resultat var i overensstemmelse med det, som tidligere var rapporteret af Belew (1999)
English: The CVMP considers that a notable decrease in blood pressure measurements was evident between pre-treatment and post-treatment values.
Danish: CVMP finder, at en bemærkelsesværdig reduktion i blodtryksmålingerne var tydelig mellem værdierne før og efter behandling.
English: the CVMP concluded that it is not clear, if the recorded reduction in systolic blood pressure and clinical signs in hypertensive cats following treatment with Vasotop P was a true treatmentrelated effect,
Danish: CVMP konkluderede, at det ikke er klart, om den registrerede reduktion i det systoliske blodtryk og de kliniske tegn hos hypertensive katte efter behandling med Vasotop P var en ægte behandlingsrelateret virkning.
English: In addition, the MAH specified that only experienced investigators with appropriate machine training were used in the study, and that measurements were performed according to the ACVIM consensus statement
Danish: Indehaveren af markedsføringstilladelsen anførte desuden, at kun erfarne investigatorer med tilstrækkelig uddannelse i brugen af apparatet deltog i undersøgelsen, og at målingerne blev udført i overensstemmelse med konsensuserklæringen fra American College of Veterinary Internal Medicine (ACVIM)
English: In addition at Day 63, only 53 % of cats still exhibited at least one clinical sign.
Danish: Desuden udviste kun 53 % af kattene stadig mindst ét klinisk tegn på dag 63.
English: Assessment of efficacy issues
Danish: Vurdering af virkning
English: A multicentre field trial with Vasotop P for the treatment of hypertension in cats
Danish: Feltforsøg på flere centre af Vasotop P til behandling af hypertension hos katte
English: The CVMP is of the opinion that there are ethical issues for veterinarians in allowing cats with significant hypertension to remain untreated, contrary to current-day best clinical practice (ACVIM Consensus Statement 2007).
Danish: CVMP finder, at det kan udgøre et etisk problem for dyrlæger, at katte med signifikant hypertension i strid med den aktuelle bedste kliniske praksis (konsensuserklæringen fra American College of Veterinary Internal Medicine) ikke behandles.
English: Whilst fully accepting the scientific validity of requiring control groups in clinical studies, the CVMP is of the opinion that a significant proportion of placebo-control cats suffering from moderate-tosevere hypertension (i.e. systolic blood pressure >180 mm Hg) would be at risk of developing target organ damage if left untreated over a potential period of 63 days.
Danish: CVMP accepterer fuldt ud den videnskabelige validitet af kravet om kontrolgrupper i kliniske forsøg, men mener, at en signifikant andel af placebokontrolkatte, der lider af moderat til svær hypertension (dvs. systolisk blodtryk >180 mm Hg), ville have risiko for at udvikle skader i målorganer, hvis de forblev ubehandlede i en periode på op til 63 dage.
English: The MAH provided data to show that of the 82 % of cats showing at least one clinical sign, 46 % had two clinical signs or more.
Danish: Indehaveren af markedsføringstilladelsen fremlagde data, der viser, at ud af de 82 % af kattene, som havde mindst ét klinisk tegn, havde 46 % to eller flere kliniske tegn.
English: (1999), who investigated the possibility of habituation in laboratory cats subjected to “sham” clinic visits to measure their blood pressure.
Danish: 3 , der undersøgte muligheden for tilvænning hos forsøgskatte, som var udsat for "simulerede" kliniske besøg for at måle deres blodtryk.
English: Around 33 % of the cases were between 160 and 180 mm Hg systolic blood pressure (risk category III) and 67 % ≥ 180 mm Hg systolic blood pressure (risk category IV) at inclusion.
Danish: Hos omkring 33 % af tilfældene var det systoliske blodtryk mellem 160 og 180 mm Hg (risikokategori III), og hos 67 % var det systoliske blodtryk ≥ 180 mm (risikokategori IV) ved inklusion.
English: The MAH presented data from their own study and the literature to refute the possibility that the improvement in systolic blood pressure measurements was related to habituation to the “white coat effect”.
Danish: Indehaveren af markedsføringstilladelsen fremlagde data fra deres egen undersøgelse og litteraturen med henblik på at afvise muligheden for, at forbedringen i målingerne af det systoliske blodtryk var relateret til tilvænning til "white coat"-effekten.
English: The MAH submitted data where 53 % (40 out of 76) of included cats had urea concentrations above the upper limit of the reference range.
Danish: Indehaveren af markedsføringstilladelsen indsendte data, hvor 53 % (40 ud af 76) af de inkluderede katte havde urinstofkoncentrationer over den øvre grænse i referenceintervallet.
English: The CVMP is of the opinion that the data from the MAH's study and that reported by Belew (1999) do not support the concept of habituation in cats in terms of blood pressure measurements.
Danish: CVMP er af den opfattelse, at dataene fra den undersøgelse, som indehaverne af markedsføringstilladelsen havde gennemført, og dataene fra Belew (1999) ikke understøtter antagelsen af tilvænning hos katte i forbindelse med blodtryksmålinger.
English: Chetboul V., Lefebvre H.P., Pinhas C., Clerc B., Boussouf M., Pouchelon J.L.
Danish: Chetboul V., Lefebvre H.P., Pinhas C., Clerc B., Boussouf M., Pouchelon J.L. Spontaneous feline hypertension: Clinical and echocardiographic abnormalities, and survival rate.
English: The MAH submitted data where ramipril (active substance of Vasotop P) produced a marked decrease of systolic blood pressure in mildly to severely hypertensive cats.
Danish: Indehaveren af markedsføringstilladelsen indsendte data, hvor ramipril (det aktive stof i Vasotop P) frembragte et markant fald i det systoliske blodtryk hos katte med mild til svær hypertension.
English: Comments on whether it is possible to devise and conduct a trial with a placebo control where an escape therapy is identified at certain points in the study period The MAH submitted argumentation which covered the following grounds:
Danish: Bemærkninger om muligheden for at udforme og gennemføre et forsøg med en placebokontrol, hvor en sikkerhedsbehandling identificeres på visse punkter i forsøgsperioden
English: The MAH provided information on the two Doppler machines employed to measure systolic blood pressure in the pivotal field study.
Danish: Indehaveren af markedsføringstilladelsen fremsendte informationer om de to Dopplerapparater, der blev brugt til at måle det systoliske blodtryk i det centrale feltforsøg.
English: From the 43 cats belonging to the severe group at Day 0, 26 cats in total (60.5 %) became normotensive or had a >20 mm Hg decrease in systolic blood pressure at Day 63.
Danish: Af de 43 katte, der tilhørte den svært påvirkede gruppe på dag 0, blev i alt 26 katte (60,5 %) normotensive eller havde et fald på >20 mm Hg i det systoliske blodtryk på dag 63.
English: The other 12 cats had a >20 mm Hg decrease in systolic blood pressure at Day 63 (mean decrease of 36.6 mm Hg, range 20 mm Hg to 57.8 mm Hg) but were still above the normotensive limit of 160 mm Hg.
Danish: De andre 12 katte havde et fald på >20 mm Hg i det systoliske blodtryk på dag 63 (gennemsnitligt fald: 36,6 mm Hg, interval: 20 mm Hg til 57,8 mm Hg), men var stadig over grænsen for normotension på 160 mm Hg.
English: the CVMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg, tablets for dogs and associated names (see Annex I), all the overall submitted data in writing and in the oral explanations,
Danish: CVMP behandlede indbringelsen i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003 for Vasotop P 0,625 mg, Vasotop P 1,25 mg og Vasotop P 2,5 mg tabletter til hunde og tilknyttede navne (se bilag I), de generelle data indsendt skriftligt og de mundtlige forklaringer.
English: The MAH's data did show that the mean reading for the first measurement (discarded) was 610 mm Hg higher than the subsequent 5 measurements used for calculating the reported value (this is in line with the ACVM Consensus Statement approach); this finding was independent of the point in time when the measurement was performed, and thus no evidence of habituation was found.
Danish: Dataene fra indehaveren af markedsføringstilladelsen viste, at den gennemsnitlige aflæsning for den første måling (kasseret) var 6-10 mm Hg højere end de efterfølgende fem målinger, som blev anvendt til beregning af den rapporterede værdi (dette er i overensstemmelse med metoden i konsensuserklæringen fra American College of Veterinary Internal Medicine).
English: In addition the MAH was requested to submit a further clarification in relation to the percentage of severely hypertensive cats (i.e. systolic blood pressure > 180 mm Hg) that subsequently became normotensive or had a >20 mm Hg decrease in systolic blood pressure following treatment.
Danish: Indehaveren af markedsføringstilladelsen blev endvidere anmodet om yderligere afklarende oplysninger om procentdelen af svært hypertensive katte (dvs. systolisk blodtryk > 180 mm Hg), der efterfølgende blev normotensive eller havde et fald på >20 mm Hg i det systoliske blodtryk efter behandling.
English: Luxemburg Intervet International B.V. P.O.
Danish: Luxemburg Intervet International B.V.
English: The MAH also considered if the mean decrease in systolic blood pressure measurements could have been attributable to other non-treatment related factors in the study.
Danish: Indehaveren af markedsføringstilladelsen overvejede også, om det gennemsnitlige fald i det systoliske blodtryk kunne skyldes andre faktorer i undersøgelsen, der ikke var relateret til behandlingen.
English: The Netherlands Intervet International B.V. P.O.
Danish: Nederlandene Intervet International B.V.
English: The MAH clarified that the mean decrease in the severely affected group (systolic blood pressure > 180 mm Hg) was of -25.5 mm Hg (while it was of -18.3 mm Hg in the moderately affected group (systolic blood pressure between 160 mm Hg and 180 mm Hg).
Danish: Indehaveren af markedsføringstilladelsen præciserede, at den gennemsnitlige reduktion i den svært påvirkede gruppe (systolisk blodtryk > 180 mm Hg) var på -25,5 mm Hg (mens den var på -18,3 mm Hg i den moderat påvirkede gruppe (systolisk blodtryk mellem 160 mm Hg og 180 mm Hg).
English: Belew A.M., Barlett T., Brown S.A.
Danish: Belew A.M., Barlett T., Brown S.A. Evaluation of the white-coat effect in cats.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF VASOTOP P 0.625 MG, TABLET FOR DOGS AND CATS, VASOTOP P 1.25 MG, TABLET FOR DOGS AND CATS AND VASOTOP P 2.5 MG, TABLET FOR DOGS AND CATS
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF VASOTOP P 0,625 MG, TABLET TIL HUNDE OG KATTE, VASOTOP P 1,25 MG, TABLET TIL HUNDE OG KATTE OG VASOTOP P 2,5 MG, TABLET TIL HUNDE OG KATTE
English: The Marketing Authorisation Holder (MAH) Intervet International B.V. submitted applications for Type II variation subject to Mutual Recognition Procedures (MRP) for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows:
Danish: Indehaveren af markedsføringstilladelsen, Intervet International B.V., indsendte ansøgninger om type II-ændring under proceduren for gensidig anerkendelse af markedsføringstilladelserne for Vasotop P 0,625 mg, Vasotop P 1,25 mg og Vasotop P 2,5 mg tabletter til hunde med henblik på at inkludere følgende nye indikation for katte:
English: Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets are veterinary medicinal products those contain the active ingredient ramipril at concentrations of 0.625 mg, 1.25 mg and 2.5 mg respectively.
Danish: Vasotop P 0,625 mg, Vasotop P 1,25 mg og Vasotop P 2,5 mg tabletter er veterinærlægemidler indeholdende det aktive stof ramipril i koncentrationer på henholdsvis 0,625 mg, 1,25 mg og 2,5 mg. Ramipril er en ACE-hæmmer (angiotensinkonverterende enzymhæmmer).
English: Three strengths of tablet are covered by the current application as follows; Vasotop P 0.625 mg tablet, Vasotop P 1.25 mg tablet and Vasotop P 2.5 mg tablet.
Danish: Følgende tre tabletstyrker er omfattet af denne ansøgning: Vasotop P 0,625 mg tablet, Vasotop P 1,25 mg tablet og Vasotop P 2,5 mg tablet.
English: J Vet Intern Med, 1999, 13.
Danish: J Vet Intern Med, 1999, 13, s.
English: However, any clinical disease sees its signs evolve over the life of the animal and the duration of the clinical trial; it is the delta in the study that either decreases or increases spontaneously.
Danish: For alle kliniske sygdomme udvikles deres tegn dog i løbet af dyrets liv og varigheden af det kliniske forsøg.
English: The mean CV was approximately 3 % at all time points studied; these values were similar to the CV values reported in the literature by Snyder
Danish: Disse værdier svarede til de CV-værdier, der rapporteres i litteraturen af Snyder (1998)
English: Belgium Intervet International B.V. P.O.
Danish: Grækenland Intervet International B.V.
English: J Vet Intern Med, 2003, 17.
Danish: J Vet Intern Med, 2003, 17, s. 89
English: Thus, the finding that 63 % of severely affected cats became normotensive or had a >20 mm Hg reduction in systolic blood pressure following treatment with Vasotop P is noted; whilst it is accepted that 12/26 cats did not become normotensive, a mean reduction of 37 mm Hg in systolic blood pressure in severely hypertensive cats has also been noted.
Danish: Resultatet, at 63 % af de svært påvirkede katte blev normotensive eller havde en reduktion >20 mm Hg i det systoliske blodtryk efter behandling med Vasotop P, bemærkes derfor.
English: P. 542-558.
Danish: J Vet Intern Med, 2007, 21, s. 542-558.
English: J Vet Intern Med, 1998, 12.
Danish: J Vet Intern Med, 1998, 12, s. 157-162.