natgillin/translations-raw huggingface dataset:
Hvilken risiko er der forbundet med AZILECT?
What is the risk associated with AZILECT?
Den almindeligste bivirkning ved brug af AZILECT( som ses hos flere end 1 ud af 10 patienter) er hovedpine.
The most common side effect with AZILECT (seen in more than 1 patient in 10) is headache.
Den fuldstændige liste over de indberettede bivirkninger for AZILECT fremgår af indlægssedlen.
For the full list of all side effects reported with AZILECT, see the Package Leaflet.
AZILECT bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for rasagilin eller andre af indholdsstofferne.
AZILECT should not be used in people who may be hypersensitive (allergic) to rasagiline or any of the other ingredients.
AZILECT bør ikke anvendes samme med andre MAO- hæmmere eller petidin (en type smertemedicin).
AZILECT should not be used with other monoamine oxidase inhibitors or pethidine (a painkiller).
Efter ophør af behandlingen med AZILECT skal der gå mindst 14 dage før påbegyndelse af behandling med andre MAO- hæmmere eller petidin.
There should be at least 14 days between stopping treatment with AZILECT and starting treatment with another monoamine oxidase inhibitor or with pethidine.
AZILECT bør ikke anvendes hos patienter med svær leversygdom.
AZILECT should not be used in patients who have severe problems with their liver.
Også når AZILECT anvendes sammen med andre lægemidler, bør der udvises forsigtighed.
Caution is also needed by patients taking AZILECT at the same time as other medicines.
Yderligere oplysninger herom fremgår af indlægssedlen.
See the Package Leaflet for more information.
Hvorfor blev AZILECT godkendt?
Why has AZILECT been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved AZILECT opvejer risiciene som eneste behandling af idiopatisk Parkinsons sygdom (uden levodopa), og som tillægsbehandling (med levodopa) hos patienter med end- of- dose fluktuationer.
The Committee for Medicinal products for Human Use (CHMP) decided that AZILECT’ s benefits are greater than its risks for the treatment of idiopathic Parkinson’ s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Udvalget anbefalede udstedelse af markedsføringstilladelse for AZILECT.
The Committee recommended that AZILECT be given marketing authorisation.
Andre oplysninger om AZILECT:
Other information about AZILECT:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for AZILECT til Teva Pharma GmbH den 21. februar 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for AZILECT to Teva Pharma GmbH on 21 February 2005.
Den fuldstændige EPAR for AZILECT findes her.
The full EPAR for AZILECT can be found here.
Særnavn
EU number
EU/ 1/ 04/ 304/ 001
Route of administration
AZILECT
Packaging
Oral anvendelse
Package size
EU/ 1/ 04/ 304/ 002
EU/ 1/ 04/ 304/ 001 EU/ 1/ 04/ 304/ 002 EU/ 1/ 04/ 304/ 003 EU/ 1/ 04/ 304/ 004 EU/ 1/ 04/ 304/ 005 EU/ 1/ 04/ 304/ 006 EU/ 1/ 04/ 304/ 007
AZILECT
AZILECT AZILECT AZILECT AZILECT AZILECT AZILECT AZILECT
1 mg
1 mg 1 mg 1 mg 1 mg 1 mg 1 mg 1 mg
Tablet
Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Blisterpakning (alu/ alu)
Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Blisters (Alu/ Alu) Bottles (HDPE)
10
7 10 28 30 100 112 30
LÆGEMIDLETS NAVN
SUMMARY OF PRODUCT CHARACTERISTICS
AZILECT 1 mg tabletter
1 1.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
NAME OF THE MEDICINAL PRODUCT
Hver tablet indeholder 1 mg rasagilin (som mesilat).
AZILECT 1 mg tablets
Alle hjælpestoffer er anført under pkt.
QUALITATIVE AND QUANTITATIVE COMPOSITION
6. 1.
Each tablet contains 1 mg rasagiline (as mesilate).
Hvide til grålighvide, runde, flade tabletter med skrå kant præget på den ene side med ” GIL ” og nedenunder ” 1 ” og uden præg på den anden side.
White to off-white, round, flat, bevelled tablets, debossed with “ GIL” and “ 1” underneath on one side and plain on the other side.
AZILECT er indiceret ved behandling af idiopatisk Parkinsons sygdom som monoterapi (uden levodopa) eller som kombinationsbehandling (med levodopa) hos patienter med end- of- dose fluktuationer.
AZILECT is indicated for the treatment of idiopathic Parkinson’ s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Dosisjustering er ikke nødvendig hos ældre patienter.
No change in dosage is required for elderly patients.
Børn og unge (< 18 år):
Children and adolescents (< 18 years):
AZILECT bør ikke anvendes til børn og unge under 18 år pga. manglende dokumentation for sikkerhed og virkning.
Not recommended as the safety and efficacy have not been established in this population.
4. 3).
Rasagiline use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Der bør udvises forsigtighed ved iværksættelse af behandling med rasagilin hos patienter med let nedsat leverfunktion.
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic insufficiency.
4. 4).
In case patients progress from mild to moderate hepatic impairment rasagiline should be stopped (see section 4.4).
Dosisjustering er ikke nødvendig ved nedsat nyrefunktion.
No change in dosage is required for renal impairment.
4. 5).
Concomitant treatment with other monoamine oxidase (MAO) inhibitors or pethidine (see section 4.5).
Der bør gå mindst 14 dage fra seponering af rasagilin til iværksættelse af behandling med MAO hæmmere eller pethidin.
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.
Rasagilin er kontraindiceret hos patienter med alvorligt nedsat leverfunktion.
Rasagiline is contraindicated in patients with severe hepatic insufficiency.
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
2 4.4 Special warnings and precautions for use
4. 5).
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
4. 5).
The concomitant use of rasagiline and dextromethorphan or sympathomimetics such as those present in nasal and oral decongestants or cold medications containing ephedrine or pseudoephedrine is not recommended (see section 4.5).
Under det kliniske udviklingsprogram gav forekomsten af melanomtilfælde anledning til overvejelser om, hvorvidt der var en mulig sammenhæng med anvendelsen af rasagilin.
During the clinical development programme the occurrence of cases of melanoma prompted the consideration of a possible association with rasagiline.
De indsamlede data tyder på, at det er Parkinsons sygdom, og ikke det anvendte lægemiddel, der er forbundet med en øget risiko for hudcancer (ikke udelukkende melanom).
The data collected suggests that Parkinson’ s disease, and not any drug in particular, is associated with a higher risk of skin cancer (not exclusively melanoma).
Der bør udvises forsigtighed ved iværksættelse af behandling med rasagilin hos patienter med let nedsat leverinsufficiens.
Caution should be used when initiating treatment with rasagiline in patients with mild hepatic insufficiency.
5. 2).
In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped (see section 5.2).
Der er flere kendte interaktioner mellem ikke- selektive MAO hæmmere og andre lægemidler.
There are a number of known interactions between non selective MAO inhibitors and other medicinal products.
4. 3).
Rasagiline should not be administered along with other MAO inhibitors as there may be a risk of non- selective MAO inhibition that may lead to hypertensive crises (see section 4.3).
Der er observeret alvorlige bivirkninger ved samtidig indtagelse af pethidin og MAO hæmmere såvel som ved samtidig indtagelse af en anden selektiv MAO- B hæmmer.
Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors as well as with another selective MAO-B inhibitor.
4. 3).
The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3).
4. 4).
The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
Der er observeret lægemiddelinteraktion ved samtidig indtagelse af sympatomimetiske lægemidler og MAO hæmmere såvel som ved samtidig indtagelse af en anden selektiv MAO- B hæmmer.
With MAO inhibitors as well as with another selective MAO-B inhibitor there have been reports of drug interactions with the concomitant use of sympathomimetic medicinal products.
4. 4).
Therefore, in view of the MAO inhibitory activity of rasagiline concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medications, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Lægemiddelinteraktion er observeret ved samtidig indtagelse af dextromethorfan og non- selektive MAO hæmmere.
There have been reports of drug interactions with the concomitant use of dextromethorphan and non selective MAO inhibitors.
4. 4).
Therefore, in view of the MAO inhibitory activity of rasagiline the concomitant administration of rasagiline and dextromethorphan is not recommended (see section 4.4).
Der er observeret alvorlige bivirkninger ved samtidig indtagelse af selektive serotoningenoptagelseshæmmere (SSRI’ ere), tricykliske og tetracykliske antidepressiva samt MAO - hæmmere såvel som ved samtidig indtagelse af en anden selektiv MAO- B hæmmer.
Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), tricyclic, tetracylic antidepressants and MAO inhibitors as well as with another selective MAO-B inhibitor.
Set i lyset af rasagilins MAO- hæmmende virkning bør antidepressiva derfor gives med forsigtighed.
Therefore, in view of the MAO inhibitory activity of rasagiline, antidepressants should be administered with caution.
3 Hos patienter med Parkinsons sygdom i vedvarende kombinationsbehandling med levodopa sås ingen klinisk signifikant effekt af levodopabehandlingen på rasagilin clearance.
In Parkinson's disease patients receiving chronic levodopa treatment as adjunct therapy there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Samtidig indgift af rasagilin og teofyllin (et substrat af CYP1A2) påvirkede ikke farmakokinetikken for nogle af produkterne.
3 theophylline (a substrate of CYP1A2) did not affect the pharmacokinetics of either product.
In vitro undersøgelser viste, at rasagilin ikke hæmmede cytochrom P450 isoenzymer, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 og CYP4A i en koncentration på 1μg/ ml (svarende til en koncentration, som er 160 gange højere end det gennemsnitlige Cmax ∼ 5, 9 – 8, 5 ng / ml hos patienter med Parkinsons sygdom efter indtagelse af 1 mg rasaglin som multipel dosis).
In vitro studies showed that rasagiline at a concentration of 1 µg/ ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ ml in Parkinson’ s disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Disse resultater tyder på, at terapeutiske koncentrationer af rasagilin sandsynligvis ikke giver anledning til klinisk relevant påvirkning af substrater for disse enzymer.
These results indicate that rasagiline’ s therapeutic concentrations are unlikely to cause any clinically significant interference with substrates of these enzymes.
Tyramin/ rasagilin interaktion:
Tyramine/ rasagiline interaction:
Resultater fra fire undersøgelser, hvor raske frivillige og patienter med Parkinsons syge fik en testdosis af tyramin, og resultaterne af hjemmeblodtryksmåling efter måltider (med 464 patienter i behandling med 0, 5 eller 1 mg rasagilin dagligt eller placebo i kombinationsbehandling med levodopa i seks måneder uden restriktioner i patienternes tyraminindtagelse) samt det faktum at der ikke sås tyramin/ rasagilin interaktion i kliniske undersøgelser gennemført uden restriktioner i tyraminindtagelse, viser, at det er sikkert at anvende rasagilin uden at begrænse indtagelsen af tyramin i kosten.
Results of four tyramine challenge studies (in volunteers and PD patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/ day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/ rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Der foreligger ikke kliniske data om eksponering for rasagilin under graviditet.
For rasagiline no clinical data on exposed pregnancies is available.
5. 3).
Animals studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Data fra undersøgelser indikerede, at rasagilin hæmmer prolaktinsekretionen og derfor kan hæmme mælkedannelsen.
Experimental data indicated that rasagiline inhibits prolactin secretion and, thus, may inhibit lactation.
I kliniske undersøgelser med rasagilin blev i alt 1361 patienter behandlet med rasagilin i 3076, 4 patientår.
In the rasagiline clinical program overall 1361 patients were treated with rasagiline for 3076.4 patient years.
I de dobbeltblinde, placebokontrollerede undersøgelser blev 529 patienter behandlet med rasagilin 1 mg dagligt i 212 patientår, og 539 patienter fik placebo i 213 patientår.
In the double blind placebo controlled studies 529 patients were treated with rasagiline 1 mg/ day for 212 patient years and 539 patients received placebo for 213 patient years.
Monoterapi Nedenstående bivirkninger blev indberettet med en højere incidens i placebokontrollerede undersøgelser hos patienter i behandling med 1 mg rasagilin dagligt (rasagilingruppen n=149, placebogruppen n=151).
Monotherapy The list below includes adverse reactions which were reported with a higher incidence in placebo- controlled studies, in patients receiving 1 mg/ day rasagiline (rasagiline group n=149, placebo group n=151).
Meget almindelige (> 1/ 10), almindelige (> 1/ 100, < 1/ 10), usædvanlige (> 1/ 1000, < 1/ 100), sjældne (> 1/ 10000, < 1/ 1000), meget sjældne (< 1/ 10000), herunder enkeltstående indberetninger.
Adverse reactions are ranked under headings of frequency using the following conventions: very common (> 1/ 10) common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10000, < 1/ 1000), very rare (< 1/ 10000) including isolated reports.
Meget almindelige: hovedpine (14, 1% vs.
Body as a Whole: very common: headache (14.1% vs.
11, 9%), almindelige: influenzasyndrom (6, 0% vs.
11.9%) common: flu syndrome (6.0% vs.
0, 7%), utilpashed (2, 0% vs.
0.7%), malaise (2.0% vs.
0%), nakkesmerter (2, 0% vs.
0%), neck pain (2.0% vs.
0%), allergisk reaktion (1, 3% vs.
0%), allergic reaction (1.3% vs.
0, 7%), feber (2, 7% vs.
0.7%), fever (2.7% vs.
Almindelige: angina pectoris (1, 3% vs.
1.3%) Cardiovascular system: common: angina pectoris (1.3% vs.
0%), usædvanlige: cerebrovaskulært tilfælde (0, 7% vs.
0%) uncommon: cerebrovascular accident (0.7% vs.
0%), myokardie- infarkt (0, 7% vs.
0%), myocardial infarct (0.7% vs.
0%) Gastrointestinale:
0%)
Almindelige: dyspepsi (6, 7% vs.
4 Digestive System: common: dyspepsia (6.7% vs.
4%), anoreksi (1, 3% vs.
4%), anorexia (1.3% vs.
Almindelige: leukopenia (1, 3% vs.
0%) Haemic and lymphatic system: common: leucopenia (1.3% vs.
Almindelige: artralgi (7, 4% vs.
0%) Musculoskeletal System: common: arthralgia (7.4% vs.
4%), artritis (2, 0% vs.
4%), arthritis (2.0% vs.
Almindelige: depression (5, 4% vs.
0.7%) Nervous System: common: depression (5.4% vs.
2%), svimmelhed (2, 0% vs.
2%), vertigo (2.0% vs.
0, 7%), hallucinationer (1, 3% vs.
0.7%), hallucinations (1.3% vs.
1, 3%) Øjne:
0.7%) Respiratory system: common: rhinitis (2.7% vs.
Almindelige: conjunctivitis (2, 7% vs.
1.3%) Special Senses: common: conjunctivitis (2.7% vs.
Almindelige: kontaktdermatitis (1, 3% vs.
0.7%) Skin and appendages: common: contact dermatitis (1.3% vs.
0%), vesikulobulbært udslæt (1, 3% vs.
0%), vesiculobullous rash (1.3% vs.
0%), hudcarcinom (1, 3% vs.
0%), skin carcinoma (1.3% vs.
Almindelige: pludseligt opstået vandladningstrang (1, 3% vs.
0.7%) Urogenital system: common: urinary urgency (1.3% vs.
0%)
0%).
Kombinationsbehandling Nedenstående bivirkninger blev observeret med en højere incidens i placebokontrollerede undersøgelser hos patienter i behandling med 1 mg rasagilin dagligt (rasagilingruppen n=380, placebogruppen n=388).
Adjunct Therapy The list below includes adverse reactions which were reported with a higher incidence in placebo- controlled studies in patients receiving 1 mg/ day rasagiline (rasagiline group n=380, placebo group n=388).
Meget almindelige (> 1/ 10), almindelige (> 1/ 100, < 1/ 10), usædvanlige (> 1/ 1000, < 1/ 100), sjældne (> 1/ 10000, < 1/ 1000), meget sjældne (< 1/ 10000), herunder enkeltstående indberetninger.
Adverse reactions are ranked under headings of frequency using the following conventions: very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10000, < 1/ 1000), very rare (< 1/ 10000) including isolated reports.
Abdominalsmerter (3, 9% vs.
Body as a Whole: common: abdominal pain (3.9% vs.
1, 3%), tilskadekomst ved uheld (primært faldulykker) (8, 2% vs.
1.3%), accidental injury (primarily falls) (8.2% vs.
5, 2%), nakkesmerter (1, 6% vs.
5.2%), neck pain (1.6% vs.
Almindelige: ortostatisk hypotension (4, 7% vs.
0.5%) Cardiovascular System: common: postural hypotension (4.7% vs.
1, 3%), usædvanlige: angina pectoris (0, 5% vs.
1.3%) uncommon: angina pectoris (0.5% vs.
0%), cerebrovaskulært tilfælde (0, 5% vs.
0%), cerebrovascular accident (0.5% vs.
Almindelige: forstoppelse (4, 2% vs.
0.3%) Digestive System: common: constipation (4.2% vs.
2, 1%), opkastning (3, 4% vs.
2.1%), vomiting (3.4% vs.
1, 0%), anoreksi (2, 1% vs.
1.0%), anorexia (2.1% vs.
0, 5%), mundtørhed (3, 4% vs.
0.5%), dry mouth (3.4% vs.
Almindelige: artralgi (3, 2% vs.
1.8%) Musculoskeletal System: common: arthralgia (3.2% vs.
1, 3%), tenosynovitis (1, 3% vs.
1.3%), tenosynovitis (1.3% vs.
1, 5%) CNS:
0%) Metabolic and Nutritional: common: weight loss (4.2% vs.
Meget almindelige: dyskinesier (10, 3% vs.
1.5%) Nervous System: very common: dyskinesia (10.3% vs.
6, 4%), almindelige: dystoni (2, 4% vs.
6.4%) common: dystonia (2.4% vs.
0, 8%), abnorme drømme (2, 1% vs.
0.8%), Abnormal dreams (2.1% vs.
0, 8%), ataksi (1, 3% vs.
0.8%), ataxia (1.3% vs.
0, 3%), hallucinationer (2, 9% vs.
0.3%), hallucinations (2.9% vs.
2, 1%), usædvanlige: forvirring (0, 8% vs.
2.1%), uncommon: confusion (0.8% vs.
Almindelige: udslæt (2, 6% vs.
0.8%) Skin and appendages: common: rash (2.6% vs.
1, 5%), usædvanlige: hudmelanom (0, 5% vs.
1.5%) uncommon: skin melanoma (0.5% vs.
Andre bivirkninger af betydning, som blev observeret i kliniske undersøgelser med rasagilin (anden dosis eller i undersøgelser uden placebokontrol), inkluderede to tilfælde af rhabdomyolyse (begge tilfælde var efter fald og langvarig immobilisering) og utilstrækkelig sekretion af antidiuretisk hormon (ADH).
Other important adverse events that were reported in clinical studies with rasagiline (other dose or in studies without placebo control) occurred in two patients each were rhabdomyolysis (both cases were following fall and prolonged immobilization) and inappropriate antidiuretic hormone (ADH) secretion.
Kompleksiteten i disse tilfælde gør det umuligt at fastslå, hvilken rolle rasagilin spiller i disses opståen, om nogen.
The complicated nature of these cases makes it impossible to determine what role, if any, rasagiline played in their pathogenesis.
Efter markedsføring er disse symptomer også set hos patienter i behandling med rasagilin for Parkinsons syge.
In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
5 Teoretisk set kan en overdosering forårsage signifikant hæmning af både MAO- A og MAO- B.
Theoretically, overdose can cause significant inhibition of both MAO-A and MAO-B.
I en enkeltdosisundersøgelse fik raske frivillige 20 mg dagligt, og i en 10 dages undersøgelse fik raske frivillige 10 mg dagligt.
In a single-dose study healthy volunteers received 20 mg/ day and in a ten-day study healthy volunteers received 10 mg/ day.
I en undersøgelse med stigende dosis til patienter i vedvarende levodopabehandling med 10 mg rasagilin dagligt blev der observeret cardiovaskulære uønskede hændelser (inkl. hypertension og ortostatisk hypotension), som forsvandt efter seponering af behandlingen.
In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/ day of rasagiline, there were reports of cardiovascular undesirable effects (including hypertension and postural hypotension) which resolved following treatment discontinuation.
Disse symptomer kan ligne dem, der blev observeret under behandling med non- selektive MAO hæmmere.
These symptoms may resemble those observed with non- selective MAO inhibitors.
Der findes ingen specifik antidot.
5 There is no specific antidote.
ATC- kode:
Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors, ATC code:
Det er vist, at rasagilin er en potent, irreversibel selektiv MAO- B hæmmer, som kan forårsage en øgning i ekstracellulær dopaminniveau i striatum.
Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an increase in extracellular levels of dopamine in the striatum.
l- Aminiondan er en aktiv hovedmetabolit og ikke en MAO- B hæmmer.
1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
I undersøgelse I blev 404 patienter randomiseret til behandling med enten placebo (138 patienter), rasagilin 1 mg dagligt (134 patienter) eller rasagilin 2 mg dagligt (132 patienter) i 26 uger; man sammenlignede ikke med et andet aktivt stof.
In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/ day (134 patients) or rasagiline 2 mg/ day (132 patients) and were treated for 26 weeks, there was no active comparator.
I denne undersøgelse var det primære effektmål ændringen fra baseline i total score på Unified Parkinson’ s Disease Rating Scale (UPDRS, del I- III).
In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson’ s Disease Rating Scale (UPDRS, parts I-III).
Forskellen mellem gennemsnitlig ændring fra baseline til uge 26/ afslutning (LOCF, Last Observation Carried Forward) var statistisk signifikant (UPDRS, del I- III: forskellen mellem rasagilin 1 mg sammenlignet med placebo var ÷4, 2, 95% CI [÷5, 7; ÷2, 7]; p < 0, 0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var ÷3, 6, 95% CI [÷5, 0; ÷2, 1]; p < 0, 0001, UPDRS Motor, del II: forskellen mellem rasagilin 1 mg sammenlignet med placebo var ÷2, 7; 95% CI [÷3, 87; ÷1, 55], p < 0, 0001; forskellen mellem rasagilin 2 mg sammenlignet med placebo var ÷1, 68; 95% CI [÷2, 85; ÷0, 51], p=0, 0050).
The difference between the mean change from baseline to week 26/ termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p < 0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p < 0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p < 0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Der var en signifikant og gavnlig effekt på livskvaliteten (målt på PD- QUALIF skalaen).
There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).