natgillin/translations-raw huggingface dataset:
uth should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
t samomorilne misli ali depresivno motnjo, se rimonabanta ne sme uporabljati, če koristi zdravljenja pri
(See section 4.3 and 4.8).
Debelost je stanje, ki je lahko povezano z depresivnimi motnjami.
Obesity is a condition that can be associated with depressive disorders.
Depresivne motnje so lahko povezane z večjim
Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
pro tveganjem za samomorilne misli, samopoškodovanje in samomor.
ra The prescriber should carefully investigate if the patient has had a depressive disorder in the past in order to evaluate the potential risks with rimonabant treatment.
Pri vrednotenju možnih tveganj zdravljenja z rimonabantom mora zdravnik skrbno preveriti, če je
ge Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
Depresivno razpoloženje se lahko razvije pri bolnikih, ki nimajo očitnih dejavnikov tveganja, razen nja debelosti same.
In postmarketing experience, more than half of the patients who develop such reactions appear to do so within 1 month of starting treatment, approximately 80% appear to do so within 3 months. lon Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly depression following the start of treatment.
Postmarketiška izkušnja je pokazala, da pri več kot polovici bolnikov, ki so razvili takšno razpoloženje, se je to pojavilo v prvem mesecu zdravljenja, pri približno 80% pa v 3 mesecih. lje Po začetku zdravljenja je potrebno pri bolnikih aktivno spremljati znake in simptome psihiatričnih motenj, še posebej depresijo.
If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped.
Če se med terapijo z rimonabantom diagnosticira depresija, se mora vo
Patients, especially those with a history of depressive disorders/ mood alterations, (and relatives or no
Bolnik mora biti primerno nadzorovan in zdravljen. do
other relevant persons) should be alerted about the need to monitor for the emergence of such symptoms and to seek medical advice immediately if these occur.
Bolnike, še posebej tiste, ki so kdaj imeli depresivno/ razpoloženjsko motnjo (in njihove sorodnike ali druge osebe, ki za njih skrbijo) je treba opozoriti, da morajo biti pozorni na pojav tovrstnih simptomov.
• Other psychiatric conditions ct
pomoč. av
Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness.
• Druge duševne motnje Pri bolnikih z nenadzorovanimi resnimi duševnimi motnjami zdravljenja z rimonabantom ne nim
If psychiatric illness is diagnosed during rimonabant therapy, treatment must be stopped. du
Če se med zdravljenjem z rimonabantom ugotovi resna duševna motnja, je treba zdravljenje z rimonabantom prekiniti. ilo
• Seizures Rimonabant has not been studied in patients being treated for epilepsy.
• Epileptični napadi rav
however, should be used with caution in these patients, see also section 5.3.
Pri bolnikih, ki so se zdravili zaradi epilepsije, uporabe rimonabanta niso proučevali.
• Hepatic impairment lp
Glejte tudi poglavje 5. 3.
Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment.
• Okvara jeter Rimonabant se presnavlja v jetrih, zato je pri bolnikih z zmerno okvaro jeter potrebna previdnost.
The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended. ina
Farmakokinetika in varnost rimonabanta nista raziskani pri bolnikih s hudo okvaro jeter; uporaba zdravila pri teh bolnikih zato ni priporočljiva.
• Renal impairment There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
Podatkov o bolnikih s hudo okvaro ledvic ni.
Rimonabant should not be used in patients with severe renal impairment (see section dic
Rimonabanta ne smete uporabljati pri bolnikih s hudo okvaro ledvic (glejte poglavji 4. 2 in 5. 2).
• Elderly The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently Me
3 • Starostniki Učinkovitost in varnost zdravljenja z rimonabantom pri bolnikih, starejših od 75 let, nista dovolj raziskani.
Rimonabant should be used with caution in this population (see section 5.2).
Rimonabant morate v tej populaciji uporabljati previdno (glejte poglavje 5. 2).
3 • Race The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians.
• Rasa Klinični učinek (zmanjšanje telesne mase) rimonabanta je bil pri črncih manjši kot pri belcih.
d (see section 5.2).
Vzrok tega bi lahko bil večji očistek rimonabanta pri črncih kot pri belcih s posledično manjšo izpostavljenostjo (glejte poglavje 5. 2).
Monitoring of blood glucose level is
• Bolniki s sladkorno boleznijo Zaradi učinka rimonabanta na koncentracijo sladkorja v krvi, se lahko pri bolnikih s sladkorno boleznijo po zaužitju rimonabanta pojavi hipoglikemija (glejte poglavje 4. 8).
or recommended in these patients.
Pri teh bolnikih je priporočljiv nadzor sladkorja v krvi.
uth Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
t me • Interakcije z zdravili Rimonabant morate uporabljati previdno v kombinaciji z močnimi zaviralci CYP3A4 (npr.
ra Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
pro ketokonazolom, itrakonazolom, ritonavirjem, telitromicinom, klaritromicinom, nefazodonom) (glejte poglavje 4. 5).
ge Patients should be instructed not to increase their dose of ACOMPLIA.
za • Laktoza Tablete ACOMPLIA vsebujejo laktozo, zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze, ne smejo jemati tega nja zdravila. lje Bolnikom morate naročiti, naj ne povečujejo odmerka zdravila ACOMPLIA. vo
Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago lon were excluded in the studies for rimonabant.
Bolniki, ki so pred manj kot 6 meseci doživeli srčno- žilni dogodek (miokardni infarkt, možgansko kap itn.), so bili izključeni iz študij z rimonabantom. do
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij eā
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in no
Rimonabant se in vitro presnavlja s CYP3A in amidohidrolazo (pretežno jetrno).
Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant. ct
Pričakovati je mogoče, da sočasna uporaba av
Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC du
induktorjev CYP3A4 zmanjša izpostavljenost rimonabantu. nim
40% - 197%).
Sočasna uporaba ketokonazola (močnega zaviralca CYP3A4) je povečala AUC rimonabanta za 104% (95% napovedni interval: od 40% do 197%).
Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone). ro
Med sočasno uporabo zdravila ACOMPLIA in ilo
Although concomitant administration of CYP3A4 inducers (e. g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John’ s wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of lp
močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, ritonavirja, telitromicina, klaritromicina, rav
efficacy.
nefazodona) je potrebna previdnost.
Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma ina
CYP3A4 zmanjša koncentracijo rimonabanta v plazmi in tako zmanjša njegovo učinkovitost.
levels of rimonabant.
Sočasna uporaba orlistata, etanola ali lorazepama ni pomembno vplivala na koncentracijo rimonabanta v plazmi.
Potential for rimonabant to affect other medicinal products:
4 Možnost vpliva rimonabanta na druga zdravila:
mild inhibitory effect on CYP2C8.
Vendar rimonabant in vitro rahlo zavira CYP2C8.
Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Rimonabant in vitro ne zavira in ne inducira drugih encimov CYP ali P- glikoproteina (P- gp).
Me
To so klinično potrdili s specifičnimi sondažnimi študijami z uporabo midazolama (substrat CYP3A4), varfarina (substrat CYP2C9) in digoksina (substrat P- gp).
The steady-state pharmacokinetics of an ethinyl estradiol/ levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
Sočasna uporaba rimonabanta ni pomembno spremenila farmakokinetike kombiniranega peroralnega kontraceptiva z etinilestradiolom/ levonorgestrelom v stanju dinamičnega ravnovesja.
4 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
Animal data are inconclusive but
Podatki iz študij na živalih sicer niso
d suggest possible deleterious effects on embryonal/ foetal development (see section 5.3).
t zadostni, vendar nakazujejo možne škodljive vplive na razvoj zarodka oz. ploda (glejte poglavje 5. 3).
The potential risk for humans is unknown.
me Možno tveganje za ljudi ni znano.
ise their physician if they become pregnant during treatment with ACOMPLIA.
Če bolnica med zdravljenjem z zdravilom ACOMPLIA zanosi, mora o tem obvestiti zdravnika.
Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex.
pro Rimonabant so našli v mleku doječih podgan in zdravilo lahko zavre sesalni refleks.
ACOMPLIA is contraindicated during
ACOMPLIA je kontraindicirana med obdobjem dojenja (glejte poglavje 4. 3).
Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect.
za 4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji nja Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli. lje Kognitivne raziskave v študijah klinične farmakologije so pokazale, da rimonabant nima pomembnega kognitivnega ali sedativnega učinka. vo
ra 4.8 Undesirable effects
4. 8 Neželeni učinki do
ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies
Varnost zdravila ACOMPLIA 20 mg so raziskali pri približno 2500 bolnikih, vključenih v študije, ki so proučevale presnovne učinke in učinke na zmanjšanje telesne mase pri čezmerno težkih in debelih eā
ge that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications.
bolnikih, ter pri približno 3800 bolnikih z drugimi indikacijami.
In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7% for patients receiving rimonabant.
Med bolniki, ki so dobivali rimonabant v študijah, kontroliranih s placebom, je bil delež prekinitev zaradi neželenih reakcij av
The most common adverse lon reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.
Najpogostejši neželeni učinki, ki so povzročili prekinitev, so bili: navzeja, spremembe razpoloženja z depresivnimi simptomi, depresivne motnje, anksioznost in omotica. nim
Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg.
Pri 3, 2% debelih bolnikov oziroma čezmerno težkih bolnikih, pri katerih so bili prisotni tudi dejavniki tveganja in ki so dobivali rimonabant 20 mg, so poročali o depresivnih motnjah.
These were usually mild or moderate in severity and no
Te motnje so bile ponavadi blage ali zmerne in so se v vseh primerih popravile (bodisi po korektivni terapiji ali ilo
resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups.
prekinitvi rimonabanta) ter niso imele drugačnih značilnosti kot v kontrolnih skupinah. rav
The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled ct
Naslednja tabela (tabela 1) prikazuje vse neželene učinke, ki so se pojavili med zdravljenjem v s placebom kontroliranih študijah, pri bolnikih zdravljenih za zmanjšanje telesne mase in zaradi Zd
studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered clinically relevant (for events < 1%). du
sorodnih presnovnih motenj, če je bila njihova incidenca statistično značilno večja kot pri placebu (za dogodke ≥1%) ali so bile ocenjene kot klinično pomembne (za dogodke < 1%).
Very common (≥ 10%); Common (≥ 1, < 10%); Uncommon (≥ 0.1, < 1%); Rare (≥ 0.01, < 0.1%); Very ro
Razvrstitev pričakovanih pogostnosti neželenih učinkov: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1, 000 do < 1/ 100); redki (≥ 1/ 10, 000 do < 1/ 1, 000); zelo redki (< 1/ 10, 000), neznani (ni mogoče oceniti iz razpoložljivih podatkov).
rare (< 0.01%), Not known (cannot be estimated from the available data). lp ina dic Me
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Table 1:
5 Tabela 1: organski sistem
d
zelo
System Organ Class
pogosti pogosti
Very common
občasni
Rare
okužba zgornjih dihal
ise
gastroenteritis
Infections infestations Metabolism and
Presnovne in prehranske motnje
and Upper respiratory Gastroenteritis tract infection
hipoglikemija *
Hypoglycaemia*
Psihiatrične motnje
or nutrition disorders
depresivne motnje spremembe
Psychiatric disorders
simptomi panike jeza disforija
Depressive disorders
halucinacije
Panic symptoms Anger
razpoloženja z
Hallucinations
čustvena motnja
uth Mood alterations Dysphoria
me
with depressive symptoms Anxiety
depresivnimi simptomi
Emotional disorder Suicidal ideation
samomorilne misli
ra
pro
Irritability Nervousness Sleep disorders Insomnia
anksioznost razdražljivost živčnost
Aggressiveness Aggressive behaviour
agresivnost agresivno vedenje
ge Parasomnias
poslabšanje lje
Nervous system disorders
letargija
Memory loss Dizziness lon Hypoaesthesia Sciatica Paresthesia
spomina omotica vo
Lethargy Tremor
tremor
Vascular disorders Respiratory,
hipestezija išias do
no
parestezija Žilne bolezni
Hot flush
eā
Hiccups
valovi vročine
thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in
Gastrointestinal
av
Nausea ct
kolcanje
Diarrhoea
mediastinalnega prostora nim
Vomiting
navzeja ilo
Skin and
driska bruhanje
du
Bolezni kože in
Pruritus
rav
Night sweats
srbenje
subcutaneous tissue disorders
nočno znojenje
Hyperhidrosis
podkožja
Musculoskeletal and ro
hiperhidroza
Tendonitis Muscle cramp
Bolezni mišično -
connective tissue disorders lp
Zd
Muscle spasms
tendinitis
General disorders
skeletnega sistema in vezivnega tkiva
Asthenia/ fatigue Influenza
mišični krč mišični spazmi
Injury, Poisoning and procedural ina
Splošne težave
Fall Contusion
astenija / utrujenost gripa
complications
Poškodbe in zastrupitve
Joint sprain
padec kontuzija zvin sklepa
*frequency is based only on reports in obese or overweight diabetic patients.
* pogostnost temelji na poročilih pri debelih ali čezmerno težkih bolnikih s sladkorno boleznijo.
6 Post-Marketing In addition the following adverse reactions were reported during postmarketing (frequency not known):
6 V kliničnih študijah pri drugih indikacijah so bili pogosto opisani naslednji dodatni neželeni učinki: − infekcijske in parazitske bolezni: sinuzitis, − presnovne in prehranske motnje: anoreksija, zmanjšanje apetita − bolezni prebavil: nelagodje v želodcu, suha usta.
d − Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia. − Skin and subcutaneous tissue disorders: rash.
Postmarketinške izkušnje Po prihodu zdravila na trg so poročali o naslednjih neželenih učinkih (pogostnost neznana): − psihiatrična motnja: psihotične motnje vključno s halucinacijami, blodnjami in paranojo. − bolezni kože in podkožja: izpuščaj. − bolezni živčevja: konvulzije, motnje pozornosti, glavobol. − bolezni prebavil: bolečina v trebuhu.
ise − Nervous disorders: convulsions, disturbance in attention, headache. − gastrointestinal disorders: abdominal pain.
t me Laboratorijski neželeni učinki Ni ugotovljeno, da bi ACOMPLIA spreminjala vrednosti laboratorijskih testov.
Laboratory adverse events
pro 4. 9 Preveliko odmerjanje
or ACOMPLIA has not been shown to alter laboratory test values.
Izkušnje s prevelikim odmerjanjem rimonabanta so omejene.
4.9 Overdose
V študijah prenašanja posamičnega
In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported.
za odmerka so omejenemu številu preiskovancev dali odmerke do 300 mg.
The pharmacokinetic profile demonstrates that a
Ob tem so zabeležili le manj pomembne simptome, med katerimi so bili glavobol, evforija, utrujenost in nespečnost.
ra plateau in exposures is reached at 180 mg.
Farmakokinetični profil kaže, da je plato izpostavljenosti dosežen s 180 mg.
There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose.
Specifičnega antidota za nja rimonabant ni, zato je treba v primeru prevelikega odmerjanja uvesti ustrezne podporne ukrepe.
Treatment should consist of the general measures employed in the management of overdoses, such as keeping airways
Zdravljenje mora obsegati splošne ukrepe, ki se uporabljajo pri prevelikem odmerjanju, npr. ohranitev lje prehodnih dihalnih poti, nadzorovanje srčno- žilnega delovanja ter splošne simptomatske in podporne ukrepe. vo do
PHARMACOLOGICAL PROPERTIES lon 5.1 Pharmacodynamic properties
5. 1 Farmakodinamične lastnosti av
Anti obesity agent ATC code:
Zaviralci apetita, brez dietnih pripravkov Oznaka ATC:
A08AX01 no
A08AX01 nim
The endocannabinoid system is a physiological system present in brain and peripheral tissues ct
Endokanabinoidni sistem je fiziološki sistem v možganih in perifernih tkivih (vključno z adipociti), ki ilo
(including adipocytes) that affects energy balance, glucose and lipid metabolism and body weight, and in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods. du
vpliva na ravnovesje energije, presnovo glukoze in lipidov ter na telesno maso in ki v nevronih mezolimbičnega sistema modulira vnos zelo okusne, sladke ali mastne hrane. rav Zd
Clinical study results
7 Rezultati kliničnih študij
Weight Management ro
Obvladovanje telesne mase
The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and lp
Bolniki v preskušanjih 3. faze so med preskušanji uživali restriktivno dieto, ki jo je predpisal dietetik, in svetovali so jim, naj povečajo svojo telesno dejavnost.
Patients had a BMI ≥ 30 kg/ m² or BMI > 27 kg/ m² with hypertension and/ or dyslipidemia at inclusion.
Bolniki so imeli ITM  30 kg/ m2 ali ITM > 27 kg/ m2 ter hipertenzijo in/ ali dislipidemijo ob vključitvi.
Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Približno 80% populacije so bile ženske, 87% je bilo belcev in 9% črncev.
Experience in patients over 75 years and ina
Ni dovolj zkušenj pri bolnikih, starejših od 75 let in pri osebah orientalskega/ azijskega porekla.
A mean weight loss of 6.5 kg dic
t Povprečno zmanjšanje telesne mase po enem letu v primerjavi z izhodiščem je bilo z zdravilom
from baseline to one year was shown for ACOMPLIA 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3; -4.4, p < 0.001).
me ACOMPLIA 20 mg 6, 5 kg in s placebom 1, 6 kg (razlika – 4, 9 kg, IZ95% – 5, 3, – 4, 4; p < 0, 001).
Me
Spodaj v tabeli 2 so prikazani deleži bolnikov, ki so imeli po 1 letu zdravljenja telesno maso za 5%
7 Table 2:
pro oz.
Non-diabetic studies
Tabela 2:
Diabetic study
študije pri nediabetikih
Placebo ACOMPLIA
študija pri diabetikih
Placebo
za
ACOMPLIA
placebo
Weight at baseline (kg)
lje izhodiščna telesna masa (kg)
101
101 vo
Subjects with a 5%
preiskovanci s 5% zmanjšanjem telesne
or weight reduction
mase
Difference (CI 95%)
razlika (IZ95%)
31.1% (28%; 34%)
31, 1% (28%, 34%) eā
34.9% (28%; 41%)
34, 9% (28%, 41%)
Subjects with a 10% 7.8% weight reduction
preiskovanci z 10%
Difference (CI 95%) 19.2% (17%; 22%)
19, 2% (17%, 22%)
14.2% (10%; 19%)
14, 2% (10%, 19%)
ra Most of the observed weight reduction was obtained within the first nine months of treatment.
Večina opaženega zmanjšanja telesne mase je bila dosežena v prvih devetih mesecih zdravljenja. ilo
Weight loss at two years
ACOMPLIA 20 mg je učinkovito vzdrževala zmanjšano telesno maso do dve leti.
ge was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p < 0.001).
Zmanjšanje telesne mase po dveh letih je bilo pri bolnikih, ki so dobivali zdravilo ACOMPLIA 20 mg, 5, 1 kg in pri rav
lon
Zd
At two years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0; - no
V dveh letih je bilo pri bolnikih, ki so dobivali rimonabant, povprečno skupno zmanjšanje telesne mase 7, 5 kg, pri bolnikih, ki so bili v drugem letu randomizirani v skupino s placebom, pa je bilo povprečno skupno zmanjšanje telesne mase v dveh letih 3, 1 kg. V dveh letih je bila razlika v skupnem zmanjšanju telesne mase med zdravilom ACOMPLIA in placebom – 4, 2 kg (IZ95% – 5, 0, – 3, 4; p < 0, 001).
Treatment with rimonabant was associated with significant reductions in waist circumference, a known marker of intra-abdominal fat. ct
Zdravljenje z rimonabantom je spremljalo pomembno zmanjšanje obsega pasu, ki je znan kazalec intraabdominalnega maščevja.
The effects on body weight appeared to be consistent among men and women.
8 Učinek na telesno maso se je pri moških in ženskah ujemal.
No du
Pri omejenem številu bolnikov črncev je bilo zmanjšanje telesne mase manj izrazito (povprečna razlika v primerjavi s placebom – 2, 9 kg).
conclusions can be drawn with regard to effects in patients over 75 years or in Asian/ Oriental patients due to the low number of patients. ro
Zaradi majhnega števila bolnikov ni mogoče sklepati o učinkih pri bolnikih, starejših od 75 let, in pri bolnikih azijskega/ orientalskega porekla.
For lp
Obvladovanje telesne mase in dodatni dejavniki tveganja V študijah nediabetičnih bolnikov, vključno z mešano populacijo preiskovancev z (zdravljeno) dislipidemijo ali brez nje, so (po enem letu) ugotovili zvišanje holesterola HDL in znižanje trigliceridov.
HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 mmol/ l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/ l).
Ob 20 mg rimonabanta se je holesterol HDL v povprečju zvišal za 16, 4% (izhodiščni holesterol HDL 1, 24 mmol/ l), ob placebu pa za 8, 9% (izhodiščni holesterol HDL 1, 21 mmol/ l).
For the ina
Razlika je bila statistično značilna (razlika 7, 9%, IZ95% 6, 6%, 9, 2%; p < 0, 001).
triglycerides an average decrease of 6.9% was seen under rimonabant 20 mg (baseline TG 1.62 mmol/ l) compared to an increase of 5.8% for placebo (baseline TG 1.65 mmol/ l).
Trigliceridi so se ob 20 mg rimonabanta v povprečju znižali za 6, 9% (izhodiščni trigliceridi 1, 62 mmol/ l), ob placebu pa zvišali za 5, 8% (izhodiščni trigliceridi 1, 65 mmol/ l).
The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p < 0.001).
Razlika je bila statistično značilna (razlika –
It is estimated that approximately half of the observed improvement in HDL-C and triglycerides in patients who received dic
Ocenjujejo, da je približno polovica ugotovljenega
rimonabant 20 mg was beyond that expected from weight loss alone.
me izboljšanja holesterola HDL in trigliceridov pri bolnikih, ki so dobivali 20 mg rimonabanta, presegala izboljšanje, ki bi ga pričakovali zgolj zaradi zmanjšanja telesne mase.