Daridorexant 25 mg le 50 mg liphetho tse ntlafalitsoeng tsa boroko, le daridoexant 50 mg le tsona li ntlafalitse ts'ebetso ea mots'eare, ho batho ba nang le lefu la ho hlobaela, ba nang le boemo bo botle ba polokeho. Kakaretso ea liketsahalo tse mpe e ne e bapisoa pakeng tsa lihlopha tsa phekolo ho batho ba baholo le batho ba baholo (ba lilemo li 65 le ho feta) ba nang le lefu la ho hlobaela. Joalokaha ho tlalehiloe, daridoexant 50 mg e bontšitse ntlafatso e kholo ea lipalo-palo likarolong tse ka sehloohong tsa ho robala le ho hlokomeloa hammoho le lintlha tsa bobeli tsa nako ea ho robala ka ho feletseng le ho robala motšehare.
Habohlokoa, liteko e bile tsona tsa pele tsa ho batlisisa phello ea phekolo ea ho hlobaela mosebetsing oa motšehare, ho sebelisa sesebelisoa se tiisitsoeng sa liphello tse tlalehiloeng ke mokuli, tse kenyelletsang libaka tse tharo tse fapaneng (tlhokomeliso / temoho, maikutlo le ho robala). Daridorexant 50 mg, e ileng ea hlahlojoa ho e 'ngoe ea liteko tse peli, e bontšitse lintlafatso ha li bapisoa le tsa motheo ho pholletsa le libaka tsohle tse sebetsang tsa letsatsi tse nang le boemo bo phahameng ba ho tsitsa.
Emmanuel Mignot, MD, Moprofesa oa Psychiatry le Behavioral Sciences Univesithing ea Stanford le mongoli ea ka sehloohong, o ile a fana ka maikutlo:
“Batho ba nang le lefu la ho hlobaela hangata ba tletleba ka ho se sebetse hantle motšehare. Ena ke taba e kholo e atisang ho hlokomolohuoa ho phekola ho hlobaela 'me ha e le hantle lithethefatsi tse ngata tse khothalletsang boroko li ka senya ts'ebetso ea motšehare ha li na le liphello tse setseng. Lenaneong lena, ha rea ka ra bona feela katleho ea daridorexant mabapi le ho kenngoa ha boroko, tlhokomelo le boleng ba boroko bo tlalehiloeng ke mokuli, empa habohlokoa, ka tekanyo ea 50 mg, ka ts'ebetso ea motšehare, haholo-holo sebakeng sa boroko joalokaha se lekantsoe ka mokhoa o mocha. sekala, IDSIQ. Barupeluoa ba sehlopha sa daridoexant 50 mg ba tlalehile lintlafatso likarolong tse ngata tsa ts'ebetso ea motšehare, joalokaha ho hlahlojoa ke sesebelisoa sena se sa tsoa ntlafatsoa le se tiisitsoeng se ileng sa hlahloba maikutlo, ho falimeha / temoho le ho robala. Hoa thabisa ho bona hore ho hlobaela qetellong ha ho nkoe e le bothata ba bosiu feela empa e le sesosa sa mahlomola a motšehare.”
Katleho le Liphello tsa Polokeho
Daridorexant 50 mg e ntlafalitse haholo ho qala ha boroko, ho boloka boroko le ho tlaleha nako eohle ea ho robala ka khoeli e le 'ngoe le tse tharo ha li bapisoa le placebo. Phello e kholo ka ho fetisisa e ile ea bonoa ka tekanyo e phahameng ka ho fetisisa (50 mg), e lateloa ke 25 mg, ha tekanyo ea 10 mg e ne e se na phello e kholo. Lihlopheng tsohle tsa phekolo likarolo tsa mekhahlelo ea boroko li ile tsa bolokoa, ho fapana le liphuputso tse tlalehiloeng ka benzodiazepine receptor agonists.
Sepheo se seholo sa liteko e ne e le ho hlahloba phello ea daridoexant nakong ea ts'ebetso ea motšehare ho bakuli ba nang le lefu la ho hlobaela, joalokaha ho hlahlojoa ke Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). IDSIQ ke sesebelisoa se netefalitsoeng sa sephetho se tlalehiloeng ke mokuli se ntlafalitsoeng ka ho khetheha ho latela litataiso tsa FDA, ho kenyelletsa le ho kenya letsoho ha mokuli, ho lekanya ts'ebetso ea mots'eare ho bakuli ba nang le lefu la ho hlobaela. Palo ea sebaka sa boroko sa IDSIQ e ile ea hlahlojoa e le ntlha ea bohlokoa ea ho qetela lithutong tse peli tsa bohlokoa le ho bapisa le placebo e kenyeletsang taolo ea bongata. Daridorexant 50 mg e bontšitse ntlafatso e kholo ea lipalo-palo ea ho robala ha motšehare ka khoeli le khoeli ea 3. Palo ea sebaka sa boroko ha ea ka ea ntlafatsoa haholo ka 25 mg thutong leha e le efe ka nako leha e le efe. Daridorexant 50 mg e boetse e ntlafalitse lintlha tse eketsehileng tsa IDSIQ domains (temoso / cognition domain, mood domain) le kakaretso ea lintlha (p-values <0.0005 khahlanong le placebo e sa lokisoang bakeng sa bongata). Lintlafatso tsa ts'ebetso ea mots'eare ka daridoexant 50 mg li ile tsa eketseha butle-butle nakong ea likhoeli tse tharo tsa thuto.
Kakaretso ea liketsahalo tse mpe e ne e ka bapisoa le lihlopha tsa phekolo. Liketsahalo tse mpe tse hlahang ho feta 5% ea barupeluoa e ne e le nasopharyngitis le hlooho e bohloko. Ho ne ho se na keketseho e itšetlehileng ka lethal dose liketsahalong tse mpe ho pholletsa le mefuta eohle ea litekanyetso, ho kenyeletsoa ho somnolence le ho oa. Ho feta moo, ha ho na ho itšetleha, lefu la ho hlobaela kapa litlamorao tsa ho tlohela ho ile ha bonoa ha ho khaotsa ka tšohanyetso kalafo. Ho pholletsa le lihlopha tsa kalafo, liketsahalo tse bohloko tse lebisang ho khaotsoe ha kalafo li ne li atisa ho ba le placebo ho feta daridoxant.
Martine Clozel, MD, le Ofisiri e ka Sehloohong ea Saense ea Idorsia, ba re:
"Lintlha tsena tse hatisitsoeng ho The Lancet Neurology li totobatsa botebo ba bopaki bo hlahisitsoeng lenaneong la ntlafatso ea daridoexant le thepa ea lithethefatsi eo ke lumelang hore e hlalosa liphello. Setlhare sena se ne se etselitsoe hore se sebetse hantle bakeng sa ho qala ho robala le ho hlokomeloa ka litekanyetso tse sebetsang hantle ha se ntse se qoba ho robala hoseng. Boemo bona, hammoho le thibelo e lekanang ea li-receptor tse peli tsa orexin - tse ka lebisang ho thibeloeng ha maikutlo a sa foleng a kutloelo-bohloko a ho hlobaela - e ka hlalosa ntlafatso eo re e bonang ts'ebetsong ea motšehare ka 50 mg ea daridoxant. "
Daridoexant ka lefu la ho hlobaela
Bothata ba ho hlobaela bo khetholloa ka mathata a ho qala kapa ho boloka boroko 'me bo amahanngoa le khatello ea maikutlo kapa ho senyeha ha mosebetsi oa motšehare. Litletlebo tse ngata tsa motšehare, ho tloha mokhathala le ho fokotsa matla ho ea ho phetoho ea maikutlo le mathata a kelello, li tlalehoa ke batho ba nang le lefu la ho hlobaela.
Ho hlobaela ho amahanngoa le mokhoa oa ho tsoha o feteletseng.
Daridorexant, mohanyetsi oa "dual orexin receptor antagonist", o entsoe le ho ntlafatsoa ke Idorsia bakeng sa kalafo ea lefu la ho hlobaela. Daridoexant e shebana le tšobotsi ea ho falimeha ho feteletseng ea ho hlobaela ka ho thibela tšebetso ea orexin. Daridorexant e shebana ka ho khetheha le sistimi ea orexin ka tlholisano e tlamang li-receptor ka bobeli, ka tsela eo e thibela tšebetso ea orexin.
Daridorexant ke FDA e amohetsoeng US tlasa lebitso la khoebo QUVIVIQ™ mme e tla fumaneha kamora kemiso ea Tsamaiso ea Ts'ebetso ea Lithethefatsi ea US ka Mots'eanong 2022.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- In this program, not only did we see efficacy of daridorexant on sleep induction, maintenance and patient-reported sleep quantity and quality, but importantly, at the dose of 50 mg, on daytime functioning, notably in the sleepiness domain as measured with a new scale, the IDSIQ.
- This profile, together with the equal blockade of both orexin receptors – which may lead to an inhibition of the chronic sympathetic hyperactivity characteristic of insomnia – may explain the improvement we see in daytime functioning with 50 mg of daridorexant.
- A major focus of the trials was to evaluate the impact of daridorexant on daytime functioning in patients with insomnia, as assessed by the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
