Sabon Rahoton Alamomin Dare da Ayyukan Rana a Manya masu fama da rashin barci

Daridorexant 25 MG da 50 MG sun inganta sakamakon barci, da kuma daridorexant 50 MG kuma sun inganta aikin rana, a cikin mutanen da ke fama da rashin barci, tare da ingantaccen bayanin martaba. Abubuwan da suka faru na gabaɗaya sun kasance daidai tsakanin ƙungiyoyin jiyya a cikin manya da tsofaffi (shekaru 65 da sama) tare da rashin barci. Kamar yadda aka ruwaito, daridorexant 50 MG ya nuna haɓakar ƙididdiga masu mahimmanci a cikin farkon ƙarshen farkon barci da kiyayewa da kuma na biyu na ƙarshen lokacin barci da barcin rana.

Mahimmanci, gwaje-gwajen sune na farko don bincika tasirin maganin rashin barci a kan aiki na rana, ta amfani da ingantaccen kayan aikin da aka ba da rahoton haƙuri, wanda ya haɗa da yankuna uku daban-daban (jijjiga / fahimta, yanayi, da barci). Daridorexant 50 MG, wanda aka kimanta a cikin ɗayan gwaje-gwajen guda biyu, ya nuna haɓakawa idan aka kwatanta da asali a duk wuraren aiki na rana tare da babban matakin daidaito.

Emmanuel Mignot, MD, Farfesa na Ilimin Halitta da Kimiyyar Halayyar a Jami'ar Stanford kuma marubucin marubuci, yayi sharhi:

“Mutanen da ke fama da rashin barci sukan yi korafin rashin aikin rana. Wannan babban al'amari ne da ake watsi da shi sau da yawa wajen magance rashin barci kuma a gaskiya yawancin magungunan da ke inganta barci na iya lalata aikin rana yayin da suke da sauran tasiri. A cikin wannan shirin, ba wai kawai mun ga tasiri na daridorexant akan shigar da barci ba, kiyayewa da kuma yawan rahotannin barci da inganci, amma mahimmanci, a kashi na 50 MG, a kan aikin rana, musamman a cikin yankin barci kamar yadda aka auna tare da sabon. Farashin IDSIQ. Mahalarta a cikin daridorexant 50 MG kungiyar sun ba da rahoton ingantawa a cikin bangarori da yawa na aikin rana, kamar yadda aka kiyasta ta wannan sabon haɓaka da ingantaccen kayan aiki wanda ya kimanta yanayi, faɗakarwa / fahimta, da barci. Abin farin ciki ne a ga cewa rashin barci a ƙarshe ba a matsayin matsalar dare kaɗai ba amma a matsayin dalilin wahala da rana.”

Inganci da Sakamako na Tsaro

Daridorexant 50 MG yana inganta ingantaccen barcin barci, kula da barci da kuma rahoton kai cikakken lokacin barci a watanni daya da uku idan aka kwatanta da placebo. An lura da sakamako mafi girma tare da mafi girman kashi (50 MG), sannan 25 MG ya biyo baya, yayin da kashi 10 na MG ba shi da tasiri mai mahimmanci. A cikin dukkanin kungiyoyin jiyya an kiyaye ma'auni na matakan barci, sabanin binciken da aka ruwaito tare da masu karɓar masu karɓar benzodiazepine.

Babban mahimmanci na gwaje-gwajen shine don kimanta tasirin darindorexant akan aikin rana a cikin marasa lafiya da rashin barci, kamar yadda aka kiyasta ta Tambayoyin Tambayoyi na Tasirin Rana (IDSIQ). IDSIQ ingantacciyar kayan aiki ne da aka ba da rahoton haƙuri da aka haɓaka musamman bisa ga jagororin FDA, gami da shigarwar haƙuri, don auna aikin rana a cikin marasa lafiya da rashin barci. An ƙididdige ƙimar yankin barci na IDSIQ a matsayin maɓalli na ƙarshe na biyu a cikin duka karatun mahimmanci da kwatancen placebo ya haɗa da sarrafawa don haɓakawa. Daridorexant 50 MG ya nuna ingantaccen ƙididdiga mai mahimmanci a cikin barcin rana a wata daya da wata 3. Ƙimar yankin barci ba ta inganta sosai akan 25 MG a kowane binciken a kowane lokaci. Daridorexant 50 MG kuma ya inganta ƙarin ƙimar IDSIQ (yankin faɗakarwa / fahimta, yankin yanayi) da jimlar ƙima (p-darajar <0.0005 tare da placebo ba a daidaita shi don yawa). Haɓakawa a cikin aikin rana ta daridorexant 50 MG a hankali ya karu a cikin watanni uku na binciken.

Gabaɗayan abin da ya faru na munanan abubuwan sun kasance daidai tsakanin ƙungiyoyin jiyya. Abubuwan da ke faruwa a cikin fiye da 5% na mahalarta sune nasopharyngitis da ciwon kai. Babu wani karuwa mai dogaro da kashi a cikin abubuwan da ba su dace ba a cikin kewayon allurai, gami da rashin jin daɗi da faɗuwa. Bugu da ari, ba a sami dogaro ba, koma-bayan rashin barci ko sakamakon janyewar da aka samu bayan dakatar da jiyya ba zato ba tsammani. A ko'ina cikin ƙungiyoyin jiyya, abubuwan da ba su da kyau da ke haifar da dakatar da jiyya sun fi yawan lokuta tare da placebo fiye da daridorexant.

Martine Clozel, MD, da Babban Jami'in Kimiyya na Idorsia, yayi sharhi:

"Wadannan bayanan da aka buga a cikin The Lancet Neurology suna nuna zurfin shaidar da aka samu a cikin shirin ci gaban daridorexant da kaddarorin maganin da na yi imani sun bayyana sakamakon. An ƙera magungunan don samun inganci don fara bacci da kiyayewa a ingantattun allurai masu inganci yayin gujewa ragowar baccin safiya. Wannan bayanin martaba, tare da daidaitaccen toshewar duka masu karɓa na orexin - wanda na iya haifar da hanawa na yanayin rashin bacci na yau da kullun na rashin bacci - na iya bayyana haɓakar da muke gani a cikin aiki na rana tare da 50 MG na daridorexant.

Daridorexant a cikin rashin barci

Rashin barci yana da alaƙa da matsalolin farawa ko kiyaye barci kuma yana da alaƙa da damuwa ko rashin ƙarfi a cikin aikin rana. Yawancin gunaguni na rana, daga gajiya da rage kuzari zuwa canjin yanayi da matsalolin fahimta, mutane masu rashin barci sun ruwaito.

Rashin barci yana da alaƙa da tsarin farkawa da yawa.

Daridorexant, wani labari na dual orexin antagonist, Idorsia ne ya tsara shi kuma ya haɓaka shi don maganin rashin barci. Daridorexant yana hari akan yanayin farkawa da yawa na rashin bacci ta hanyar toshe ayyukan orexin. Daridorexant na musamman yana kai hari ga tsarin orexin ta hanyar yin gasa tare da masu karɓa biyu, ta haka ne ke toshe ayyukan orexin.

Daridorexant shine FDA da aka amince da ita a cikin Amurka a ƙarƙashin sunan kasuwanci QUVIVIQ ™ kuma zai kasance samuwa bayan tsarawa ta Hukumar Kula da Magunguna ta Amurka a watan Mayu 2022.