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³­Ä¡¼º ³úÀüÁõ ȯÀÚ¿¡¼­ lacosamide Ä¡·á°¡ È¿°úÀûÀ̾ú´ø Áõ·Ê
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35¼¼ ³²ÀÚȯÀÚ°¡ ³»¿ø 1ÀÏÀü ¹ã¿¡ ÀÚ´Â µµÁß Àü½Å¼º °­Á÷-°£´ë¼º ¹ßÀÛÀÌ ¹ß»ýÇÏ¿© ÀÀ±Þ½Ç·Î ³»¿øÇÏ¿´´Ù. ÀÌ·¯ÇÑ °æ·Ã¹ßÀÛÀº ÃÖ±Ù 6°³¿ù µ¿¾È 1ÁÖÀÏ¿¡ 3-4ȸ ºóµµ·Î ¹ß»ýÇÏ¿´´Ù. °ú°Å·Â¿¡¼­ ȯÀÚ´Â ³»¿ø 10³âÀüºÎÅÍ Æ¯¹ß¼ºÀü½Å¹ßÀÛ(idiopathic generalized epilepsy)À» Áø´Ü¹Þ°í °æ±¸¿ë valproic acid¿Í oxcarbazepineÀ» º¹¿ëÇÏ¿´À¸³ª ¹ßÀÛÀº Àß Á¶ÀýµÇÁö ¾Ê¾Ò´Ù. ³»¿øÇÏ¿© ½ÃÇàÇÑ ³úÀÚ±â°ø¸í¿µ»ó°Ë»ç(brain magnetic resonance imaging, MRI)»ó ¶Ñ·ÇÇÑ ±¸Á¶Àû ÀÌ»óÀº ¾ø¾ú´Ù. ³»¿ø ´çÀÏ ½ÃÇàÇÑ ³úÆÄ°Ë»ç»ó ¾çÃø ÀüµÎ¿± ºÎÀ§¿¡¼­ Áö¼ÓÀûÀÎ 3-5 HzÀÇ ¼­Æĸ¦ º¸¿´À¸³ª °£Áú¾çÆÄ´Â °üÂûµÇÁö ¾Ê¾Ò´Ù.

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ȯÀÚ´Â ÀáÀ缺 ¾çÃø ÀüµÎ¿± °£Áú·Î »õ·Ó°Ô Áø´ÜÇÏ°í ±âÁ¸¿¡ º¹¿ëÇÏ°í ÀÖ¾ú´ø Ç׳úÀüÁõ¾àÀ» ´Ù¸¥ ¾àÁ¦·Î º¯°æÇϱâ·Î ÇÏ¿´´Ù. ÇöÀç±îÁö valproate(750mg bid), oxcarbazepine(450mg bid)¸¦ º¹¿ë Áß¿¡ ÀÖÀ½¿¡µµ º¹ÇպκйßÀÛÀÌ 1´Þ¿¡ 10-15¹øÀÇ ºóµµ·Î °è¼Ó ¹ß»ýÇÏ¿´´Ù. ÇöÀç º¹¿ëÁßÀÎ Ç׳úÀüÁõ¾àÁ¦ Áß oxcarbazepine(450mg bid)À» lacosamide(100mg bid)·Î º¯°æÇÏ¿´´Ù. ¾àÁ¦ º¯°æ ÈÄ ¼ö¸é Áß ¹ß»ýÇÏ¿´´ø °æ·Ã ¹ßÀÛÀÇ ºóµµ°¡ 1´Þ¿¡ 1-2¹øÀÇ ºóµµ·Î °¨¼ÒÇÏ¿´´Ù.

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º» Áõ·Ê´Â ³­Ä¡¼º ÀüµÎ¿± ³úÀüÁõȯÀÚ¿¡¼­ lacosamideÀÇ add-on therapy·Î °æ·Ã¹ßÀÛÀÇ Á¶ÀýÀ» È¿°úÀûÀ¸·Î º¸¿´´ø »ç·Ê´Ù. ³úÀüÁõÀº °¡Àå ÈçÇÏ°í ¸¸¼ºÀûÀÎ ½Å°æ°úÀû ÁúȯÀ̸ç, Àü ¼¼°èÀûÀ¸·Î 6,500¸¸¸í ÀÌ»ó °íÅë ¹Þ°í ÀÖ°í ¿ì¸® ³ª¶óÀÇ ÃÖ±Ù À¯º´·ü ¿¬±¸¿¡¼­µµ 10¸¸¸í ÀÌ»óÀÇ È¯ÀÚ°¡ ³úÀüÁõÀ» ¾Î°í ÀÖ´Â °ÍÀ¸·Î ¹àÇôÁ³´Ù. ³úÀüÁõ ȯÀÚ´Â Áúº´ ÀÚü»Ó¸¸ ¾Æ´Ï¶ó »çȸÀû Â÷º°·Î °íÅë ¹Þ°í ÀÖÀ¸¸ç, ¸¸¼ºÀûÀ¸·Î ¿¹»óÄ¡ ¸øÇÑ Áõ»óÀÌ °©ÀÛ½º·´°Ô ¹ß»ýÇÏ´Â °Í ¶§¹®¿¡ »îÀÇ ÁúÀÇ ¾Ç¿µÇâÀ» ¹Þ°Ô µÈ´Ù. ¾à 70-80%ÀÇ È¯ÀÚ¿¡¼­´Â ¾à¹°Ä¡·á°¡ È¿°úÀûÀ̶ó°í ¾Ë·ÁÁ® ÀÖ´Ù. ±×·¯³ª ³úÀüÁõ ȯÀÚ Áß 30% ÀÌ»óÀº 2°¡Áö ÀÌ»óÀÇ ¾à¹°¿¡ ÀÇÇؼ­ ¹ßÀÛÀÌ Á¶ÀýÀÌ µÇÁö ¾ÊÀ¸¸ç À̸¦ ¾à¹° ³­Ä¡¼º ³úÀüÁõÀ̶ó ÀÏÄ´´Ù. ³úÀüÁõ¿¡ ´ëÇÑ ¾à¹°Ä¡·á´Â ÇöÀç±îÁö È®½ÇÇÑ ÁöħÀÌ ºÎÁ·ÇÑ »óÅÂÀÌ¸ç °³ÀÎÀûÀÎ ¼Ò°ßÀÌ ¸¹Àº ¿µÇâÀ» ³¢Ä¡¹Ç·Î ºÎÁ¤È®ÇÑ Áø´Ü, ºÎÀûÀýÇÑ ¾à¹° ȤÀº ¿ë·® ¼±Åà ¹× ºÒ¿ÏÀüÇÑ ¼øÀÀµµ¿Í ºÎÀûÀýÇÑ »ýÈ°¹æ½Ä µîµîÀÇ ¿©·¯ °¡Áö ¿äÀÎÀ¸·Î ÀûÀýÈ÷ Ä¡·á°¡ µÇÁö ¾Ê´Â °æ¿ì°¡ ¸¹´Ù. º» Áõ·Ê¿¡¼­ Áø´ÜµÈ ÀüµÎ¿± ³úÀüÁõÀº ÃøµÎ¿± ³úÀüÁõ ´ÙÀ½À¸·Î ¸¹Àº ¼ö¼úÀû Ä¡·á°¡ ÇÊ¿äÇÑ ³­Ä¡¼º ³úÀüÁõÀ¸·Î ȯÀÚÀÇ 5-15%Á¤µµ Â÷ÁöÇÑ´Ù. ÃøµÎ¿± ³úÀüÁõ°ú ´Þ¸® ÀüµÎ¿± ³úÀüÁõÀÇ º´ÀÎÀº Àß ¾Ë·ÁÁ® ÀÖÁö ¾Ê¾Æ ¼ö¼ú ¹× ¾à¹°Àû Ä¡·á¿¡ ¾î·Á¿òÀÌ ¸¹´Ù. ¶ÇÇÑ ÀüµÎ¿± ³úÀüÁõÀÇ °æ¿ì ÀÓ»óÀûÀ¸·Î ¹ßÀÛ ¾ç»óÀÌ ¸Å¿ì ´Ù¾çÇÏ°í ³úÆÄ °Ë»ç»ó °£ÁúÆÄ°¡ º¸ÀÌÁö ¾Ê°Å³ª º¸ÀÌ´õ¶óµµ °£ÁúÆÄ°¡ »¡¸® ¹øÁ®³ª°¡ º´¼ÒÀÇ È®ÀÎÀÌ ¾î·Á¿î °æ¿ì°¡ ¸¹´Ù.
º» Áõ·Ê¿¡¼­ ºÎ°¡¿ä¹ý(add-on therapy)·Î »ç¿ëÇÑ Lacosamide´Â 3¼¼´ë Ç׳úÀüÁõ¾àÀ¸·Î ±¹³»¿¡ 2012³âºÎÅÍ Ãâ½ÃµÇ¾î »ç¿ëµÇ°í ÀÖÀ¸¸ç, ¾à¸®ÀÛ¿ëÀ¸·Î´Â voltage-gated sodium channelÀÇ slow inactivationÀ» ¼±ÅÃÀûÀ¸·Î °­È­ÇÔÀ¸·Î Ç×Àü°£ È¿°ú¸¦ ³ªÅ¸³½´Ù[±×¸²1]. ±âÁ¸¿¡ »ç¿ëµÇ¾ú´ø carbamazepine, phenytoin, lamotrigineÀÌ voltage-gated sodium channelÀÇ fast inactivationÀ» ÃËÁø½ÃŲ´Ù´Â Á¡¿¡¼­ lacosamide´Â ´Ù¸¥ sodium channel blockerº¸´Ù Áö¼ÓÀûÀ̸鼭 ´Ù¾çÇÑ ¾à¸®ÀÛ¿ëÀ» º¸ÀδÙ. ¾àµ¿ÇÐÀû Ãø¸éÀ» º¸¸é Àå¿¡¼­ °ÅÀÇ 100%ÀÇ ¿ÏÀüÇÑ Èí¼ö¸¦ º¸À̸ç, À½½Ä ¼·Ãë¿¡ ¿µÇâÀ» °ÅÀÇ ¹ÞÁö ¾Ê´Â´Ù. ±×¸®°í Èí¼öµÈ lacosamide´Â ¾à 40%´Â ´ë»çµÇÁö ¾Ê´Â »óÅ·Π½ÅÀåÀ¸·Î ¹è¼³µÇ°í ¾à 30%´Â °£¿¡¼­ O-desmethyl lacosamide metabolite·Î ³ª¸ÓÁö´Â ¸íÈ®ÇÏ°Ô ¹àÇôÁöÁö ¾ÊÀº ¹°Áú·Î ´ë»çµÈ´Ù. Lacosamide´Â CYP°è È¿¼ÒÀÇ inhibitor ¶Ç´Â inducer·Î ÀÛ¿ëÇÏÁö ¾Ê¾Æ ´Ù¸¥ Ç×Àü°£Á¦³ª ´Ù¸¥ ¾à¹°°ú ¾à¹°»óÈ£ÀÛ¿ëÀÇ °¡´É¼ºÀÌ ¸Å¿ì ³·°í »ýüÀÌ¿ë·üÀÌ 100%¿¡ ´ÞÇϸç T max°¡ 0.5 hr¿¡ À̸£´Â µîÀÇ ¸¹Àº ÀåÁ¡À» Áö´Ï°í ÀÖ´Ù. ÇÑÆí 2015³â º¸°íµÈ VITOBA study¿¡¼­ ±âÁ¸¿¡ 2°¡Áö ÀÌ»óÀÇ Ç׳úÀüÁõ¾àÀ» ó¹æ ¹Þ°í ÀÖ´Â ¾à¹° ³­Ä¡¼º ³úÀüÁõȯÀÚ¿¡¼­ ºÎ°¡¿ä¹ýÀ¸·Î lacosamide¸¦ º¹¿ëÇÑ °á°ú ¹ßÀÛ Á¶Àý¿¡ È¿°úÀûÀ̾ú´Ù´Â ¿¬±¸°á°ú¸¦ ¹ßÇ¥ÇÏ¿´´Ù[±×¸²2]. ¾ÈÁ¤¼º Ãø¸é¿¡¼­ º¸¸é ÁÖ·Î ¹ß»ýÇÒ ¼ö ÀÖ´Â ºÎÀÛ¿ëÀ¸·Î´Â ÇǷΰ¨ ¹× ¾îÁö·¯¿òÁõÀÌ ÀÖ¾úÀ¸³ª Ä¡¸íÀûÀÎ ºÎÀÛ¿ëÀº º¸°íµÈ ¹Ù ¾ø¾ú´Ù[Ç¥1]. ±¹³»¿¡¼­´Â ÇöÀç 16¼¼ ÀÌ»óÀÇ ³úÀüÁõ ȯÀÚ¿¡¼­ 2Â÷¼º Àü½Å¹ßÀÛÀ» µ¿¹ÝÇϰųª µ¿¹ÝÇÏÁö ¾Ê´Â ºÎºÐ¹ßÀÛ Ä¡·áÀÇ ºÎ°¡¿ä¹ýÀ¸·Î ÀûÀÀÁõÀ» °¡Áö°í ÀÖ´Ù. ¿ë¹ýÀº ½Ä»ç¿Í °ü°è¾øÀÌ 1ÀÏ 2ȸ º¹¿ë ÇØ¾ß ÇÏ°í ÃÊȸ ±ÇÀå·®Àº 1ȸ 50mgÀÌ°í ¸ÅÁÖ 1ȸ 50mg¾¿ Áõ·®ÇÒ ¼ö ÀÖÀ¸¸ç ÃÖ´ë ±ÇÀåÅõ¿©·®Àº 1ÀÏ 400mgÀÌ´Ù. ÀÌó·³ ±¹³»¿¡¼­´Â ÇöÀç±îÁö ´Üµ¶¿ä¹ýÀ¸·Î ÀûÀÀÁõÀ» °¡ÁöÁö ¸øÇØ »õ·Î Áø´ÜµÈ ³úÀüÁõȯÀÚ¿¡°Ô ó¹æÇϱâ´Â ½±Áö ¾ÊÀº Á¦ÇÑÁ¡ÀÌ ÀÖ´Ù.
   
¡ã [±×¸² 1] Potential mechanisms of action of lacosamide. (from Beyreuther BK et al. CNS Drug Rev. 2007 Spring;13(1):21-42 )

 

 

 

 

 

 

 

 

 





   
¡ã [±×¸² 2] Seizure control and responder rates. Percentage calculations are based on the number of subjects at the final visit. (CBZ, carbamazepine; LEV, levetiracetam; LTG, lamotrigine; OXC, oxcarbazepine; TPM, topiramate; VPA, valproate. SCB(+), sodium channel blocker; SCB(-), not considered a traditional sodium channel blocker). (from Runge U et al. Epilepsia. 2015 Dec;56(12):1921-30)

 

 

 

 

 

 

 

 

 

   
¡ã [Ç¥ 1] Incidence of most common treatment-emergent adverse events (≥15% of the Safety Set)a Medical Dictionary for Regulatory Activities (MedDRA), version 9.1 preferred term.b Percentage of patients who reported ≥1 event during treatment. (from Rosenfeld W et al. Epilepsy Behav. 2014 Dec;41:164-70 )














º» Áõ·Ê¿¡¼­Ã³·³ ±âÁ¸ÀÇ Ç׳úÀüÁõ¾à¹É·Î °æ·Ã Á¶ÀýÀÌ ÀßµÇÁö ¾Ê´Â ³úÀüÁõ ȯÀÚ±º¿¡¼­ »õ·Î¿î ¾à¹° lacosamideÀÇ ºÎ°¡¿ä¹ýÀ» ½ÃÇàÇÔÀ¸·Î ¾à¹°À» »ç¿ëÇϸ鼭 »ý±â´Â ºÎÀÛ¿ëÀ» ÃÖ¼ÒÈ­Çϸ鼭 ºÎºÐ¹ßÀÛÀ» È¿°úÀûÀ¸·Î Á¶ÀýÇÒ ¼ö ÀÖÀ» °Å¶ó »ý°¢ÇÑ´Ù.


 Reference
1. Bettina K. B., Joachim F., Cara H., Niels K., Ute S., and Thomas S. Lacosamide: A Review of Preclinical Properties. CNS Drug Reviews Vol. 13, No. 1, pp. 21–42
2. Uwe R., Stephan A., Christian B., Fritjof R., Frank K., Kathleen I., Francisco R., Peter D., Thomas L.,
Matthias N., and Thomas M. A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study. Epilepsia, 56(12):1921–1930, 2015
3. William R., Nathan B. F., Gintaras K., Elinor B., Cindy M., Jouko I., Pamela D., Safety and efficacy of adjunctive lacosamide among patients with partial-onset seizures in a long-term open-label extension trial of up to 8 years. Epilepsy & Behavior 41 (2014) 164–170

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