급성 편두통 환자에서 Eletriptan, Lasmiditan, Ubrogepant 간의 유효성과 안전성 평가: 체계적 문헌고찰 및 간접비교 분석
Evaluation of the Efficacy and Safety of Eleriptan vs. New Drugs (Lasmiditan and Ubrogepant) in Patients with Acute Migraine: Systematic Review and Indirect Comparison Analysis
OBJECTIVE To compare the efficacy and safety of two new drugs for acute migraine (lasmiditan and ubrogepant) with placebo and eletriptan as well as between the two new drugs. METHOD The PubMed, Cochrane Library, and Clinical Trial.gov databases were searched for randomized-controlled trials of Eletriptan, Lasmiditan and Ubrogepant for patients with migraine. Systematic reviewer screened the literature according to inclusion and exclusion criteria and performed quality assessment and data extraction. Review Manager 5.4 software was used for the meta-analysis. A meta-analysis of clinical studies were performed, as well as an indirect comparison of Eletriptan versus Lasmiditan, Eletripatan versus Ubrogepant and Lasmiditan versus Ubrogepant. The primary efficacy endpoint was pain-free response at 2hours. secondary efficacy endpoint was Sustained pain-free at 24 hours. In addtion, The primary safety endpoint was TEAEs and secondary safety endpoint was incidence of cardiac disorder TEAEs. RESULTS We identified 11 single migraine attack trials, of which eight trials assessed the new drugs and three trials assessed eletriptan. The network meta analysis showed that lasmiditan and ubrogepant were statistically superior to placebo in terms of relieving pain in 2 hours (lasmiditan; OR 2.18 [1.83, 2.60]), (ubrogepant; OR 1.79 [1.44, 2.21]); however, there was no statistically significant difference between lasmiditan and ubrogepant. In contrast, eletriptan showed higher odds of achieving pain freedom at 2 hours than lasmiditan and ubrogepant; OR 3.03 (95% CI:1.59, 5.77) and OR 3.69 (95% CI: 1.92, 7.11). Indirect comparison results showed no differences in the odds of cardiovascular treatment emergent adverse events among lasmiditan, ubrogepant, and eletriptan in the trials. However, lasmiditan had higher odds of causing treatment emergent adverse events than ubrogepant (OR 4.79 [2.73, 8.40]). CONCLUSION An indirect comparison showed that lasmiditan and ubrogepant provided substantial benefits relative to placebo in acute migraine patients. Moreover, they had similar benefits, but lasmiditan had more side effects. However, lasmiditan and ubrogepant are less effective than eletriptan. Long-term and large-scale randomized studies are required to confirm the study results.
목차
Abstract 서론 연구방법 1. 문헌 검색 방법 및 기간 2. 문헌 선정 기준 3. 문헌 선정 과정 4. 문헌의 질 평가 5. 자료 합성 및 간접비교분석 연구결과 1. 문헌 검색 및 선정 결과 2. 선정된 연구의 특징 3. 비뚤림 위험 평가 4. 간접비교 가능 여부에 대한 최종 평가 및 교환 가능성 평가 5. 유효성 평가 항목 분석 결과 6. 안전성 평가 항목 분석 결과 7. 유효성 평가항목에 대한 간접비교 결과 8. 안전성 평가항목에 대한 간접비교 결과 고찰 결론 References
키워드
Acute migraineeletriptanlasmiditanubrogepant
저자
이성민 [ Sung min Lee | 연세대학교 대학원 제약산업학 협동과정, 연세대학교 약학대학, 연세대학교 종합약학연구소 ]
서재경 [ Jae Kyung Suh | 한국보건의료연구원 ]
한은아 [ Euna Han | 연세대학교 약학대학, 연세대학교 종합약학연구소 ]
강혜영 [ Hye-Young Kang | 연세대학교 약학대학, 연세대학교 종합약학연구소 ]
Corresponding Author
한국보건사회약료경영학회 [Korean Academy of Social & Managed Care Phemacy]
설립연도
2009
분야
의약학>약학
소개
본 학회는 비영리 학술단체로서 환자의 삶의 질 향상을 위한 약료(pharmaceutical care)가 보장될 수 있도록 약료경영약학(managed care pharmacy)을 발전시키는 데 궁극 목적을 두고 다음과 같은 활동을 전개하여 사회에 기여하며 회원 상호간의 친목을 도모한다.
간행물
간행물명
한국보건사회약료경영학회지 [Journal of Korean Academy of Managed Care Pharmacy]