십이지장궤양에 대한 레바프라잔 정제의 제3상 임상시험 = Revaprazan (Revanex？), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial

다국어 초록 (Multilingual Abstract)

Background/Aims: To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial. Methods: Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain. Results: Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated. Conclusions: Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer.

국문 초록 (Abstract)

목적: 레바프라잔은 세계 최초로 개발된 위산펌프 길항제로 강력한 위산분비 억제력을 가지고 있다. 십이지장궤양 환자에 대한 레바프라잔의 유효성과 안전성을 평가하고자 오메프라졸을 대조군으로 하여 이중맹검, 평행, 다기관 3상 시험을 실시하였다. 대상 및 방법: 국내 17개 병원에서 십이지장궤양 환자 228명을 대상으로 하여 레바프라잔 200 mg군과 오메프라졸 20 mg 두 군으로 무작위로 배정하였으며, 4주 동안 1일 1회 경구로 투약하였다. 1차 유효성 평가기준은 내시경 검사에 의한 십이지장궤양의 완전한 치유로 정하였으며, 2차 유효성 평가기준은 주간 및 야간 통증의 호전 정도로 판정하였다. 결과: 내시경 검사에 의한 완치율은 intention-to-treat (ITT) 분석결과 레바프라잔 200 mg 투여군과 오메프라졸 20 mg 투여군에서 각각 91.7% (99/108)와 91.3% (105/115)로 두 군간에 통계적으로 유의한 차이는 없었으며(p=0.9228), 95% 신뢰구간은 각각 86.5～96.9%와 86.2～96.5%를 보였다. Per-protocol (PP) 분석결과에서는 레바프라잔 200 mg 투여군과 오메프라졸 20 mg 투여군의 완치율은 각각 94.4% (84/89)와 92.3% (96/104)로 두 군 간에 통계적으로 유의한 차이는 없었으며(p=0.5666), 95% 신뢰구간은 각각 89.6～99.2%와 87.2～97.4%를 보였다. 주간 및 야간 통증의 유효율은 ITT분석 및 PP분석 결과 모두에서 투약 후 2, 4주 시점에 두 군 간 통계적으로 차이가 없었다. 각 시험군에서 관찰된 이상반응은 모두 경미한 정도였으며 레바프라잔 200 mg 투여군과 오메프라졸 20 mg 투여군에서 유사한 빈도로 관찰되었다. 결론: 십이지장궤양에 대한 레바프라잔 200 mg의 3상 시험결과 내시경 검사에 의한 완치율과 주간 및 야간 통증의 유효율 등에서 대조약인 오메프라졸 20 mg과 차이가 없었으며, 안전성 측면에서도 두 약물의 이상반응 발현율과 빈도는 차이가 없었다.

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