贝罗司他胶囊(奥拉迪约)在研究中的安全性和耐受性良好

Capsules (Oradio) were safe and well-tolerated in studies:

Berosostat is a once-daily oral form of kallikrein used to prevent attacks of hereditary angioedema (HAE).

PURPOSE: To determine the efficacy, safety, and tolerability of berosostat over a 24-week treatment period in patients with HAE (Phase 3 APeX-2 trial).

Methods: A double-blind parallel study in which 40 patients in 11 countries were randomly assigned in a 1:1:1 ratio to once-daily beroxostat capsules 110 mg, 150 mg, or placebo (Clinicaltrials.gov, NCT03485911). Patients ≥12 years of age with HAE due to C1 inhibitor deficiency and ≥2 investigator-confirmed HAE episodes during the first 56 days of the pre-run-in period were eligible. The primary efficacy endpoint was the rate of investigator-confirmed HAE episodes during the 24-week treatment period.

Results: 121 patients were randomized, 120 of whom received ≥1 dose of study drug (N = 41, 40, and 39 for beroxostat 110 mg, 150 mg, and placebo, respectively). Beroxostat significantly reduced attack rates compared with placebo (2.35 attacks/month) at both 110 mg (1.65 attacks/month; p = 0.024) and 150 mg (1.31 attacks/month; p < 0.001). The most common treatment-emergent adverse events (TEAEs) with berosostat compared with placebo were abdominal pain, vomiting, diarrhea, and back pain. No serious drug-related TEAEs occurred.

Conclusions: Beroxostat 110 mg and 150 mg doses reduced HAE attack rates compared with placebo and was safe and well tolerated. The most favorable risk profile was observed at the 150 mg/day dose.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.

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