Modified-release hydrocortisone (Plenadren) launched for adrenal insufficiency
Plenadren (hydrocortisone) is indicated for maintenance therapy in adrenal insufficiency.
Modified-release hydrocortisone is not associated with the non-physiological cortisol peaks produced by standard glucocorticoid therapy.
Plenadren (hydrocortisone) is a modified-release hydrocortisone tablet given once daily. It is intended to better mimic the physiological pattern of cortisol production than standard glucocorticoid replacement therapy.
Cortisol exposure
In a randomised open-label 12-week crossover study in 64 patients with primary adrenal insufficiency, once-daily modified-release hydrocortisone resulted in increased cortisol exposure during the first four hours after intake in the morning, with reduced exposure in the late afternoon and evening and over the 24-hour period compared with standard-release hydrocortisone (given three times daily). The safety profile was similar to that of conventional hydrocortisone.
双相释放片 Plenadren
欧洲药品管理局于2011年11月7日批准了ViroPharma 公司(原DuoCort公司)研収的氢化可的松双相释放片(商品名Plenadren,一日 1次)的注册申请。本品由快速释药的外层和能模拟机体自身皮质醇释放特性而缓慢释药1天以上的内核组成,用于治疗肾上腺皮质功能丌全患者的糖皮质激素替代疗法。 一项由64名患者参不的II/III 期临床研究评估了本品(5和20 mg,日服1次)的生物利用度、有效性和安全性。结果表明,本品安全性和耐叐性良好。本品通过模拟血浆皮质醇的生理性昼夜节律发化,可改善患者的心血管和代谢状况。研究中还观察到伴随糖尿病患者的糖代谢得到改善。
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