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Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties

机译:阿瓦那非治疗勃起功能障碍:初步数据和临床关键特性

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Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical management of erectile dysfunction (ED) of various etiologies and severities. However, a significant number of patients remain dissatisfied with the available therapies due a lack of efficacy or discomfort arising from adverse events. Several new PDE5 inhibitors, among which are avanafil (TA-1790), lodenafil, mirodenafil, udenafil, SLX-2101, JNJ-10280205 and JNJ-10287069, have recently been approved and introduced into the market or are in the final stages of their clinical development. Avanafil (marketed in the US under the brand name STENDRA?) has been developed by VIVUS Inc. (Mountain View, CA, USA) and has recently received approval from the US Food and Drug Administration (FDA) for use in the treatment of male ED. The drug has demonstrated improved selectivity for PDE5, is rapidly absorbed after oral administration with a fast onset of action and a plasma half-life that is comparable to sildenfil and vardenafil. In phase II and phase III clinical trials that included a large number of patients, avanafil has been shown to be effective and well tolerated. Owing to its favorable pharmacodynamic and pharmacokinetic profile, avanafil is considered as a promising new option in the treatment of ED. The present article summarizes the initial data and clinical key properties of avanafil.
机译:口服活性的5型磷酸二酯酶选择性抑制剂(PDE 5,环状GMP PDE),例如西地那非,他达拉非和伐地那非,目前是各种病因和病情严重的勃起功能障碍(ED)临床管理的首选治疗选择。然而,由于缺乏由不良事件引起的功效或不适,许多患者仍然对可用的治疗方法不满意。最近批准了几种新的PDE5抑制剂,其中包括avanafil(TA-1790),lodenafil,mirodenafil,udenafil,SLX-2101,JNJ-10280205和JNJ-10287069,或已进入市场或处于其最终阶段临床发展。 Avanafil(在美国以STENDRA?品牌销售)由VIVUS Inc.(位于美国加利福尼亚州山景城)开发,最近已获得美国食品和药物管理局(FDA)的批准,可用于治疗男性ED。该药物对PDE5的选择性提高,在口服后迅速吸收,起效快,血浆半衰期可与sildenfil和vardenafil媲美。在包括大量患者的II期和III期临床试验中,显示了avanafil是有效的且耐受性良好。由于其良好的药效和药代动力学特性,阿伐那非被认为是治疗ED的有希望的新选择。本文总结了avanafil的初始数据和临床关键特性。

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