Green Roger, Hicks Rodney W
The University of Arizona College of Nursing, Tucson, AZ, USA;
Patient Prefer Adherence. 2011 Apr 13;5:181-5. doi: 10.2147/PPA.S14030.
Erectile dysfunction (ED) is a well-documented medical condition that is expected to increase significantly over the next several decades, especially as men live longer and the prevalence of diabetes and cardiovascular diseases increase. Pharmacology agents are often the first line treatment approach. Newer solid dosage forms, known as orally disintegrating tablets (ODT), are now available as one treatment option.
To review the drug delivery mechanisms of ODTs in general and to review safety and efficacy of vardenafil ODT (a PDE-5 inhibitor) as a treatment option for management of ED.
Literature reviews were performed of pharmaceutical dosage forms and the POTENT I (n = 358 subjects) and POTENT II (n = 337 subjects) studies that investigated vardenafil ODT.
Vardenafil ODT has been successfully used in multiple age groups and in multiple settings with men from various ethnic backgrounds. Efficacy of vardenafil ODT, as measured using the International Index of Erectile Function (IIEF-EF) and from the Sexual Encounter Profile (SEP) was significantly greater than placebo (P < 0.0001) at 12 weeks. Safety profiles were similar to film-coated dosage forms with no patient deaths reported.
Vardenafil ODT offers a convenient, ready-to-use approach for combating ED. Safety concerns are similar to other PDE-5 inhibitors and practitioners should counsel patients accordingly.
勃起功能障碍（ED）是一种有充分文献记载的医学病症，预计在未来几十年中会显著增加，尤其是随着男性寿命延长以及糖尿病和心血管疾病患病率上升。药物治疗通常是一线治疗方法。新型固体剂型，即口腔崩解片（ODT），现已作为一种治疗选择。
综述ODT的一般药物递送机制，并综述伐地那非ODT（一种磷酸二酯酶-5抑制剂）作为ED治疗选择的安全性和有效性。
对药物剂型以及研究伐地那非ODT的POTENT I（n = 358名受试者）和POTENT II（n = 337名受试者）研究进行了文献综述。
伐地那非ODT已成功用于多个年龄组以及来自不同种族背景男性的多种情况。使用国际勃起功能指数（IIEF-EF）和性活动记录（SEP）衡量，伐地那非ODT在12周时的疗效显著高于安慰剂（P < 0.0001）。安全性概况与薄膜包衣剂型相似，未报告患者死亡。
伐地那非ODT为对抗ED提供了一种方便、即用型的方法。安全性问题与其他磷酸二酯酶-5抑制剂相似，从业者应据此为患者提供咨询。
