在年龄≥12岁的日本患者中,52周应用盐酸奥昔布宁20%洗剂(20%OL)治疗原发性手汗症(PPHH)的长期安全性和有效性在4周的开放标签扩展(OLE)中进行了评估,随机化,双盲(DB)研究。OLE包括114名完成DB研究并希望继续治疗的患者和12名新患者。在安全性分析人群(125名患者)中,不良事件(AE)和药物不良反应(ADR)的发生率分别为79.2%和36.0%,分别。在两名患者中观察到严重的AE,但认为与研究药物无关。导致研究中止的AE发生率为1.6%。应用场所不良事件和不良反应发生率分别为35.2%和26.4%,分别。大多数事件的严重程度为轻度。与口干相关的抗胆碱能AEs的发生率为口渴的3.2%,咽干的0.8%。20%OL的长期疗效通过持续减少汗液量和改善多汗症疾病严重程度量表和皮肤病生活质量指数得到证实。这项研究有几个局限性:首先,结果可能包括一些偏见,因为大多数参与者来自先前的DB研究;其次,结果可能无法推广,因为只有少数参与者处于最容易患PPHH的年龄组(即,<15岁);第三,这项研究没有从治疗中获得安全性信息超过52周,因此,这些信息必须在未来的临床实践中收集。在本研究中,在应用20%OL52周后,在PPHH患者中没有观察到降低的治疗效果。此外,少数患者出现严重AE或导致研究治疗中止的AE.
The long-term safety and efficacy of 52-week application of oxybutynin hydrochloride 20% lotion (20% OL) for the treatment of primary palmar hyperhidrosis (PPHH) in Japanese patients aged ≥12 years were evaluated in an open-label extension (OLE) of a 4-week, randomized, double-blind (DB) study. The OLE included 114 patients who completed the DB study and wished to continue treatment and 12 new patients. In the safety analysis population (125 patients), the incidence of adverse events (AEs) and adverse drug reactions (ADRs) was 79.2% and 36.0%, respectively. Serious AEs were observed in two patients but were considered unrelated to the investigational drug. The incidence of AEs that led to study discontinuation was 1.6%. The incidence of application site AEs and ADRs was 35.2% and 26.4%, respectively. The severity of most events was mild. The incidence of anticholinergic AEs related to dry mouth was 3.2% for thirst and 0.8% for dry throat. The long-term efficacy of 20% OL was confirmed by a long-lasting reduction in sweat volume and improvement in the Hyperhidrosis Disease Severity Scale and Dermatology Life Quality Index. This study has several limitations: First the results may include some bias because most of the participants were from the prior DB study; second, the results may not be generalizable because only a few participants were in the age group most susceptible to PPHH (i.e., < 15 years old); and third, the study did not obtain safety information from treatment for more than 52 weeks, so this information must be collected in clinical practice in the future. No reduced therapeutic effect was observed in patients with PPHH in this study after 52-week application of 20% OL. Also, few patients experienced serious AEs or AEs that led to study treatment discontinuation.