Drug Safety Research Unit, Bursledon Hall, Southampton, UK.
Drug Saf. 2010 Mar 1;33(3):213-21. doi: 10.2165/11533720-000000000-00000.
Intrinsa is a transdermal testosterone patch that is indicated for use in hypoactive sexual desire disorder (HSDD) in women who have undergone bilateral oophorectomy and hysterectomy (surgically-induced menopause) receiving concomitant oestrogen therapy.
To describe the utilization characteristics of the patients prescribed testosterone patch (Intrinsa) based on an interim analysis of an ongoing Prescription-Event Monitoring study in England, and to assess, where possible, if the product is being used within the licensed therapeutic indication.
In this interim analysis, patients were identified from dispensed prescriptions that had been issued by general practitioners (GPs) for Intrinsa from March 2007. 'Green form' questionnaires were sent to GPs 6 months following the date of the first prescription for Intrinsa for each individual patient, requesting information including age, sex, start and stop dates of treatment (if stopped), prescribing indication and reasons for stopping. Additional questions were asked regarding the patient's menopausal status and use of concomitant oestrogen therapy.
The interim cohort consisted of 756 patients. The majority of patients were reported to be female (746 [98.7%]) with a median (interquartile range) age of 50 years (44-55 years). The most commonly reported indication was the licensed indication of HSDD in 580 patients (76.7%). Just under one-half of the patients (n = 364 [48.1%]) were reported to have been hysterectomized and bilaterally oophorectomized (surgically-induced menopause) prior to starting Intrinsa; 127 patients (16.8%) were naturally menopausal. For 222 patients (29.4%) the GP specified that the patient was not using concomitant oestrogen therapy. Overall, only 219 patients (29.0%) in the cohort were being prescribed Intrinsa according to the manufacturer's recommendations.
This study has highlighted that some clinicians are prescribing this product outside the recommended terms of the licence, with less than 30% of patients receiving Intrinsa according to prescribing guidelines. All events experienced by these patients will be analysed to detect any possible adverse events from using Intrinsa outside of the licensed therapeutic indication. The findings support the ongoing postmarketing risk management of the product.
Intrinsa 是一种经皮睾酮贴片，适用于已接受双侧卵巢切除术和子宫切除术（手术诱导绝经）且正在接受联合雌激素治疗的女性的低性欲障碍（HSDD）。
根据英国正在进行的处方事件监测研究的中期分析，描述使用睾酮贴片（Intrinsa）的患者的利用特征，并在可能的情况下评估该产品是否在许可的治疗适应证范围内使用。
在本次中期分析中，从 2007 年 3 月开始，从全科医生（GP）为 Intrinsa 开出的处方中确定了患者。在每位患者的第一份 Intrinsa 处方后 6 个月，向 GP 发送了“绿色表格”问卷，要求提供包括年龄、性别、治疗开始和结束日期（如果已停止）、处方适应证和停药原因在内的信息。还询问了患者的绝经状态和是否同时使用雌激素治疗的情况。
中期队列包括 756 名患者。大多数患者报告为女性（746 [98.7%]），中位（四分位间距）年龄为 50 岁（44-55 岁）。最常报告的适应证是 HSDD 的许可适应证，有 580 名患者（76.7%）。近一半的患者（n = 364 [48.1%]）在开始使用 Intrinsa 前已接受子宫切除术和双侧卵巢切除术（手术诱导绝经）；127 名患者（16.8%）自然绝经。对于 222 名患者（29.4%），GP 指出患者未同时使用雌激素治疗。总体而言，在该队列中，只有 219 名患者（29.0%）按照制造商的建议处方 Intrinsa。
本研究表明，一些临床医生在处方该产品时超出了许可证的推荐条款，不到 30%的患者按照处方指南接受 Intrinsa 治疗。将分析这些患者经历的所有事件，以检测在许可的治疗适应证之外使用 Intrinsa 可能产生的任何不良反应。研究结果支持该产品正在进行的上市后风险管理。
