Glass Daniel J, Harper Anne S
Zynx Life Sciences, Cerner Corporation, Beverly Hills, CA, USA.
BMC Fam Pract. 2003 Aug 13;4:10. doi: 10.1186/1471-2296-4-10.
The FDA recently moved loratadine (Claritin) from prescription only status to over-the-counter (OTC). In response to the availability of an OTC non-sedating antihistamine, many managed care organizations are reevaluating which if any prescription antihistamines should remain on formulary. From a managed care perspective, determining which of the remaining prescription antihistamines results in the greatest patient satisfaction with allergy treatment would be informative.
We report on a weighted cross sectional survey (n = 10,023) delivered online to a sample of allergy sufferers in the U.S. during the month of December 2002. Two segments were identified for analysis: patient who were dissatisfied with loratadine and converted to desloratadine (Clarinex; n = 61), and patients who were dissatisfied with loratadine and converted to fexofenadine (Allegra; n = 211). The two segments were compared along a series of measures that the literature suggests are related to treatment satisfaction.
The survey found that two of the satisfaction measures differentiated desloratadine converters from fexofenadine converters (p <.05): mean sum of self-reported adverse events and nighttime awakening due to allergy symptoms. For the remainder of satisfaction measures though, patients who were dissatisfied with loratadine reported equal duration of coverage and satisfaction with desloratadine as fexofenadine. When severity of disease was controlled for in the analysis, a pattern emerged suggesting greater levels of satisfaction amongst loratadine dissatisfied patients who converted to desloratadine. Point estimates suggest a consistent pattern favoring desloratadine patient satisfaction, with statistically significant results reported for sum of adverse effects, nighttime awakening due to symptoms, symptom severity just prior to the next dose, and overall satisfaction (p < 0.05).
On average, patients who were dissatisfied with loratadine reported equal or better satisfaction with desloratadine as fexofenadine. Patients with severe allergic rhinitis reported greater satisfaction when converted from loratadine to desloratadine than fexofenadine for select satisfaction measures. These results suggest that if managed care intends to position prescription antihistamines as second line for OTC loratadine treatment dissatisfaction, desloratadine is a useful treatment alternative. These findings, while informative to formulary decision-makers, must be interpreted with caution. Only through head-to-head controlled clinical trials can differences in efficacy and safety be established.
美国食品药品监督管理局（FDA）最近将氯雷他定（克敏能）从仅需处方用药改为非处方（OTC）药。鉴于一种非处方非镇静抗组胺药的出现，许多管理式医疗组织正在重新评估哪些处方抗组胺药（如果有的话）应保留在药品目录中。从管理式医疗的角度来看，确定剩余的哪种处方抗组胺药能使患者对过敏治疗的满意度最高将很有意义。
我们报告了一项于2002年12月在线开展的加权横断面调查（n = 10,023），调查对象为美国的过敏患者样本。确定了两个分析组：对氯雷他定不满意并改用地氯雷他定（恩理思；n = 61）的患者，以及对氯雷他定不满意并改用非索非那定（阿乐格拉；n = 211）的患者。根据文献表明与治疗满意度相关的一系列指标对这两组进行了比较。
调查发现，有两项满意度指标区分了改用氯雷他定的患者和改用非索非那定的患者（p <.05）：自我报告的不良事件总和以及因过敏症状导致的夜间觉醒。然而，对于其余的满意度指标，对氯雷他定不满意的患者报告称，使用地氯雷他定和非索非那定的覆盖时长和满意度相同。在分析中对疾病严重程度进行控制后，出现了一种模式，表明改用氯雷他定的对氯雷他定不满意的患者满意度更高。点估计表明存在一种始终有利于地氯雷他定患者满意度的模式，不良反应总和、因症状导致的夜间觉醒、下次服药前的症状严重程度以及总体满意度均报告有统计学显著结果（p < 0.05）。
总体而言，对氯雷他定不满意的患者报告称，使用地氯雷他定的满意度与使用非索非那定相同或更高。对于某些满意度指标，患有严重过敏性鼻炎的患者从氯雷他定改用氯雷他定后的满意度高于改用非索非那定后的满意度。这些结果表明，如果管理式医疗打算将处方抗组胺药定位为对非处方氯雷他定治疗不满意的二线用药，地氯雷他定是一种有用的替代治疗药物。这些发现虽然对药品目录决策者有参考价值，但必须谨慎解读。只有通过直接对照的临床试验才能确定疗效和安全性的差异。
