Real-Life Effectiveness of MP-AzeFlu (Dymista^®) in Swedish Patients with Persistent Allergic Rhinitis, Assessed by the Visual Analogue Scale.

IF 2.3 Q2 MEDICINE, GENERAL & INTERNAL

Pragmatic and Observational Research Pub Date : 2023-01-01 DOI:10.2147/POR.S375403

Pär Stjärne, Duc Tung Nguyen, Hans Christian Kuhl

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Abstract

Background: Many allergic rhinitis (AR) patients have moderate/severe persistent disease. MP-AzeFlu (Dymista^®) comprises intranasal azelastine hydrochloride and fluticasone propionate in a novel formulation delivered in a single device.

Objective: This prospective, noninterventional study assessed the effectiveness of MP-AzeFlu (one spray/nostril twice daily; azelastine hydrochloride = 548 μg; fluticasone propionate = 200 μg) on relieving AR symptom severity.

Methods: A visual analogue scale (VAS; 0 mm [not at all bothersome] to 100 mm [very bothersome]) was used during a 42-day MP-AzeFlu treatment period by 161 persistent AR (PER) patients in routine clinical practice in Sweden. Patients also assessed their sleep quality.

Results: VAS scores decreased from baseline during the treatment period and patients achieved a clinically relevant VAS score cutoff before Day 7, with 89.3% reporting well or partly controlled symptoms on Day 1. VAS score decreased from 61.4 ± 22.4 mm (baseline) to 32.1 ± 24.6 mm on Day 28 and 26.1 ± 24.3 mm on Day 42 (both p < 0.0001), an overall reduction from baseline on Day 42 of 38.1 ± 28.2 mm. The percentage of patients with very good/good sleep quality increased from 3.7%/28.6% on Day 0 to 16.5%/51.5% on Day 42.

Conclusion: MP-AzeFlu provides effective, rapid control of PER assessed by VAS in a real-world clinical setting in Sweden. Symptom improvement was observed at Day 1, sustained for 42 days, and associated with improved sleep quality. MP-AzeFlu significantly improved the QoL of the patients and was well tolerated.

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MP-AzeFlu (Dymista®)在瑞典持续性变应性鼻炎患者中的实际疗效:通过视觉模拟量表评估

背景:许多变应性鼻炎(AR)患者具有中/重度持续性疾病。MP-AzeFlu (Dymista®)由鼻用盐酸氮唑elastine和丙酸氟替卡松组成，是一种通过单一装置递送的新型制剂。目的:这项前瞻性、非介入性研究评估了MP-AzeFlu的有效性(每日两次，每次喷鼻;盐酸氮扎elastine = 548 μg;丙酸氟替卡松= 200 μg)缓解AR症状严重程度。方法:采用视觉模拟量表(VAS);在瑞典的常规临床实践中，161名持续性AR (PER)患者在42天的MP-AzeFlu治疗期间使用了0毫米[完全不麻烦]到100毫米[非常麻烦])。患者还评估了他们的睡眠质量。结果:VAS评分在治疗期间较基线下降，患者在第7天之前达到临床相关的VAS评分截止点，89.3%的患者在第1天报告症状良好或部分控制。VAS评分从61.4±22.4 mm(基线)下降到第28天的32.1±24.6 mm和第42天的26.1±24.3 mm(均p < 0.0001)，从第42天的基线总体下降38.1±28.2 mm。非常好/良好睡眠质量的患者比例从第0天的3.7%/28.6%上升到第42天的16.5%/51.5%。结论:MP-AzeFlu在瑞典的现实世界临床环境中提供了有效、快速的PER控制。第1天观察到症状改善，持续42天，并与睡眠质量改善相关。MP-AzeFlu显著改善了患者的生活质量，且耐受性良好。

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Pragmatic and Observational Research MEDICINE, GENERAL & INTERNAL-

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期刊介绍： Pragmatic and Observational Research is an international, peer-reviewed, open-access journal that publishes data from studies designed to closely reflect medical interventions in real-world clinical practice, providing insights beyond classical randomized controlled trials (RCTs). While RCTs maximize internal validity for cause-and-effect relationships, they often represent only specific patient groups. This journal aims to complement such studies by providing data that better mirrors real-world patients and the usage of medicines, thus informing guidelines and enhancing the applicability of research findings across diverse patient populations encountered in everyday clinical practice.