Methods: Data on treatment-emergent AEs were pooled from 6 randomized, double-blind studies in which patients with symptomatic allergic rhinitis received DL 2.5-20 mg/d or placebo (PBO) for 2-12 wk. Participants had to be free of other clinically significant disease that would interfere with study evaluations. In the present analysis, data were pooled for all participants aged ³55 y. AEs assessed in this analysis included: 1) those reported in the package insert as occurring more frequently in DL-treated than PBO-treated subjects (COM-AE), 2) those that may be related to anticholinergic activity (ACh-AE), and 3) those associated with drug hypersensitivity (HS-AE). AE rates are summarized descriptively; no statistical analysis was conducted.
Results: The pooled population was 150 subjects (mean age 61.3 y) for DL and 100 (mean age 61.3 y) for PBO. Total incidence of AEs was 43% for DL and 42% for PBO. Several of the COM-AEs occurred as or less frequently with DL than PBO; fatigue was more common in DL-treated subjects (DL 7% vs PBO 1%). Gastrointestinal and mucosal ACh-AEs were infrequent in DL-treated and PBO-treated subjects. HS-AEs were generally less frequent in DL-treated vs PBO-treated subjects. No serious AEs were reported for DL or PBO.
Conclusions: This analysis adds to the limited published data on the safety and tolerability of second-generation antihistamines in older adults with AR and demonstrates that DL was well tolerated in this patient population. The pattern and frequency of AEs—including those that have been associated with DL or with the antihistamine class—were similar between patients treated with DL and those who received PBO.