78 patients were included in two treatment arms of a placebo-controlled multicenter trial that was conducted in Germany to examine the efficacy and safety of mizolastine (M) (n = 39) as a one-daily 10 mg dose in chronic urticaria vs. placebo (P) (n = 39). Treatment was given over a 4-week period. The patients (mean age 40 ± 13 years) had a mean number of urticarial episodes per week of 7.6 (M) and 8.4 (P). The main characteristics of the two groups regarding demography, disease history and disease severity were comparable at inclusion. 19 patients (24.4%) dropped out during the study (M: 11; P: 8). The mean total symptom score of the patient diary card dropped to a significant greater extent in the M arm (-1.6) compared to the P arm (- 0.7) (p = 0.039). Also the decrease in the mean number of urticaria crises per week was statistically significant greater in the M group (-2.8) than in the P group (+0.6) (p = 0.023). As another efficacy criterion, the daily number of urticaria crises was reduced significantly in the M arm (-0.8) compared to the P arm (+0.1) (p = 0.043). The cardiovascular parameters as well as the body weight did not vary significantly between the two treatment arms. A total of 14 adverse events in 13 patients in the P group and 19 adverse events in 14 patients in the M group were reported. Asthenia/fatigue, headache, and influenza-like symptoms were reported slightly more frequently under M treatment, whereas rhinitis and bronchitis were more frequent in the P arm. Longer lasting drowsiness or sedation was not observed in either of the two treatment groups. The therapeutic efficacy of 10 mg M given once a day was clinically and statistically superior to P in the treatment of chronic urticaria. M showed a good safety profile that was comparable to P.
|Translated title of the contribution||Successful treatment of chronic urticaria with mizolastine - Results of a placebo-controlled study|
|Issue number||SUPPL. 1|
|Publication status||Published - 1999|
- Urticaria therapy