Safety of 25- and 50-mg capsules in the initiation of zonisamide therapy in patients with epilepsy: an uncontrolled,open-label study

SUMMARY

Objective: This study was designed to assess the safety of 25- and 50-mg dosage strengths of zonisamide for initial titration in patients with epilepsy.

Research design and methods: This phase 3, multicenter, open-label, uncontrolled study conducted at 26 study sites in the United States included male and female patients with epilepsy ≥ 12?years of age. After a screening visit, subjects began zonisamide therapy at a dosage depending on their body weight. Zonisamide was titrated to 100?mg/day.

Main outcome measures: At the study's conclusion, information regarding adverse events (AEs) and body weight was recorded.

Results: One hundred forty-three subjects enrolled and received at least one zonisamide dose. Of these subjects, 125 reached at least the 100-mg dosage before terminating the study. Eighty-two subjects (57.3%) experienced at least one AE. Most commonly reported AEs included headache, somnolence, asthenia, rhinitis, nausea, and rash. No significant change in patient body weight was noted during the study (95% confidence interval: –0.1, 0.6).

Conclusions: Study limitations include the open-label design and the lack of direct comparison between lower (25- and 50-mg) and higher (100-mg) starting dosages. Despite these limitations, the 25- and 50-mg zonisamide dosage formulations were well tolerated in this study.     

Gemifloxacin versus Amoxicillin/Clavulanate in the Treatment of Acute Exacerbations of Chronic Bronchitis

Abstract

Six hundred patients were evaluated in this randomized, double-blind, double-dummy, multicenter, parallel-group study comparing the efficacy and safety of gemifloxacin (320 mg once-daily for 5 days) and amoxicillin/clavulanate (500/125 mg three-times daily for 7 days) for the treatment of acute exacerbations of chronic bronchitis (AECB). Of note, more than 90% of study participants had stage 2 disease at study entry. The two drugs were found to be equally effective, with clinical success rates of 93.6% for gemifloxacin and 93.2% on amoxicillin/clavulanate (95% CI ?3.9 to 4.6). Bacteriological success rates favored gemifloxacin (90.9% compared with 79.5% for amoxicillin/clavulanate; 95% CI ?3.3 to 26.0); however, this difference was not statistically significant. Gemifloxacin and amoxicillin/clavulanate were both well tolerated. In summary, gemifloxacin was found to be well tolerated and effective for the treatment of AECB, suggesting it is well suited for empirical treatment of this common respiratory condition in the current clinical environment.