Greatest International ANtiinfective Trial (GIANT) with moxifloxacin in the treatment of acute exacerbation of chronic bronchitis: subanalysis of Chinese data of a global, multicenter, noninterventional study
Yulin Feng1, Faguang Jin2, Shuang Mu3, Hong Shen4, Xiaohong Yang5, Yuling Wang6, Zhenshan Wang7, Yingjun Kong8, Zuke Xiao9, Qiming Feng10
1Respiratory Department, West China Hospital, Sichuan University, China; 2Respiratory Department, Tang Du Hospital, China; 3Respiratory Department, Peking University People’s Hospital, China; 4Emergency Department, The General Hospital of the People’s Liberation Army, China; 5Respiratory Department, Xinjiang People’s Hospital, China; 6Respiratory Department, Shi Jiazhuang First Hospital, China; 7Respiratory Department, The Second Affiliated Hospital of Dalian Medical University, China; 8Respiratory Department, The First Clinical College of Harbin Medical University, China; 9Respiratory Department, The Jiangxi Provincial People’s Hospital, China; 10Emergency Department, Shanghai Sixth People’s Hospital, China
Background and objective: A single infective acute exacerbation of chronic bronchitis (AECB) has a sustained effect on health status. Although a number of clinical investigations have demonstrated the efficacy of antibiotics in AECB, increased bacterial resistance has caused concern about the efficacy of currently available antibiotic therapies. This subanalysis of a global noninterventional study aimed to evaluate the impact of AECB on the patient and the community and the effectiveness and safety of a treatment with moxifloxacin (MXF) tablets in daily life clinical practice in China.
Methods: This prospective, noninterventional, noncontrolled, multicenter observational study, which started in China in April 2004 and ended in February 2007, was part of the global GIANT study. Patients with a diagnosis of mild to severe AECB were treated with MXF tablets 400 mg for a period at the physician’s discretion. The observation period for each patient covered a complete treatment period with MXF. For each patient, the physician documented data at an initial visit (baseline) and at least one follow-up visit. Data were collected on demography, diagnosis of infection, pretreatment, concomitant diseases and medications, MXF therapy, course of symptoms during investigations, and final assessment of therapy with respect to MXF.
Results: In the Chinese subset of the GIANT study, a total of 11,377 patients were included in the intention-to-treat/safety population. At the end of the initial treatment period, improvement and recovery from infection was observed for 98.6% (n = 11,217/11,377) and 92.6% (n = 10,540/11,377) of all patients. After 1 week of treatment, 76.3% (n = 8681/11,377) of patients had recovered. Median time until improvement and recovery was 3.0 and 6.0 days, respectively. Correspondingly, in 95.8% (n = 10,903/11,377) of all patients, overall effectiveness during the initial treatment period with MXF was assessed as “very good” or “good”. Compared with the last AECB, the number of days with impact on daily-life activities and the number of nights with sleep disturbances decreased from 3.0 to 2.0 (median) and from 2.0 to 1.0 (median), respectively. In general, MXF treatment was very well tolerated, with physician’s overall assessment of tolerability as “good” or “very good” in 95.2% (n = 10,834/11,377) of patients. The incidence rate of adverse events and adverse drug reactions was 0.82% (n = 93) and 0.67% (n = 76), respectively. The most frequent adverse events were gastrointestinal disorders such as nausea (0.31%, n = 35) and vomiting (0.19%, n = 22), which were mostly drug-related. One individual serious adverse event (dyspnea) occurred during the observation period, which was assessed as drug-related.
Conclusion: MXF was effective and well tolerated in patients suffering from AECB. The fast speed of the drug’s onset of action was associated with rapid improvement of clinical parameters.
Keywords: China, moxifloxacin, chronic bronchitis, acute exacerbation, GIANT
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