Safety Of Gemifloxacin Research Articles

EFFICACY AND SAFETY OF GEMIFLOXACIN CONTAINING TREATMENT REGIMEN IN FIRST-LINE TREATMENT OF HELICOBACTER PYLORI.

•In eradication treatment of H. pylori gemifloxacin containing triple treatment regimen was as effective as bismuth containing quadruple treatment. •Drug adverse effects were fewer and milder in the gemifloxacin group. •Since treatment period was shorter and pills to be taken were fewer compared to quadruple treatment, patient compliance was significantly higher in the gemifloxacin group. Background - After eradication of Helicobacter pylori (H. pylori) chronic gastritis will resolve, complications due to H. pylori infection and recurrence of infection will be prevented. Objective - To determine efficacy and safety of gemifloxacin containing treatment regimen in first line treatment of H. pylori with comparison to bismuth containing quadruple therapy. Methods - This retrospective study was conducted in a tertiary care university hospital between January 2018 and January 2021 with 410 participants who were diagnosed to have H. pylori infection with biopsies obtained during upper gastrointestinal system endoscopy. Patients were distributed into two groups according to their first-line treatment regimens. First group patients were treated with amoxicillin, gemifloxacin and pantoprazole and second group patients were treated with amoxicillin, metronidazole, bismuth subcitrate and pantoprazole for seven days. Results - Intention to treat and per protocol ratios for gemifloxacin containing regimen were 90.0% and 91.2%, while quadruple treatment has these ratios as 91.7% and 93.8% respectively. Treatment success rate in both regimens were similar. But adverse effects were lower and patient compliance were better in patients who had gemifloxacin containing treatment (P<0.001). Conclusion - Gemifloxacin containing treatment regimen is as effective as bismuth containing quadruple treatment regimen for H. pylori infection and patient compliance is better in this group. Gemifloxacin containing treatment regimens may be novel and effective alternatives for eradication of H. pylori infection.

Safety Evaluation of repeated oral administration of Gemifloxacin in Broiler Birds

Gemifloxacin is a fourth generation fluoroquinolone drug having broad-spectrum and good antibacterial activity at low plasma/tissue concentration. The present study was designed to investigate safety of gemifloxacin @ 10 mg/kg body weight after repeated oral administration at 24 hr interval for 5 days in 6 broiler birds of 5-6 week age. It was found safe based on non-significant alteration in haematological (Hb, PCV, TEC and TLC) and serum biochemical (AST, ALT, ACP, ALP, LDH, creatinine, total bilirubin and uric acid) parameters that were evaluated before and at 24 hourly interval for 5 days during treatment.

A randomised open label parallel group study on evaluation of efficacy and safety of gemifloxacin versus cefpodoxime in chronic obstructive pulmonary disease patients.

A randomised open label parallel group study on evaluation of efficacy and safety of gemifloxacin versus cefpodoxime in chronic obstructive pulmonary disease patients.

Efficacy and safety of gemifloxacin in the treatment of acute exacerbation of chronic obstructive pulmonary disease: open prospective multicentre study

Objective: to study the clinical and antibacterial efficacy and safety of gemifloxacin in the treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE COPD) hospitalized into pulmonology departments. Study design: open non-comparative prospective study. Settings: 25 different pulmonology centres in Russia. A total of 222 patients with AE COPD (156 males and 66 females, mean age 56,4 ± 11,9 years) were included in the study. The majority of patients (70.3 %) were classified as I type Anthonisen of AE COPD. All patients received oral gemifloxacin (Factive ® , Veropharm, Russia) 320 mg once daily for 7 days. Clinical and bacteriological outcomes and treatment safety were assessed at the end of therapy (7–8 days of study) and at follow up (14–16 days of study). At the end of therapy (7–8 days) statistically significant improvements were noted in all symptoms of AE COPD (improvement of cough, dyspnea, sputum volume and purulence). No clinical improvement was seen in 5.6 % of patients, so the clinical success rate of gemifloxacin therapy was 94.4 %. Sputum cultures were performed in 73.0 % of patients and in 60.4 % of them respiratory pathogens were isolated. The leading pathogens were Streptococus pneumoniae (37.7 %) and Haemophilus influenzae (27.8 %). Eradication and presumed eradication of all pathogens were 69.4 % and 26.9 %, respectively. The bacteriological success rate of gemifloxacin therapy was 96.3 %. A total of 15 patients reported adverse events (AEs), most frequent AEs was diarrhea (4.7 %). All AEs were no severe and transitory, and did not require the withdrawal of antibiotic therapy. Oral gemifloxacin had high clinical and bacteriological efficacy in hospitalized patients with AE COPD. The treatment with gemifloxacin was generally well tolerated and was convenient to patients.

Efficacy of Gemifloxacin in Acute Exacerbations of Chronic Bronchitis: a Randomised, Double-Blind Comparison with Trovafloxacin

This randomised, double-blind, double-dummy, multinational study compared the efficacy and safety of gemifloxacin with trovafloxacin in the treatment of acute exacerbations of chronic bronchitis. There were 617 patients randomised: 303 to gemifloxacin and 314 to trovafloxacin. Clinical success rates at follow-up (clinical per-protocol population) were 91.5% for gemifloxacin and 87.6% for trovafloxacin. For the intent-to-treat population, the clinical efficacy of gemifloxacin was statistically significantly superior to that of trovafloxacin. In general, the in vitro activity of gemifloxacin against the major respiratory bacterial pathogens was superior to that of other antibiotics tested. Per-patient bacteriological success rates at follow-up (bacteriology per-protocol population) were 86.8% for gemifloxacin and 82.4% for trovafloxacin. Both agents were well tolerated. The clinical and bacteriological efficacy of a once-daily 5-day course of gemifloxacin is at least as good as that of a similar regimen of trovafloxacin in the treatment of acute exacerbations of chronic bronchitis.

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

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.