EFFICACY AND TOLERABILITY OF TWICE-DAILY CIPROFLOXACIN 750MG IN THE TREATMENT OF PATIENTS WITH ACUTE EXACERBATIONS OF CHRONIC-BRONCHITIS AND PNEUMONIA

In a review of the US Bayer ciprofloxacin (CIP) database, an analysis was undertaken to summarize the effectiveness and tolerability of CIP 750 mg BID in the treatment of patients with acute exacerbations of ch ronic bronchitis (AECB) and pneumonia. In five controlled studies, com parator (COMP) agents included ampicillin, intravenous cefuroxime/cefa clor, and other unspecified agents. Primary efficacy end points were c linical success (resolution plus improvement) and bacteriologic eradic ation at the end of therapy. The incidence of adverse events for CIP 7 50 mg BID was compared with that for COMP and with that in the CIP 500 -mg-BID AECB and pneumonia clinical trials database. In five uncontrol led studies, 443 patients received CLP 750 mg BID; in 5 controlled tri als comprising 344 patients, 169 received CIP 750 mg BID and 175 recei ved COMP. Clinical success for CIP was 93% (368/396) and 99% (160/162) , respectively, in the uncontrolled and controlled studies versus 98% (156/160) for COMP agents. Corresponding bacteriologic eradication rat es for CIP 750-mg-BID-treated patients were 77% (273/356) and 95% (122 /128), respectively, and 77% (96/125) for COMP agents. Overall bacteri ologic eradication by organism for CIP 750 mg BID included Streptococc us pneumoniae 96% (51/53), Haemophilus influenzae 98% (92/94), Haemoph ilus parainfluenzae 100% (56/56), Moraxella catarrhalis 100% (14/14; 1 3 of 14 organisms were isolated in patients with AECB), and Pseudomona s aeruginosa 66% (135/204). Drug-related adverse events were reported in 113 (26%) CIP 750-mg-BID-treated patients in uncontrolled trials an d in 62 (37%) CIP 750-mg-BID- and 61 (35%) COMP-treated patients in co ntrolled trials. In the combined data from the CIP 750-mg-BID uncontro lled and controlled trials, adverse events occurred with similar frequ ency compared with COMP except for nausea (CLP 10%, COMP 7%) and diarr hea (CIP 3%, COMP 13%). fn conclusion CTP 750 mg BID provided excellen t clinical success rates in the treatment of patients with AECB and pn eumonia. CIP 750 mg BID was well tolerated compared with the COMP agen ts administered.