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| |  ICMAS-KO: Clarithromycin Extended Release as Effective as Levofloxacin for Community-Acquired Pneumonia By Pamela Hunter Special to DG News BOLOGNA, ITALY -- January 29, 2002 -- A new extended-release preparation of the macrolide clarithromycin shows similar safety and efficacy as the fluoroquinolone levofloxacin in adults with community-acquired pneumonia, according to a double-blind, randomised, multicentre study. Therapy for community-acquired pneumonia (CAP) has to be empiric, as the causative organism is not known. Macrolides and fluoroquinolones have a spectrum of activity that includes the majority of pathogens likely to be encountered and are frequently used in the treatment of CAP. Robert Palmer, MD, and colleagues, from Abbott Laboratories, in Abbott Park, Illinois, United States, conducted a study to compare the safety and efficacy of the new extended release formulation of clarithromycin, now available as once daily dosing, to levofloxacin in outpatients with CAP. He presented the study findings on January 25, 2002, at the 6th International Congress on Macrolides, Azalides, Streptogramins, Ketolides and Oxazolidones (ICMAS-KO), in Bologna, Italy. Ambulatory patients were recruited from 75 centres in the United States and Canada. All patients were over 18 years of age and presented with clinical signs and symptoms of CAP. Diagnosis was confirmed on chest X-ray and purulent sputum. One-hundred-and-fifty-six patients received clarithromycin and 143 patients received levofloxacin. Clarithromycin was administered as two 500 mg tablets once daily and levofloxacin as two 250 mg tablets once daily for seven days. Safety was assessed by laboratory tests, physical examinations, and monitoring adverse events. Drug efficacy was determined by the cure rates 14-21 days post treatment. Results showed there was no significant difference in efficacy between two drugs. Both clarithromycin and levofloxacin resulted in similar clinical and radiological cure rates. Eighty-eight percent of clinically evaluable patients in the clarithromycin group (113/128) achieved a clinical cure compared to 86 percent for those on levofloxacin (107/124). The bacteriological eradication rate was 86 percent of clinically and evaluable patients (80/93) and 88 percent (85/97), respectively. A substantial number of atypical pathogens were isolated from each group, including Chlamydia pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila. There was no significant difference in the eradication rates for these pathogens in the two treatment groups. The overall pathogen eradication rate was 87 percent of clinically and evaluable patients (134/154) in the clarithromycin group compared to 88 percent (136/155) in the levofloxacin group. The incidence of most side effects was similar in the two treatment groups. Diarrhoea was present in six percent and nausea in three percent of patients in both groups, headache in three percent of patients on clarithromycin and four percent on levofloxacin. Taste perversion, however, was significantly higher (13 percent) in the clarithromycin group compared to the levofloxacin group (less than one percent). Dr. Palmer concluded that the extended release formulation of clarithromycin was safe and well tolerated in patients with CAP. Clarithromycin was as effective as levofloxacin in eradicating target pathogens, resolving the signs and symptoms of CAP and improving radiographic evidence of the disease.
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