Dirithromycin is a recently developed oral
antibiotic, and has been shown to be effective in the treatment of respiratory tract, skin and
soft tissue infections.
Dirithromycin is administered once daily which may contribute to patient compliance. In this paper we review the data from studies conducted in Europe, USA, Israel and South Africa over a six-year period to assess the safety and efficacy of
dirithromycin in the treatment of a variety of acute infectious illnesses, and to compare it with structurally related
antibiotics (
erythromycin base,
roxithromycin, and
miocamycin) given orally. A total of 7437 patients have been enrolled from a total of 66 studies and trials, 4263 (57.3%) treated with
dirithromycin and 3174 (42.7%) treated with a comparator
antibiotic. Patients received either 500 mg
dirithromycin (two
tablets once daily), 1000 mg
erythromycin base (250 mg qid), 300 mg
roxithromycin (150 mg bid), or 1200
miocamycin (600 mg bid); the length of
therapy ranged from 7 to 14 days. These studies have shown that
dirithromycin has a safety profile similar to the comparator agents. The most frequently reported adverse events for both
dirithromycin and comparator treatment groups were gastrointestinal in nature. The majority (99%) of adverse events reported from patients treated with
dirithromycin were considered mild or moderate in severity. Early discontinuation of
antibiotic therapy was infrequent (3-4%) in both treatment groups, and considered to be possibly
drug-related in 2-3% of the population. The safety profile of
dirithromycin in elderly patients was comparable to that recorded in the overall patient population. The incidence and nature of abnormal clinical laboratory evaluation were similar in
dirithromycin and comparator groups. Notable alterations in laboratory tests of haematological or hepatic function were infrequent and were not associated with clinical manifestations. Routine monitoring of standard clinical laboratory tests in patients prescribed
dirithromycin does not appear to be necessary.