TOLERABILITY OF ROXITHROMYCIN VS ERYTHROMYCIN IN COMPARATIVE CLINICAL-TRIALS IN PATIENTS WITH LOWER RESPIRATORY-TRACT INFECTIONS

The comparative tolerability and rate of withdrawal from clinical tria ls was established from a pooled analysis of comparative clinical stud ies of roxithromycin and/or erythromycin in patients with lower respir atory tract infections. Where stated, 65% of patients were managed in the community and some as inpatients. 942 patients in 13 studies recei ved roxithromycin 300 mg/day and 1253 patients in 15 studies received erythromycin in various formulations and dosages. 47% of patients had an initial diagnosis of community-acquired pneumonia, 20% had an acute infectious exacerbation of chronic bronchitis, 30% had acute bronchit is, and a further 4% had unspecified lower respiratory infection. The incidence of adverse events that were definitely or probably associate d with antibacterial therapy (excluding laboratory abnormalities) was 2.5-fold higher for patients receiving erythromycin compared with roxi thromycin (24.8 vs 10.1%), and the rate of withdrawal from clinical tr ials due to adverse events was 3.6-fold higher (7.1 vs 2.0%). Most of the adverse events associated with erythromycin were gastrointestinal in nature. Since adverse events and withdrawals help determine the com pliance rate and the clinical value of an antibacterial agent in routi ne clinical practice, they should be taken into account when prescribi ng a macrolide for a respiratory tract infection.