Pristinamycin versus cefuroxime axetil in the treatment of acute sinusitis in adults

Abstract

In a placebo-controlled, double-blind, multicenter study, 308 patients aged from 18 to 88 years with clinical evidence of acute sinusitis lasting less than ten days and defined by the presence of pus in the middle meatus on rhinoscopy and sinus pain were randomly assigned to receive eight days of treatment with pristinamycin 1 g twice daily (n=160) or cefuroxime axetil 250 mg twice daily (n=148). Patients were assessed for both clinical and bacteriological responses at the baseline visit (V1), once during treatment V2 (3 to 5 days), at the end of treatment V3 (10 to 12 days) and at the follow-up visit V4 three to four weeks after the end of treatment. A sinus X-ray was taken at baseline and at the final visit. For evaluable patients, the clinical success rate at the end of treatment (V3) was 83.9% (125/149) in patients treated with pristinamycin and 87.2% (123/141) in patients treated with cefuroxime axetil (95% CI: ]−∞,10.12%]). At the follow-up visit (V4), clinical success (primary endpoint) was observed in 72.6% (106/146) of patients in the pristinamycin group and 75% (105/140) of those in the cefuroxime axetil group (95% CI: ]−∞,10.95%]). The efficacy of pristinamycin in acute sinusitis was equivalent to that of cefuroxime axetil in the two populations (Intention to treat-ITT-, Evaluable Population-EP-) and in both evaluation periods (V3, V4). Eleven patients in the pristinamycin group and 2 in the cefuroxime axetil group discontinued treatment prematurely due to adverse events ( p=0.02). Serious adverse event were reported in three patients in the cefuroxime-axetil group and none in the pristinamycin group. In conclusion, these results confirm the value of pristinamycin as first-line treatment in acute sinusitis in adults.