The efficacy and safety of two oral moxifloxacin regimens compared to oral clarithromycin in the treatment of community-acquired pneumonia

Abstract

An international multi-centre, randomized, prospective, double-blind study compared oral moxifloxacin (200 mg or 400 mg once daily for 10 days) with oral clarithromycin (500 mg, twice daily for 10 days) in the treatment of community-acquired pneumonia (CAP). The clinical success rate in the evaluable population at the primary efficacy assessment, 3-5 days after the end of study treatment, was 93.9% in patients treated with 200 mg moxifloxacin; 94.4%, with 400 mg moxifloxacin; and 94.3%, with clarithromycin. Clinical success rates were maintained at follow-up, 21-28 days after the end of treatment: 90.7% (200 mg moxifloxacin), 92.8% (400 mg moxifloxacin) and 92.2% (clarithromycin). The 95% confidence intervals indicated that all three treatment regimens were equally effective in treating CAP. At follow-up, the 400 mg moxifloxacin dose had a slightly higher observed cure rate than the 200 mg moxifloxacin dose, but this was not statistically significant. The most frequently isolated pathogens were Streptococcus pneumoniae (42%), Haemophilus influenzae (19%), Haemophilus parainfluenzae (10%), Moraxella catarrhalis (6%), Klebsiella pneumoniae (5%) and Staphylococcus aureus (4%). The bacteriological success rate (eradication and presumed eradication) was 72.5% (29/40) for 200 mg moxifloxacin, 78.7% (37/47) for 400 mg moxifloxacin and 70.7% (29/41) for clarithromycin. The adverse event profile was comparable between the three treatment groups. Most adverse events, possibly or probably related to the study drug, were generally mild or moderate in severity and mostly related to the digestive system: diarrhoea, nausea and abdominal pain in 200 mg moxifloxacin patients; diarrhoea, liver function abnormalities and nausea in 400 mg moxifloxacin patients and liver function abnormalities, diarrhoea, nausea and taste perversion in clarithromycin patients. Study drugs were discontinued because of adverse events in 7/229 (3%) patients treated with 200 mg moxifloxacin, 11/224 (5%) with moxifloxacin 400 mg and 11/222 (5%) with clarithromycin. In all assessments, moxifloxacin was at least as effective clinically, and as well tolerated as clarithromycin in the treatment of CAP. Bacteriological success rates in moxifloxacin-treated patients were greater than those of clarithromycin. Moxifloxacin, given once daily, is free of many drug-drug interactions and requires no dosage adjustments in most renal hepatic deficient patients.

Respiratory fluoroquinolones for the treatment of community-acquired pneumonia: a meta-analysis of randomized controlled trials

“…Five trials included outpatients. 15,20,23,24,33 Both intravenous and oral administration were used depending on the severity of pneumonia and the ability of patients to receive medications orally.…”

“…Data about mortality in the intention-to-treat population were provided in 18 trials [14][15][16][17][18][19]21,22,24,26,27,[29][30][31][32][33][34]36 and ranged from 0% to 7% (mean 2.7%) in the fluoroquinolone groups and from 0.5% to 8% (mean 3.4%) in the comparator groups. Mortality rates were not different between the 2 groups of patients (Figure 2, OR 0.85, 95% CI 0.65-1.12).…”

“…18,22,25,27,31,35 However, they were not more effective in the analysis that included trials funded by pharmaceutical companies (OR 1.13, 95% CI 0.93-1.38). [14][15][16][17][19][20][21]23,24,26,[28][29][30][32][33][34]36 Twelve trials included patients with severe pneumonia; of these, 7 reported data from this population. 16,19,26,27,29,33,34 In this subgroup, fluoroquinolones were more effective than the comparator antibiotics (OR 1.84, 95% CI 1.02-3.29).…”

Moxifloxacina: profilo farmacologico, terapeutico e farmacoeconomico

“…L'efficacia clinica e la tollerabilità della moxifloxacina nella CAP, nelle AECB e nelle ABS sono state studiate su un numero elevato di pazienti, nel corso di diversi trial multicentrici controllati, nazionali e internazionali, strutturati nella maggior parte come studi in doppio cieco [101][102][103][104][105][106][107][108][109][110][111][112][113][114][115][116][117][118].…”

Levofloxacino frente a betalactámicos en el tratamiento de la neumonía adquirida en la comunidad con ingreso hospitalario

“…; Pseudomonas a. sólo es moderadamente sensible in vitro (17), es difícil saber el papel que jugó este germen en los casos de neumonía curados en nuestra serie. Muchos ensayos clínicos han demostrado la eficacia de las fluorquinolonas en el tratamiento de la NAC leve a moderada (2,3,5,18). En la neumonía grave con presencia de factores de riesgo para presentar etiología no habitual, en el espectro etiológico, además del neumococo (que sigue siendo el agente etiológico más probable), hay que contemplar L. pneumophila, H. influenzae, bacterias de la flora orofaríngea y, en menor medida, algunas enterobacterias y S. aureus.…”