[Double-blind clinical trial comparing 5 days of dirithromycin versus 7 days of diacetylmidecamycin in acute bronchitis and acute exacerbations of chronic bronchitis].
BACKGROUND
Dirythromycin has several pharmacokinetic characteristics (long half life and high tissue concentrations) which suggest the possibility of administering shorter treatments than those conventionally used. The aim of this study was to determine and compare the efficacy of a 5 day treatment with dirythromycin once a day, versus diacetylmidecamycin twice a day over 7 days in the treatment of patients with acute bronchitis and acute exacerbations of chronic bronchitis.


METHODS
A parallel, multicentric, randomized, double blind clinical study was carried out in 8 Spanish hospitals.


RESULTS
One hundred seventy-four patients were included in the study, with 87 (80 evaluable) being randomly assigned to receive dirythromycin (500 mg/day over 5 days) and 87 (83 evaluable) diacetylmidecamycin (600 mg, twice daily over 7 days). A favorable symptomatic response (cure or improvement) was observed in 72/80 of the first group (90%) and in 74/83 (89.2%) of the second group. No statistically significant differences were found in the efficacy and safety between the two treatment groups in either the evaluable patients or on intention to treat analysis.


CONCLUSIONS
The results of this study suggest that the administration of dirythromycin, once a day over 5 days, is as safe and effective as diacetylmidecamycin, twice a day over 7 days, in the treatment of acute bronchitis and acute exacerbations of chronic bronchitis.
Sacristán
J A
JA
Departamento de Investigación Cínica, Lilly S.A., Madrid.
Elviro
J
J
García de Lomas
J
J
Palomino-Nicás
J
J
Sobradillo
V
V
Sánchez Gascón
F
F
Valencia
A
A
Calbo
F
F
Viejo
J L
JL
Zamarrón
C
C
Coca
E
E
Casado
M A
MA
García Pérez
L E
LE
Hernández
J M
JM
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001991:Bronchitis / Q000188:drug therapy*; D002908:Chronic Disease; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004917:Erythromycin / Q000031:analogs & derivatives / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007933:Leucomycins / Q000627:therapeutic use*; D018942:Macrolides; D008297:Male; D008875:Middle Aged
D000900:Anti-Bacterial Agents; D007933:Leucomycins; D018942:Macrolides; C053853:dirithromycin; D004917:Erythromycin; C026483:midecamycin