N-acetylcysteine reduces the exacerbation rate in patients with moderate to severe COPD.
OBJECTIVE
This study was performed to confirm the efficacy of a 6-month therapy with a formulation of N-acetylcysteine (NAC; 600 mg/day p.o.) on frequency and severity of exacerbations in patients suffering from chronic obstructive pulmonary disease (COPD).


METHODS
One hundred sixty-nine patients attending five Italian centres were recruited in an open, randomized, controlled study. The patients were randomly allocated to standard therapy plus NAC 600 mg once a day or standard therapy alone over a 6-month period. At baseline, medical history was evaluated, and physical examination was performed; occurrence and severity of exacerbations and side effects of NAC were analyzed after 3 and 6 months.


RESULTS
The results showed a decreased number of exacerbations (by 41%) in the group of patients treated with NAC and standard treatment: 46 patients had at least one exacerbation as compared with 63 patients of the group treated with standard therapy alone. Also the number of the patients with two or more exacerbations was lower in the NAC group (26%) than in the standard-therapy group (49%). The number of sick days was less (82) in the NAC group as compared with the standard-therapy group (155). There was a small but significant improvement in FEV(1) and MEF(50) in the NAC group. NAC once a day was well tolerated. There were no differences in the number of side effects reported in both groups.


CONCLUSIONS
These data confirm results of previous studies which reported a reduction in the number of exacerbations in patients having moderate to severe COPD treated with the antioxidant NAC. Further, the once-daily formulation is well tolerated and is likely to improve patient compliance with the prescribed regimen.
Pela
R
R
Unità Operativa di Pneumologia, Presidio Ospedaliero Unificato ASL/Ancona, Regione Marche, Osimo, Italia.
Calcagni
A M
AM
Subiaco
S
S
Isidori
P
P
Tubaldi
A
A
Sanguinetti
C M
CM
D000111:Acetylcysteine / Q000008:administration & dosage*; D000284:Administration, Oral; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016166:Free Radical Scavengers / Q000008:administration & dosage*; D006801:Humans; D008173:Lung Diseases, Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011336:Probability; D012129:Respiratory Function Tests; D055502:Secondary Prevention; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D016166:Free Radical Scavengers; D000111:Acetylcysteine