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Original Research: COPD |

Benefits of High-Dose N-Acetylcysteine to Exacerbation-Prone Patients With COPDEffect of N-Acetylcysteine in High-Risk COPD

Hoi Nam Tse, MBChB, FCCP; Luca Raiteri, MD; King Ying Wong, MBBS, FCCP; Lai Yun Ng, MBChB; Kwok Sang Yee, MBBS; Cee Zhung Steven Tseng, MBBCh BAO
Author and Funding Information

From the Kwong Wah Hospital (Drs Tse, Ng, and Tseng), Hong Kong, SAR; Medical Department (Dr Raiteri), Innovation & Medical Sciences, Zambon SpA, Vicenza, Italy; and Wong Tai Sin Hospital (Drs Wong and Yee), Hong Kong.

CORRESPONDENCE TO: Hoi Nam Tse, MBChB, FCCP, Medical and Geriatric Department, Kwong Wah Hospital, Waterloo Rd, Yau Ma Tei, Hong Kong, 852, Hong Kong; e-mail: drhoinam@gmail.com


FUNDING/SUPPORT: Zambon SpA donated the study drugs. This work was supported by the Tung Wah Group of Hospitals Research Fund.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;146(3):611-623. doi:10.1378/chest.13-2784
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BACKGROUND:  Although high-dose N-acetylcysteine (NAC) has been suggested to reduce COPD exacerbations, it is unclear which category of patients with COPD would benefit most from NAC treatment. The objective of this study was to compare the effect of high-dose NAC (600 mg bid) between high-risk and low-risk Chinese patients with COPD.

METHODS:  Patients with spirometry-confirmed stable COPD were randomized to treatment with either NAC 600 mg bid or placebo in addition to their usual treatments. Patients were followed up every 16 weeks for a total of 1 year. Further analysis was performed according to each patient’s exacerbation risk at baseline as defined by the current GOLD (Global Initiative for Chronic Obstructive Lung Disease) strategy to analyze the effect of high-dose NAC in high-risk and low-risk patients.

RESULTS:  Of the 120 patients with COPD randomized (men, 93.2%; mean age, 70.8 ± 0.74 years; prebronchodilator FEV1, 53.9 ± 2.0%; baseline characteristics comparable between treatment groups), 108 (NAC, 52; placebo, 56) completed the 1-year study. For high-risk patients (n = 89), high-dose NAC compared with placebo significantly reduced exacerbation frequency (0.85 vs 1.59 [P = .019] and 1.08 vs 2.22 [P = .04] at 8 and 12 months, respectively), prolonged time to first exacerbation (P = .02), and increased the probability of being exacerbation free at 1 year (51.3% vs 24.4%, P = .013). This beneficial effect of high-dose NAC vs placebo was not significant in low-risk patients.

CONCLUSIONS:  High-dose NAC (600 mg bid) for 1 year reduces exacerbations and prolongs time to first exacerbation in high-risk but not in low-risk Chinese patients with COPD.

TRIAL REGISTRY:  ClinicalTrials.gov; No.: NCT01136239; URL: www.clinicaltrials.gov

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