Safety of nicotine replacement therapy in critically ill smokers: a retrospective cohort study

TY - JOUR

T1 - Safety of nicotine replacement therapy in critically ill smokers

T2 - a retrospective cohort study

AU - Gillies, Michael A.

AU - McKenzie, Catherine

AU - Whiteley, C.

AU - Beale, R. J.

AU - Tibby, Shane

PY - 2012/10

Y1 - 2012/10

N2 - Purpose Nicotine replacement therapy (NRT) has been used to ameliorate nicotine withdrawal in the intensive care unit (ICU). Previous cohort studies have suggested an increased mortality with NRT use: methodological problems may call into question the validity of these findings. We undertook a retrospective cohort study to determine if NRT use was associated with adverse outcomes. Methods This retrospective cohort study was conducted in a 30-bed, university affiliated, teaching hospital ICU. Results We identified 423 smokers admitted over 2 years, of whom 73 received transdermal NRT. Cox proportional hazard regression models, with NRT modelled as a time-varying covariate, were used to test the hypothesis that NRT was associated with an altered ICU or hospital mortality. A second analysis utilized propensity scores. The unadjusted ICU and hospital mortalities were lower for the NRT group; although both differences were non-significant. The Cox models showed that, after adjustment for APACHE risk, age, sex and alcohol use, risk associated with NRT administration was not statistically different than non-administration for both ICU (hazard ratio 0.50, [95 % CI 0.20-1.24], p = 0.14) and hospital (hazard ratio 0.95, [95 % CI 0.52-1.75], p = 0.88) mortality. Similar findings occurred with the propensity matched analysis. Conclusions We were unable to demonstrate any harm associated with NRT, with the ICU model actually trending towards benefit. We conclude that a randomised, blinded, placebo controlled trial is required to assess adequately the safety and efficacy of NRT as a treatment in critically ill smokers.

AB - Purpose Nicotine replacement therapy (NRT) has been used to ameliorate nicotine withdrawal in the intensive care unit (ICU). Previous cohort studies have suggested an increased mortality with NRT use: methodological problems may call into question the validity of these findings. We undertook a retrospective cohort study to determine if NRT use was associated with adverse outcomes. Methods This retrospective cohort study was conducted in a 30-bed, university affiliated, teaching hospital ICU. Results We identified 423 smokers admitted over 2 years, of whom 73 received transdermal NRT. Cox proportional hazard regression models, with NRT modelled as a time-varying covariate, were used to test the hypothesis that NRT was associated with an altered ICU or hospital mortality. A second analysis utilized propensity scores. The unadjusted ICU and hospital mortalities were lower for the NRT group; although both differences were non-significant. The Cox models showed that, after adjustment for APACHE risk, age, sex and alcohol use, risk associated with NRT administration was not statistically different than non-administration for both ICU (hazard ratio 0.50, [95 % CI 0.20-1.24], p = 0.14) and hospital (hazard ratio 0.95, [95 % CI 0.52-1.75], p = 0.88) mortality. Similar findings occurred with the propensity matched analysis. Conclusions We were unable to demonstrate any harm associated with NRT, with the ICU model actually trending towards benefit. We conclude that a randomised, blinded, placebo controlled trial is required to assess adequately the safety and efficacy of NRT as a treatment in critically ill smokers.

KW - Intensive care

KW - Nicotine

KW - Smoking

KW - Delirium

KW - Cohort study

KW - INTENSIVE-CARE-UNIT

KW - MECHANICALLY VENTILATED PATIENTS

KW - PROPENSITY-SCORE

KW - OBSERVATIONAL COHORT

KW - DELIRIUM

KW - MORTALITY

KW - REGRESSION

KW - WITHDRAWAL

KW - SURGERY

KW - SMOKING

U2 - 10.1007/s00134-012-2604-2

DO - 10.1007/s00134-012-2604-2

M3 - Article

SN - 0342-4642

VL - 38

SP - 1683

EP - 1688

JO - Intensive Care Medicine

JF - Intensive Care Medicine

IS - 10

ER -