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Biomedical subjects

J E Connett

Publications and source records attributed to J E Connett.

At least 19 recordsLinked to original sources

The FEV1/FEV6 predicts lung function decline in adult smokers.

The use of FEV1/FEV6 in place of the traditional FEV1/FVC to detect airways obstruction during spirometry testing performed by primary care providers would reduce time and patient effort. We hypothesized that the FEV1/FEV6, would predict the subsequent decline in FEV1 in adult cigarette smokers who enrolled in the multicenter Lung Health Study. Ten clinical centers in the U.S. and Canada recruited 5887 male and female smokers, aged 35-60 years, with borderline to mild airways obstruction by spirometry. Those who successfully stopped smoking during the 5-yr study (usually as the result of the smoking cessation intervention) were excluded from this analysis. In those continuing to smoke, the relative strength of spirometric predictors of the change in FEV1 during 5 years of follow-up (DFEV1) was determined using a linear regression model. The following covariates were significant independent predictors of DFEV1: the baseline degree of airways obstruction, age, gender, cigarettes per day, years of education, and bronchial hyperresponsiveness. The FEV1/FEV6 was nearly as strong an independent predictor as was the FEV1/FVC (a traditional index of airways obstruction). The degree of airways obstruction, as determined by the FEV1/FEV6 from spirometry, is an independent predictor of subsequent decline in lung function; and therefore, may be used to detect smokers at higher risk of developing COPD.

Adult↗

Graphical model checking with correlated response data.

Correlated response data arise often in biomedical studies. The generalized estimation equation (GEE) approach is widely used in regression analysis for such data. However, there are few methods available to check the adequacy of regression models in GEE. In this paper, a graphical method is proposed based on Cook and Weisberg's marginal model plot. A bootstrap method is applied to obtain the reference band to assess statistical uncertainties in comparing two marginal mean functions. We also propose using the generalized additive model (GAM) in a similar fashion. The proposed two methods are easy to implement by taking advantage of existing smoothing and GAM softwares for independent data. The usefulness of the methodology is demonstrated through application to a correlated binary data set drawn from a clinical trial, the Lung Health Study.

Adult↗

Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study.

We analyzed Lung Health Study (LHS) data to assess the effect of self-reported lower respiratory illnesses resulting in physician visits (LRI) on lung function. Participants were 5,887 smokers aged 35-60 yr, FEV(1)/FVC < 0.70 and FEV(1) of 55-90% predicted. Two-thirds were randomized into an intensive smoking cessation program (SI); one-third were advised only to stop smoking (UC). For 5 yr participants had annual spirometry and questioning regarding LRI. SI had greater rates of smoking cessation than usual care (UC) with fewer LRI (p = 0.0008). Sustained quitters had fewer LRI than continuing smokers (p = 0.0003). In the year LRI occurred, FEV(1) did not change in sustained quitters, but decreased significantly in smokers (p = 0.0001) with some recovery the following year if no LRI occurred. Over 5 yr, LRI had a significant effect on rate of decline of FEV(1) only in smokers. In smokers averaging one LRI/yr over 5 yr there were additional declines in FEV(1) of 7 ml /yr (p = 0.001). Smokers with more than one LRI/yr had greater declines. Chronic bronchitis was associated with increased frequencies of LRI, but did not affect their influence on lung function. Smoking and LRI had an interactive effect on FEV(1) in people with mild COPD, and in smokers frequent LRI may influence the long-term course of the disease.

Adult↗

A multiple imputation approach to linear regression with clustered censored data.

We extend Wei and Tanner's (1991) multiple imputation approach in semi-parametric linear regression for univariate censored data to clustered censored data. The main idea is to iterate the following two steps: 1) using the data augmentation to impute for censored failure times; 2) fitting a linear model with imputed complete data, which takes into consideration of clustering among failure times. In particular, we propose using the generalized estimating equations (GEE) or a linear mixed-effects model to implement the second step. Through simulation studies our proposal compares favorably to the independence approach (Lee et al., 1993), which ignores the within-cluster correlation in estimating the regression coefficient. Our proposal is easy to implement by using existing softwares.

Algorithms↗

Experience of Black participants in the Lung Health Study smoking cessation intervention program.

This paper evaluates the hypothesis that Black smokers will respond differently than Whites to a smoking cessation intervention program where no adjustments are made in recognition of cultural differences. The responses of Black smokers who were recruited into the Lung Health Study (LHS) to the smoking cessation intervention are described. Black quit rates are compared with those of Whites. The LHS enrolled 5887 men and women smokers, aged 35-60 years, of whom 3923 were randomized to a group cessation intervention and 1964 to usual care. Blacks and Whites from six clinics who had complete covariate data (200 Blacks and 2868 Whites) were compared on baseline smoking characteristics and subsequent smoking cessation outcomes. Logistic models were constructed to adjust for baseline smoking variables and demographic characteristics to evaluate the effect of treatment group on smoking cessation among Blacks and Whites. At baseline, Blacks reported smoking fewer cigarettes than Whites, but had higher mean levels of salivary cotinine. The adjusted odds ratio of quitting at 1 year for the smoking intervention group vs. the usual care group was 1.48 for Blacks and 5.99 for Whites. This difference between Blacks and Whites was highly significant (p = 0.002). Across 5 years, the adjusted odds ratios of quitting were 1.87 for Blacks and 3.34 for Whites (p = 0.06). Although the treatment effect was stronger for Whites than for Blacks, over the 5 years of the study there was a significant treatment effect for Blacks. Indicators of physical dependence on nicotine at baseline were inconsistent in indicating whether Blacks were more dependent. We conclude that Blacks and Whites differed significantly in their response to the LHS group smoking intervention program.

Adult↗

Association of IL-1beta and IL-1 receptor antagonist haplotypes with rate of decline in lung function in smokers.

BACKGROUND: There is increasing evidence that the cytokine network is central to the immunopathology of inflammatory airway diseases. The interleukin 1 (IL-1) receptor antagonist (IL-1RN) is a naturally occurring anti-inflammatory agent that binds to the IL-1 receptor but does not possess agonist activity. Each of the genes of the IL-1 locus on chromosome 2q14 is polymorphic. The IL1RN gene contains an 86 bp tandem repeat and allele 2 of this polymorphism has been associated with various inflammatory diseases. The IL-1beta (IL1B) gene contains a promoter polymorphism (C-511T) that has been associated with inflammatory diseases and is in linkage disequilibrium with the IL1RN polymorphism. METHODS: We investigated whether polymorphisms in the IL1B and IL1RN genes were associated with rate of decline of lung function. Genotypes were determined in 284 smokers with a rapid decline in lung function and 306 smokers with no decline in lung function. RESULTS: None of the genotypes was associated with the rate of decline of lung function. However, the distribution of IL1B/IL1RN haplotypes was different between smokers with a rapid decline in lung function and those with no decline in lung function (p=0.0005). CONCLUSION: These results suggest that IL1B/IL1RN haplotypes play a role in the rate of decline in lung function in smokers.

Algorithms↗

Susceptibility genes for rapid decline of lung function in the lung health study.

The genes that contribute to the genetic susceptibility to chronic obstructive pulmonary disease (COPD) remain largely unknown. We hypothesized that widely divergent rates of decline in lung function in smokers would be a robust phenotype for detection of genes that contribute to COPD severity. We selected 283 rapid decliners (deltaFEV1 = -154 +/- 3 ml/yr) and 308 nondecliners (deltaFEV1 = +15 +/- 2 ml/yr) from among smokers followed for 5 yr in the NHLBI Lung Health Study. Rapid decline of FEV1 was associated with the MZ genotype of the alpha1-antitrypsin gene (odds ratio [OR] = 2.8, p = 0.03). This association was stronger for a combination of a family history of COPD with MZ (OR = 9.7, p = 0.03). These data suggest that the MZ genotype results in an increased rate of decline in lung function and interacts with other familial factors. Haplotype frequencies of the microsomal epoxide hydrolase (mEH) gene were significantly different between rapid decliners and nondecliners (p = 0.03). A combination of a family history of COPD with homozygosity for the His113/His139 mEH haplotype was also associated with rapid decline of lung function (OR = 4.9, p = 0.04). The alpha1-antitrypsin S and 3' polymorphisms, vitamin D-binding protein isoforms, and tumor necrosis factor (TNF-alpha G-308A and TNF-beta A252G) polymorphisms were not associated with rate of decline of lung function.

Adult↗

Neurodevelopmental follow-up at 36 months' corrected age of preterm infants treated with prophylactic indomethacin.

BACKGROUND: Previous reports have suggested that prophylactic indomethacin decreases cerebral blood flow and may play a role in the development of ischemic brain injury and developmental handicaps. OBJECTIVE: To assess the neurodevelopmental outcome of subjects at 36 months' corrected age (CA) who, as low-birth-weight infants, received prophylactic low-dose indomethacin within the first 24 hours of life to prevent patent ductus arteriosus. SETTING: Newborn intensive care nursery and outpatient follow-up clinic at Children's Hospitals and Clinics of Minneapolis, Minneapolis, Minn. DESIGN: Ninety infants with birth weights of 600 to 1250 g were entered into a prospective, randomized, controlled trial to receive either prophylactic indomethacin, 0.1 mg/kg, or placebo in the first 24 hours and again every 24 hours for 6 doses to prevent patent ductus arteriosus. Nonresponders were treated with standard therapeutic indomethacin or ligation. Neurodevelopmental assessment at approximately 36 months' CA included medical and developmental histories, physical examinations, and developmental testing using the Bayley II Scales of Infant Development on subjects up to 42 months' CA. Subjects were classified as (1) normal, (2) mildly to moderately abnormal, or (3) severely impaired. RESULTS: Forty-two (98%) of 43 subjects who received prophylactic indomethacin survived compared with 46 (98%) of 47 who received placebo. Sixty-six (75%) of 88 survivors were seen for neurodevelopmental assessment at 36 months' CA. This group included 29 (69%) of 42 who received prophylactic indomethacin and 37 (80%) of 46 who received placebo. Twenty-three (79%) of 29 infants in the prophylactic indomethacin group had normal neurodevelopmental assessments at 36 months' CA compared with 26 (70%) of 37 placebo-treated subjects (P = .68). Of 4 significantly impaired subjects treated with prophylactic indomethacin, 1 had spastic diplegia; 1, spastic quadriplegia; 1, cognitive delay; and 1, significant motor delay. Of 8 significantly impaired placebo-treated subjects, 7 had spastic diplegia; 1, microcephaly. CONCLUSION: The use of prophylactic low-dose indomethacin when initiated in the first 24 hours of life in low-birth-weight infants to prevent patent ductus arteriosus is not associated with adverse neurodevelopmental outcome at 36 months' CA.

Cardiovascular Agents↗

Randomized controlled trial of volume-targeted synchronized ventilation and conventional intermittent mandatory ventilation following initial exogenous surfactant therapy.

We set out to evaluate the impact of volume-targeted synchronized ventilation and conventional intermittent mandatory ventilation (IMV) on the early physiologic response to surfactant replacement therapy in neonates with respiratory distress syndrome (RDS). We hypothesized that volume-targeted, patient-triggered synchronized ventilation would stabilize minute ventilation at a lower respiratory rate than that seen during volume-targeted IMV, and that synchronization would improve oxygenation and decrease variation in measured tidal volume (V(t)). This was a prospective, randomized study of 30 hospitalized neonates with RDS. Infants were randomly assigned to volume-targeted ventilation using IMV (n = 10), synchronized IMV (SIMV; n = 10), or assist/control ventilation (A/C; n = 10) after meeting eligibility requirements and before initial surfactant treatment. Following measurements of arterial blood gases and cardiovascular and respiratory parameters, infants received surfactant. Infants were studied for 6 hr following surfactant treatment. Infants assigned to each mode of ventilation had similar birth weight, gestational age, and Apgar scores at birth, and similar oxygenation indices at randomization. Three patients were eliminated from final data analysis because of exclusionary conditions unknown at randomization. Oxygenation improved significantly following surfactant therapy in all groups by 1 hr after surfactant treatment (P < 0.05). No further improvements occurred with time. Total respiratory rate was lowest (P < 0.05) and variation in tidal volume (V(t)) was least in the A/C group (P < 0. 05). Minute ventilation (V(')(E)), delivered airway pressures, respiratory system mechanics, and hemodynamic parameters were similar in all groups. We conclude that volume-targeted A/C ventilation resulted in more consistent tidal volumes at lower total respiratory rates than IMV or SIMV. Oxygenation and lung mechanics were not altered by synchronization, possibly due to the volume-targeting strategy. Of the modes studied, A/C, a fully-synchronized mode, may be the most efficient method of mechanical ventilator support in neonates receiving surfactant for treatment of RDS.

Blood Gas Analysis↗

Characteristics of participants who stop smoking and sustain abstinence for 1 and 5 years in the Lung Health Study.

BACKGROUND: This study describes baseline and Year 1 predictors of abstinence from smoking for the 3,523 intervention participants who had complete annual 5-year follow-up data in the Lung Health Study (LHS). METHODS: The LHS enrolled 5,887 smokers, aged 35 to 60 years, of whom 3,923 were offered a cessation intervention. Of these, 22% achieved biochemically verified abstinence for 5 years. Logistic regressions were performed. The first outcome variable was abstinence from smoking at 1 year. Then for those who were quit at 1 year, the outcome variable was 5 years of sustained abstinence. RESULTS: All participants who were not using nicotine gum after 1 year in the study were more likely to sustain cessation over 5 years than were gum users at year 1 (OR ranged from 0.31 to 0.44 for four age- and sex-specific groups). Baseline number of previous quit attempts was negatively associated with 5-year quitting success among younger and older men (OR = 0.82 and 0.83). Older participants who were less likely to associate smoking with emotional coping had higher abstinence rates at 5 years of follow-up (OR = 0.89 and 0.84). CONCLUSIONS: Different mechanisms may be responsible for achieving cessation in age/gender groups. These results have implications for planning successful interventions.

Adult↗

Smoking cessation and lung function in mild-to-moderate chronic obstructive pulmonary disease. The Lung Health Study.

Previous studies of lung function in relation to smoking cessation have not adequately quantified the long-term benefit of smoking cessation, nor established the predictive value of characteristics such as airway hyperresponsiveness. In a prospective randomized clinical trial at 10 North American medical centers, we studied 3, 926 smokers with mild-to-moderate airway obstruction (3,818 with analyzable results; mean age at entry, 48.5 yr; 36% women) randomized to one of two smoking cessation groups or to a nonintervention group. We measured lung function annually for 5 yr. Participants who stopped smoking experienced an improvement in FEV(1) in the year after quitting (an average of 47 ml or 2%). The subsequent rate of decline in FEV(1) among sustained quitters was half the rate among continuing smokers, 31 +/- 48 versus 62 +/- 55 ml (mean +/- SD), comparable to that of never-smokers. Predictors of change in lung function included responsiveness to beta-agonist, baseline FEV(1), methacholine reactivity, age, sex, race, and baseline smoking rate. Respiratory symptoms were not predictive of changes in lung function. Smokers with airflow obstruction benefit from quitting despite previous heavy smoking, advanced age, poor baseline lung function, or airway hyperresponsiveness.

Adult↗

Variations in end-expiratory pressure during partial liquid ventilation: impact on gas exchange, lung compliance, and end-expiratory lung volume.

STUDY OBJECTIVES: To determine the effects of different levels of positive end-expiratory pressure (PEEP) during partial liquid ventilation (PLV) on gas exchange, lung compliance, and end-expiratory lung volume (EELV). DESIGN: Prospective animal study. SETTING: Animal physiology research laboratory. SUBJECTS: Nine piglets. INTERVENTIONS: Animals underwent saline solution lavage to produce lung injury. Perflubron was instilled via the endotracheal tube in a volume estimated to represent functional residual capacity. The initial PEEP setting was 4 cm H(2)O, and stepwise changes in PEEP were made. At 30-min intervals, the PEEP was increased to 8, then 12, then decreased back down to 8, then 4 cm H(2)O. MEASUREMENTS AND RESULTS: After 30 min at each level of PEEP, arterial blood gases, aortic and central venous pressures, heart rates, dynamic lung compliance, and changes in EELV were recorded. Paired t tests with Bonferroni correction were used to evaluate the data. There were no differences in heart rate or mean BP at the different PEEP levels. CO(2) elimination and oxygenation improved directly with the PEEP level and mean airway pressure (Paw). Compliance did not change with increasing PEEP, but did increase when PEEP was lowered. EELV changes correlated directly with the level of PEEP. CONCLUSIONS: As previously reported during gas ventilation, oxygenation and CO(2) elimination vary directly with PEEP and proximal Paw during PLV. EELV also varies directly with PEEP. Dynamic lung compliance, however, improved only when PEEP was lowered, suggesting an alteration in the distribution of perflubron due to changes in pressure-volume relationships.

Animals↗

Synchronized gas and partial liquid ventilation in lung-injured animals: improved gas exchange with decreased effort.

We hypothesized that partial liquid ventilation (PLV) with perflubron in spontaneously breathing lung-injured animals would increase respiratory workload compared to animals treated with gas ventilation (GV), and that a fully synchronized mode, assist-control ventilation (AC), would reduce the piglets' effort when compared to intermittent mandatory ventilation (IMV) or synchronized IMV (SIMV) during both GV and PLV. Newborn piglets with saline lavage-induced lung injury were randomized to sequential 30-min periods of IMV --> SIMV --> AC (n = 5), or AC --> SIMV --> IMV (n = 5) during GV followed by PLV. Pulmonary mechanics measurements and an esophageal patient effort index (PEI, defined as the product of the area below baseline of the esophageal pressure-time curve and respiratory rate [RR]) were determined to estimate the patient's nonmechanical work of breathing, using a computer-assisted lung mechanics analyzer. GV to PLV comparisons showed no change in PEI (IMV, 57.8 vs. 49.7; SIMV, 52.3 vs. 46.8; AC, 15.7 vs. 13.7 cm H2O x s/min); intermode comparisons showed significantly decreased PEI in AC vs. IMV and SIMV during GV, and in AC vs. SIMV (AC vs. IMV, P = 0.06) during PLV. AC consistently resulted in the highest minute ventilation, lowest total respiratory rate, most physiologic pH, and least tidal volume variability. These observations suggest that synchronization with AC during GV and PLV may have substantial physiologic benefits.

Animals↗

Relation of salivary cotinine to blood pressure in middle-aged cigarette smokers.

BACKGROUND: In laboratory research, nicotine administration is associated with increases in blood pressure. In epidemiologic research, however, the amount of reported cigarette smoking has no consistent relation with blood pressure. The objective of this study was to examine the relation of a nicotine metabolite (salivary cotinine) to systolic and diastolic blood pressure in current smokers being screened for entry to a clinical trial. METHODS AND RESULTS: Data were obtained from 5164 middle-aged cigarette smokers during screening for the Lung Health Study. Multiple linear regression was used to examine the association of salivary cotinine and number of cigarettes smoked per day to systolic and diastolic blood pressure with age, body mass, years of education, alcohol intake, and recent caffeinated beverage use controlled in all analyses. Although smoking frequency was unrelated to blood pressure, salivary cotinine was related to greater systolic blood pressure in both men and women and greater diastolic blood pressure in men. CONCLUSIONS: The association between salivary cotinine and blood pressure in these analyses suggests that long-term nicotine exposure may be related to modest elevations in blood pressure in cigarette smokers.

Biomarkers↗

Effects of randomized assignment to a smoking cessation intervention and changes in smoking habits on respiratory symptoms in smokers with early chronic obstructive pulmonary disease: the Lung Health Study.

PURPOSE: To evaluate the effects of randomly assigning smokers who have early chronic obstructive pulmonary disease (COPD) to a smoking-cessation intervention on the symptoms of chronic cough, chronic phlegm production, wheezing and shortness of breath, and to determine the effects of quitting smoking on these symptoms. SUBJECTS AND METHODS: A total of 5,887 male and female smokers 35 to 60 years of age with early COPD [defined as a forced expiratory volume in the first second (FEV1) of 55% to 90% of predicted and FEV1/forced vital capacity (FVC) <0.70] were enrolled in a 5-year clinical trial. Two-thirds of participants were randomly assigned to smoking-intervention groups and one-third to a usual-care group. The intervention groups attended 12 intensive smoking-cessation sessions that included behavior modification techniques and the use of nicotine chewing gum. One intervention group was treated with ipratropium bromide by inhaler; the other intervention group received placebo inhalers. The usual-care group was advised to stop smoking. All participants were followed annually. Smoking status was biochemically validated by salivary cotinine measurements or exhaled carbon monoxide values. RESULTS: Validated 5-year sustained smoking cessation occurred in 22% of participants in the intervention compared with only 5% of participants in the usual-care group. At the end of the study, the prevalence of each of the four symptoms in the two intervention groups was significantly less than in the usual-care group (P <0.0001). For example, among participants who did not report cough at baseline, 15% of those in the intervention groups had cough at least 3 months during the year, compared with 23% of those in usual care. Sustained quitters had the lowest prevalence of all four symptoms, whereas continuous smokers had the greatest prevalence of these symptoms. Changes in symptoms occurred primarily in the first year after smoking cessation. Respiratory symptoms were associated with greater declines in FEV1 during the study (P <0.001). Ipratropium bromide had no long-term effects on respiratory symptoms. CONCLUSIONS: In this prospective randomized trial using an intention-to-treat analysis, smokers with early COPD who were assigned to a smoking-cessation intervention had fewer respiratory symptoms after 5 years of follow-up.

Adult↗

Perfluorocarbon priming and surfactant: physiologic and pathologic effects.

OBJECTIVE: To test the hypothesis that perfluorocarbon (PFC) priming before surfactant administration improves gas exchange and lung compliance, and also decreases lung injury, more than surfactant alone. DESIGN: Prospective, randomized animal study. SETTING: Animal research laboratory of Children's Hospital of St. Paul. SUBJECTS: Thirty-two newborn piglets, weighing 1.55 +/- 0.18 kg. INTERVENTIONS: We studied four groups of eight animals randomized after anesthesia, paralysis, tracheostomy, and establishment of lung injury using saline washout to receive one of the following treatments: a) surfactant alone (n = 8); b) priming with the PFC perflubron alone (n = 8); c) priming with perflubron followed by surfactant (n = 8); and d) no treatment (control; n = 8). Perflubron priming was achieved by instilling perflubron via the endotracheal tube in an amount estimated to represent the functional residual capacity, ventilating the animal for 30 mins, and then removing perflubron by suctioning. After all treatments were given, animals were mechanically ventilated for 4 hrs. MEASUREMENTS AND MAIN RESULTS: We evaluated oxygenation, airway pressures, respiratory system compliance, and hemodynamics at baseline, after induction of lung injury, and at 30-min intervals for 4 hrs. Histopathologic evaluation was carried out using a semiquantitative scoring system and by computer-assisted morphometric analysis. After all treatments, animals had decreased oxygenation indices (p < .001) and increased respiratory system compliance (p < .05). Animals in PFC groups had similar physiologic responses to treatments as animals treated with surfactant only; both the PFC-treated groups and the surfactant-treated animals required lower mean airway pressures throughout the experiment (p < .001) and had higher pH levels at 90 and 120 mins (p < .05) compared with the control group. Pathologic analysis demonstrated decreased lung injury in surfactant-treated animals compared with animals treated with PFC or the controls (p < .02). CONCLUSIONS: Priming the lung with PFC neither improved the physiologic effects of exogenous surfactant nor improved lung pathology in this animal model.

Animals↗

Does social integration confound the relation between alcohol consumption and mortality in the Multiple Risk Factor Intervention Trial (MRFIT)?

OBJECTIVE: It has been proposed that social integration would act as a confounder in the relationship between alcohol consumption and all-cause mortality. This study tested the assumption that the J-shaped relationship between drinking and all-cause mortality may partly reflect a protective effect of social integration, to the extent that moderate drinkers are more socially integrated than either abstainers or heavy drinkers, and to the extent that social integration offers direct protection from mortality. METHOD: This hypothesis was tested using data from 10,832 of the 12,866 men in the Multiple Risk Factor Intervention Trial (MRFIT). Indicators of social integration were derived from an exploratory factor analysis of 25 relevant items in the MRFIT data and from a scale of six items selected by the investigators. RESULTS: We failed to confirm a direct protective effect of social integration. Nondrinkers had the highest rates of all-cause mortality. Compared with heavy drinking, relative risks of all-cause mortality for abstinence, light and moderate drinking were unaffected by inclusion of social integration variables in the proportional hazards models. CONCLUSIONS: The MRFIT data fail to confirm a confounding effect of social integration.

Alcohol Drinking↗

Early and late weight gain following smoking cessation in the Lung Health Study.

The authors examine weight gains associated with smoking cessation in the Lung Health Study (1986-1994) over a 5-year follow-up period. A cohort of 5,887 male and female smokers in the United States and Canada, aged 35-60 years, were randomized to either smoking intervention or usual care. Among participants who achieved sustained quitting for 5 years, women gained a mean of 5.2 (standard error, 5.0) kg in year 1 and a mean of 3.4 (standard error, 5.5) kg in years 1-5. Men gained a mean of 4.9 (standard error, 4.9) kg in year 1 and a mean of 2.6 (standard error, 5.8) kg in years 1-5. In regression analyses, smoking-change variables were the most potent predictors of weight change. Participants going from smoking to quit-smoking in a given year had mean weight gains of 2.95 kg/year (3.61%) in men and 3.09 kg/year (4.69%) in women. Over 5 years, 33% of sustained quitters gained > or = 10 kg compared with 6% of continuing smokers. Also among sustained quitters, 7.6% of men and 19.1% of women gained > or = 20% of baseline weight; 60% of the gain occurred in year 1, although significant weight gains continued through year 5. The average gains and the high proportions of sustained and intermittent quitters who gained excessive weight suggest the need for more effective early interventions that address both smoking cessation and weight control.

Adult↗