Psoriasis-related treatment exposure and hospitalization or in-hospital mortality due to COVID-19 during the first and second wave of the pandemic: cohort study of 1 326 312 patients in France.

BACKGROUND: Data on treatment exposures for psoriasis and poor COVID-19 outcomes are limited. OBJECTIVES: To assess the risk of hospitalization or in-hospital mortality due to COVID-19 by treatment exposure in patients with psoriasis. METHODS: All adults with psoriasis registered in the French national health-insurance (Système National des Données de Santé, SNDS) database between 2008 and 2019 were eligible. Two study periods were considered: 15 February to 30 June 2020 and 1 October 2020 to 31 January 2021, the first and second waves of the COVID-19 pandemic in France, respectively. Patients were classified according to their baseline treatment: biologics, nonbiologics, topicals or no treatment. The primary endpoint was hospitalization for COVID-19 using Cox models with inverse probability of treatment weighting. The secondary endpoint was in-hospital mortality due to COVID-19. RESULTS: We identified 1 326 312 patients with psoriasis (mean age 59 years; males, 48%). During the first study period, 3871 patients were hospitalized for COVID-19 and 759 (20%) died; during the second period 3603 were hospitalized for COVID-19 and 686 (19%) died. In the propensity score-weighted Cox models, risk of hospitalization for COVID-19 was associated with exposure to topicals or nonbiologics [hazard ratio (95% confidence interval): 1·11 (1·04-1·20) and 1·27 (1·09-1·48), respectively] during the first period, and with all exposure types, during the second period. None of the exposure types was associated with in-hospital mortality due to COVID-19. CONCLUSIONS: Systemic treatments for psoriasis (including biologics) were not associated with increased risk of in-hospital mortality due to COVID-19. These results support maintaining systemic treatment for psoriasis during the pandemic.

Thromboembolic risk after lumbar spine surgery: a cohort study on 325 000 French patients.

Essentials The risk of venous thromboembolism (VTE) after lumbar spine surgery (LBS) is not precisely known. More than 320 000 patients who underwent LBS in France between 2009 and 2014 were followed-up. The overall risk of VTE after LBS is less than 1% but modulated by patient and procedural factors. Surgical device implantation, anterior approach and complex surgery increase the risk of VTE. SUMMARY: Background Postoperative venous thromboembolism (VTE) is a severe complication, the risk of which after lumbar spine surgery (LBS) is not precisely known. Objective To estimate the incidence of VTE after LBS, and to identify individual and surgical risk factors. Methods All patients aged >18 years who underwent LBS in France between 2009 and 2014 were identified. Among 477 024 patients screened, exclusions concerned recent VTE or surgery, and multiple surgeries during the same hospital stay. Results In 323 737 patients (mean age 52.9 years, 51.4% male), we observed 2911 events (0.91%) after a median time of 12 days (Q1-Q3: 5-72 days). The multivariate adjusted Cox model showed increased risks associated with age (4% per year of age; 95% confidence interval [CI] 3.8-4.3), obesity (hazard ratio [HR] 1.32, 95% CI 1.18-1.46), active cancer (HR 1.65, 95% CI 1.5-1.82), previous thromboembolism (HR 5.41, 95% CI 4.74-6.17), severe paralysis (HR 1.47, 95% CI 1.17-1.84), renal disease (HR 1.28, 95% CI 1.04-1.6), psychiatric disease (HR 1.21, 95% CI 1.1-1.32), use of antidepressants (HR 1.13, 95% CI 1.03-1.24), use of contraceptives (HR 1.56, 95% CI 1.19-2.03), extended surgery for scoliosis (HR 3.61, 95% CI 2.96-4.4), implantation of pedicular screws with a 'dose-effect' association, and an anterior approach (HR 1.97, 95% CI 1.6-2.43) or a combined approach (HR 2.03, 95% CI 1.44-2.84). Conclusions The overall VTE risk after LBS is moderate (< 1%) but is widely modulated by several easily identifiable risk factors. The surgical community should be aware of this heterogeneity, adapt prevention according to patients and to the procedure, and use drug prophylaxis in the event of a high risk being present.

Therapeutic management of inflammatory bowel disease in real-life practice in the current era of anti-TNF agents: analysis of the French administrative health databases 2009-2014.

BACKGROUND: Management of inflammatory bowel disease (IBD) has evolved in the last decade. AIM: To assess IBD therapeutic management, including treatment withdrawal and early treatment use in the current era of anti-TNF agents (anti-TNFs). METHODS: All patients affiliated to the French national health insurance diagnosed with IBD were included from 2009 to 2013 and followed up until 31 December 2014. Medication uses, treatment sequences after introduction of thiopurine or anti-TNF monotherapies or both (combination therapy), surgical procedures and hospitalisations were assessed. RESULTS: A total of 210 001 patients were diagnosed with IBD [Crohn's disease (CD), 100 112; ulcerative colitis (UC), 109 889]. Five years after diagnosis, cumulative probabilities of anti-TNF monotherapy and combination therapy exposures were 33.8% and 18.3% in CD patients and 12.9% and 7.4% in UC patients, respectively. Among incident patients who received thiopurines or anti-TNFs, the first treatment was thiopurine in 69.1% of CD and 78.2% of UC patients. Among patients treated with anti-TNFs, 45.2% and 54.5% of CD patients and 38.2% and 39.9% of UC patients started monotherapy and combination therapy within 3 months after diagnosis, respectively; 31.3% of CD and 27.1% of UC incident patients withdrew from thiopurine or anti-TNFs for more than 3 months after their first course of treatment. Five years after diagnosis, the cumulative risks of first intestinal resection in CD patients and colectomy in UC patients were 11.9% and 5.7%, respectively. CONCLUSIONS: Step-up approach remains the predominant strategy, while exposure to anti-TNFs is high. Surgery rates are low. Treatment withdrawal in IBD is more common than expected.

Impact of the sharp changes in the use of contraception in 2013 on the risk of pulmonary embolism in France.

BACKGROUND: In late 2012, a national pill crisis led French women to promptly change their behavior regarding contraception, with a significant increase in the use of first-generation and second-generation combined oral contraceptives to the detriment of third-generation and fourth-generation products (C3Gs and C4Gs). OBJECTIVE: To assess the impact of the sharp changes in 2013 on the rate of women hospitalized for pulmonary embolism in France. METHODS: All hospitalized pulmonary embolisms in women aged 15-49 years, excluding those occurring during delivery stay, were identified from the French national hospital discharge databases from 2010 to 2013. Hospitalization rates, overall and by age group, were calculated. We compared rates in 2013 with those in 2012, and with mean rates over the preceding 3-year period (2010-2012). Two populations of non-users of contraceptives were used as control groups: men aged 15-49 years, and women aged 50-69 years. The expected reduction in pulmonary embolism incidence, estimated by modeling the number of expected cases based on modifications of combined oral contraceptive exposure, was also considered. RESULTS: In France, in 2013 as compared with 2012, the pulmonary embolism hospitalization incidence rate in women aged 15-49 years fell by 10.6%, corresponding to a reduction of 322 hospitalizations (95% confidence interval -468 to -156). The expected pulmonary embolism reduction is consistent with the observed reduction in hospitalization incidence rate (-10.2% and -10.6%, respectively). Such a pattern was not observed in the control groups. CONCLUSIONS: The sharp change in contraception methods, with decreased use of C3Gs and C4Gs, probably played a major role in the reduction in venous thromboembolism morbidity in France.

Contraceptive pills and thrombosis: effects of the French crisis on prescriptions and consequences for medicine agencies.

The higher risk of venous thromboembolism with 3rd and 4th- generations combined oral contraceptives compared to 2nd generation triggered a media crisis in France. Exposure to 3rd or 4th-generation combined oral contraceptives led to an annual excess of around 100 premature deaths in Europe. In the absence of any demonstrated additional benefit of these combined oral contraceptives, measures were taken to decrease exposure of women to this illegitimate excess of risk. As a consequence, this crisis saw a 45% decrease in the prescription of 3rd and 4th-generations combined oral contraceptives, without adverse consequences.

Five-year survival for lung cancer patients managed in general hospitals.

INTRODUCTION: In 2000, the college of pulmonologists of general hospitals undertook an epidemiological study (KBP-2000-CPHG) enrolling all new cases of histologically confirmed lung cancer managed in general hospitals. This paper reports the 5-year survival in these cases. METHODS: Vital status was available for 5447 out of 5667 patients included in the original study. The effect of different prognostic factors on mortality was assessed. RESULTS: At 5 years, 567 patients (10.4%) were still alive. Median survival for the 4880 (89.6%) deceased patients was 7 months. Univariate analysis identified age, smoking history, performance status, histological type and disease stage (TMN classification) as determinants of survival. For non-small cell lung cancer (n=4885) multivariate analysis identified five predictive factors for mortality - age, gender, histological type, performance status and stage. CONCLUSIONS: Five-year survival in lung cancer continues to be poor. As the risk factors for poor outcome at the time of diagnosis are not modifiable and pending, the results of screening studies reduction in mortality must rest on primary prevention.

[Study KBP-2010-CPHG: inclusion of new cases of primary lung cancer diagnosed in general hospital pneumology departments between 1st January and 31 December 2010]. / Étude KBP-2010-CPHG: recueil des nouveaux cas de cancer bronchopulmonaire primitif diagnostiqués dans les services de pneumologie des centres hospitaliers généraux du 1(er) janvier au 31 décembre 2010.

INTRODUCTION: The College of General Hospital Respiratory Physicians (CPHG) is following up the KBP-2000-CPHG study, performed ten years ago, with a new observational epidemiological study of primary lung cancer. PATIENTS AND METHODS: The study includes all new cases of primary lung cancer diagnosed on histology or cytology between 1 January and 31 December 2010 and managed by one of the general hospital pneumology departments participating in the study. The primary objective is to estimate five-year mortality and to analyze risk factors. Secondary objectives are to describe the characteristics of this patient population and their management, and to estimate one, four and five-year survival rates. These data will be compared to those of the KBP-2000-CPHG study. The four-year prognosis score developed in 2000 will also be assessed in the new study. Data are collected by standardized questionnaire with exhaustiveness control. EXPECTED RESULTS: One hundred and eight investigating centers have agreed to participate; 4000 to 5000 new cases of primary lung cancer should be collected and analyzed. CONCLUSION: The study will describe the characteristics of patients presenting with primary lung cancer in the participating pneumology departments during the year 2010, and their diagnostic and therapeutic management, and assess changes over the last ten years.

[Chronic obstructive pulmonary disease (COPD) in the elderly]. / La bronchopneumopathie chronique obstructive (BPCO) du sujet âgé en huit questions/réponses.

Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by incompletely reversible airflow limitation, measured by a decrease of FEV(1)/FVC ratio. International consensus does not agree on a single threshold for this ratio, which can define airflow obstruction. Although the prevalence of COPD in the elderly population varies according to the definition used, it definitely increases with age and could reach 15% in those over 65 years of age. Therefore, ageing of the population should result in increased prevalence and socioeconomical costs of COPD during coming years. In France, diagnosis of COPD in the elderly is difficult, late and insufficient. Management, which has the same goals as in younger populations, has to be global and coordinated. Some points should be considered with particular attention considering the cumulative risks related on the one hand to COPD and on the other to ageing: pharmacological side-effects, decreased physical and social autonomy, nutritional impairment, comorbidities. Given the lack of specific data in elderly populations, pharmacological indications are generally considered to be the same as in younger populations, but some additional precautionary measures are necessary. Pulmonary rehabilitation seems to be beneficial at any age. Palliative care comes up against important difficulties: an indefinite beginning of the palliative stage in COPD; insufficient palliative care resources; insufficient communication; insufficient utilization of palliative care resources. Global COPD management in elderly requires coordination, best reached in health care network organizations involving medical and/or social professionals.

[Intrahospital mortality during acute exacerbations of COPD. Study EABPCO-CPHG of the College of the Lung specialists of General hospitals (CPHG)]. / Mortalité intrahospitalière au cours des exacerbations aiguës de BPCO. Etude EABPCO-CPHG du Collège des pneumologues des hôpitaux généraux (CPHG).

INTRODUCTION: The objective of the present study was to determine the in-hospital mortality rate in the EAPCO-CPHG cohort and to identify risk factors. METHODS: All patients with COPD acute exacerbation admitted to the pneumology department of 68 French general hospitals between October 2006 and June 2007 were included in the EABPCO-CPHG cohort. RESULTS: At discharge, vital status was known for 1817 patients. Forty-five patients died during their hospital stay, i.e., an in-hospital mortality rate of 2.5%. Mutivariate analysis identified age (OR=1.07 [1.03-1.11]), grade greater than 2 dyspnea in stable state (OR=3.77 [1.68-8.57]), and number of clinical signs of severity during the acute exacerbation (OR=1.36 [1.11-1.55]) as independent risk factors for in-hospital mortality. CONCLUSIONS: In-hospital mortality in patients admitted to a pneumology department of a general hospital is quite low. Simple clinical criteria allow easy identification of at-risk patients and should enable management to be improved.

[Acute COPD exacerbations in women: EABPCO-CPHG study by the College of general hospital pneumologists]. / Les exacerbations aiguës de BPCO chez la femme : étude EABPCO-CPHG du Collège des pneumologues des hôpitaux généraux.

INTRODUCTION: Emerging evidence suggests that gender differences exist in the prevalence, susceptibility, severity and response to the treatment of COPD. This article compares the characteristics of acute exacerbation in male and female patients hospitalized for acute chronic obstructive pulomnary disease (COPD) exacerbation. METHODS: This observational study collected data from 1,824 patients admitted to the pneumology department in 68 general hospitals between October 2006 and June 2007. RESULTS: The 423 (23.2%) women were younger than the men (69.1 versus 70.6 years; p=0.016) and more frequently non-smokers (14.4% versus 4.2%; p<0.0001). Before the acute exacerbation, they more frequently reported asthma (18% versus 11.6%; p=0.0006) or bronchiectasis (10.4% versus 5.9%; p=0.002). They also more often presented consciousness disorders (6.4% versus 3.9%; p=0.033) and desaturation (SpO2<90%: 50.4% versus 42%; p=0.002) during acute exacerbation and their hypercapnia was more severe (50.7 versus 46.5mmHg; p<0.0001). During hospitalization, they were more frequently ventilated (23.9 versus 17.1%; p=0.002). There was no difference in the mortality between the sexes (1.4% versus 2.8%; p=0.11). Age and smoking behavior were closely related in the female patients: the smokers were younger (62.5 years) than the ex-smokers (73.7 years) or non-smokers (78.1 years). Of the six women who died during hospitalization, two were smokers and four ex-smokers. In addition, four were over 80 years old. CONCLUSION: The women hospitalized for acute COPD exacerbation differed from the men with respect to risk factors, steady-state COPD severity and exacerbation severity.

[Characteristics and management of acute exacerbations of COPD in hospital. EABPCO-CPHG study by the college of general hospital respiratory physicians]. / Caractéristiques et prise en charge des exacerbations aiguës de BPCO hospitalisées. Etude EABPCO-CPHG du Collège des pneumologues des hôpitaux généraux.

INTRODUCTION: A cohort was formed to explore the evolution of COPD patients treated in general hospitals for acute exacerbations (AE). The present article describes and compares patient characteristics according to whether COPD was diagnosed before the AE or not. METHODS: Data were analyzed for 1,824 patients admitted between October 2006 and June 2007 to 68 departments of respiratory medicine. RESULTS: Population characteristics were: male, 77%; mean age, 70.3+/-11.3 years; current smokers, 33%; baseline grade 3-4 dyspnoea, 47%; FEV1

[Chronic bronchitis: prevalence and quality of life. Analysis of data from the French Health Interview Survey 2002-2003]. / Bronchite chronique: prévalence et qualité de vie.

INTRODUCTION: Chronic bronchitis is associated with an increased risk of COPD and health-related quality of life (HRQoL) impairment. The objectives of the study were to estimate the prevalence of chronic bronchitis and to describe its relations with quality of life. METHODS: The French Health Interview Survey was conducted in 2003 in a representative sample of households. Data were collected during an interviewer's visits to the home. Respiratory symptoms and HRQoL (SF-36) were assessed in 9,050 adults aged 45 years and older using a self-administered questionnaire. RESULTS: The prevalence of chronic bronchitis was estimated at 3.5%. Chronic bronchitis was associated with an impaired physical component summary score after adjusting for sex, age and dyspnoea. It was associated with a reduced mental component summary score (MCS) among men. In women, this association was only significant in the absence of dyspnoea. CONCLUSION: The prevalence of chronic bronchitis was 3.5% among adults aged 45 years and older. Chronic bronchitis was associated with impairment in health-related quality of life.

[Five year survival for lung cancer patients managed in general hospitals]. / Survie à cinq ans des cancers bronchiques primitifs dans les centres hospitaliers généraux.

INTRODUCTION: In 2000 the College of Pulmonologists of General Hospitals undertook an epidemiological study (KBP-2000-CPHG) enrolling all new cases of histologically confirmed lung cancer managed in general hospitals. This paper reports the five year survival in these cases. METHODS: Vital status was available for 5447 out of 5667 patients included in the original study. The effect of different prognostic factors on mortality was assessed. RESULTS: At 5 years 567 patients (10.4%) were still alive. Median survival for the 4880 (89.6%) deceased patients was 7 months. Univariate analysis identified age, smoking history, performance status, histological type and disease stage (TMN classification) as determinants of survival. For non-small cell lung cancer (n=4885) multivariate analysis identified five predictive factors for mortality - age, gender histological type, performance status and stage. CONCLUSIONS: Five year survival in lung cancer continues to be poor. As the risk factors for poor outcome at the time of diagnosis are not modifiable and pending the results of screening studies reduction in mortality must rest on primary prevention.

Predictors of outcomes in COPD exacerbation cases presenting to the emergency department.

The aim of the present prospective multicentric study was to develop a simple rule for the prediction of poor outcome in patients presenting to emergency departments with initially non-life threatening-chronic obstructive pulmonary disease (COPD) exacerbations in a real-life setting. All patients with an acute exacerbation of COPD visiting the emergency departments of 103 hospitals during a 3-month period were included, except those who immediately required intensive care unit admission and/or ventilatory support. The data collected included patient characteristics, in-hospital outcomes (mortality and length of stay) and mode of discharge (unsupported or need for post-hospital assistance). The in-hospital mortality rate was 7.4% (59 out of 794). Independent prognostic factors were age, number of clinical signs of severity (among cyanosis, impaired neurological status, lower limb oedema, asterixis and use of accessory inspiratory or expiratory muscles) and dyspnoea grade in the stable state. The need for post-hospital support was also predicted by female sex. In order to construct and validate a prediction score for mortality based on these items, patients were randomly allocated to a derivation and a validation cohort. The prediction score showed good discrimination, with a c-statistic of 0.79 in the derivation cohort and 0.83 in the validation cohort. Thus simple purely clinical factors can reliably predict the risk of death and requirement for post-hospital support in an initially non-life threatening-acute exacerbation of chronic obstructive pulmonary disease. Their use needs to be prospectively validated.

[Acute exacerbations of COPD admitted to hospital: predictive factors of 3 year mortality]. / Exacerbations aiguës de BPCO hospitalisées: facteurs prédictifs de mortalité à trois ans.

INTRODUCTION: COPD is a disease whose gravity is underestimated by doctors and patients. The development of acute exacerbations (AE) accelerates the progression of the disease and leads to increased financial costs, notably on account of hospitalisation. MATERIALS AND METHODS: An observational prospective study will be undertaken based on a cohort of consecutive patients hospitalised in departments of respiratory medicine in general hospitals. The main objective is to study the factors predictive of mortality at 3 years after one admission for AE. The secondary objectives are to describe the characteristics of the AE on arrival and 3 months after discharge from hospital. A register will be set up and a questionnaire will be completed for each patient, consisting of items concerning COPD, the AE and the condition of the patient and his treatments 3 months after discharge. The level of mortality at 3 years and the predictive factors will be calculated from the data in the register. EXPECTED RESULTS: Identification the characteristics of the AE and determination of a predictive score for mortality should allow optimisation of the management of patients suffering from COPD.

Dietary iron intake and serum ferritin in relation to 7.5 years structure and function of large arteries in the SUVIMAX cohort.

AIM: Few studies have investigated the relationship between iron stores and measures of atherosclerosis. Most of these studies were cross-sectional and yielded conflicting results. We aimed to assess the relationship between serum ferritin concentrations and dietary iron intake measured at baseline and 7.5 year pulse wave velocity (PWV), intima-media thickness (IMT) and plaques in a group of 824 men and women without known CVD, cancer or hemochromatosis. METHODS: The SUVIMAX study is a randomized double-blind, placebo-controlled primary prevention trial designed to test the effect of antioxidant supplementation in reducing ischemic cardiovascular diseases and cancer. RESULTS: In multivariate analyses, no association was found between baseline serum ferritin levels and IMT 7 years later (beta (95% CI)=0.003 (-0.005;0.011) in men; -0.005 (-0.013;0.004) and -0.001 (-0.011;0.009) in women, before and after menopause, respectively), plaques (OR (95% CI)=1.09 (0.88;1.34) in men; 0.93 (0.66;1.31) and 0.95 (0.70;1.29) in women, before and after menopause, respectively) or PWV (beta (95% CI)=0.078 (-0.154;0.310) in men; -0.018 (-0266;0.231) in women before and after menopause). Results for dietary iron intake were similar. CONCLUSION: Our results do not support the hypothesis that dietary iron intake and body iron stores are deleterious to the structure and function of large arteries in subjects free of CVD, cancer or hemochromatosis.

Mannheim carotid intima-media thickness consensus (2004-2006). An update on behalf of the Advisory Board of the 3rd and 4th Watching the Risk Symposium, 13th and 15th European Stroke Conferences, Mannheim, Germany, 2004, and Brussels, Belgium, 2006.

Intima-media thickness (IMT) is increasingly used as a surrogate end point of vascular outcomes in clinical trials aimed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral artery diseases). The necessity to promote further criteria to distinguish early atherosclerotic plaque formation from thickening of IMT and to standardize IMT measurements is expressed through this updated consensus. Plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness >1.5 mm as measured from the media-adventitia interface to the intima-lumen interface. Standard use of IMT measurements is based on physics, technical and disease-related principles as well as agreements on how to perform, interpret and document study results. Harmonization of carotid image acquisition and analysis is needed for the comparison of the IMT results obtained from epidemiological and interventional studies around the world. The consensus concludes that there is no need to 'treat IMT values' nor to monitor IMT values in individual patients apart from exceptions named, which emphasize that inside randomized clinical trials should be performed. Although IMT has been suggested to represent an important risk marker, according to the current evidence it does not fulfill the characteristics of an accepted risk factor. Standardized methods recommended in this consensus statement will foster homogenous data collection and analysis. This will help to improve the power of randomized clinical trials incorporating IMT measurements and to facilitate the merging of large databases for meta-analyses.

[Cohort KBP-2000-CPHG: Evaluation of factors influencing survival in lung cancer]. / Cohorte KBP-2000-CPHG: évaluation des facteurs pronostiques de la survie du cancer bronchique primitif à 2 et 5 ans.

INTRODUCTION: Lung cancer continues to have a poor prognosis despite some therapeutic advances. BACKGROUND: The last fifteen years has seen a dramatic increase in the incidence of lung cancer in women and an increased proportion of adenocarcinomas in both sexes. A study of overall survival as a function of gender and other prognostic factors has been established using the cohort of patients from the study KBP-2000-CPHG. METHODS: KBP-2000-CPHG is an epidemiological study carried out throughout the year 2000 looking at histologically confirmed primary lung cancers managed in general hospitals. 5,667 patients have been included. The study of survival looks at 2 and 5-year outcomes. The date and cause of death are recorded for each patient. In the absence of these data the date of the last contact is noted. If this is less than 4 months the patient is considered to be alive. If more than four months have elapsed a graduated strategy for establishing vital status is pursued which involves reviewing records from various different sources. RESULTS AWAITED: A preliminary review of the data was undertaken between September 2004 and March 2005 which obtained data on 5 567 patients. The analysis of survival according to sex and other forecast prognostic factors is underway.

Serum carotenoids, vitamins A and E, and 8 year lung function decline in a general population.

BACKGROUND: Oxidative stress is thought to have a major role in the pathogenesis of airway obstruction. A study was undertaken to determine whether subjects with low levels of antioxidants (serum beta-carotene, alpha-carotene, vitamins A and E) would be at a higher risk of accelerated decline in forced expiratory volume in 1 second (FEV1) as their lungs would be less protected against oxidative stress. METHODS: 1194 French subjects aged 20-44 years were examined in 1992 as part of the European Community Respiratory Health Survey (ECRHS); 864 were followed up in 2000 and 535 (50% men, 40% lifelong non-smokers) had complete data for analysis. RESULTS: During the 8 year study period the mean annual decrease in FEV1 (adjusted for sex, centre, baseline FEV1, age, smoking, body mass index and low density lipoprotein cholesterol) was 29.8 ml/year. The rate of decrease was lower for the subjects in tertile I of beta-carotene at baseline than for those in the two other tertiles (-36.5 v -27.6 ml/year; p = 0.004). An increase in beta-carotene between the two surveys was associated with a slower decline in FEV1. No association was observed between alpha-carotene, vitamin A, or vitamin E and FEV(1) decline. However, being a heavy smoker (> or =20 cigarettes/day) in combination with a low level of beta-carotene or vitamin E was associated with the steepest decline in FEV1 (-52.5 ml/year, p = 0.0002 and -50.1 ml/year, p = 0.010, respectively). CONCLUSIONS: These results strongly suggest that beta-carotene protects against the decline in FEV1 over an 8 year period in the general population, and that beta-carotene and vitamin E are protective in heavy smokers.