Adherence to long-acting bronchodilator therapy for management of chronic obstructive pulmonary disease (COPD) is a critical clinical and cost issue. Low adherence is associated with relatively higher exacerbation rates and illness burden.

PURPOSE: To compare adherence between patients with COPD initiating therapy on tiotropium or fluticasone/salmeterol and examine the association between adherence and respiratory-related costs.

PATIENTS AND METHODS: This retrospective claims data analysis evaluated patients initiating tiotropium or combination fluticasone/salmeterol from December 1, 2004 to December 31, 2005. Patients had ≥1 COPD diagnosis (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] 491.xx, 492.x, 496) and were observed during 6-month pre-index and variable (12-18-month) post-index periods. Outcomes were adherence to and discontinuation of therapy, and respiratory-related inpatient, medical, and total health care costs. Adherence was medication possession ratio ≥0.80. Discontinuation, adherence, and costs were analyzed with Cox proportional hazards regression, logistic regression, and generalized linear model regressions, respectively. Regressions controlled for demographic, sociodemographic, and health status factors.

RESULTS: The study population comprised 1561 tiotropium and 2976 fluticasone/salmeterol patients. In unadjusted comparisons: 19.5% and 8.5% of tiotropium and fluticasone/salmeterol patients, respectively, were adherent (P < 0.001); tiotropium patients versus fluticasone/salmeterol patients had higher mean respiratory-related pharmacy costs (US$1080 versus US$974, P = 0.002) and health care costs (US$3751 versus US$2932, P = 0.031). Regression analysis showed tiotropium patients were 31.6% less likely to discontinue therapy (95% confidence interval [CI]: 0.64-0.73) and had 2.25 times higher odds of adherence (CI: 1.85-2.73) versus fluticasone/salmeterol patients. The associations between index therapy and costs were not significant. Adherence versus nonadherence was associated with: 46.9% higher health care costs (CI: 1.13-1.91); 37.1% lower medical costs (CI: 0.43-0.91); and 53.4% lower inpatient costs (CI: 0.30-0.72).

CONCLUSION: Patients with COPD initiating long-acting bronchodilator therapy were more likely to be adherent to tiotropium than to fluticasone/salmeterol. Adherence to either tiotropium or to fluticasone/salmeterol was associated with lower respiratory-related medical and inpatient costs, and with higher respiratory-related total health care costs.

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To derive and validate a new clinical risk prediction algorithm (QThrombosis, www.qthrombosis.org) to estimate individual patients' risk of venous thromboembolism.

DESIGN: Prospective open cohort study using routinely collected data from general practices. Cox proportional hazards models used in derivation cohort to derive risk equations evaluated at 1 and 5 years. Measures of calibration and discrimination undertaken in validation cohort.

SETTING: 564 general practices in England and Wales contributing to the QResearch database.
PARTICIPANTS: Patients aged 25-84 years, with no record of pregnancy in the preceding 12 months or any previous venous thromboembolism, and not prescribed oral anticoagulation at baseline: 2 314 701 in derivation cohort and 1 240 602 in validation cohort. Outcomes Incident cases of venous thromboembolism, either deep vein thrombosis or pulmonary embolism, recorded in primary care records or linked cause of death records.

RESULTS: The derivation cohort included 14 756 incident cases of venous thromboembolism from 10 095 199 person years of observation (rate of 14.6 per 10 000 person years). The validation cohort included 6913 incident cases from 4 632 694 person years of observation (14.9 per 10 000 person years). Independent predictors included in the final model for men and women were age, body mass index, smoking status, varicose veins, congestive cardiac failure, chronic renal disease, cancer, chronic obstructive pulmonary disease, inflammatory bowel disease, hospital admission in past six months, and current prescriptions for antipsychotic drugs. We also included oral contraceptives, tamoxifen, and hormone replacement therapy in the final model for women. The risk prediction equation explained 33% of the variation in women and 34% in men in the validation cohort evaluated at 5 years The D statistic was 1.43 for women and 1.45 for men. The receiver operating curve statistic was 0.75 for both sexes. The model was well calibrated.

CONCLUSIONS: We have developed and validated a new risk prediction model that quantifies absolute risk of thrombosis at 1 and 5 years. It can help identify patients at high risk of venous thromboembolism for prevention. The algorithm is based on simple clinical variables which the patient is likely to know or which are routinely recorded in general practice records. The algorithm could be integrated into general practice clinical computer systems and used to risk assess patients before hospital admission or starting medication which might increase the risk of venous thromboembolism.

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Around the world, the timing of referral of chronic obstructive pulmonary disease (COPD) patients for pulmonary rehabilitation differs from immediately after exacerbation (early) to later on when patients are in a stable state (late). There are no trials comparing the different time points of referral for pulmonary rehabilitation.

Objectives: Our aim was to compare the effects of early and late pulmonary rehabilitation on exacerbation rates and health-related quality of life (HRQOL) in COPD patients with exacerbations.

Methods: We randomized COPD patients (Global Initiative for Chronic Obstructive Lung Disease stages II-IV) with a recent exacerbation to early (within 2 weeks) or late pulmonary rehabilitation (starting 6 months after randomization and in a stable state). The primary outcome was the exacerbation rate over 18 months, and secondary outcomes included HRQOL and mortality. We used multivariate analyses and an intention-to-treat analysis approach.

Results: We randomized 36 patients to pulmonary rehabilitation. On average, patients with early rehabilitation (n = 19) had 2.61 (SD 2.96) exacerbations requiring systemic corticosteroids and/or antibiotics, compared to 2.77 (SD 3.41) in patients with late rehabilitation (adjusted incidence rate ratio 0.83, 95% confidence interval 0.43-1.63; p = 0.60). Over the 18-month period, patients with late rehabilitation experienced more dyspnea (difference on Chronic Respiratory Questionnaire dyspnea domain 0.74 and on the Medical Research Council dyspnea scale 0.37), but neither these differences nor any difference in HRQOL domains reached statistical significance.

Conclusions: We did not find any statistically significant differences between early and late pulmonary rehabilitation. However, our trial indicates that early rehabilitation may lead to faster recovery of HRQOL after exacerbations compared to rehabilitation later on when patients are in a stable state.

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Worldwide, COPD is a leading cause of chronic morbidity and mortality. Although its prevalence is already well documented, very few studies have measured its incidence. We therefore investigated the prevalence, incidence and lifetime risk of COPD in the general population.

In a population-based study including subjects ≥ 40, with 12 months of history available in the Dutch IPCI database, we identified COPD cases by a two-step validation algorithm. Among 185,325 participants with 601,283 years of follow-up, 7308 subjects with COPD were identified, and 1713 had incident COPD. The overall IR of physician-diagnosed COPD was 2.92/1000PY (95%CI 2.78-3.06).

The incidence of COPD was higher in men (3.54; 95%CI 3.33-3.77) than in women (2.34; 95%CI 2.17-2.52), and the overall baseline prevalence of COPD was 3.02% (95%CI 2.94-3.10). For people who had entered the study free of COPD at the age of 40, the risk of developing COPD within the next 40 years was 12.7% for men and 8.3% for women. In patients with very severe COPD, 26% died after 1 year of follow-up, whereas 2.8% died among the non-COPD subjects. In the general population in the Netherlands, three on 1000 subjects were diagnosed with COPD per year.

The incidence increased rapidly with age and was higher in men than in women. One in eight men and one in 12 women, being COPD free at the age of 40, will develop COPD during their further life. Mortality rates differed substantially between COPD patients and non-COPD subjects of the same age, underlining the burden of this disease.

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