Disease Management plus Recommended Care versus Recommended Care Alone for Ambulatory Patients with Chronic Obstructive Pulmonary Disease.

Rationale: The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain.Objectives: To study the effect of disease management (DM) added to recommended care (RC) in ambulatory patients with COPD.Measurements and Main Results: In this trial, 1,202 patients with COPD (age, ≥40 yr), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and by remote contacts with the patients between these visits, included patient self-care education, monitoring patients' symptoms and adherence to treatment, provision of advice in case of acute disease exacerbation, and coordination of care vis-à-vis other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 patients (47.2%) in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95% confidence interval, 0.77-1.08).Conclusions: DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory patients with COPD.

Severe and non-severe asthma in the community: A large electronic database analysis.

BACKGROUND: A large electronic database analysis was conducted in a community of 351,799 people, ages 20-70 years to determine the prevalence and clinical characteristics of severe asthma, according to 2014 international guidelines and healthcare utilization. METHODS: Severe asthmatics were grouped into controlled severe-asthma and uncontrolled severe-asthma and additional subgroups of uncontrolled severe asthma on the basis of medications dispensed. Non-asthmatic population at the same ages served as controls. RESULTS: A total of 19,991 (5.68%) were diagnosed as asthmatic, of which 4.65% had severe asthma. Of these, one-third was uncontrolled severe-asthma. Controlled severe-asthma group was similar to non-severe asthma and non-asthmatics in the rate of emergency room visits (21.5%, 22%, and 20%, respectively) and to all cause hospitalizations (7.4%, 7.4%, and 6.4%, respectively). Uncontrolled severe-asthmatics had significantly more hospitalizations (RR = 2.9) than controlled severe-asthmatics. Only 19.2% of uncontrolled-severe asthmatics had IgE testing and 3.6% were dispensed omalizumab. CONCLUSIONS: The prevalence of severe asthma is slightly less than 5% of all asthmatics. Controlling severe asthma is crucial to reducing healthcare utilization. A simple electronic database analysis, based on dispensed medications, can help healthcare providers identify subgroups of uncontrolled severe asthmatics that require focused efforts. CLINICAL TRIAL REGISTRATION: NCT01961258. Ethics Committee approval: 032/2013C.

Thyrotropin levels within the lower normal range are associated with an increased risk of hip fractures in euthyroid women, but not men, over the age of 65 years.

CONTEXT: The contemporary literature on the relationship between serum TSH levels and osteoporotic fractures in euthyroid individuals is limited by conflicting results and analyses conducted on a small number of fractures. OBJECTIVE: Our objective was to examine the association between the normal range of variation of TSH and the incidence of hip fractures in male and female euthyroid patients aged 65 years or older. DESIGN AND SETTING: We performed a population-based historical prospective cohort study within the Clalit Health Services population. PARTICIPANTS: Clalit Health Services members aged ≥65 years with at least 1 TSH measurement during the year 2004. We excluded patients with preexisting hip fracture, thyroid disease, malignancy, or chronic kidney disease. OUTCOME MEASURES: The primary outcome was hip fracture, and the secondary outcome was any other osteoporotic fracture. STATISTICAL ANALYSIS: Adjusted odds ratios comparing episodes of each outcome across 3 TSH groups (low, 0.35-1.6 mIU/L; intermediate, 1.7-2.9 mIU/L; high, 3-4.2 mIU/L) were generated using logistic regression models. RESULTS: The 14 325 included participants suffered from 514 hip fractures (mean follow-up, 102 ± 3 months). Women, but not men, in the lowest TSH group had a higher incidence of hip fractures (odds ratio = 1.28, 95% confidence interval = 1.03-1.59, P = .029) when compared with the intermediate group, after multivariate adjustment for age, comorbidities, and use of drugs affecting bone metabolism. There was no difference in hip fracture incidence between intermediate- and high-TSH groups. No association was found between TSH levels and other osteoporotic fractures. CONCLUSIONS: TSH levels within the lower normal range are associated with an increased risk of hip fractures in euthyroid women, but not men, aged 65 years and more.

Comparison of mortality in patients with coronary or peripheral artery disease following the first vascular intervention.

OBJECTIVES: Patients with peripheral artery disease (PAD) less frequently achieve secondary prevention goals compared with patients with coronary artery disease (CAD). We aimed to compare mortality rates in patients with PAD and CAD following first vascular intervention. PATIENTS AND METHODS: Patients 18 years of age or older without a history of cardiovascular disease, who underwent first coronary or lower limb vascular intervention between 2002 and 2010, were included in this study. The primary endpoint was all-cause mortality. RESULTS: Of the 9950 participants, 8242 (82.8%) underwent first coronary revascularization and 1708 (17.2%) received first peripheral vascular intervention. During a mean follow-up period of 5.6±2.3 years, 1283 (12.9%) participants died. Compared with CAD patients, patients with PAD had significantly worse long-term prognosis with an increased risk for all-cause mortality (hazard ratio=2.95, 95% confidence interval 2.6-3.3, P<0.0001). This association remained statistically significant following a multivariable analysis (hazard ratio=1.86, 95% confidence interval 1.6-2.1, P<0.0001). Furthermore, PAD patients were less frequently treated with cardioprotective medications including statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, aspirin, and clopidogrel (P<0.001). CONCLUSION: Patients with PAD have worse outcome compared with patients with CAD, even in the specific group of patients following first vascular intervention. These findings demand more effort to improve secondary prevention guidelines in all patients with cardiovascular diseases, but especially in PAD patients.

Lipid control in patients with coronary heart disease treated in primary care or cardiology clinics.

BACKGROUND: Guidelines recommend low-density lipoprotein-cholesterol (LDL-C) target of <70 mg/dL in patients with coronary disease. However, this goal is not achieved in many patients. OBJECTIVES: We compared LDL-C control in patients with coronary disease treated by a primary care physician or with the addition of a cardiologist. METHODS: Included were patients with coronary disease who had full lipid profile. Primary end points included the percentage of patients who achieved the LDL-C goals of <100 mg/dL and <70 mg/dL. RESULTS: Of the 27,172 patients, 12,965 (47.7%) were followed only by a primary care physician and 14,207 (52.3%) were also followed by a cardiologist. Overall, 18,366 patients (67.6%) achieved the LDL-C goal of <100 mg/dL, and 6517 patients (24%) achieved the LDL-C goal of <70 mg/dL. Patients followed by a cardiologist more frequently achieved the LDL-C goal of <100 mg/dL (74.3% and 60.3%; P < .0001, in patients treated by a cardiologist or by a primary care physician, respectively), as well as the lower LDL-C goal of <70 mg/dL (27.2% and 20.4%; P < .0001, in patients treated by a cardiologist or by a primary care physician, respectively). Differences in LDL-C control remained significant after a multivariate adjustment. Patients followed by a cardiologist were more commonly treated with highly potent statins and with non-statin cholesterol-lowering drugs. CONCLUSIONS: Among patients with coronary disease, those followed by a cardiologist receive a more aggressive antilipid treatment and more frequently achieve lipids goals. Nevertheless, the disappointingly poor lipid control in both groups warrants an effort to improve adherence for guidelines in both primary care and cardiology clinics.

Comparison of lipid control in patients with coronary versus peripheral artery disease following the first vascular intervention.

Peripheral arterial disease (PAD) is a strong risk factor for cardiovascular morbidity and mortality. Therefore, target low-density lipoprotein (LDL) cholesterol level in patients with PAD is ≤70 mg/dl, similar to patients with coronary artery disease (CAD). However, despite their high cardiovascular risk, patients with PAD less frequently achieve LDL cholesterol goals compared to patients with CAD. We aimed to compare LDL cholesterol control in patients after first coronary or peripheral vascular intervention. Included were patients ≥18 years of age without a history of cardiovascular disease who underwent first coronary or peripheral vascular intervention from 2004 through 2010. Primary end points were percentage of patients who achieved the LDL cholesterol goal of <100 and <70 mg/dl. Of 9,138 patients available for analysis, 7,512 (82.2%) underwent first coronary revascularization and 1,626 (17.8%) underwent first peripheral revascularization. Patients after first coronary revascularization were treated more frequently with any statin and with highly potent statins. Furthermore, they more frequently achieved the LDL cholesterol goals compared to patients after first peripheral intervention. This was true for the LDL cholesterol goal of <100 mg/dl (65% and 46.7%, p <0.0001) and for the lower LDL cholesterol goal of <70 mg/dl (23.3% and 13.3%, p <0.0001). Differences in LDL cholesterol control between the 2 groups remained statistically significant after multivariate adjustment. In conclusion, lipid control in patients with PAD is poor and significantly inferior to that of patients with CAD even after the first vascular intervention.

Mortality and coronary heart disease in euthyroid patients.

BACKGROUND: Subclinical thyroid dysfunction is associated with increased mortality and cardiovascular risk. It is unknown whether this association remains within normal thyroid function range. METHODS: The study was conducted using the computerized database of the Sharon-Shomron district of Clalit Health services. Included were subjects aged ≥40 years with normal thyroid function. Patients with a history of thyroid or cardiovascular diseases or diabetes were excluded. The primary end points were all-cause mortality and the need for coronary revascularization with either percutaneous coronary intervention or coronary artery bypass grafting. RESULTS: The 42,149 participants were stratified into 3 groups of equal thyrotropin intervals (0.35-1.6, 1.7-2.9, and 3-4.2 mIU/L). During a mean follow-up of 4.5±2.1 years, 4239 (10.1%) participants died and 1575 (3.7%) underwent coronary revascularization. For both women and men, the lowest mortality rates were observed in the intermediate thyrotropin group. Nevertheless, only for the low thyrotropin group, mortality risk remained significantly higher as compared with the intermediate thyrotropin group, even following multivariate model adjusted for the conventional cardiovascular risk factors, in both women (odds ratio 1.22; 95% confidence interval, 1.09-1.36 for the low thyrotropin group, compared with the intermediate group) and men (odds ratio 1.14; 95% confidence interval, 1.01-1.3 for the low thyrotropin group, compared with the intermediate group). There was no significant difference in the need for coronary revascularization among the 3 thyrotropin groups in both men and women. CONCLUSIONS: Low thyrotropin level within the reference range is associated with increased risk for all-cause mortality.

HDL-C levels and revascularization procedures in coronary heart disease patients treated with statins to target LDL-C levels.

BACKGROUND: A low level of high-density lipoprotein cholesterol (HDL-C) is a strong predictor for cardiovascular disease morbidity and mortality at all low-density lipoprotein cholesterol (LDL-C) concentrations. HYPOTHESIS: We evaluated this association in routine clinical practice among statin-treated coronary heart disease patients who achieved LDL-C target levels. This association also exists in routine clinical practice. METHODS: A retrospective dynamic cohort included all male coronary heart disease patients of the Sharon-Shomron district, Clalit Health Services, Israel, with LDL-C levels < 100 mg/dL and who were receiving statins (≥ 6 purchases/y) from January 1998 to June 2008. Data were collected on demographic variables; coexistence of hypertension, diabetes mellitus, and peripheral vascular diseases; details of revascularization procedures; and lipid levels. The outcome variable was revascularization procedure, by either percutaneous intervention or coronary artery bypass graft. RESULTS: The study group of 909 male patients was stratified into quintiles, based on mean HDL-C levels: Q1 (n = 179): ≤ 26.4 mg/dL; Q2 (n = 190): 26.4-≤ 30.0 mg/dL; Q3 (n = 191): > 30.0-≤ 34.0 mg/dL; Q4 (n = 186): > 34.0-≤ 41.0 mg/dL; Q5 (n = 163): > 41.0 mg/dL. During the study period, 307 (33.8%) of the cohort required ≥ 1 revascularization procedure. Those in the highest quintile underwent significantly fewer procedures (40.8% for Q1 vs 16.6% for Q5, P<0.001). This significant effect of the highest HDL-C quintile was not influenced by any variable. CONCLUSIONS: The protective effect of high HDL-C levels, regardless of other risk factors, in preventing revascularization procedures was confirmed in the routine clinical practice among statin-treated CHD patients who reached LDL-C level < 100 mg/dL. Possible additional benefits of using agents to raise HDL-C levels should be investigated.