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McNicholas W.T.,University College Dublin | Verbraecken J.,University of Antwerp | Marin J.M.,Hospital Universitario Miguel Servet
European Respiratory Review

Sleep in chronic obstructive pulmonary disease (COPD) is commonly associated with oxygen desaturation, which may exceed the degree of desaturation during maximum exercise, both subjectively and objectively impairing sleep quality. The mechanisms of desaturation include hypoventilation and ventilation to perfusion mismatching. The consequences of this desaturation include cardiac arrhythmias, pulmonary hypertension and nocturnal death, especially during acute exacerbations. Coexistence of COPD and obstructive sleep apnoea (OSA), referred to as overlap syndrome, has been estimated to occur in 1% of the general adult population. Overlap patients have worse sleep-related hypoxaemia and hypercapnia than patients with COPD or OSA alone. OSA has a similar prevalence in COPD as in a general population of similar age, but oxygen desaturation during sleep is more pronounced when the two conditions coexist. Management of sleep-related problems in COPD should particularly focus on minimising sleep disturbance via measures to limit cough and dyspnoea; nocturnal oxygen therapy is not generally indicated for isolated nocturnal hypoxaemia. Treatment with continuous positive airway pressure alleviates hypoxaemia, reduces hospitalisation and pulmonary hypertension, and improves survival. © ERS 2013. Source

Introduction: Trouble sleeping is common in the elderly population and is attributed to changes that aging brings in the sleep architecture and circadian rhythm. The prevalence of insomnia shows a marked increase with advancing age, in a proportion of 14 to 32% among those over 65 years. If we add these physiological changes of sleep with those found in patients admitted to the Intensive Care Unit (ICU), the problem worsens. The prevalence of these disorders in these units is from 22 - 61%. Sleep deprivation may contribute to worsening of the patients.The main objective is to describe the quality of sleep of patients admitted to the Coronary ICU of the Hospital Miguel Servet and the environmental factors that contribute to these disorders. Material and methods: A total of 75 conscious and oriented patients in the Coronary ICU Hospital Miguel Servet were included. Data was collected between February 17 and April 30, 2011. The subjects were asked to state if they had slept well by means of a survey and to score the environmental factors that may have bothered them. Results and discussion: Most patients said they had slept well (66.7%). Noise was the environmental factor that bothered them most. In analyzing the different noises, patients identified hearing people talking as being the most annoying. Conclusion: Changes must be implemented in the unit that would favor restful sleep. © 2012 Elsevier España, S.L. y SEEIUC. Source

San Miguel R.,Complejo Hospitalario de Navarra | Gimeno-Ballester V.,Hospital Universitario Miguel Servet | Mar J.,Clinical Management Unit
Expert Review of Pharmacoeconomics and Outcomes Research

The treatment of chronic hepatitis C has experienced a substantial progress with the arrival of Boceprevir and Telaprevir due to the significant increase in sustained viral response. Given the high cost, their approval has been followed by great deal of pharmacoeconomic literature analysing their efficiency. A systematic review of this literature was carried out, evaluating both its results and the methodology employed. 54 references were revised including 11 studies, 6 on naive populations, 3 on pre-treated patients and 2 in both of them. As the clinical heterogeneity of patients influenced sustained viral response, therapy regimens were assessed conditioned to the interleukin 28B polymorphism, the early response to treatment and the level of fibrosis, among other variables. Most of the options evaluated on a naive population presented ICERs below the acceptability threshold. The same occurred in the pre-treated population, where the subgroups analysis is perceived as a methodological limitation. © 2014 Informa UK, Ltd. Source

Divo M.,Harvard University | Cote C.,University of South Florida | De Torres J.P.,University of Navarra | Casanova C.,University of La Laguna | And 7 more authors.
American Journal of Respiratory and Critical Care Medicine

Rationale: Patients with chronic obstructive pulmonary disease (COPD) are afflicted by comorbidities. Few studies have prospectively evaluated COPD comorbidities and mortality risk. Objectives: To prospectively evaluate COPD comorbidities and mortality risk. Methods: We followed 1,664 patients with COPD in five centers for a median of 51 months. Systematically, 79 comorbidities were recorded. We calculated mortality risk using Cox proportional hazard, and developed a graphic representation of the prevalence and strength of association to mortality in the form of a "comorbidome." A COPD comorbidity index (COPD specific comorbidity test [COTE]) was constructed based on the comorbidities that increase mortality risk using a multivariate analysis. We tested the COTE index as predictor of mortality and explored whether the COTE index added predictive information when used with the validated BODE index. Measurements and Main Results: Fifteen of 79 comorbidities differed in prevalence between survivors and nonsurvivors. Of those, 12 predicted mortality and were integrated into the COTE index. Increases in the COTE index were associated with an increased risk of death from COPD-related (hazard ratio [HR], 1.13; 95% confidence interval, 1.08-1.18; P < 0.001) and non-COPD-related causes (HR, 1.18; 95% confidence interval, 1.15-1.21; P < 0.001). Further, increases in the BODE and COTE were independently associated with increased risk of death. A COTE score of greater than or equal to 4 points increased by 2.2-fold the risk of death (HR, 2.26-2.68; P < 0.001) in all BODE quartile. Conclusions: Comorbidities are frequent in COPD and 12 of them negatively influence survival.Asimple disease-specific comorbidities index (COTE) helps assess mortality risk in patients with COPD. Copyright © 2012 by the American Thoracic Society. Source

Koren M.J.,Jacksonville University | Giugliano R.P.,Harvard University | Raal F.J.,University of Witwatersrand | Sullivan D.,Royal Prince Alfred Hospital | And 9 more authors.

BACKGROUND-: Evolocumab (AMG 145), a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein cholesterol (LDL-C) in phase 2 studies of 12 weeks' duration. The longer-term efficacy and safety of PCSK9 inhibition remain undefined. METHODS AND RESULTS-: Of 1359 randomized and dosed patients in the 4 evolocumab phase 2 parent studies, 1104 (81%) elected to enroll into the Open-Label Study of Long-term Evaluation Against LDL-C (OSLER) study. Regardless of their treatment assignment in the parent study, patients were randomized 2:1 to receive either open-label subcutaneous evolocumab 420 mg every 4 weeks with standard of care (SOC) (evolocumab+SOC, n=736) or SOC alone (n=368). Ninety-two percent of patients in the evolocumab+SOC group and 89% of patients in the SOC group completed 52 weeks of follow-up. Patients who first received evolocumab in OSLER experienced a mean 52.3% [SE, 1.8%] reduction in LDL-C at week 52 (P<0.0001). Patients who received 1 of 6 dosing regimens of evolocumab in the parent studies and received evolocumab+SOC in OSLER had persistent LDL-C reductions (mean reduction, 50.4% [SE, 0.8%] at the end of the parent study versus 52.1% [SE, 1.0%] at 52 weeks; P=0.31). In patients who discontinued evolocumab on entry into OSLER, LDL-C levels returned to near baseline levels. Adverse events and serious adverse events occurred in 81.4% and 7.1% of the evolocumab+SOC group patients and 73.1% and 6.3% of the SOC group patients, respectively. CONCLUSION-: Evolocumab dosed every 4 weeks demonstrated continued efficacy and encouraging safety and tolerability over 1 year of treatment in the largest and longest evaluation of a PCSK9 inhibitor in hypercholesterolemic patients to date. CLINICAL TRIAL REGISTRATION-: URL: http://clinicaltrials.gov. Unique identifier: NCT01439880. © 2013 American Heart Association, Inc. Source

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