Cost-effectiveness of combination therapy umeclidinium/vilanterol versus tiotropium in symptomatic COPD Spanish patients.

PURPOSE: Umeclidinium/vilanterol (UMEC/VI) is a novel fixed dose combination of a long-acting muscarinic receptor antagonist (LAMA) and a long-acting beta 2 receptor antagonist (LABA) agent. This analysis evaluated the incremental cost-effectiveness ratio (ICER) of UMEC/VI compared with tiotropium (TIO), from the Spanish National Health System (NHS) perspective. METHODS: A previously published linked equations cohort model based on the epidemiological longitudinal study ECLIPSE (Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points) was used. Patients included were COPD patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤70% and the presence of respiratory symptoms measured with the modified Medical Research Council dyspnea scale (modified Medical Research Council ≥2). Treatment effect, expressed as change in FEV1 from baseline, was estimated from a 24-week head-to-head phase III clinical trial comparing once-daily UMEC/VI with once-daily TIO and was assumed to last 52 weeks following treatment initiation (maximum duration of UMEC/VI clinical trials). Spanish utility values were derived from a published local observational study. Unitary health care costs (€2015) were obtained from local sources. A 3-year time horizon was selected, and 3% discount was applied to effects and costs. Results were expressed as cost/quality-adjusted life years (QALYs). Univariate and probabilistic sensitivity analysis (PSA) was performed. RESULTS: UMEC/VI produced additional 0.03 QALY and €590 vs TIO, leading to an ICER of €21,475/QALY. According to PSA, the probability of UMEC/VI being cost-effective was 80.3% at a willingness-to-pay of €30,000/QALY. CONCLUSION: UMEC/VI could be considered as a cost-effective treatment alternative compared with TIO in symptomatic COPD patients from the Spanish NHS perspective.

Normativa SEPAR sobre disfunción muscular de los pacientes con enfermedad pulmonar obstructiva crónica / Guidelines for the evaluation and treatment of muscle dysfunction in patients with chronic obstructive pulmonary disease

La disfunción muscular de pacientes con enfermedad pulmonar obstructiva crónica (EPOC) constituye una de las comorbilidades más importantes, con repercusiones negativas en su capacidad de ejercicio y calidad de vida. En la presente normativa se ha resumido la literatura publicada más recientemente sobre los diferentes aspectos del tema y se ha utilizado también la escala Grading of Recommendations Assessment, Development, and Evaluation (GRADE) de recomendaciones sobre el grado de evidencia de las diferentes propuestas de la normativa. Respecto a una población control, se estima que en un tercio de los pacientes EPOC la fuerza del cuádriceps es un 25% inferior incluso en estadios precoces de su enfermedad. Aunque tanto los músculos respiratorios como los de las extremidades están alterados, estos últimos suelen verse mayormente afectados. Diversos factores y mecanismos biológicos están involucrados en la disfunción muscular de los pacientes. Se proponen diversas pruebas para evaluar y diagnosticar el grado de afectación de los músculos respiratorios y de las extremidades (periféricos), así como identificar la capacidad de esfuerzo de los pacientes (prueba de marcha de 6 min y cicloergometría). Se describen también las posibles estrategias terapéuticas vigentes que incluyen las diversas modalidades de entrenamiento y de soporte farmacológico y nutricional

In patients with chronic obstructive pulmonary disease (COPD), skeletal muscle dysfunction is a major comorbidity that negatively impacts their exercise capacity and quality of life. In the current guidelines, the most recent literature on the various aspects of COPD muscle dysfunction has been included. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) scale has been used to make evidence-based recommendations on the different features. Compared to a control population, one third of COPD patients exhibited a 25% decline in quadriceps muscle strength, even at early stages of their disease. Although both respiratory and limb muscles are altered, the latter are usually more severely affected. Numerous factors and biological mechanisms are involved in the etiology of COPD muscle dysfunction. Several tests are proposed in order to diagnose and evaluate the degree of muscle dysfunction of both respiratory and limb muscles (peripheral), as well as to identify the patients’ exercise capacity (six-minute walking test and cycloergometry). Currently available therapeutic strategies including the different training modalities and pharmacological and nutritional support are also described

Guidelines for the evaluation and treatment of muscle dysfunction in patients with chronic obstructive pulmonary disease.

In patients with chronic obstructive pulmonary disease (COPD), skeletal muscle dysfunction is a major comorbidity that negatively impacts their exercise capacity and quality of life. In the current guidelines, the most recent literature on the various aspects of COPD muscle dysfunction has been included. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) scale has been used to make evidence-based recommendations on the different features. Compared to a control population, one third of COPD patients exhibited a 25% decline in quadriceps muscle strength, even at early stages of their disease. Although both respiratory and limb muscles are altered, the latter are usually more severely affected. Numerous factors and biological mechanisms are involved in the etiology of COPD muscle dysfunction. Several tests are proposed in order to diagnose and evaluate the degree of muscle dysfunction of both respiratory and limb muscles (peripheral), as well as to identify the patients' exercise capacity (six-minute walking test and cycloergometry). Currently available therapeutic strategies including the different training modalities and pharmacological and nutritional support are also described.

Muscle training with repetitive magnetic stimulation of the quadriceps in severe COPD patients.

BACKGROUND: Previous studies have used electrical neuromuscular stimulation as a physical training method in patients with severe COPD. We introduce the use of the more tolerable magnetic stimulation for the same purpose, investigating the effectiveness of an eight-week protocol. METHODS: Eighteen patients with severe COPD were randomly assigned to a magnetic stimulation training protocol, n=10, FEV(1)=30% (SD: 7) or to parallel clinical monitoring, control group, n=8, FEV(1)=35% (SD: 8). During eight weeks, patients were stimulated for 15min on each quadriceps femoris, three times per week. Quadriceps muscle strength and endurance measurements, quality-of-life questionnaires (SF36, SGRQ) and a six-minute walking test were all carried out before and after the training period in the stimulated and control subjects. RESULTS: All patients completed the training with increasing intensity of stimulation, displaying a significant improvement in voluntary quadriceps strength (17.5% of the baseline value) and exercise capacity, with a mean increase of 23m in the six-minute walking test. The questionnaire scores showed greater increases in quality-of-life scores in the trained subjects compared to the controls, particularly in the physical function areas: mean increments in SF36 in "physical function": +26, "role limitations due to physical problems": +40 and "vitality": +17.5, while +13, -4 and +1, respectively in controls. Saint George's "Activity" score improved by 19.6 points, for 11.5 in controls. CONCLUSIONS: In COPD patients who are limited due to dyspnoea, magnetic neuromuscular stimulation of the quadriceps constitutes a feasible training method for the lower limbs, with positive effects on the muscle function, effort capacity and perception areas.

Redox balance following magnetic stimulation training in the quadriceps of patients with severe COPD.

In severe COPD patients, oxidative stress, which is involved in their peripheral muscle dysfunction, increases in response to exercise. In this study, muscle oxidative stress was explored after quadriceps magnetic stimulation training. A randomized controlled study was conducted on very severe COPD patients, who underwent quadriceps magnetic stimulation training for 8 weeks. A control group was also studied. In both groups, vastus lateralis specimens were obtained before and after the 8-week period. Muscle protein carbonylation and nitration and antioxidant enzymes were determined using immunoblotting and proportions and sizes of type I and II fibres using immunohistochemistry. Compared to controls, magnetic stimulation muscle training did not modify redox balance, whilst inducing a significant increase in type I fibre sizes. In severe COPD patients, it is concluded that quadriceps magnetic stimulation training was a well-tolerated therapeutic intervention, which did not enhance muscle oxidative stress, while increasing the size of slow-twitch fibres.