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Clinical role of dual bronchodilation with an indacaterol-glycopyrronium combination in the management of COPD: its impact on patient-related outcomes and quality of life.

Chronic obstructive pulmonary disease (COPD) is the result of persistent and progressive pathologic abnormalities in the small airways, most often associated with alveolar loss. Smoking cessation is the most effective intervention to slow down the progression of COPD. Long-acting inhaled bronchodilators are prescribed for the symptomatic relief at any stage of disease severity.

For patients whose COPD cannot be not sufficiently controlled with long-acting bronchodilator monotherapy, international guidelines suggest the possibility of associating a long-acting beta2 agonist (LABA) with a long-acting muscarinic antagonist (LAMA), ie, dual bronchodilation. This is not a new concept as the combination of short-acting agents has been popular in the past. In recent years, several fixed-dose combinations containing a LAMA and a LABA in a single inhaler have been approved by regulatory authorities in several countries.

Among the new LAMA/LABA combinations, the fixed-dose combination of indacaterol 110 µg/glycopyrronium 50 µg (QVA149) has been shown in a series of clinical trials to be as safe as the single components and placebo, and more effective than placebo and the single components with regard to lung function, symptoms, and patient-oriented outcomes. Furthermore, QVA149 achieved better bronchodilation than salmeterol 50 µg/fluticasone 500 µg twice daily. Compared with tiotropium, a well-recognized treatment for COPD, the percentage of patients that exceed the minimal clinical important difference for dyspnea and health-related quality of life measurements was superior with QVA149. Other patient-oriented outcomes, such as daily symptoms, night-time awakening, and use of rescue medication consistently favored QVA149.

Finally, QVA149 was significantly superior to LAMAs for reducing all types of exacerbation. In conclusion, several years after introduction of dual bronchodilation, the fixed-dose combination of indacaterol 110 µg/glycopyrronium 50 µg in a single inhaler for once-daily administration via the Breezhaler(®) device (QVA149) has been demonstrated to be a safe and effective treatment for COPD patients.

Cost-effectiveness analysis of three different combinations of inhalers for severe and very severe chronic obstructive pulmonary disease patients at a tertiary care teaching hospital of South India.

BACKGROUND: This study aims at simplifying the practical patient management and offers some general indications for pharmacotherapeutic choice by the implementation of (Global Initiative for Chronic Lung Disease) guidelines. This study was designed to evaluate the clinical and economic consequences of salmeterol/fluticasone (SF), formoterol/budesonide (FB), and formoterol/fluticasone (FF) in severe and very severe chronic obstructive pulmonary disease (COPD) patients.

OBJECTIVES: The aim was to find out the most cost-effective drug combination between the three combinations (SF/FB/FF) in COPD patients.

MATERIALS AND METHODS: A prospective observational comparative study (cost-effectiveness analysis), in which 90 severe (30 ≤ forced expiratory volume in 1 s [FEV1] <50% predicted) and very severe (FEV1 < 30% predicted) COPD patients (outpatients/inpatients) who are prescribed with any one of the following combinations (SF/FB/FF) were selected. In our study, we have divided 90 COPD patients into three groups (Group I, Group II, and Group III) each group consisting of 30 patients. Group I was prescribed with medication SF, Group II with medication FB, and Group III with medication FF. We used five different parameters such as spirometry test (mean FEV1 initial and final visit), number of symptom-free days (SFDs), number of moderate and severe exacerbations, Number of days of hospitalization and direct, indirect, and total cost to assess the cost-effectiveness of SF/FB/FF. Comparison of cost and effects was done during the period of 6 months of using SF/FB/FF.

RESULTS: The average FEV1 for Group I, Group II, and Group III subjects at initial visit was 33.47%, 33.73%, and 33.20% and was increased to 36.60%, 35.8%, and 33.4%, respectively. A 3% increment in FEV1 was reported for Group I subjects (SF) and was highly significant statistically (t = -8.833, P = 0.000) at 95% CI. For Group II subjects (FB), a 2% increment in FEV1 was reported and was highly significant statistically (t = -9.001, P = 0.000) at 95% CI. For Group III (FF) subjects 0.2% increment in FEV1. The overall mean total cost for Group I, Group II, and Group III subjects during the 6 months period was found to be Rs. 29,725/-, Rs. 32,602/- and Rs. 37,155/-. Incremental cost-effectiveness of FB versus SF was Rs. 37,781/- per avoided exacerbation and Rs. 661/-per SFD.

CONCLUSION: This study highlights the favorable therapeutic performance of combined inhaled bronchodilators and corticosteroids (SF/FB/FF), thus suggesting that healthcare costs would be also affected positively. Results from our study showed that SF and FB were the most effective strategies in the treatment of COPD, with a slight clinical superiority of SF. The FF strategy was not much effective (i.e. associated with fewer outcomes and higher costs).

Validation of the 'Test of the Adherence to Inhalers' (TAI) for asthma and COPD patients.

OBJECTIVE : To validate the 'Test of Adherence to Inhalers' (TAI), a 12-item questionnaire designed to assess the adherence to inhalers in patients with COPD or asthma.

METHODS: A total of 1009 patients with asthma or COPD participated in a cross-sectional multicenter study. Patients with electronic adherence ≥80% were defined as adherents. Construct validity, internal validity, and criterion validity were evaluated. Self-reported adherence was compared with the Morisky-Green questionnaire.

RESULTS: Factor analysis study demonstrated two factors, factor 1 was coincident with TAI patient domain (items 1 to 10) and factor 2 with TAI health-care professional domain (items 11 and 12). The Cronbach's alpha was 0.860 and the test-retest reliability 0.883. TAI scores correlated with electronic adherence (ρ=0.293, p=0.01). According to the best cut-off for 10 items (score 50, area under the ROC curve 0.7), 569 (62.5%) patients were classified as non-adherents. The non-adherence behavior pattern was: erratic 527 (57.9%), deliberate 375 (41.2%), and unwitting 242 (26.6%) patients. As compared to Morisky-Green test, TAI showed better psychometric properties.

CONCLUSIONS: The TAI is a reliable and homogeneous questionnaire to identify easily non-adherence and to classify from a clinical perspective the barriers related to the use of inhalers in asthma and COPD.

The development and first validation of the Manchester Early Morning Symptoms Index (MEMSI) for patients with COPD

Aim

Early morning symptoms (EMS) in people with COPD are associated with poor health, impaired activities and increased exacerbation risk. We describe the development and preliminary validation of the Manchester Early Morning Symptom Index (MEMSI) to quantify EMS in COPD.

 Methods

Focus groups and cognitive debriefing with patients with COPD were used to develop the potential item list, followed by a cross-sectional study to finalise the items for inclusion. In addition to test-retest reliability, comparisons with the St George's Respiratory Questionnaire-C (SGRQ-C), modified Medical Research Council Dyspnoea Scale, Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) and Hospital Anxiety and Depression Scale (HADS) evaluated construct validity. Hierarchical methods informed item deletion and Rasch analysis was applied to assess scale unidimensionality.

 Results

23 items were identified from the focus groups and debriefings. The cross-sectional study involved 203 patients with COPD (mean age 64.7 SD 7.5 years, male 63%, Global Initiative for Chronic Obstructive Lung Disease (GOLD): 1:14% 2:41% 3:25% 4: 7%). 13 items were removed during item reduction. MEMSI contains 10 items, demonstrates good overall fit to the Rasch model (2 p=0.26) and item score distribution; excellent reliability (Person Separation Index: 0.91) and good test-retest repeatability (r=0.82). It correlates with the SGRQ-C (r=0.73), FACIT-F (r=–0.65) and HADS (r=0.53–0.54) indicating good construct validity.

 Conclusions

MEMSI is a reliable and valid unidimensional measure of EMS for patients with COPD. It is simple to use and score supporting its suitability for research and clinical use. Work is underway to determine the minimal clinical important difference and cross-cultural validity.

Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab.

Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150 mg daily) and bevacizumab (15 mg·kg–1 on day 1, every 3 weeks) (EB) until progression, or cisplatin (80 mg·m–2 on day 1, every 3 weeks) and gemcitabine (1250 mg·m–2 on days 1 and 8, every 3 weeks) up to six cycles and bevacizumab (15 mg·kg–1 on day 1, every 3 weeks) (PGB) until progression.

224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9 months; hazard ratio (HR) 1.85, 95% CI 1.39–2.45; p<0.0001) and overall survival (median 12.6 versus 17.8 months; HR 1.41, 95% CI 1.01–1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB.

Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

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