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Impact of multiple-dose versus single-dose inhaler devices on COPD patients' persistence with long-acting β₂-agonists: a dispensing database analysis.

ABSTRACT: With a growing availability of different devices and types of medication, additional evidence is required to assist clinicians in prescribing the optimal medication in relation to chronic obstructive pulmonary disease (COPD) patients' persistence with long-acting β2-agonists (LABAs).To assess the impact of the type of inhaler device (multiple-dose versus single-dose inhalers) on 1-year persistence and switching patterns with LABAs.A retrospective observational cohort study was performed comparing a cohort of patients initiating multiple-dose inhalers and a cohort initiating single-dose inhalers. The study population consisted of long-acting bronchodilator naive COPD patients, initiating inhalation therapy with mono-LABAs (formoterol, indacaterol or salmeterol). Analyses were performed using pharmacy dispensing data from 1994 to 2012, obtained from the IADB.nl database. Study outcomes were 1-year persistence and switching patterns. RESULTS were adjusted for initial prescriber, initial medication, dosing regimen and relevant comorbidities.In all, 575 patients initiating LABAs were included in the final study cohort. Among them, 475 (83%) initiated a multiple-dose inhaler and 100 (17%) a single-dose inhaler. Further, 269 (47%) initiated formoterol, 9 (2%) indacaterol and 297 (52%) salmeterol. There was no significant difference in persistence between users of multiple-dose or single-dose inhalers (hazard ratio: 0.98, 95% confidence interval: 0.76-1.26, P=0.99). Over 80% re-started or switched medication.There seems no impact of inhaler device (multiple-dose versus single-dose inhalers) on COPD patients' persistence with LABAs. Over 80% of patients who initially seemed to discontinue LABAs, re-started their initial medication or switched inhalers or medication within 1 year.

SUBMITTER: van Boven JF

PROVIDER: S-EPMC4373462 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Project description:IntroductionTriple inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist (ICS/LAMA/LABA) combination therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) who experience further exacerbations/symptoms on dual LAMA/LABA or ICS/LABA therapy. The relative efficacy of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler 320/18/9.6 µg (BGF MDI) in COPD was compared with other ICS/LAMA/LABA fixed-dose and open combination therapies in a network meta-analysis (NMA).MethodsA systematic literature review was conducted to identify randomized controlled trials of at least 10-week duration, including at least one fixed-dose or open combination triple therapy arm, in patients with moderate to very severe COPD. Studies were assessed for methodological quality and risk of bias. A three-level hierarchical Bayesian NMA model was used to determine the exacerbation rate per patient per year as well as the following outcomes at week 24: changes from baseline in pre-dose trough forced expiratory volume in 1 s (FEV1), post-dose peak FEV1, and St. George's Respiratory Questionnaire (SGRQ) total score; proportion of SGRQ responders; and Transition Dyspnea Index focal score. Change from baseline in rescue medication use over weeks 12-24 was also analyzed. Meta-regression and sensitivity analyses were used to assess heterogeneity across studies.ResultsEighteen studies (n = 29,232 patients) contributed to the NMA. ICS/LABA dual combinations were combined as a single treatment group to create a connected network. Across all outcomes, there were no statistically significant differences between BGF MDI and other triple ICS/LAMA/LABA fixed-dose (fluticasone furoate/umeclidinium/vilanterol and beclomethasone dipropionate/glycopyrronium/formoterol fumarate) and open combinations with data available within the network. Results from sensitivity analyses and meta-regression were consistent with the base-case scenario.ConclusionThis NMA suggested that BGF MDI has comparable efficacy to other ICS/LAMA/LABA fixed-dose and open triple combination therapies in reducing exacerbations and improving lung function and symptoms in patients with moderate to very severe COPD. Further research is warranted as additional evidence regarding triple therapies, especially fixed-dose combinations, becomes available.

Project description:BackgroundDual bronchodilation with a long-acting muscarinic antagonist (LAMA)/long-acting ?2-agonist (LABA) fixed-dose combination (FDC) is an established treatment strategy for chronic obstructive pulmonary disease (COPD). The relative efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI 18/9.6??g) in patients with moderate-to-very severe COPD, compared with other licensed LAMA/LABA FDCs, was investigated using an integrated Bayesian network meta-analysis (NMA).MethodsA systematic literature review and subsequent screening process identified randomized controlled trials of ?10?weeks' duration that enrolled patients aged ?40?years with moderate-to-very severe COPD and included at least one LAMA/LABA FDC or open LAMA?+?LABA treatment arm. NMAs were conducted for outcomes including change from baseline in forced expiratory volume in 1?s (FEV1), St George's Respiratory Questionnaire (SGRQ), and transition dyspnea index (TDI) parameters, annualized rate of exacerbations, use of rescue medication, adverse events, and all-cause withdrawals. Meta-regression and sensitivity analyses accounted for heterogeneity across studies.ResultsIn total, 29 studies including 34,617 patients contributed to the NMA for efficacy or safety outcomes at week 24 or exacerbations. For all LAMA/LABA FDCs with data available, significantly greater improvements in FEV1 [trough, peak, and area under the curve (AUC)0-4], SGRQ total score and TDI focal score at week 24, and annualized rate of moderate-to-severe exacerbations, were observed versus placebo. Where indirect comparisons were possible, differences between GFF MDI and other LAMA/LABA FDCs were small relative to established margins of clinical relevance, and not statistically significant. The safety and tolerability profile of GFF MDI was consistent with other LAMA/LABA FDCs and placebo. The results of the meta-regression were generally similar to the base case.ConclusionsGFF MDI demonstrated comparable efficacy and safety outcomes to other LAMA/LABA FDCs. Personalization of treatment choice within the class on the basis of other factors such as patient preference may be appropriate.

Project description:Background:Recurrent use of oral corticosteroids (OCS) and over-use of short-acting beta-2-agonists (SABA) are factors associated with adverse side effects and asthma-related death. We aim to quantify high OCS exposure, SABA over-use and its association with prescription and adherence to maintenance treatment for respiratory disease, among patients with prescriptions for respiratory disease, from the Portuguese electronic prescription and dispensing database (BDNP). Methods:This was a 1-year (2016) retrospective population-based analysis of a random sample of adult patients from the BDNP, the nationwide compulsory medication prescription system. We assessed high OCS exposure (dispensing???4 packages containing 20 doses of 20 mg each of prednisolone-equivalent, ??1600 mg/year) on patients on persistent respiratory treatment (PRT-prescription for >?2 packages of any respiratory maintenance medications). Excessive use of SABA was defined as having a ratio of SABA-to-maintenance treatment >?1 or having SABA over-use (dispensing of >?1?×?200 dose canister/month, of 100 ?g of salbutamol-equivalent). Factors associated with high OCS exposure were assessed by multinomial logistic regression. Results:The estimated number of patients on PRT was 4786/100,000 patients. OCS was prescribed to more than 1/5 of the patients on PRT and 101/100,000 were exposed to a high-dose (??1600 mg/year). SABA excessive use was found in 144/100,000 patients and SABA over-use in 24/100,000. About 1/6 of SABA over-users were not prescribed any controller medication and 7% of them had a ratio maintenance-to-total ??70% (high prescription of maintenance treatment). Primary adherence (median%) to controller medication was 66.7% for PRT patients, 59.6% for patients exposed to high OCS dose and 75.0% for SABA over-users. High OCS exposure or SABA over-use were not associated with primary adherence. High OCS exposure was associated with a maintenance-to-total medication ratio <?70% (insufficient prescription of maintenance treatment), age >?45 years old and male sex. Conclusions:Exposure to high-dose of OCS (101 per 100,000 patients) and SABA over-use (24 per 100,000) were frequent, and were associated with a low maintenance-to-total prescription ratio but not with primary non-adherence. These results suggest there is a need for initiatives to reduce OCS and SABA inappropriate prescribing.

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Impact of multiple-dose versus single-dose inhaler devices on COPD patients' persistence with long-acting β₂-agonists: a dispensing database analysis.

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