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Efficacy and safety of tiotropium and olodaterol in COPD: a systematic review and meta-analysis.

ABSTRACT: Long-acting bronchodilators are the cornerstone of pharmacologic treatment of COPD. The new combination of long-acting muscarinic antagonist (LAMA) tiotropium (TIO) and long acting beta-agonists (LABA) olodaterol (OLO) has been introduced as fist line therapy for COPD. This article analyses the evidence of efficacy and safety of the TIO/OLO combination.A systematic review and metaanalysis of randomized controlled trials (RCT) with a period of treatment of at least 6 weeks, in patients with COPD confirmed by spirometry, comparing combined treatment with TIO/OLO (approved doses only), with any of the mono-components or any other active comparator administered as an inhalator.A total of 10 Randomized controlled trials (RCT) were identified (N?=?10,918). TIO/OLO significantly improved trough FEV1 from baseline to week 12 versus TIO, OLO and LABA/ICS (0.06 L, 0.09 L and between 0.04 and 0.05 L, respectively). TIO/OLO improved transitional dyspnea index (TDI) and St. George's Respiratory Questionnaire (SGRQ) compared with mono-components, with patients more likely to achieve clinically important improvements in TDI (risk ratio [RR]: 1.17, 95% confidence interval [CI]: [1.07, 1.28] versus TIO and RR: 1.14, 95%CI: [1.01, 1.28] versus OLO) and in SGRQ (RR: 1.21, 95%CI: [1.12, 1.30] versus TIO and RR: 1.28, 95%CI: [1.18, 1.40] versus OLO). Patients treated with TIO/OLO showed a significant reduction in the use of rescue medication and no significant differences in frequency of general and serious adverse events were observed between TIO/OLO and mono-components.Treatment with TIO/OLO provided significant improvements in lung function versus mono-components and LABA/ICS with more patients achieving significant improvements in dyspnea and health status. No differences in adverse events were observed compared with other active treatments.PROSPERO register of systematic reviews ( CRD42016040162 ).

SUBMITTER: Miravitlles M

PROVIDER: S-EPMC5702233 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Efficacy and safety of tiotropium and olodaterol in COPD: a systematic review and meta-analysis.

Miravitlles Marc M Urrutia Gerard G Mathioudakis Alexander G AG Ancochea Julio J

Respiratory research 20171125 1

<h4>Background</h4>Long-acting bronchodilators are the cornerstone of pharmacologic treatment of COPD. The new combination of long-acting muscarinic antagonist (LAMA) tiotropium (TIO) and long acting beta-agonists (LABA) olodaterol (OLO) has been introduced as fist line therapy for COPD. This article analyses the evidence of efficacy and safety of the TIO/OLO combination.<h4>Methods</h4>A systematic review and metaanalysis of randomized controlled trials (RCT) with a period of treatment of at le ...[more]

PMID: 29178871

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Project description:Increasing age is associated with poor prognosis in patients with COPD.This analysis from the replicate Phase III OTEMTO® and TONADO® studies examined the efficacy and safety of tiotropium, a long-acting anticholinergic, combined with olodaterol, a long-acting ?2-agonist, compared to monotherapies and placebo in patients with COPD aged 40 years to <65 years, 65 years to <75 years, 75 years to <85 years, and ?85 years.In these double-blind, parallel-group, active-controlled, multicenter, randomized studies, patients received tiotropium + olodaterol 2.5/5 ?g or 5/5 ?g, tiotropium 5 ?g or 2.5 ?g (TONADO only), olodaterol 5 ?g (TONADO only), or placebo (OTEMTO only). This analysis used the approved doses of tiotropium + olodaterol 5/5 ?g, tiotropium 5 ?g, and olodaterol 5 ?g. Primary end points at 12 weeks (OTEMTO) or 24 weeks (TONADO) included St George's Respiratory Questionnaire (SGRQ) total score, forced expiratory volume in 1 second (FEV1) area under the curve from 0 hour to 3 hours (AUC0-3) response, and trough FEV1 response.A total of 1,621 patients were randomized (40 years to <65 years, n=749; 65 years to <75 years, n=674; 75 years to <85 years, n=186; ?85 years, n=12) in OTEMTO and 5,162 patients (40 years to <65 years, n=2,654; 65 years to <75 years, n=1,967; 75 to <85 years, n=528; ?85 years, n=13) in TONADO. FEV1 AUC0-3 and trough FEV1 responses improved with tiotropium + olodaterol 5/5 ?g at 12 weeks and 24 weeks compared to monotherapies or placebo for all age groups. SGRQ scores generally improved with tiotropium + olodaterol 5/5 ?g after 12 weeks in OTEMTO and improved after 24 weeks in all age groups in TONADO. In all age groups receiving tiotropium + olodaterol 5/5 ?g compared to monotherapies or placebo, transition dyspnea index scores generally improved, while rescue medication usage improved.No differences were noted in relative responses to treatment or safety when using tiotropium + olodaterol 5/5 ?g compared to monotherapies or placebo across all age groups.

Project description:Aclidinium bromide is a new long-acting muscarinic antagonist (LAMA) indicated for maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD). The efficacy of aclidinium was compared with tiotropium and glycopyrronium, using a network meta-analysis (NMA) of randomized controlled trials (RCTs) in moderate-to-severe COPD patients.A systematic review was performed to identify RCTs evaluating aclidinium 400 ?g twice daily (BID), glycopyrronium 50 ?g once daily (OD), tiotropium 18 ?g OD, or tiotropium 5 ?g OD in adults with moderate-to-severe COPD. The outcomes of interest were: trough forced expiratory volume in 1 second (FEV1); St George's Respiratory Questionnaire (SGRQ) total score and proportion of patients achieving ?4 unit change; Transition Dyspnea Index (TDI) focal score and proportion of patients achieving ?1 point change. The results were synthesized by means of a Bayesian NMA.Twenty-one studies (22,542 patients) were included: aclidinium 400 ?g BID (three studies); tiotropium 5 ?g OD (three studies); tiotropium 18 ?g OD (13 studies); and glycopyrronium 50 ?g OD (two studies). Regarding trough FEV1 at 24 weeks, aclidinium demonstrated comparable efficacy to tiotropium 5 ?g (difference in change from baseline [CFB]), (0.02 L [95% credible interval CrI -0.05, 0.09]); tiotropium 18 ?g (0.02 L [95% CrI -0.05, 0.08]); and glycopyrronium (0.00 L [95% CrI -0.07, 0.07]). Aclidinium resulted in higher improvement in SGRQ score at 24 weeks, compared to tiotropium 5 ?g (difference in CFB, -2.44 [95% CrI -4.82, -0.05]); and comparable results to tiotropium 18 ?g (-1.80 [95% CrI -4.52, 0.14]) and glycopyrronium (-1.52 [95% CrI -4.08, 1.03]). Improvements in TDI score were comparable for all treatments.Maintenance treatment with aclidinium 400 ?g BID is expected to produce similar improvements in lung function, health-related quality of life, and dyspnea compared to tiotropium 5 ?g OD; tiotropium 18 ?g OD; and glycopyrronium 50 ?g OD.

Project description:IntroductionIn patients with chronic obstructive pulmonary disease (COPD), treatment with long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combination therapy significantly improves lung function versus LABA/inhaled corticosteroid (ICS). To investigate whether LAMA/LABA could provide better clinical outcomes than LABA/ICS, this non-interventional database study assessed the risk of COPD exacerbations, pneumonia, and escalation to triple therapy in patients with COPD initiating maintenance therapy with tiotropium/olodaterol versus any LABA/ICS combination.MethodsAdministrative healthcare claims and laboratory results data from the US HealthCore Integrated Research Databasesm were evaluated for patients with COPD initiating tiotropium/olodaterol versus LABA/ICS treatment (January 2013-March 2019). Patients were aged at least 40 years with a diagnosis of COPD (but not asthma) at cohort entry. A Cox proportional hazard regression model was used (as-treated analysis) to assess risk of COPD exacerbation, community-acquired pneumonia, and escalation to triple therapy, both individually and as a combined risk of any one of these events. Potential imbalance of confounding factors between cohorts was handled using fine stratification, reweighting, and trimming by exposure propensity score (high-dimensional); subgroup analyses were conducted on the basis of blood eosinophil levels and exacerbation history.ResultsThe total population consisted of 61,985 patients (tiotropium/olodaterol n = 2684; LABA/ICS n = 59,301); after reweighting, the total was 42,953 patients (tiotropium/olodaterol n = 2600; LABA/ICS n = 40,353; mean age 65 years; female 54.5%). Patients treated with tiotropium/olodaterol versus LABA/ICS experienced a reduction in the risk of COPD exacerbations (adjusted hazard ratio 0.76 [95% confidence interval 0.68, 0.85]), pneumonia (0.74 [0.57, 0.97]), escalation to triple therapy (0.22 [0.19, 0.26]), and any one of these events (0.45 [0.41, 0.49]); the combined risk was similar irrespective of baseline eosinophils and exacerbation history.ConclusionsIn patients with COPD, tiotropium/olodaterol was associated with a lower risk of COPD exacerbations, pneumonia, and escalation to triple therapy versus LABA/ICS, both individually and in combination; the combined risk was reduced irrespective of baseline eosinophils or exacerbation history.Trial registrationClinicalTrials.gov identifier, NCT04138758 (registered 23 October 2019).

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Efficacy and safety of tiotropium and olodaterol in COPD: a systematic review and meta-analysis.

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Efficacy and safety of tiotropium and olodaterol in COPD: a systematic review and meta-analysis.

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