scholarly journals The once-daily fixed-dose combination of olodaterol and tiotropium in the management of COPD: current evidence and future prospects

2019 ◽  
Vol 13 ◽  
pp. 175346661984342 ◽  
Author(s):  
Eric Derom ◽  
Guy G. Brusselle ◽  
Guy F. Joos
Keyword(s):  
Statistical Significance ◽  
Fixed Dose Combination ◽  
Current Evidence ◽  
Fixed Dose ◽  
Chronic Obstructive ◽  
Early Introduction ◽  
Patient Reported ◽  
Dose Combination ◽  
Clinically Significant ◽  
Long Acting

Long-acting bronchodilators are the cornerstone of pharmacologic treatment of chronic obstructive pulmonary disease (COPD). Spiolto® or Stiolto® is a fixed-dose combination (FDC) containing two long-acting bronchodilators, the long-acting muscarinic receptor antagonist tiotropium (TIO) and the long-acting β2-adrenoceptor agonist olodaterol (OLO), formulated in the Respimat® Soft Mist™ inhaler. A total of 13 large, multicentre studies of up to 52 weeks’ duration have documented its efficacy in more than 15,000 patients with COPD. TIO/OLO 5/5 µg FDC significantly increases pulmonary function compared with placebo and its respective constituent mono-components TIO 5 µg and OLO 5 µg. TIO/OLO 5/5 µg also results in statistically and clinically significant improvements in patient-reported outcomes, such as dyspnoea, use of rescue medication, and health status. Addition of OLO 5 µg to TIO 5 µg reduces the rate of moderate-to-severe exacerbations by approximately 10%. Compared with placebo and TIO 5 µg, TIO/OLO 5/5 µg significantly improves exercise capacity (e.g. endurance time) and physical activity, the latter increase being reached by a unique combination behavioural modification intervention, dual bronchodilatation and exercise training. Overall, the likelihood for patients to experience a clinically significant benefit is higher with TIO/OLO 5/5 µg than with its constituent mono-components, which usually yield smaller improvements which do not always reach statistical significance, compared with baseline or placebo. This supports the early introduction of TIO/OLO 5/5 µg in the management of patients with symptomatic COPD.

scholarly journals Cost-effectiveness of the fixed-dose combination tiotropium/olodaterol versus tiotropium monotherapy or a fixed-dose combination of long-acting β2-agonist/inhaled corticosteroid for COPD in Finland, Sweden and the Netherlands: a model-based study

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e049675
Author(s):  
Martine Hoogendoorn ◽  
Isaac Corro Ramos ◽  
Stéphane Soulard ◽  
Jennifer Cook ◽  
Erkki Soini ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
The Netherlands ◽  
Cost Effective ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Inhaled Corticosteroid ◽  
Dose Combination ◽  
Long Acting ◽  
Β2 Agonist ◽  
Country Specific

ObjectivesChronic obstructive pulmonary disease (COPD) guidelines advocate treatment with combinations of long-acting bronchodilators for patients with COPD who have persistent symptoms or continue to have exacerbations while using a single bronchodilator. This study assessed the cost-utility of the fixed dose combination of the bronchodilators tiotropium and olodaterol versus two comparators, tiotropium monotherapy and long-acting β2 agonist/inhaled corticosteroid (LABA/ICS) combinations, in three European countries: Finland, Sweden and the Netherlands.MethodsA previously published COPD patient-level discrete event simulation model was updated with most recent evidence to estimate lifetime quality-adjusted life years (QALYs) and costs for COPD patients receiving either tiotropium/olodaterol, tiotropium monotherapy or LABA/ICS. Treatment efficacy covered impact on trough forced expiratory volume in 1 s (FEV1), total and severe exacerbations and pneumonias. The unit costs of medication, maintenance treatment, exacerbations and pneumonias were obtained for each country. The country-specific analyses adhered to the Finnish, Swedish and Dutch pharmacoeconomic guidelines, respectively.ResultsTreatment with tiotropium/olodaterol gained QALYs ranging from 0.09 (Finland and Sweden) to 0.11 (the Netherlands) versus tiotropium and 0.23 (Finland and Sweden) to 0.28 (the Netherlands) versus LABA/ICS. The Finnish payer’s incremental cost-effectiveness ratio (ICER) of tiotropium/olodaterol was €11 000/QALY versus tiotropium and dominant versus LABA/ICS. The Swedish ICERs were €6200/QALY and dominant, respectively (societal perspective). The Dutch ICERs were €14 400 and €9200, respectively (societal perspective). The probability that tiotropium/olodaterol was cost-effective compared with tiotropium at the country-specific (unofficial) threshold values for the maximum willingness to pay for a QALY was 84% for Finland, 98% for Sweden and 99% for the Netherlands. Compared with LABA/ICS, this probability was 100% for all three countries.ConclusionsBased on the simulations, tiotropium/olodaterol is a cost-effective treatment option versus tiotropium or LABA/ICS in all three countries. In both Finland and Sweden, tiotropium/olodaterol is more effective and cost saving (ie, dominant) in comparison with LABA/ICS.

scholarly journals Patient Reported Outcome (PRO) in Patients Receiving High and Moderate Emetogenic Chemotherapy (Ctx) - Results of a German Prospective Non-Interventional Study with Netupitant/Palonosetron Fixed Dose Combination (NEPA)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4844-4844 ◽  
Author(s):  
Meinolf Karthaus ◽  
P Klare ◽  
N Gazawi ◽  
MO Zahn ◽  
B Reimann ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Fixed Dose Combination ◽  
Moderate Intensity ◽  
Fixed Dose ◽  
Interventional Study ◽  
Patient Reported ◽  
Dose Combination ◽  
Good For

Abstract Introduction:NEPA is a fixed dose combination of the NK1-receptor antagonist (RA) netupitant and 5-HT3-RA palonosetron approved for prevention of chemotherapy-induced nausea and vomiting (CINV) in pts receiving highly emetogenic (HEC) on cisplatin-basis or moderately emetogenic Ctx (MEC). NEPA demonstrated safety and efficacy in platinum, anthracycline and cyclophosphamid based Ctx, These drugs are frequently used in regimens for hematology pts. A German non-interventional study investigated NEPA's efficacy and impact on quality of life in adult cancer pts by patient-related outcomes (PRO) and physicians' personal assessment under real life conditions. Primary objective was the evaluation of quality of life (QoL) in adults receiving NEPA for CINV prevention. Secondary endpoints were efficacy and safety of NEPA. Methods: Open label, non-interventional, prospective, national, multicenter study that evaluates CINV prevention and patients' QoL receiving NEPA in pts with either HEC or MEC on up to 2 consecutive Ctx days for at least consecutive 3 cycles. QoL was evaluated by the validated FLIE questionnaires at the end of each Ctx cycle. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hrs and on 4 additional d after Ctx. Safety, additional medication and physicians' overall satisfaction was reported via eCRF. Results: Between June 2015 and Sept 2017 a total of 2429 pts were enrolled with 1997 pts being eligible for the 2nd interim analysis. 1901 pts were included in the efficacy analysis in the 1st, 1808 pts in the 2nd and 1734 pts in the 3rd cycle. Median age was 58 (range of 28-89). A total of 630 evaluable pts received MEC (53% carboplatin based) and 1185 pts received HEC (88% anthracycline/ cyclophosphamide based), PRO with complete response (CR=no nausea, no vomiting, no rescue medication) was analyzed based on patient diaries. Diaries for PRO in MEC-pts (n=401) reported CR in 94% in cycle 1, 85% in cycle 2 and 86% in cycle 3. Efficacy, assessed by physicians (n=630 pts) on a 4-point scale, was rated very good/good for 91%, 93%, and 94% in cycle 1, 2 and 3, respectively. PRO of 896 pts with HEC reported 81% CR in cycle 1, 82% in cycle 2 and 83% in cycle 3. Efficacy, assessed by physicians (1185 HEC pts), was rated very good/good for 88%, 89%, and 90% in cycle 1, 2 and 3, respectively. A high percentage of patients receiving HEC or MEC did not suffer from any emesis (93%, 93% and 94% in cycle 1-3, respectively). Over 85%of pts reported no impact on daily QoL due to vomiting in all 3 cycles with HEC or MEC.The most common treatment emergent adverse events were constipation and insomnia of mild-moderate intensity. Conclusions: NEPA prevented CINV highly effective in the acute and delayed phase of HEC and MEC with no impact on daily life due to vomiting in >85% of pts. Physicians evaluation was concordant to PRO.Safety profile was good. Disclosures Karthaus: Riemser: Consultancy. Schilling:Riemser: Honoraria.

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