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Home , Olodaterol

04 2016 olodaterol striverdi®, ® for copd drug assessment report Nothing to puff up with pride www.dtb.navarra.es DTB_Navarre

abstract Indications1 been compared directly with , the It is indicated as a maintenance only once-daily LABA.8 Olodaterol is a new long-acting treatment in patients with chronic obstructive beta2-agonists for control of pulmonary disease (COPD). Safety . Adverse reactions1 Mechanism of action and The most frequent adverse reactions included It has only been actively compa- pharmacokinetics1 nasopharyngitis, dizziness, hypertension, rash red with in terms of Olodaterol is a long-acting beta2-agonists and arthralgia. Intensity was generally mild improvement of lung function in (LABA) with a fast onset of action and a dura- to moderate. Although the systemic effects a small 6-week study, without tion of action of at least 24 hours. of LABA are generally mild, they may cause any significant differences musculoskeletal tremor, insommia, palpita- found. Posology and administration1 tions, tachycardia, , hyperglyce- The recommended dose of olodaterol is 5mcg mia, and lengthened QTc interval.10 Given that Its safety profile seems to be si- administered in 2 puffs once daily at the same safety data on olodaterol are limited, it should milar to that of other LABA. time. The recommended dose should not be be used with caution in risk patients. exceeded. Data supporting its effective- ness when used alone are very Clinical efficacy limited. The clinical development of olodaterol included ten randomized, double-blind, placebo-contro- It does not lled phase III trials,2,3 four pivotal 48-week ran- domized clinical trials (RCTs) (n=3104),4,5 four improve dyspnoea, 6-week RCTs (n=429) to evaluate its broncho- CLASSIFICATION dilating profile and two 6-week RCTs (n=308) exacerbations, or to evaluate its effect on endurance time during exercise. quality of life IMPORTANT THERAPEUTIC In pivotal RCTs, the patients had moderate to INNOVATION very severe COPD and were allowed to conti- 4 nue their usual therapy, which primarily consis- MODEST THERAPEUTIC ted of and tiotropium. The pri- INNOVATION mary endpoints were FEV AUC (0-3 h) and FEV 3 (12-24 h) as compared to placebo. Although Contraindications1 statistically significant differences were obtai- Hypersensitivity to olodaterol or to any of its SOME ADDED VALUE IN SPECIFIC ned in pulmonary function between groups in excipients. 2 SITUATIONS the two endpoints, only differences in FEV AUC (0-3 h) were clinically relevant. The Transitio- Special warnings and precautions for use1 NO THERAPEUTIC nal Dyspnea Index (TDI) was also included in Olodaterol should not be used in asthma or as INNOVATION two pivotal RCTs, but no statistically significant a rescue therapy. If paradoxical bronchospasm 1 differences were observed.5 Although patients occurs olodaterol therapy should be discon- treated with olodaterol used less rescue medi- tinued immediately and alternative therapy INSUFFICIENT cation,4 differences were not clinically relevant substituted. EVIDENCE 5 0 in terms of quality of life. Both variables were LABAs may cause hyperglycemia and hypoka- used as secondary endpoints. Exacerbations lemia which can provoke adverse cardiovas- could not be assessed due to the design and cular effects. Olodaterol should not be admi- duration of the RCTs. nistered concomitantly with other medicinal Some RCTs included an arm that received products causing hypokalemia. either formoterol5 or tiotropium,6 but the effects of these substances on lung function Usage in special situations1 were not directly compared with those of olo- Pregnancy and breast-feeding: No data avai- daterol. The exception was a small 6-week lable. trial assessing the effects of olodaterol on lung Renal impairment: Dose adjustment is not re- function vs formoterol, but no statistically sig- quired in patients with mild or moderate renal The qualification assigned to the drug was agreed by the Drug Assessment Commit- 7 nificant differences were observed. In placebo- impairment. Olodanerol should be administe- tees of Andalusia, Basque Country, Catalo- controlled studies, olodaterol was not proven red with caution in patients with severe renal nia Institute of Health, Aragon and Navarre. The current report is based on the available to be superior to formoterol and tiotropium in impairment. information and is susceptible to be updated improving lung function. No comparative stu- Liver impairment: Dose adjustment is not re- according to the latest evidence. Let us remind dies were conducted assessing other variables quired in patients with mild or moderate liver the reader about the importance of notifying the Pharmacovigilance Centre when there are of clinical interest. Finally, olodaterol has not impairment. Olodanerol should be administe- suspicions of adverse reactions to drugs. TREATMENT COST / DAY (E) References

Formoterol 24 mcg 0.75 1. Ficha Técnica de Striverdi Respimat. 2013. http://www.aemps.gob.es 100 mcg 1.19 2. AWMSG. Olodaterol (as hydrochloride) (StriverdiR RespimatRˇ) 2.5 microgram so- Olodaterol 5 mcg 1.39 lution for inhalation. Reference number:153. 2015. http://www. awmsg.org Umeclidinium 55 mcg 1.51 3. HAS. Striverdi Respimat 2,5 μg/dose, Aclidinium 644 mcg 1.59 solution pour inhalation Boite de 60 doses (CIP:34009 277 232 7 8). 2015 http://www. Glicopirronium 44 mcg 1.59 has-sante.fr 4. Ferguson GT, et al. Efficacy and safety of Tiotropium 18 mcg 1.64 olodaterol once daily delivered via Respima- tR in patients with GOLD 2-4 COPD: results Indacaterol 300 mcg 1.67 from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014;9:629-45. http://www.ncbi.nlm.nih.gov 0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 5. Koch A, et al. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via RespimatR versus placebo red with caution in patients with severe liver pidly control asthma symptoms. In patients and formoterol twice daily in patients with impairment. with permanent symptoms, the treatment GOLD 2-4 COPD: results from two replicate Advanced age: dose adjustment is not re- of choice are long-acting 48-week studies. Int J Chron Obstruct quired. -either LABA or (LAMA)- Pulmon Dis. 2014;9:697-714. http://www. Patients < 18 years: no recommendations alone. Concomitant use of LABA and in- ncbi.nlm.nih.gov have been published on the use of olodane- haled corticosteroids is only indicated in 6. Lange P, et al. The 24 hour lung function rol in patients aged < 18 years. patients with frequent exacerbations and time profile of olodaterol once daily versus

FEV1 < 50%. There is no sufficient eviden- placebo and tiotropium in patients with Drug interactions1 ce supporting the superiority of LAMA over moderate to very severe chronic obstructive Olodanerol should only be used concomi- LABA, nor a specific combination of LAMA/ pulmonary disease. J Pulm Respir Med. tantly with beta-blockers (including eye- LABA over other combinations or over CI/ 2014;4:4. http://omicsonline.org drops) if there are compelling reasons for LABA combinations. The effectiveness and 7. Feldman GJ, et al. The 24-h FEV1 time their use. In this setting, cardioselective safety of triple therapy LAMA/LABA/CI has profile of olodaterol once daily via RespimatR beta-blockers could be considered, although not been investigated yet.10 and formoterol twice daily via AerolizerR in they should be administered with caution. Olodaterol is another LABA for maintenance patients with GOLD 2-4 COPD: results from Concomitant treatment with deri- therapy of COPD. Compared to placebo, olo- two 6-week crossover studies. Springerplus. 2014;3:419. http://www.ncbi.nlm.nih.gov vatives, steroids, or (other than po- daterol only improves lung function within tassium sparing ones) may potentiate any the first hours, without statistically signifi- 8. Roskell NS, et al. Once-daily long-acting hypokalemic effect of adrenergic agonists. cant differences with formoterol and tiotro- beta-agonists for chronic obstructive pium vs placebo. Olodaterol has not been pulmonary disease: an indirect comparison Place in therapeutics demonstrated to yield clinically relevant of olodaterol and indacaterol. Int J Chron Obstruct Pulmon Dis. 2014;9:813-24. http:// The goal of drug therapy for stable COPD results in relation to dyspnea and quality www.ncbi.nlm.nih.gov is relieving asthma symptoms, reducing the of life. No direct comparative studies have frequency and severity of exacerbations, been conducted comparing olodaterol vs 9. Olodaterol (Striverdi Respimat) for COPD. and improving quality of life and tolerance indacaterol, the only once-daily LABA. Ne- Med Lett Drugs Ther 2015;57(1459). http:// to exercise. Treatment choice should be vertheless, there is scant evidence on the secure.medicalletter.org made on a case-by-case basis and consists use of olodaterol alone, as it has been used 10. Nuevos medicamentos inhalados en la of a dose-escalation scheme in accordance concomitantly with other medical products EPOC: ¿qué nos aportan? INFAC 2015;23(9). with the severity of symptoms and the risk in clinical trials. 11. NICE. Chronic obstructive pulmonary of exacerbations, and by weighing adverse In light of the above, and considering that disease: Olodaterol. NICE (ESNM 54). 2015. effects, patient’s preferences and response, other more widely-used LABA are already http://www.nice.org.uk and the cost of the devices used.10 available, olodaterol does not offer any the- Inhaled bronchodilators are the base of drug rapeutic advance for the treatment of COPD. therapy for COPD. Short-acting bronchodi- lators are primarily used on demand to ra- Presentations Striverdi Respimat® ( España) 2.5mcg inhalation solution provi- ding 60 puffs (30 medicinal doses) (€41.68)

Information: Servicio de Prestaciones Farmacéuticas Plaza de la Paz s/n, 4ª planta 31002 Pamplona Teléfono 848429047 Fax 848429010 New Drugs Assessment Committee: Iñaki Abad, Mª José Ariz, Ana Azparren, Mª Concepción Celaya, Marcelo Domínguez, Juan Erviti, Javier Gar- jón, Isabel García, Isabel Aranguren, Rodolfo Montoya, Mikel Moreno, Lourdes Muruzábal