ME TOO: OLODATEROL INHALANT (STRIVERDI RESPIMAT) FOR COPD

Since May 15, 2014, the olodaterol inhalant (STRIVERDI RESPIMAT) has been the fifth long-acting beta-2 agonist for the maintenance treatment of chronic obstructive pulmonary disease (COPD) on the German market.

1,843 patients, suffering from COPD classified at least as moderate (forced expiratory volume in one second [FEV1] below 80% of the predicted value), participated in the two pivotal randomised double-blind phase III studies. They were permitted to continue taking their usual COPD maintenance medication, with the exception of long-acting beta-2 agonists. With olodaterol, in the approved dosage of 5µg, once daily, the improvement in pulmonary function within 24 weeks was only modest in comparison to placebo (1). Compared to a formoterol inhalant (2 x daily 12µg, FORADIL, generics; a-t 1999; Nr. 9, 91-4), the planned proof of superiority failed (1, 2). Not even equivalence was proven, as this was not investigated. Neither of the two bronchodilators reduced the exacerbation rate versus placebo, although the studies were not specifically designed to demonstrate this (3). Symptoms, measured using the validated St. George's Respiratory Questionnaire*, did not show, on average, a clinically relevant improvement versus placebo with either of the two inhalants (2).

There were also no benefits demonstrated in comparison to formoterol with regard to side effects. Malignant neoplasia was observed with olodaterol, as well as with formoterol, with a higher numeric frequency than with the placebo (1.6% and 1.7% versus 1.0%) (3).

The inhalation of 5µg olodaterol (STRIVERDI RESPIMAT), once daily, has a monthly cost of €38 (in Austria €52), which is 55% higher than a low-priced formoterol generic (€24 for 12 µg FORMOLICH twice daily, list prices). The German Federal Joint Committee (G-BA) will, however, allocate olodaterol to the corresponding reference price group, as Boehringer Ingelheim has apparently relinquished an early benefit assessment (4).

	With the olodaterol inhalant (STRIVERDI RESPIMAT), the fifth long-acting beta-2 agonist for the maintenance inhalative treatment of chronic obstructive pulmonary disease has arrived on the German market.
	In comparison to the formoterol inhalant (FORADIL, generics), no increase in efficacy has been demonstrated, not even equivalence has been proven. Nor could any benefits in terms of tolerability be shown. It is our opinion that olodaterol is a variant of no special significance.

1

FDA: Briefing Package, Advisory Committee Meeting, 29 Jan. 2013; http://www.a-turl.de/?k=chin

2

Boehringer Ingelheim: FDA Advisory Committee Briefing Document, Dec. 2012, Doc. No. U12-3926-01; http://www.a-turl.de/?k=ttri

3

Medicines Evaluation Board in the Netherlands: Public Assessment Report STRIVERDI RESPIMAT; as at Febr. 2014; http://www.a-turl.de/?k=rane

4

G-BA: Nutzenbewertungsverfahren zum Wirkstoff Olodaterol [Benefit assessment procedure for the active substance olodaterol]; https://www.g-ba.de/informationen/nutzenbewertung/114/; accessed in July 2014

5

JONES, P.W. et al.: Am. Rev. Respir. Dis. 1992; 145: 1321-7

Disease-specific questionnaire filled out by patients about their symptoms, activity and impairments (5).

Caution: less than five years on the market or under additional monitoring according to the European Medicines Agency