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Oxis – high safety margin. Oxis – less systemic effect Pulse rate. 112. Formoterol 90 µg total dose Terbutaline 10 mg total dose. 108. Administration of formoterol/terbutaline. 104. 100. Administration of methylprednisolone. bpm. 96. 92. 88. 84. N = 36 adults
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Oxis – less systemic effectPulse rate 112 Formoterol 90 µg total dose Terbutaline 10 mg total dose 108 Administration of formoterol/terbutaline 104 100 Administration of methylprednisolone bpm 96 92 88 84 N = 36 adults Randomized, parallel, double-blind Emergency room treatment of acute bronchoconstriction 0 60 120 180 240 300 360 720 Mins after first dose Malolepszy et al. Eur Respir J 2001
Oxis – less systemic effectMean serum potassium 4.4 Formoterol 90 µg total dose Terbutaline 10 mg total dose 4.2 4.0 Administration of formoterol/terbutaline mmol/l 3.8 Administration of methylprednisolone 3.6 3.4 3.2 N = 36 adults Randomized, parallel, double-blind Emergency room treatment of acute bronchoconstriction 0 60 120 180 240 300 360 720 Mins after first dose Malolepszy et al. Eur Respir J 2001
Oxis – less systemic effect Cardiac frequency Daily doses 84 Formoterol 54 µg 80 Formoterol 90 µg Terbutaline 6 mg 76 Cardiac frequency (beats/min) Terbutaline 10 mg 72 68 Dosing times 64 60 Day 1 Day 2 Day 3 Day 4 Tötterman et al, Eur Respir J 1998
Oxis – less systemic effect Mean serum potassium 4.1 3.9 Serum potassium (mmol/l) Formoterol 90 µg/day 3.7 Terbutaline 10 mg/day 3.5 Dosing times 3.3 Day 1 Day 2 Day 3 Day 4 Tötterman et al, Eur Respir J 1998
Oxis has short-acting systemic effects At comparable maximal effects, similar time profiles were observed 4.4 4.2 4.0 Serum potassium (mmol/L) dosing time 3.8 3.6 3.4 Oxis Turbuhaler 54 mg / day terbutaline Turbuhaler 6 mg / day 1 2 3 4 Days Tötterman et al, Eur Respir J 1998
Oxis minimises systemic burden A schematic summary of clinical results arbitrary units Oxis Therapeutic effects short-acting ß2-agonists 0 6 12 short-acting ß2-agonists Time after dose (hrs) Oxis Systemic effects Derived from: 1. Ringdal N et al. Respir Med 19982. Palmqvist M et al. ERJ 1997 3. Borgström L et al. AJRCCM 1996 4. Tötterman KJ et al. ERJ 19985. Rosenborg J et al. Eur J Clin Pharmacol 2000 6. Malolepszy J et al. ERJ 2001
4,000 3,500 3,000 2,500 2,000 1,500 1,000 500 Oxis as needed is cost-effective 3,709 3,386 cost of staying away from work duringa severe exacerbation health care costs for severe exacerbations Cost per patient for a 12 week treatment (SEK) inhaled and oral steroids study drug costs N = 362 asthmatics formoterol 4.5 g and terbutaline 0.5 mg used as needed Oxis Turbuhaler Terbutaline Turbuhaler Berggren et al. Respir Med 2001