Transcript Budesonide
Symbicort - the budesonide component Inhaled corticosteroids are first line maintenance therapy Laitinen LA, et al. J Allergy Clin Immunol 1992;90(1):32-42 LAA / ICS rationale Early intervention with budesonide in children provides long-term improvement in lung function FEV1 % change from baseline Budesonide (N = 216, age = 3-11yrs) Controls (N = 62, age = 3-11yrs) 40 30 *** 20 10 ***p<0.001 0 -10 0 0.5 1 1.5 2 2.5 3 3.5 Treatment duration (years) Agertoft L, et al. Respir Med 1994;88:373-81 Budesonide Early intervention with budesonide is associated with greater subsequent improvement in lung function in children Annual change in % predicted FEV1 n = 216 p = 0.02 for correlation 12 10 8 6 4 2 0 <2 2–3 3–5 >5 Asthma duration at start of budesonide (years) Agertoft L, et al. Respir Med 1994;88:373-81 Budesonide Budesonide, 400µg once daily significantly improved evening PEF compared to 200 µg twice daily in children Change in PEF (L/min) N = 167 30 25 Age = 5-12 yrs p = 0.01 20 15 10 Week 4 5 Week 8 0 Budesonide 400 µg once daily Budesonide 200 µg twice daily Campbell LM, et al. Int J Clin Pract 1998;52:213-9 Budesonide A similar reduction in bronchodilator usage was seen in children receiving either 400g once daily or 200g twice daily N=167 Age=5-12 years ß2-agonist use per day (no. of actuations) 2.5 Budesonide Turbuhaler® 400 µg once daily evening (n=71) 2.0 1.5 Budesonide Turbuhaler® 200 µg twice daily (n=86) 1.0 0.5 0 Baseline Week 4 Week 8 Campbell LM, et al. Int J Clin Pract 1998;52:213-9 Each group vs baseline p=0.0001 Budesonide Budesonide once daily is as effective as budesonide twice daily in protecting against exercise induced bronchoconstriction Budesonide Turbuhaler® Maximum % fall in FEV1 30 Baseline 12 weeks 25 20 N = 57 Mean age = 9.7 years 15 10 5 0 200 µg once daily 100 µg twice daily 100 µg once daily Jónasson G, et al. Pediatr Allergy Immunol 2000;11:120-5 Placebo Budesonide Adjusting the dose of budesonide to respond to a sudden deterioration is effective in controlling asthma in children Percent of children N =150 Age=1-14 years 50 40 Initial dose of budesonide = 800 - 1,600 g/day, reducing to 400 g/day over 4 - 8 days 30 20 10 0 <1 1 to 2 2 to 3 >3 Mean time from onset of treatment to control of exacerbation (Days) Volovitz B, et al. Clin Pediatr (Phila) 2001;40(2);79-86 Budesonide Long-term growth in children is unaffected by budesonide Mean daily dose of budesonide decreased from 710 to 430 g during the treatment period Height SDS 0.2 0 -0.2 -0.4 -0.6 -0.8 -1 Controls (n = 62, age = 3 -11 yrs) Budesonide (n = 216, age = 3 -11 yrs) Run-in -2 -1.5 -1 -0.5 0 0.5 1 1.5 2 2.5 3 3.5 Time (years) Agertoft L et al. Respir Med 1994;88:373-81 Budesonide Final adult height is unaffected by budesonide in children Measured target height (cm) 200 190 Boys 180 Girls 170 Mean predicted = 172.9 cm Mean measured = 173.2 cm 160 150 150 160 170 180 190 200 Predicted target height (cm) Agertoft L et al. N Engl J Med 2000;343:1064-9 Budesonide Bone mineral density (BMD) in children is unaffected by budesonide BMD g/cm2 NS 1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3 n= 157 0.917 g/cm2 0.915 g/cm2 Control Budesonide (average daily dose = 504 g for 3-6 years) 0.2 0.1 0 Agertoft L. Am J Respir Crit Care Med 1998;157:178-83 Budesonide No effect on HPA-axis was seen in children receiving budesonide over 12 weeks Baseline After 12 weeks Plasma cortisol (mmol/litre) 600 ns ns ns ns Placebo 100 µg 200 µg 400 µg 500 400 300 200 100 0 Pulmicort Turbuhaler twice daily Shapiro et al. J Pediatr 1998; 132:976-982. Budesonide Clinical trials have provided great reassurance of the safety of budesonide Clinical adverse events >38,000 patients and healthy volunteers >580 clinical trials • no difference compared to placebo in type of event or frequency • No gender difference • No particular pattern in children or adults • No influence on final adult height • No influence on bone density Budesonide Pulmicort® postmarketing exposure • Pulmicort® first launched in 1982 as a pMDI. • Pulmicort Turbuhaler® is marketed in 59 countries (first launch 1989). • The estimated exposures to Q3/2001 is more than 10 billion treatment days (Pulmicort Turbuhaler® 7.2 billion treatment days). • 4041 received case reports. Budesonide