corticosteroids in chronic asthma - inhaled vs oral therapy?

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Corticosteroids in chronic asthma - inhaled vs oral therapy? Several recent studies comparing the clinical efficacy of inhaled budesonide with that of oral prednisone have suggested that inhaled steroids may have some advantages over oral steroids in the treatment of severe chronic asthma. The established efficacy and tolerability of low dose alternate-morning prednisone has made it the maintenance steroid regimen of choice for many patients. However, the studies demonstrating efficacy equivalent to that of daily single- or divided-dose prednisone have not been adequately controlled prospective comparisons. In a double-blind double-dummy study, patients well controlled on alternate-morning prednisone 15mg + inhaled beclomethasone OSmg daily were given inhaled budesonide via a cone spacer qid or alternate-morning oral prednisone in 3 graduated doses of each drug for 14 days at each dose level, and then crossed over to the alternate drug. On changing to budesonide O.S mg/day FEV, increased significantly from baseline, and remained at that level during budesonide therapy. Asthma symptoms, optimally controlled at baseline, were unchanged. On changing to prednisone, FEV 1 and symptoms deteriorated and did not return to baseline or improve on doubling or quadrupling the dosage Clinically relevant significant differences in favour of budesonide were seen at nearly all individual dose levels. Systemic glucocorticoid activity was unaltered from baseline by budesonide OS or 1 6mg daily. Budesonide was more effective than prednisone at all 3 doses used on FEV 1 (p = 0.06), asthma attack frequency (p = 002), patient-rated asthma severity (p = O.OOS). and physiCian-rated asthma disability (p = 0.05) In a trial the same in design as that described above, once-daily oral prednisone and inhaled budesonide qid via a cone spacer had similar effects on asthma symptoms and systemic glucocorticoid activity Budesonide 24mg daily reduced the incidence of disabling asthma relapses to zero and had an equivalent systemic effect to that of prednisone 13mg daily. However, the dose of prednisone required to produce an equivalent antiasthmatic effect consistently produced more systemic glucocorticoid activity. Thus, budesonide seems to be more clinically effective in severely asthmatic patients. In a tertiary referral practice, half of the group of 34 adult asthmatic patients were not successfully controlled on beclomethasone 04- O.Smg daily. and needed doses of > 1.0mg daily: 2S/34 were using oral steroid supplements in the last 6 months of an 1S-month follow-up. It is suggested that replacement of oral prednisone by higher doses of inhaled beclomethasone would be more successful. 0156-2703/87/0912-0003/0$01.00/0 © ADIS Press Despite suggestions that the use of inhaled and oral steroids together provides limited advantage and additive systemic effects, benefits of such combination treatment are apparent. Of 34 chronic asthmatic patients being weaned off prednisone and receiving high dose beclomethasone by individually titrated doses, 2S patients currently receive both regular oral and inhaled therapy. Significant increases were seen in the number of patients with zero asthma attacks (p = 0.02), those with no disability (p = 0.001), those no longer receiving prednisone (p = 0.001), those weaned off daily prednisone (p = 0.0005) and weaned off high risk dosage, > 15mg daily (p = 0.05). There was no concomitant increase in the number of patients with a normal serum cortisol concentration at OSOO hours. Further research is required to investigate the advantages of inhaled steroids other than budesonide compared with oral prednisone, but the evidence compiled here supports ' ... a more aggressive role in future for inhaled steroid drugs in the treatment of chronic asthma'. Toogood JH New England and Regional Allergy Proceedings 8 98,'03. Mar Apr 1987 INPHARMA" 12 September 1987 3

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Page 1: Corticosteroids in chronic asthma - inhaled vs oral therapy?

Corticosteroids in chronic asthma - inhaled vs oral therapy?

Several recent studies comparing the clinical efficacy of inhaled budesonide with that of oral prednisone have suggested that inhaled steroids may have some advantages over oral steroids in the treatment of severe chronic asthma.

The established efficacy and tolerability of low dose alternate-morning prednisone has made it the maintenance steroid regimen of choice for many patients. However, the studies demonstrating efficacy equivalent to that of daily single- or divided-dose prednisone have not been adequately controlled prospective comparisons.

In a double-blind double-dummy study, patients well controlled on alternate-morning prednisone 15mg + inhaled beclomethasone OSmg daily were given inhaled budesonide via a cone spacer qid or alternate-morning oral prednisone in 3 graduated doses of each drug for 14 days at each dose level, and then crossed over to the alternate drug. On changing to budesonide O.S mg/day FEV, increased significantly from baseline, and remained at that level during budesonide therapy. Asthma symptoms, optimally controlled at baseline, were unchanged. On changing to prednisone, FEV 1 and symptoms deteriorated and did not return to baseline or improve on doubling or quadrupling the dosage Clinically relevant significant differences in favour of budesonide were seen at nearly all individual dose levels. Systemic glucocorticoid activity was unaltered from baseline by budesonide OS or 1 6mg daily. Budesonide was more effective than prednisone at all 3 doses used on FEV 1 (p = 0.06), asthma attack frequency (p = 002), patient-rated asthma severity (p = O.OOS). and physiCian-rated asthma disability (p = 0.05)

In a trial the same in design as that described above, once-daily oral prednisone and inhaled budesonide qid via a cone spacer had similar effects on asthma symptoms and systemic glucocorticoid activity Budesonide 24mg daily reduced the incidence of disabling asthma relapses to zero and had an equivalent systemic effect to that of prednisone 13mg daily. However, the dose of prednisone required to produce an equivalent antiasthmatic effect consistently produced more systemic glucocorticoid activity. Thus, budesonide seems to be more clinically effective in severely asthmatic patients.

In a tertiary referral practice, half of the group of 34 adult asthmatic patients were not successfully controlled on beclomethasone 04-O.Smg daily. and needed doses of > 1.0mg daily: 2S/34 were using oral steroid supplements in the last 6 months of an 1S-month follow-up. It is suggested that replacement of oral prednisone by higher doses of inhaled beclomethasone would be more successful.

0156-2703/87/0912-0003/0$01.00/0 © ADIS Press

Despite suggestions that the use of inhaled and oral steroids together provides limited advantage and additive systemic effects, benefits of such combination treatment are apparent. Of 34 chronic asthmatic patients being weaned off prednisone and receiving high dose beclomethasone by individually titrated doses, 2S patients currently receive both regular oral and inhaled therapy.

Significant increases were seen in the number of patients with zero asthma attacks (p = 0.02), those with no disability (p = 0.001), those no longer receiving prednisone (p = 0.001), those weaned off daily prednisone (p = 0.0005) and weaned off high risk dosage, > 15mg daily (p = 0.05). There was no concomitant increase in the number of patients with a normal serum cortisol concentration at OSOO hours.

Further research is required to investigate the advantages of inhaled steroids other than budesonide compared with oral prednisone, but the evidence compiled here supports ' ... a more aggressive role in future for inhaled steroid drugs in the treatment of chronic asthma'. Toogood JH New England and Regional Allergy Proceedings 8 98,'03. Mar Apr 1987

INPHARMA" 12 September 1987 3