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Comparison of Intramuscular Betamethasone and Oral

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Comparison of Intramuscular Betamethasone and Oral Color profile: Disabled Composite Default screen 100 ORIGINAL ARTICLE 100 95 95 75 75 25 25 5 5 0 Comparison of intramuscular 0 betamethasone and oral prednisone in the prevention of relapse of acute asthma John S Chan MD1, Robert L Cowie MD1, Gerald C Lazarenko MD2, Cinde Little RRT1, Sandra Scott RRT1, Gordon T Ford MD FCCP1 1Division of Respiratory Medicine and 2Department of Emergency Medicine, University of Calgary, Calgary, Alberta JS Chan, RL Cowie, GC Lazarenko, C Little, S Scott, tively) and use of inhaled corticosteroids (46% versus 64.3% GT Ford. Comparison of intramuscular betamethasone respectively) (P<0.05). Using intention-to-treat analysis, the and oral prednisone in the prevention of relapse of acute relapse rates for betamethasone and prednisone at day 7 were asthma. Can Respir J 2001;8(3):147-152. 14.9% (13 of 87 patients) and 25% (21 of 84 patients), respectively (P=0.1), and at day 21, the rates were 36.8% (32 OBJECTIVE: To compare the relapse rate after a single intra- of 87 patients) and 31% (26 of 84 patients), respectively muscular injection of a long acting corticosteroid, betametha- (P=0.4). There were no differences in symptom score, peak sone, with oral prednisone in patients discharged from the flows and adverse effects between the two groups at days 7 emergency department (ED) for acute exacerbations of and 21. asthma. CONCLUSIONS: A single dose of intramuscular betametha- PATIENTS AND METHODS: Patients with acute exacer- sone 12 mg was safe and as efficacious as prednisone in pre- bations of asthma who were suitable for discharge from the venting the relapse of acute asthma. There was a trend toward ED were enrolled in a double-blind, randomized, placebo a reduced relapse rate at seven days. In select ED patients dis- controlled pilot study. At discharge, patients were ran- charged for acute asthma, intramuscular betamethasone may domly assigned to receive either intramuscular betametha- be an effective alternative to prednisone. sone 12 mg and placebo capsules, or a placebo intramuscular Key Words: Asthma; Betamethasone; Emergency department; injection and prednisone 50 mg daily for seven days. At days 7 Randomized, controlled trial and 21, patients were contacted by telephone to determine re- lapse. Relapse was defined as an unscheduled visit to a physi- Comparaison entre la bétaméthasone 100 cian for treatment of continuing or worsening symptoms of 100 asthma. intramusculaire et la prednisone orale pour 95 RESULTS: One hundred and seventy-one patients were en- prévenir les rechutes d’asthme aigu 95 rolled, of whom 87 were randomly assigned to the betametha- 75 OBJECTIF : Comparer le taux de rechute après l’injection 75 sone group and 84 to the prednisone group. Baseline char- acter- intramusculaire d’une seule dose d’un corticostéroïde à action istics were matched evenly between the groups, with the exception of asthma duration (15.5 versus 21.2 years, respec- voir page suivante 25 25 Correspondence and reprints: Dr John S Chan, Respiratory Medicine, Rockyview General Hospital, 4th floor, 7007 14th Street SW, 5 Calgary, Alberta T2V 1P9. Telephone 403-541-3283, fax 403-212-1053, e-mail [email protected] 5 0 0 Can Respir J Vol 8 No 3 May/June 2001 147 1 G:...chan.vp Tue Jun 05 15:47:41 2001 Color profile: Disabled Composite Default screen Chan et al 100 100 prolongée, la bétaméthasone, à celui enregistré après l’adminis- base entre les deux groupes, à l’exception de la durée de l’asth- 95 95 tration de prednisone par voie orale chez les patients traités pour me (15,5 ans contre 21,2 respectivement) et de l’utilisation de 75 une poussée d’asthme et ayant obtenu leur congé du service corticostéroïdes en aérosol (46 % contre 64,3 % respectivement) 75 d’urgence. (P<0,05). Selon l’analyse fondée sur le principe de vouloir traiter, PATIENTS ET MÉTHODE : Des patients traités au service le taux de rechute pour la bétaméthasone et la prednisone au d’urgence pour une poussée d’asthme, puis renvoyés au domi- 7e jour a été de 14,9 % (13 patients sur 87) et de 25 % (21 pa- e 25 cile ont participé à un essai pilote, mené contre placebo, à double tients sur 84) respectivement (P=0,1) et au 21 jour, de 36,8 % 25 insu, avec hasardisation. Au moment du congé, les patients ont (32 patients sur 87) et de 31 % (26 patients sur 84) respective- 5 reçu au hasard ou bien une injection intramusculaire de bétamé- ment (P=0,4). Aucune différence n’a été enregistrée quant à la 5 thasone de 12 mg et des capsules placebo ou bien une injection cote des symptômes, au débit de pointe et aux effets indésirables e e 0 intramusculaire placebo et des capsules de prednisone de 50 mg entre les deux groupes au 7 et au 21 jour. 0 à prendre tous les jours pendant sept jours. Au bout du 7e et du CONCLUSION : L’injection intramusculaire d’une seule dose 21e jour, les chercheurs ont communiqué avec les patients pour de bétaméthasone de 12 mg s’est avérée sûre et aussi efficace savoir s’ils avaient fait des rechutes. On entendait par rechute que la prednisone pour prévenir les rechutes d’asthme aigu. Une toute consultation médicale non prévue pour persistance ou ag- tendance à une réduction du taux de rechute a même été obser- gravation des symptômes d’asthme. vée au 7e jour. Aussi la bétaméthasone intramusculaire peut-elle RÉSULTATS : Cent soixante et onze patients ont participé à remplacer efficacement la prednisone chez les patients sélec- l’étude : 87 ont reçu au hasard de la bétaméthasone, 84, de la tionnés, traités pour une poussée d’asthme et renvoyés du ser- prednisone. Ilyaeurépartition égale des caractéristiques de vice d’urgence. cute exacerbations of asthma are a common presenta- for acute exacerbations of asthma who were suitable for dis- Ation to emergency departments (EDs). Most patients charge. can be adequately treated and safely discharged home with The inclusion criteria were a diagnosis of asthma with an the appropriate medications and follow-up. Recent studies acute exacerbation, being at least 18 years of age, the ab- and a systematic review have shown the benefit of a course of sence of contraindications to prednisone or betamethasone, corticosteroids following discharge from the ED in reducing and suitability for discharge from the ED. The diagnosis of the risk of relapse (1-3). However, the relapse rate at 21 days asthma was made clinically by the ED physician. Patients remains as high as 25% despite the use of corticosteroids (4). were excluded if any of the following conditions were pres- Patients with asthma who use the ED during acute exacer- ent: complicating illnesses (congestive heart failure, chronic bations are thought to have high indexes of denial and poor obstructive pulmonary disease or other pulmonary condi- compliance, thus leading to poor control of their disease. tions); chronic infections; acute bacterial pneumonia; preg- Compliance with pulmonary medications has been reported nancy or breastfeeding; being a nonresident of Alberta; and to be as low as 30% (5). Twelve per cent to 22% of patients current oral corticosteroid use for longer than 24 h. leaving the ED do not fill their prescriptions (6,7). They are Written informed consent was obtained from each patient often given complex regimens of corticosteroids involving by an ED respiratory therapist. The study was approved by multiple tablets, which may further decrease compliance. A the Conjoint Health Research Ethics Board of the University single depot injection of corticosteroid administered at the of Calgary, Calgary, Alberta. time of discharge may bypass these compliance issues and ED protocol: The treatment of the asthma exacerbation was lead to a reduction in relapse rates. McNamara and Rubin (8) determined by the ED physician and included oxygen, nebu- compared intramuscular methylprednisone with placebo af- lized salbutamol and, in some cases, intravenous or oral ter discharge for acute asthma and found a significant re- corticosteroids. The use of parenteral or oral corticosteroids duction in relapse rates. There are few studies directly within 24 h of enrolment was not considered an exclusion comparing intramuscular with oral corticosteroids after criterion. The decision regarding discharge was made by the exacerbations (9-11). ED physician. We undertook this pilot study to compare the relapse rates The hospital pharmacy provided sequentially numbered, in patients with acute exacerbations of asthma discharged sealed kits that were randomized to contain either an injec- from the ED who had been given a single intramuscular injec- tion of betamethasone 2 mL (betamethasone sodium phos- tion of betamethasone 12 mg/day or prednisone 50 mg/day for phate 6 mg and betamethasone acetate 6 mg; Celestone seven days. Our primary end point was the relapse rate at Soluspan, Schering Canada Inc, Canada) and seven placebo 100 100 days 7 and 21, and secondary end points were symptom capsules, or an injection of saline 2 mL and seven capsules 95 score, peak flows and adverse effects. containing prednisone 50 mg each (Novopharm Limited, 95 Canada). Saline was used as the placebo injection because 75 PATIENTS AND METHODS a control solution identical to the betamethasone solution 75 Patients: This randomized, double-blind, controlled clinical was unavailable. trial was conducted at two hospitals in Calgary, Alberta. The The dose and duration of use of the prednisone were cho- 25 EDs of these hospitals provide 24 h coverage in a community sen in accordance with the published clinical practice 25 of 853,711 people (12). From June 1997 to August 1999, guidelines of the Canadian Association of Emergency 5 ED physicians were asked to refer patients treated in the ED Room Physicians and the Canadian Thoracic Society (13).
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