Yelda Ceviker1, Abdullah Sayiner2. 1. Department of Chest Diseases, Ege University, Faculty of Medicine, Izmir 35100, Turkey. Electronic address: yeldaceviker@yahoo.com. 2. Department of Chest Diseases, Ege University, Faculty of Medicine, Izmir 35100, Turkey. Electronic address: abdullah.sayiner@ege.edu.tr.
Abstract
RATIONALE: Systemic steroids shorten recovery time, improve lung function and hypoxemia in COPD exacerbations. Although several studies have shown that both parenteral and oral steroids are effective and GOLD guideline recommends use of oral steroids at a dose of 30-40 mg/day, very little data exists as to whether any route of admininstration (parenteral vs oral) or any dose is more effective and/or safer. METHODS: This was a randomized, parallel-group study aiming to compare the effectiveness and safety of orally administered lower dose of steroids with parenteral administration of higher doses. Thus, a total of 40 patients were included; one group (Group 1, n = 20) received methylprednisolone (MP) as recommended by the GOLD guideline (PO 32 mg/day for seven days) and the other (Group 2, n = 20) was given IV MP at 1 mg/kg/day for four days and 0.5 mg/kg/day for three days. RESULTS: The two groups were similar with regards to age (69.0 ± 10.5 vs 67.1 ± 8.4 years), duration of COPD (11.8 ± 8.3 vs 9.7 ± 7.7 years), FEV1 (41.3 ± 17.3 vs 34.0 ± 12.0%), PaO2 levels (55.5 ± 9.9 vs 59.1 ± 11.0 mmHg) and dyspnea scores (9.4 ± 1.1 vs 10.0 ± 1.0). Worsening hypercapnic respiratory failure developed in two patients from Group 1 on days 1 and 2, these were intubated and thus excluded from the study. At day 7, both groups showed significant improvements in FEV1 levels (50.8 ± 19.4 and 43.8 ± 21.4%, respectively) (Table 2), PaO2 levels (66.5 ± 12.5 and 65.3 ± 10.6 mmHg, respectively) (Table 3) and dyspnea scores (3,5 ± 2,8 and 4.2 ± 2.8) (Fig. 1). The length of hospital stay was similar for the two groups (11.0 ± 3.9 vs 12.7 ± 6.4). Regarding adverse events, four patients in Group 1 vs 11 patients in group 2 developed hyperglycemia. Besides, three patients in group 2 had worsening of previously controlled hypertension. All events were treated and controlled with administration of proper medications. All patients were followed up for three months. Eight patients in group 1 and 15 patients in group 2 had unplanned visits to their physicians or to the emergency rooms for recurring exacerbations. Four patients in group 1 and five patients in group 2 were readmitted to hospital for recurrence (p = NS). During the follow-up two patients from group 1 died. CONCLUSION: These data show that oral administration of MP at a dose 32 mg/day for seven days significantly improves lung function, symptom scores and oxygenation in patients admitted to the hospital for COPD exacerbation and is as effective as and possibly safer than parenteral admininistration of higher doses.
RCT Entities:
RATIONALE: Systemic steroids shorten recovery time, improve lung function and hypoxemia in COPD exacerbations. Although several studies have shown that both parenteral and oral steroids are effective and GOLD guideline recommends use of oral steroids at a dose of 30-40 mg/day, very little data exists as to whether any route of admininstration (parenteral vs oral) or any dose is more effective and/or safer. METHODS: This was a randomized, parallel-group study aiming to compare the effectiveness and safety of orally administered lower dose of steroids with parenteral administration of higher doses. Thus, a total of 40 patients were included; one group (Group 1, n = 20) received methylprednisolone (MP) as recommended by the GOLD guideline (PO 32 mg/day for seven days) and the other (Group 2, n = 20) was given IV MP at 1 mg/kg/day for four days and 0.5 mg/kg/day for three days. RESULTS: The two groups were similar with regards to age (69.0 ± 10.5 vs 67.1 ± 8.4 years), duration of COPD (11.8 ± 8.3 vs 9.7 ± 7.7 years), FEV1 (41.3 ± 17.3 vs 34.0 ± 12.0%), PaO2 levels (55.5 ± 9.9 vs 59.1 ± 11.0 mmHg) and dyspnea scores (9.4 ± 1.1 vs 10.0 ± 1.0). Worsening hypercapnic respiratory failure developed in two patients from Group 1 on days 1 and 2, these were intubated and thus excluded from the study. At day 7, both groups showed significant improvements in FEV1 levels (50.8 ± 19.4 and 43.8 ± 21.4%, respectively) (Table 2), PaO2 levels (66.5 ± 12.5 and 65.3 ± 10.6 mmHg, respectively) (Table 3) and dyspnea scores (3,5 ± 2,8 and 4.2 ± 2.8) (Fig. 1). The length of hospital stay was similar for the two groups (11.0 ± 3.9 vs 12.7 ± 6.4). Regarding adverse events, four patients in Group 1 vs 11 patients in group 2 developed hyperglycemia. Besides, three patients in group 2 had worsening of previously controlled hypertension. All events were treated and controlled with administration of proper medications. All patients were followed up for three months. Eight patients in group 1 and 15 patients in group 2 had unplanned visits to their physicians or to the emergency rooms for recurring exacerbations. Four patients in group 1 and five patients in group 2 were readmitted to hospital for recurrence (p = NS). During the follow-up two patients from group 1 died. CONCLUSION: These data show that oral administration of MP at a dose 32 mg/day for seven days significantly improves lung function, symptom scores and oxygenation in patients admitted to the hospital for COPD exacerbation and is as effective as and possibly safer than parenteral admininistration of higher doses.
Authors: Diego Bonilla Arcos; Jerry A Krishnan; R William Vandivier; Jonathan E Sevransky; William Checkley; Tyree H Kiser; Jamie L Sullivan; John W Walsh; Robert A Wise; Kevin C Wilson Journal: Chronic Obstr Pulm Dis Date: 2016-02-17
Authors: Fanny W Ko; Ka Pang Chan; David S Hui; John R Goddard; Janet G Shaw; David W Reid; Ian A Yang Journal: Respirology Date: 2016-03-30 Impact factor: 6.424