Outpatient Oral Prednisone after Emergency Treatment of COPD

1
Outpatient Oral Prednisone after Emergency
Treatment of COPD

• Maggie Czarnogorski, MD
• Journal Club
• July 9, 2003

2
Primary Purpose of Study

• To study the effectiveness of prednisone in
  reducing the risk of relapse after outpatient
  exacerbations of COPD.

3
Secondary Outcomes

• Change in FEV1 at 10 days
• Change in dyspnea score at 10 days
• Change in disease-specific quality of life at 10
  days

4
Bottom Line

• Prednisone reduces the risk of relapse for at
  least 30 days post presentation to ER for COPD
  (ARR 16 NNT6)
• Significant improvement in FEV1 and dyspnea
  sub-score on Chronic Respiratory Disease Index
  questionnaire
• No improvement of overall disease-specific
  quality of life
• More side effects in the prednisone group

5
Study Design

• Randomized, double-blind, placebo controlled
  trial
• 147 patients, upon discharge from ER
• Treatment 10 days of oral prednisone 40mg/day
  vs. 10 days of placebo
• All patients received 10 days of antibiotics and
  bronchodialators (albuterol and ipatropium)
• Assessed at Day 3, 10, and 30

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Enrolled Patients

• Pt had 2 out of 3 Increased dyspnea, sputum
  volume, sputum purulence
• All had previous diagnosis of COPD or 1 yr Hx of
  dyspnea
• gt35 yrs old gt15 pack/yr hx of smoking
• FEV1/FVC of 0.70 or less
• Less than 20 improvement of FEV1 with
  bronchodilator.

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Excluded Patients

• Admitted to Hospital
• Asthma
• Oral or IV corticosteriods in past 30 d
• CHF or Pneumonia on CXR
• Uncontrolled DM
• Renal, Hepatic, or Cardiac Failure

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Patients

• Similarly matched
• Ample sample size
• Smokers
• Use of Inhaled corticosteriods
• Coexisting illnesses
• Few dropouts
• gt 95 white

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Validity

• Randomization schedule was prepared by a computer
  generated listing
• Neither patients nor researchers were aware of
  treatment assignments
• An adjudication committee, unaware of Tx
  assignments, confirmed relapses
• Final analysis was conducted on intention to
  treat basis

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Results
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Rates of Relapse and Hospitalization

• Relapse in 30 days
• ARR of 16
• NNT 6
• Time to 25 relapse
• Longer in prednisone Tx group
• Hospitalization for COPD
• ARR of 10
• NNT 10

12
Secondary Outcomes

• Prednisone group
• Greater increase in FEV1
• Greater improvement of dyspnea score
• No significant change in CRDI score

13
Quality of Life

• Prednisone group reported more
• Increased appetite
• Weight gain
• Insomnia
• Depression
• Anxiety

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Strengths

• Well designed randomized, double-blinded, placebo
  controlled study
• Treatment and placebo groups similar
• Good follow-up, few dropouts
• Excluded patients with asthma
• Statistically significant results
• Clinically relevant outcomes

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Weaknesses/Limitations

• Short-term study
• Only tested one dose, no tapering
• Did not address effects of multiple short term
  courses of prednisone
• Patients excluded for several co-morbid
  conditions
• More than 95 were white

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Summary

• Fewer relapses at 30 days in prednisone group
• For every 6 patients treated 1 relapse is
  prevented in the next 30 days
• FEV1 improves after short-term use of prednisone
• Patients on prednisone had greater improvement
  with dyspnea
• Disease-specific quality of life did not
  significantly improve with prednisone

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Economics

• Average total direct cost of a COPD relapse is
  477.50
• Prednisone costs pennies a day
• You Do the Math

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Citations

• Irwin, Richard Mark Madison Systemic
  Corticosteroids for Acute Exacerbations of
  Chronic Obstructive Pulmonary Disease Editorial,
  NEJM vol 348, June 2003.
• Arron, Shawn et al. Outpatient Oral Prednisone
  after Emergency Treatment of COPD NEJM, Vol 348,
  June 2003.