Content
Volume 5, 2001
Follow-up analyses of the International Multicenter Aprotinin Graft Patency Experience
(IMAGE)
SJ Niemcryk, G Pettersson, C Rasmussen, P Cislo
Pages 1-10 ¦ Abstract ¦
Health-related quality of life, symptoms, exercise capacity and lung function
during treatment for moderate to severe COPD
E Stähl, M Wadbo, T Bengtsson, K Ström, C-G Löfdahl
Pages 11-24 ¦ Abstract ¦
Niemcryk SJ, Pettersson G, Rasmussen C, Cislo P
Follow-up analyses of the International Multicenter Aprotinin Graft Patency Experience
(IMAGE)
J Outcomes Res 2001; 5: 1-10
A multicenter prospective, randomised, double-blinded clinical trial investigated
graft patency of patients undergoing primary coronary artery bypass graft surgery
(CABG) treated with high-dose aprotinin or placebo. Using a novel post-study follow-up
survey questionnaire, the present study assessed long-term cardiac-related mortality
and morbidity in these patients. Mortality was assessed in patients who completed
the original trial (aprotinin, n=436; placebo, n=434) and cardiac morbidity was
assessed in those surviving the original trial and follow-up period (aprotinin,
n=402; placebo, n=408). The survey response rate was 75.3% (n=645) with a mean
post-trial follow-up period of 4 years. No significant demographic or medical
characteristics were observed between responder and non-responder groups or between
US and non-US subsets. No difference in survival rates was observed (aprotinin,
94.3%; placebo, 95.0%; p = 0.657, RR=1.16; CI=0.602 - 2.233), excluding those
who died from non-cardiac causes. Overall survival rates for the combined trial
and survey periods were similar (aprotinin, 92.5%; placebo, 92.9%; p= 0.810).
Causes of mortality occurring after the trial, and rates of self-reported angina
and myocardial infarction, were similar between the treatment groups. No differences
in cardiac-related mortality by treatment group were observed between US and non-US
subsets. This novel post-study follow-up survey questionnaire provided a uniform
sample to address long-term cardiac-related mortality and morbidity in patients
enrolled in the initial clinical evaluation. No observed treatment differences
in mortality and morbidity were observed after completion of the trial. Benefits
of administering aprotinin intraoperatively to patients undergoing primary CABG
are not diminished, enhanced, or negated by treatment differences in the long-term.
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Stähl E, Wadbo M, Bengtsson T, Ström K, Löfdahl C-G
Health-related quality of life, symptoms, exercise capacity and lung function
during treatment for moderate to severe COPD
J Outcomes Res 2001; 5: 11-24
Patients with moderate to severe non-reversible chronic obstructive pulmonary
disease (COPD) experience marked impairment in their health and well-being. It
is known that it is difficult to measure benefits of interventions in this patient
group. The aim of this study was to evaluate correlation between health-related
quality of life using the St George's Respiratory Questionnaire (SGRQ) and other
objective measures such as walking distance in the shuttle walking test (SWT),
forced expiratory volume in one second (FEV1), and peak expiratory flow (PEF).
A comparison with symptoms (breathlessness and cough) was also performed. In a
3-month study, two bronchodilators [formoterol (Oxis¨*) and ipratropium bromide
(Atrovent¨ )] were compared with placebo in 144 patients with non-reversible COPD,
a mean age of 64 years and a mean FEV1 of 33% predicted, and mean total SGRQ score
of 47. There were no or very small changes in SGRQ, total; after formoterol 0%
and after ipratropium Ð0.5%. At baseline, the coefficients of correlation (r)
of SGRQ total score were as follows: versus the SWT: Ð0.51 (p<0.001), versus
breathlessness: 0.67 (p=0.000), and versus cough: 0.48 (p=0.000). All correlations
between SGRQ and lung function measurements were weak. The correlation between
change in SGRQ, total score, and changes in SWT, symptoms and lung function were
all weaker than the baseline value comparisons. The study has demonstrated that
limitation at baseline in walking distance and symptoms were related to baseline
health-related quality of life measures in patients with moderate to severe COPD.
The relations with spirometry variables were weak. All relations were weaker when
comparing changes after treatment.
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