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43A Patients over 70 years in a clinical trial: The experience of GISSI-3
62S
Abstracts groups. We conclude that the test should be used in a trial only after carefully considering its limitations and the design of the proposed study.
43A PATIENTS OVER 70 YEARS IN A CLINICAL TRIAL: THE EXPERIENCE OF GISSI-3
E. Gardinale, E. Bonfanti, M.G. Franzosi, E. Santoro on behalf of GISSI-3 Investigators
GISSI Coordinating Centre Milano, Italy Traditionally, elderly patients constitute a population that is underrepresentedin many randomized clinical trial (RCT); moreover, where the protocol allows their inclusion, reasons for non eligibility are more frequent and adherence to treatment less satisfactory. Aims of fltis analysis were to analyze the reasons of exclusion from the randomization, the adherence to treatments and to follow-up visits according to age in the GISSI-3 study, a multicenter RCT testing the efficacy of iisinopril, nitrates and their combination in improving survival and ventricular function in patients with acute myocardial infarction (AMI). Over a period of 24 months, out of the 40,000 patients admitted to the 200 participating Coronary Care Units (CCUs) 19,394 were randomized to the study (27 % of whom over 70 years), and 23,653 were excluded (41% of whom over 70 years). The main reasons of exclusion were: more than 24 hrs after the onset of symptoms ( > 24hrs), conla'aindications to randomized treatment (Contr), persistent clinical instability (PCI), administrative reasons (AR). Age
> 24hrs(%)
Contr(%)
PCI(%)
AR(%)
<70
22.4
22.1
14.0
34.5
>70
23.3 n.s
27.1 79.7% 90.3% p < .001 p < .001 p < .001 The execution of 6 week-follow up visit (6wFU) and the adherence to randomized treatments of randomized patients were: Age
6wFU(%)
Adherence Lisinopril
< 70
93.4
83.5 %
Nitrates 87.8 %
>70 91.1 p<.001 79.7% p<.001 90.3~ p<.001 The present aata show that some reasons for exclusion were more frequent in elderly patients than in younger ones; in particular hemodynamic instability and contraindications to the randomized treaUnents were more represented in elderly. The adherence to treatments and follow-up visits were less good in elderly even ff can be considered satisfactory.
Abstracts groups. We conclude that the test should be used in a trial only after carefully considering its limitations and the design of the proposed study.
43A PATIENTS OVER 70 YEARS IN A CLINICAL TRIAL: THE EXPERIENCE OF GISSI-3
E. Gardinale, E. Bonfanti, M.G. Franzosi, E. Santoro on behalf of GISSI-3 Investigators
GISSI Coordinating Centre Milano, Italy Traditionally, elderly patients constitute a population that is underrepresentedin many randomized clinical trial (RCT); moreover, where the protocol allows their inclusion, reasons for non eligibility are more frequent and adherence to treatment less satisfactory. Aims of fltis analysis were to analyze the reasons of exclusion from the randomization, the adherence to treatments and to follow-up visits according to age in the GISSI-3 study, a multicenter RCT testing the efficacy of iisinopril, nitrates and their combination in improving survival and ventricular function in patients with acute myocardial infarction (AMI). Over a period of 24 months, out of the 40,000 patients admitted to the 200 participating Coronary Care Units (CCUs) 19,394 were randomized to the study (27 % of whom over 70 years), and 23,653 were excluded (41% of whom over 70 years). The main reasons of exclusion were: more than 24 hrs after the onset of symptoms ( > 24hrs), conla'aindications to randomized treatment (Contr), persistent clinical instability (PCI), administrative reasons (AR). Age
> 24hrs(%)
Contr(%)
PCI(%)
AR(%)
<70
22.4
22.1
14.0
34.5
>70
23.3 n.s
27.1 79.7% 90.3% p < .001 p < .001 p < .001 The execution of 6 week-follow up visit (6wFU) and the adherence to randomized treatments of randomized patients were: Age
6wFU(%)
Adherence Lisinopril
< 70
93.4
83.5 %
Nitrates 87.8 %
>70 91.1 p<.001 79.7% p<.001 90.3~ p<.001 The present aata show that some reasons for exclusion were more frequent in elderly patients than in younger ones; in particular hemodynamic instability and contraindications to the randomized treaUnents were more represented in elderly. The adherence to treatments and follow-up visits were less good in elderly even ff can be considered satisfactory.