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A Journal on Angiology

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 1999 March;18(1):52-7

Impaired ­results of a ran­dom­ised dou­ble blind­ed clin­i­cal trial of pro­pran­o­lol ver­sus pla­ce­bo on the expan­sion rate of small abdom­i­nal aor­tic aneu­rysms

Lindholt J. S., Henneberg E. W., Juul S. *, Fasting H.

From the Department of Vascular Surgery, Hospital of Viborg
* Institute of Epidemiology and Social Medicine, University of Aarhus, Denmark


Background. To study the pro­pran­o­lol treat­ment of small abdom­i­nal aor­tic aneu­rysms (AAA) con­cern­ing inten­tion to treat, side ­effects, and inhi­bi­tion of expan­sion.
Methods. Design: Two-year last­ing pros­pec­tive ran­dom­ised dou­ble-blind­ed inter­ven­tion trial. Setting: Hospital-based mass screen­ing for AAA with annu­al ambu­la­to­ry con­trol of small AAA. Participants: Of 122 screen­ing-diag­nosed small AAA, 51 (42%) were exclud­ed ­because of con­tra­in­di­ca­tions or ­present beta-block­age, and 17 ­refused par­tic­i­pa­tion. Thus, 54 (44.3%) were includ­ed. Intervention: Participants were ran­dom­ised to 40 mg pro­pran­o­lol twice a day or pla­ce­bo. Measures: The same ­observed was used to fol­low-up AAA-expan­sion, side ­effects, qual­ity of life (QL), bran­chi­al and ankle blood pres­sure (ABI), and pul­mo­nary func­tion (FEV1 and FVC).
Results. Sixty per­cent in the pro­pran­o­lol group, and 25% in the pla­ce­bo group ­dropped out, main­ly ­caused by dysp­noea in the pro­pran­o­lol group (RR=1.74, 95% C.I.: 1.06-2.86). Five (16.7%) died in the pro­pran­o­lol group, while 1 (4.2%) died in the pla­ce­bo group (RR=1.6 (1.02-2.51)). Furthermore, ­decreased pul­mo­nary func­tion, ABI, and QL was ­noticed in the pro­pran­o­lol group. Consequently, the trial was ­stopped after two years.
Ninety-five percent of the meas­ure­ments of the AAA were meas­ured with­in 2 mm vari­a­tion. If expan­sion was ­defined as above 2 mm annu­al­ly, the rel­a­tive risk of expan­sion in the pla­ce­bo group was 1.17 (0.74-1.85), and 2.44 (0.88-6.77) among the non-drop-outs.
Conclusions. Only 22% of small screen­ings-diag­nosed AAA were treat­able with pro­pran­o­lol for two years. Consequently, only large scale stud­ies are ­capable of show­ing poten­tial minor inhi­bi­tion of expan­sion by pro­pran­o­lol. However, wheth­er such treat­ment ever ­becomes eth­i­cally accept­able is debat­able.

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