Authors' objectives:

The endpoints of this study were to evaluate the evidence on the efficacy and safety of self-control of oral anticoagulant treatments (OAT) and secondly to make a study of the cost-effectiveness of this technology so as to support the CatSalut in the strategy to be used/implemented.

Authors' results and conclusions: Regarding the results, 68 publications were selected, 12 of which complied with the pre-established inclusion criteria. The quality of the 7 randomised clinical tests was very variable, with differences in the blind method of assignment, the number and comparison of the patients lost to follow-up and in bias control. The quality of the 5 quasi experimental studies was average or low, with shortcomings in the comparability of the study populations, the correct definition of the end of follow-up and the control of confusion factors. The efficacy of the PC is analysed mainly depending on the percentage of samples that are within the therapeutic range, being between 53% and 89% in the self-control group and between 43% and the 74% in the patients on regular treatment (statistically significant differences in 3 of the 7 studies that present data). In 8 of the 12 studies, efficacy as a percentage of the time for which the samples are within the therapeutic range was studied, being a more reliable measurement than the previous one, and less subject to biases(b). In this case, patients on a self-control regimen ranged between 69% and 78% of the time in therapeutic range, whereas in the controls (on regular treatment) it was between 53% and 77% (in six studies the difference is statistically significant). However, the real measure of efficacy can only be evaluated as the appearance or not of complications, both thrombotic(c) and haemorrhagic, which in patients on self-control is between 0% and 30%, whereas in the controls it is between 0% and 15% (there are no solid data on statistical significance). The data on satisfaction seem to indicate that the patients prefer self-control, although the measuring instruments for evaluating this point are, generally speaking, deficient.

Authors' recommendations: Finally, we believe it is very important to take the current health context into account, where new molecules are being developed for the treatment of thrombotic and embolic diseases. Thus, the results obtained to date with the xi-melagatran, an oral prodrug of melagatran (direct coagulation inhibitor), are promising, and different Phase III studies have been successfully completed, with commercialisation scheduled for the coming months.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.aatrm.net/html/en/dir393/doc7921.html

Year Published: 2003

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Qualitat i Avaluacio Sanitries de Catalunya

Contact Address: Antoni Parada, CAHTA, Roc Boronat, 81-95 (2nd floor), 08005 Barcelona, Spain, Tel. +34 935 513 928, Fax: +34 935 517 510

Contact Name: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Contact Email: direccio@aatrm.catsalut.net / aparada@aatrm.catsalut.net

Copyright: Catalan Agency for Health Technology Assessment and Research (CAHTA)