[Quality of life of patient with peripheral arterial obliterative disease treated with ifenprodil tartrate. Results of an ARTEMIS study].

A clinical trial was performed to assess the effects on quality of life of a treatment (ifenprodil tartrate 20 mg, 3 times daily for one year) in patients suffering from peripheral arterial obliterative disease of the lower extremities with intermittent claudication. A specific questionnaire--ARTEMIS--was used to evaluate quality of life. The study enabled the responsiveness over time of the ARTEMIS questionnaire to be checked. During this open, prospective, multicentre study, patients requiring treatment for peripheral arterial disease of the lower extremities and recruited by angiologists and general practitioners filled in the complete or short form of the ARTEMIS questionnaire, respectively, at baseline, and at 3, 6, 9 and 12 months. 4821 patients were recruited. 4494 questionnaires were analysed (169 from the angiologist group and 4325 from the general practitioner group). The majority of the patients (mean age 67 years) were men (70%), either former or current smokers (68%), with high blood pressure (54%), hyperlipidaemia (48%) and type 2 (non-insulin-dependent) diabetes mellitus (16%), and with a 3-year history of intermittent claudication (+/- 3.5) on average. Quality-of-life scores improved (as from month 3) between baseline and month 12. This progression was significant for all dimensions of the reduced questionnaire (p < or = 0.0001) and for 12 of the 15 dimensions of the complete version. These quality-of-life results should be measured against the global clinical improvement, which was rated as good by the investigators (70% of cases). Treatment tolerability was assessed for the 4821 patients recruited and was judged satisfactory. The number and type of serious events and recorded deaths corresponded to events commonly observed in this elderly population. These results show how the ARTEMIS quality-of-life scales can be used in community practice during symptomatic treatment with a vasoactive agent such as ifenprodil, to assess quality-of-life improvements in patients suffering from stage II peripheral arterial disease of the lower extremities.