Cost consequence analysis of fondaparinux versus enoxaparin in the prevention of venous thromboembolism after major orthopaedic surgery in Belgium.

Fondaparinux, a selective inhibitor of activated factor X, has been shown to reduce further the risk of venous thromboembolism (VTE) in major orthopaedic surgery compared to the low molecular weight heparin enoxaparin, when both were applied for 7 days after surgery. To compare the expected costs and clinical outcomes of fondaparinux with enoxaparin applied for 7 days after surgery, we conducted a cost-consequence analysis in patients undergoing major orthopaedic surgery, i.e. total hip replacement, total knee replacement and hip fracture repair. Our decision model included endpoints relevant in routine clinical practice and the natural history of VTE over a long term period of 5 years. Costs for prevention, diagnosis and treatment of VTE and its complications were estimated from the Belgian health care payer perspective. Analyses were conducted for different time horizons and for the three indications, separately, and then combined. Overall, our results indicated that the initial investment in fondaparinux (cost per day: 10.39 euros versus 3.74 euros for enoxaparin) was soon compensated by savings due to avoided VTE events, with cost neutrality being achieved after 90 days and further savings being incurred over longer time periods mainly due to avoided post-thrombotic syndromes. These findings were most pronounced in patients undergoing hip fracture repair. Sensitivity analyses showed these findings to be robust for the three indications separately, and combined. We conclude that our analysis of health and economic consequences over a long term period, demonstrates the value for money of fondaparinux versus enoxaparin for the prevention of VTE events after total hip replacement, total knee replacement and hip fracture repair.

Validation of the Quality of Life in Depression Scale in a population of adult depressive patients aged 60 and above.

The aim of this study is to evaluate the validity of the Dutch version of the Quality of Life in Depression Scale (QLDS) in a population of depressive patients aged 60 years and over, who were seen on an outpatient basis by psychiatrists in the Flemish region of Belgium. A sample of severely depressive patients was followed during an eight-week medical treatment. During this period, each patient was evaluated four times with the Hamilton Rating Scale for Depression and with the QLDS. We observed that the QLDS was very sensitive to the failing of the quality of life in depressive states. The QLDS was also a very good measure of change during the improvement of depressives states. Furthermore, the scale appears to be very homogeneous across the depressive states range. The results are very encouraging, and constitute strong corroboration of the construct validity of the scale.

An open multicentre study to evaluate the efficacy and tolerance of fluoxetine 20 mg in depressed ambulatory patients.

In this study, 544 out-patients suffering from depressive disorders were enrolled in 6 weeks open study with fluoxetine 20 mg. A statistically significant decrease of the Hamilton Rating Scale for Depression (HRS-D) score is observed during treatment. All individual item HRS-D scores and in particular suicidal ideation, sleep disturbances and anxiety showed the same improvement. Side-effects were carefully recorded and presented a lower incidence rate than in other studies. New issues in methodology management concerning ambulatory studies are discussed.

Fluoxetine in major depression: efficacy, safety and effects on sleep polygraphic variables.

Fluoxetine (60 mg), a selective inhibitor of the reuptake of 5-HT, was compared in a double-blind trial to amitriptyline (150 mg) in a sample of 34 patients fitting the Research Diagnostic Criteria for a major depressive disorder. Patients were studied after a drug washout period of 10 days and an active treatment period of 42 days. Sleep polygraphic recordings were performed before and at the end of the study. As indicated by the significant decrease in the Hamilton Depression scale and the Montgomery Asberg Depression scale, fluoxetine showed similar antidepressant effects to amitriptyline with significantly fewer adverse effects. Fluoxetine and amitriptyline decreased the amount of REM sleep, a well known effect of classical antidepressants. Fluoxetine showed some specific effects on sleep continuity (potentially dose related) as indicated by the significant increase in the number of awakenings and in stage shifts, without interfering with the therapeutic response.