[Double-blind randomized comparative study of nicergoline naftidrofuryl on the quality of life in chronic obliterative arteriopathy of lower limbs with intermittent claudication]. / Etude comparative randomisée en double-aveugle de la nicergoline et du naftidrofuryl sur la qualité de vie dans l'artériopathie chronique oblitérante des membres inférieurs au stade de la claudication intermittente.

The functional limitation of patients with obliterative arterial disease, and with intermittent claudication, damages their quality of life. The purpose of this trial was to compare the effects of nicergoline and naftidrofuryl on the quality of life and the functional discomfort of the 131 patients with claudication. It was a multicentre, randomised, double-blind trial with parallel groups. The patients were asked to complete a quality of life questionnaire and a Visual Analogue Scale, and to evaluate the number of steps on flat ground before the pain began. After 6 months of treatment, we observed, for all treatments combined, a significant improvement (p = 0.0001) in the quality of life and in the functional discomfort. Three variables favoured nicergoline: the estimated time before the onset of the pain (p = 0.003), the functional discomfort quantified by the Visual Analogue Scale (p < 0.05), the distance covered on flat ground (p = 0.013). The other variables, and especially the total score on the self-questionnaire, confirmed this impression, without reaching significance (p = 0.136). The data suggest that in terms of quality of life nicergoline is superior. The clinical tolerance is good and comparable between the two treatments.

Colonic ischemia reveals thromboangiitis obliterans (Buerger's disease).

Two years before the appearance of distal peripheral manifestations of thromboangiitis obliterans (Buerger's disease), a young man had acute peritonitis attributable to an ischemic perforation of the sigmoid colon. Only the histological examination of excised tissue was able to differentially diagnose this entity unambiguously.

[Double-blind randomized controlled trial of ifenprodil tartrate versus placebo in chronic arterial occlusive disease of the legs at stage II of the Leriche and Fontaine classification]. / Essai comparatif randomisé en double-aveugle du tartrate d'ifenprodil versus placebo dans l'artériopathie oblitérante chronique des membres inférieurs au stade II de la classification de Leriche et Fontaine.

Authors report results on a comparative multicenter double blind trial carried out to assess the efficacy of Ifenprodil tartrate (*) (60 mg a.d.) versus placebo in symptomatic treatment of stable peripheral arterial occlusive disease (Fontaine stage II). Ninety four patients were included in this six months, two parallel group study (2 homogeneous groups) which shows a statistically significant functional improvement in the treatment group versus the placebo group. After six months of treatment, the maximum walking distance (MWD)--main assessment criteria--was 126.0 +/- 18.5 meters in the Ifenprodil group versus 46.4 +/- 20.2 meters in the placebo group (p = 0.005). This represents an improvement of 62.1% in the Ifenprodil group versus 21.0% in the placebo group. An improvement of at least 50% in MWD was observed in 41.3% of patients treated by Ifenprodil and in only 12.5% of patients receiving placebo (p = 0.002). The evolution of ankle/brachial systolic post exercise index from JO to J180 was not significantly different in the two groups. Clinical and biological tolerance of Ifenprodil tartrate was excellent.

[Thromboembolic disease and cancer]. / Maladie thromboembolique et cancer.

Many anomalies in primary haemostasis, coagulation and fibrinolysis have been described which favour thrombosis in cancer patients. Cancer is often associated with other risk factors for thromboembolism which explain much of the increased frequency of thrombosis in these patients. Thromboembolism may precede cancer and sometimes is the inaugural manifestation leading to the diagnosis of cancer. Cancer occurs more frequently in patients with idiopathic recurrent venous thrombosis than in those with thrombosis due to other risk factors for thromboembolism. The results of antivitamin K therapy are disappointing: in retrospective series, recurrent thromboembolism occurred in 9% of the treated patients and severe haemorrhage in 27%. New therapies should be assessed in cancer patients with thromboembolism.

[Malignant transformation of leg ulcers]. / Transformation maligne des ulcères des membres inférieurs.

The authors report a case of malignant transformation (carcinoma cuniculatum) of a venous leg ulcer developed since 60 years. They draw the principal lessons from the review of literature.

[Treatment of venous thromboembolic disease in patients with cancer]. / Traitement de la maladie thromboembolique veineuse (MTE) chez les patients cancéreux.

Results of classical anticoagulant therapy in cancer patients with venous thromboembolism (VT) are highly discussed. We retrospectively analysed the outcome of 43 patients with VT and cancer: 32% developed specific complications during either i.v. heparin therapy (10 +/- 0.9 days) or treatment by antivitamin K (106 +/- 14.9 days). Recurrence of thromboembolism (16%) and/or hemorrhages (16%) were much more frequent than in patients without cancer, underlying need for alternative therapy in cancer patients with VT.

A comparison study of lipid and androgen metabolism with triphasic oral contraceptive formulations containing norgestimate or levonorgestrel.

The effects of norgestimate triphasic (Ortho Tri-Cyclen, Tri-Ciles) and levonorgestrel triphasic (Triphasi) formulations on lipid and androgen metabolism were assessed in a study of 66 healthy women treated through six menstrual cycles. Levels of the following were measured: cholesterol and its subfractions, triglycerides, carrier lipoproteins, estradiol, testosterone, and sex hormone binding globulin (SHBG). Comparison of baseline values with values after 3 and 6 months of treatment indicated that both regimens influenced lipid and androgen metabolism. There was a statistically significant between-regimen difference in levels of high-density lipoprotein, which were favorably increased with norgestimate triphasic but reduced with levonorgestrel triphasic. Related data on SHBG showed that plasma levels of this marker of estrogen/androgen balance were increased significantly more in the norgestimate triphasic group, providing additional evidence of low androgenicity. Both regimens inhibited follicular growth to the same extent, as evidenced by low mean levels of estradiol in all on-therapy cycles; and both decreased free testosterone. Side effects in both groups were minor and characteristic of those observed with low-dose oral contraceptive agents. The results of the study support the reported safety and positive effects of norgestimate on lipid and androgen metabolism, in comparison with a levonorgestrel-containing combined oral contraceptive.

PIP: The effects of norgestimate triphasic (Ortho Tri-Cyclen, Tri-Cilest) and levonorgestrel triphasic (Triphasil) formulations on lipid and androgen metabolism were assessed in a study of 66 healthy women who were treated through 6 menstrual cycles. Levels of the following were measured: cholesterol and its subfractions, triglycerides, carrier lipoproteins, estradiol, testosterone, and sex hormone binding globulin (SHBG). Comparison of baseline values after 3 and 6 months of treatment indicated that both regimens influenced lipid and androgen metabolism. There was a statistically significant between-regimen difference in the levels of high-density lipoprotein, which increased favorably with norgestimate triphasic but were reduced with levonorgestrel triphasic. Related data on SHBG showed that plasma levels of this marker of estrogen/androgen balance were increased significantly more in the norgestimate triphasic group, providing additional evidence of low androgenicity. Both regimens inhibited follicular growth to the same extent, as seen by low mean levels of estradiol in all of the on-therapy cycles. Both decreased free testosterone. Side effects in both groups were minor and characteristic of those observed with low-dose oral contraceptives (OCs). The results of the study support the reported safety and positive effects of norgestimate on lipid and androgen metabolism, in comparison with a levonorgestrel-containing combined OC.

[What to do with a free-floating venous thrombus]. / Que faire devant un caillot veineux flottant.

Among patients with deep vein thrombosis (DVT), the frequency of pulmonary embolism seems conditioned by the location of DVT and thrombus adherence. Consequently, patients with free-floating iliac thrombus are at high risk of life-threatening pulmonary embolism. As regards their definition, non adherent thrombus and free-floating thrombus are not synonymous. Non adherent thrombi are usual in recent DVT and have the same prognosis and treatment as common DVT. The term of free-floating thrombi should be reserved for the iliac location when a small area of the thrombus is attached to the iliac vessel wall but the rest of it does not adhere to the wall. At present, venography is the gold standard for diagnosis but duplex scanning and scanner or magnetic resonance imaging should also be evaluated for this purpose. The treatment comprises the usual anticoagulant therapy with heparin and a specific treatment for the free-floating thrombus. 1) Vena cava filter is a rapid safe solution that avoids severe pulmonary embolism, but in the case of thrombus detachment, vena cava obliteration might occur with the subsequent risk of severe bilateral venous stasis and insufficiency. The indications for such treatment might be elderly patients in a poor general condition. 2) Venous thrombectomy. Venous thrombectomy only removes the free part of the thrombus, thus preserving the contralateral iliac vein from further complications. A clip is positioned on the inferior vena cava. 3) Protected fibrinolysis. The latest catheters allow transient vena cava filter device placement. Thrombolytic therapy with rTPa might achieve thrombolysis and subsequently restore the venous circulation.(ABSTRACT TRUNCATED AT 250 WORDS)

[Alpha-1 inhibition. Prevention of coronary risk factors]. / L'inhibition alpha 1. Prévention des facteurs de risque coronarien.

Although diuretics and beta-blockers are efficient in treating high blood pressure and in decreasing the occurrence of strokes, these therapeutics have deleterious effects concerning lipidic metabolism, therefore worsening another cardiovascular risk factor. A comparative study evaluates the effects of prazosin and atenolol on plasmatic lipids of hypertensive patients. The results of this study confirm that prazosin can avoid an increase in plasmatic lipids. This therapy could therefore be prescribed to improve the ratio risk/benefit of the hypertensive therapy.

Beneficial effects of indapamide on lipoproteins and apoproteins in ambulatory hypertensive patients.

Among the numerous risk factors for atherosclerosis, 2 are particularly important: hypertension and primary or secondary abnormalities of plasma lipids and lipoproteins. Antihypertensive treatments significantly decrease the risk of cerebrovascular accidents, renal failure or hypertensive cardiomyopathy, but they have little influence on coronary artery disease. It has been suggested that some antihypertensive agents may have deleterious effects by altering serum lipoproteins and this may override the benefit of blood pressure reduction. Diuretics increase the blood concentration of total cholesterol, low-density lipoproteins and triglycerides. Indapamide, a methylindoline agent with vasodilator activity, has no adverse lipid effects. Twenty-six studies have clearly demonstrated that indapamide appears to be unique among diuretics because of an absence of adverse lipid effects. In some studies indapamide significantly increased high-density lipoprotein cholesterol, apoproteins A1, A2 and apoprotein E. When a thiazide diuretic had been given previously, indapamide treatment normalized the lipid and lipoprotein profiles. The reason for the lack of adverse lipid effects of indapamide is discussed. Thus indapamide, 2.5 mg once daily, is effective and safe for the control of mild to moderate hypertension, both in young and older patients. It may be an optimal diuretic for use in normolipidemic or hyperlipidemic patients, as it increases high-density lipoprotein but not low-density lipoprotein cholesterol.

Efficacy and safety of simvastatin (alone or in association with cholestyramine). A 1-year study in 66 patients with type II hyperlipoproteinaemia.

The effects and safety of simvastatin, an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, were investigated alone or in association with cholestyramine in 66 patients with hypercholesterolaemia, in a 1-year study. In type IIa hypercholesterolaemia (41 patients), the association was more effective than simvastatin used alone in lowering total cholesterol (37% vs 29%) and LDL-cholesterol (45% vs 37%). In type IIb hypercholesterolaemia (23 patients), the association simvastatin-cholestyramine did not appear more effective than simvastatin used alone. The decrease of apoprotein B was parallel to the LDL-cholesterol decrease. Apoprotein A1 did not change significantly. The long-term safety of simvastatin was good. No lens opacity was noted. The most serious side-effect in our study was myolysis which occurred in two patients with a marked increase in creatine phosphokinase.