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PubMed1986

In vitro binding study of gemfibrozil to human serum proteins and erythrocytes: interactions with other drugs.

The binding of gemfibrozil to human serum, isolated proteins and erythrocytes was studied in vitro by equilibrium dialysis. Our results show that this drug is highly bound to serum (99%) at therapeutic levels. Human serum albumin was shown to be mainly responsible for this binding (98.6%) with a saturable process characterized by two binding sites with a moderate affinity. Like many acidic drugs with a carboxylic acidic group, gemfibrozil showed none or negligible binding to alpha 1 acid glycoprotein, lipoproteins and gamma-globulins. The drug binding to erythrocytes is very low (0.8%). The unbound fraction in blood remains constant (0.8%) within the range of therapeutic concentrations. Moreover, interactions were studied with bilirubin and palmitic acid at pathophysiological concentrations and acenocoumarol, salicylic acid, valproic acid, furosemide, phenylbutazone, tolbutamide, warfarin and sulfamethoxazol at therapeutic concentrations. Neither endogenous compounds nor the other drugs studied altered gemfibrozil binding in serum. Likewise, the binding of warfarin to serum and to human serum albumin (600 microM) is not influenced by gemfibrozil.

Blood Proteins↗
PubMed1986

Late results of mitral valve replacement with the Björk-Shiley prosthesis in children under 16 years of age.

The late results of isolated mitral valve replacement were evaluated in 37 children under 16 years of age receiving a Björk-Shiley prosthesis for the treatment of rheumatic mitral lesions. Three patients died, one during the operation and the others 2 months postoperatively. Of the latter two, one had a cerebral hemorrhage and the second had septicemia. The survivors were followed up for a mean of 4.7 years (range 2.8 to 8.9 years). After the operation, all patients were placed on a strict anticoagulant regimen with acenocoumarol. The actuarial survival rate was 92% at the end of the follow-up period. Before valve replacement two patients were in New York Heart Association Class I, 15 in Class II, 18 in Class III, and two in Class IV. After treatment 33 were in Class I and one in Class II. No instances of thromboembolism or infective endocarditis were observed in the survivors. Twenty-one patients underwent cardiac catheterization 2 to 7 years after the operation for evaluation of surgical results. The mean pulmonary artery systolic pressure decreased significantly after operation (p = 0.001), and the mean pulmonary artery wedge pressure decreased to normal values (p = 0.001). A mild mean diastolic gradient across the mitral valve at rest was found after the operation (4.9 +/- 2.4 mm Hg). During isometric exercise this gradient increased to 6.5 +/- 4.6 mm Hg. In two patients a discrete paravalvular leak was demonstrated by cineangiography, but the pulmonary wedge pressure was normal in both. The overall results with the Björk-Shiley prosthesis are encouraging in patients in whom reconstructive operations cannot be performed.

Adolescent↗
PubMed1986

[Treatment of diffuse glomerulonephritis in adults with Schönlein-Henoch disease using a combination of anticoagulants, corticosteroids and immunosuppressants].

The results are reported from the treatment of seven patients with severe diffuse chronic glomerulonephritis in Schönlein--Henoch disease with manifested clinical and laboratory manifestations (nephrotic syndromes, arterial hypertension, anemia, renal insufficiency, chronic from of the syndrome of disseminated intravascular coagulation). Combined treatment with anticoagulants (heparin and acenocoumarol), corticosteroids (with initial introducing "pulse" trarment with 300 mg methylprednisolone) and immunosuppressors was administered to all. Complete clinical-laboratory remission was attained in 57.1% of the patients, and in 28.5%--partical. One of the patients died from mesenterial thrombosis. The anticoagulants and "pulse" treatment with high corticosteroid doses are of the greatest importance for the favourable therapeutic result.

Adolescent↗
PubMed1979

Diclofenac sodium (Voltarol): drug interactions and special studies.

Diclofenac (Voltarol) has no effect on carbohydrate metabolism, insulin levels or tolbutamide metabolism, nor does it enhance the effect of tolbutamide, biguanide or glibenclamide. Although it produces minimal increases in prothrombin and partial thromboplastin times in healthy volunteers, it does not significantly affect the individual clotting factors, nor does it, in patients, enhance the effect of acenocoumarol or phenprocoumon. Like many other other non-steroidal anti-inflammatory drugs, it increases platelet aggregation time. There is a pharmacokinetic interaction between aspirin and diclofenac. Two independent studies have shown that aspirin markedly reduces the bioavailability of diclofenac, as measured by "area under the curve". Furthermore, patients exhibiting aspirin sensitivity as bronchospasm are likely to react to diclofenac in the same manner. Finally, diclofenac, as tested using excretion of 51Cr labelled red cells, induces minimal gastrointestinal blood loss, significantly less so than aspirin or naproxen.

Adult↗
PubMed1985

[Treatment of diffuse glomerulonephritis in systemic lupus erythematosus with a combination of anticoagulants, corticosteroids and immunosuppressors].

The results from the combined treatment with anticoagulants (heparin and acenocoumarol), corticosteroids and immunosuppressors are reported in 27 patients with diffuse lupus glomerulonephritis. In 14 patients (51,9%) complete clinical-laboratory remission was obtained, and in 9 patients (33,3%)--partial. Two patients (7,4%) deteriorated and one female of them--died. Two patients (7,4%) died from the complications in connection with the treatment. The following conditions are necessary for the attainment of favourable therapeutic effect: intravenous administration of 30 000 U heparin for at least 60 days; high initial dose of corticosteroids (60 mg prednisolone) in the course of 2-3 months or initiation with "pulse" methylprednisolone treatment (300 mg methylprednisolone intravenously for 3 to 5 days), when a shortening of the periods with the high initial doses to 1-2 months is possible; considerable duration of the treatment as a whole--at least I and 1/2 year; qualitative follow up care. With alternating intake of corticosteroids--the dose for two days, taken as a single dose every second day--reduces sharply the incidence and severity of the adverse effects, induced by them, but with no effect on therapeutic outcome.

Adolescent↗
PubMed1985

[Is optimal anticoagulation possible in ambulatory practice? Report on a retrospective 5-year study of a cardiology practice].

In a 5-year retrospective study (1982-1978) in a well defined population of 332 patients (representing greater than or equal to 2140 anticoagulation years) from a heart specialist's practice, the question was studied whether optimum anticoagulation (Quick test between 18-29%, INR 4.0-2.75, Geigy thromboplastin, capillary blood method) with minimum complications could be achieved. In the qualitative study it was found that 75% of Quick determinations were in the optimum range for phenprocoumon, 71.6% for clorindion, 62% for acenocoumarol and 72% for all anticoagulants. 77% of phenprocoumon patients were optimally anticoagulated for more than 3 years. With phenprocoumon there was no difference in intensity of anticoagulation between the oldest and youngest patient groups, as all mean Quick values ranged over 20% (means Q% 1982-1978 = 25, INR = 3.0). It was also shown that after 6 months' anticoagulant therapy it is clearly recognizable whether optimum anticoagulation is feasible or not: at that moment the criteria for halting or continuing anticoagulant therapy can and should be reviewed.

Aged↗
PubMed1979

Metabolism of the coagulation factors of the prothrombin complex in hypothyroidism in man.

The metabolic rate of prothrombin, factors VII, IX and X, was studied in nine hypothyroid patients. Disappearance rates of the four vitamin-K-dependent factors, called the prothrombin complex, were measured after assumedly complete blocking of their synthesis with adequate doses of a coumarin congener (acenocoumarol). Reappearance rates were assessed by induction of synthesis with high doses of vitamin K1 (phytomenadion) when stable hypocoagulability had been achieved. Normal values for these rates were derived from earlier studies in our laboratory. In hypothyroid patients the rates of both disappearance and reappearance were significantly slower for all factors tested. Practical consequences of these observations are discussed. The initial level of factor-IX activity in all nine patients was substantially lower than in normal individuals. Therapy by thyroxine-substitution led to normal levels of factor-IX. This implies a divergency in the retardation of the breakdown and production rates in hypothyroidism. The reappearance rate was indeed found to be more retarded than the disappearance rate.

Adult↗
PubMed1981

Inhibition and induction of microsomal enzymes in rat. A comparative study of four antimycotics: miconazole, econazole, clotrimazole and ketoconazole.

The interaction of four imidazole antimycotics clotrimazole, econazole, ketoconazole and miconazole with other drugs was studied in in vivo models known to reveal inhibition and induction of microsomal enzymes. In rats the duration of methohexital hypnosis and the prothrombin time prolongation induced by acenocoumarol were changed after oral administration of all four antimycotics. The oral ED50-values of miconazole, econazole and clotrimazole for prolongation of methohexital hypnosis in female rats (acute inhibiton of microsomal enzymes) were 3.55, 3.56 and 10.7 mg/kg. Ketoconazole, inhibited microsomal enzymes at the oral ED50 of 30.4 mg/kg in female and 97.0 mg/kg in male rats. After subchronic treatment only clotrimazole reduced the hypnosis time below control values (induction of microsomal enzymes); the ED50 of clotrimazole for his activity was 14.9 mg/kg. The lowest effective dose of ketoconazole for extra-prolongation of the prothrombin time was 50 mg/kg, whereas the other antimycotics showed this effect at much lower doses. The implications of these results for the therapeutic use of these compounds are discussed and it is concluded that ketoconazole can be considered to be devoid of interaction with drugs, of which the intensity and duration of action strongly depends on their metabolic transformation rate in the liver.

Animals↗
PubMed1984

[The artificial St. Jude valve: clinical course and complications recorded in 155 patients].

The St. Jude Medical cardiac valve is a low-profile, bileaflet, central-flow prosthesis made of pyrolitic carbon. During a 39-month period (October 1, 1979 to December 31, 1982) a total of 169 St. Jude valves were implanted in 155 patients. While 141 patients received one valve, 95 in the aortic, 45 in the mitral and 1 in the tricuspid position, 14 patients had a double (aortic and mitral) valve replacement. The perioperative mortality rate was 3.2%. All surviving patients had anticoagulation treatment with acenocoumarol and there was a 98% follow-up during a period of 19.5 +/- 4.5 months. The late mortality rate was 4.7%. Substantial clinical improvement resulted with the St. Jude valve: whereas 81.9% of patients were in NYHA functional class III or IV preoperatively, 87.1% were in class I or II after valve replacement. The patients generally had a slight increase in LDH levels but hemolysis was responsible for moderate anemia only in 5 cases. There were 10 nonfatal neurological accidents, probably due to thromboembolic events, resulting in a risk of thromboembolism of 4.04% per patient year; 4 of the 10 patients were incompletely anticoagulated and 3 had cardiac arrhythmia. There were 5 hemorrhagic complications, one of which was fatal (subarachnoidal hemorrhage). Endocarditis occurred in 4 patients and death ensued in one of these. Seven patients developed perivalvular leak which was moderate in 5 cases and severe in 2 cases. In conclusion, these results are promising and the St. Jude Medical cardiac valve appears to be a valid alternative in surgical therapy of valvular heart disease. However, the risk of thromboembolism justifies long-term anticoagulation.

Adult↗
PubMed1984

[Digestive hemorrhage under anticoagulant treatment. Retrospective analysis of a series of 178 consecutive cases].

The aim of this study was to describe the clinical characteristics, prognosis and epidemiological pattern of gastrointestinal bleeding occurring in patients receiving anticoagulant therapy. From 1971 to 1981, among 3,194 consecutive patients admitted to a gastrointestinal unit because of acute gastrointestinal bleeding, 178 were under anticoagulant therapy (i.e. antivitamin K and heparin or heparin derivative in respectively 85 and 13 p. 100 of the cases). Fourteen percent of these 178 patients had also taken gastrotoxic drugs before the bleeding occurred. Indications for anticoagulant therapy were as follows: ischemic heart disease (21 p. 100), arrhythmias (20.3 p. 100), venous thrombosis and pulmonary embolism (15.8 p. 100), arteritis (10.8 p. 100), aortic, coronary or peripheral arterial grafts (8.4 p. 100), prophylaxis of venous thrombosis (8.4 p. 100), valve prosthesis (7.3 p. 100). The lesion responsible for bleeding was found in 80 p. 100 of the cases. Surgical hemostasis was required in only 4 patients. Ten patients died (2 postoperatively). During the study period, the incidence of bleeding associated with anticoagulant therapy in the group of patients admitted to the unit with gastrointestinal hemorrhage increased from 1.5 p. 100 to 8.0 p. 100. This fact appeared to be closely related to new indications (valve prosthesis, arterial grafts, prophylaxis of venous thrombosis) and to an increased incidence of gastrointestinal bleeding especially in association with acenocoumarol treatment. These results show that, although occurring in a high risk population, gastrointestinal bleeding related to anticoagulant therapy generally has a favorable outcome. They also suggest that a prospective epidemiological study may be of interest to determine the reasons for the increasing incidence and to propose preventive measures.

Adult↗
PubMed1982

Benoxaprofen: plasma binding and binding interactions with some drugs and endogenous compounds.

The binding of benoxaprofen to human serum albumin (HSA) was investigated by equilibrium dialysis at pH 7.4 and 37 degrees C. As most acidic drugs, almost completely ionized at plasma pH, benoxaprofen was avidly bound to HSA (7.5 x 10(-6) M) with the following parameters: n1 = 3.3 and K1 = 325 x 10(3) M-1; n2 = 16.2 and K2 = 2.1 x 10(3) M-1 At normal HSA plasma concentration in humans benoxaprofen was more than 99.5% bound, either when a pure HSA solution or when a pooled serum was used. Such results were obtained within a wide range of benoxaprofen concentrations and benoxaprofen binding did not significantly differ whatever its concentration might be. The influence of liver failure on benoxaprofen serum binding was investigated in five patients whose bilirubinaemia was from 15 to 28 x 10(-6) M, and the results were compared to those of five normal volunteers. There was no difference between the two groups: 99.30 +/- 0.30% versus 99.62 +/- 0.30%. However, in four other patients whose bilirubinaemia was greater than 130 x 10(-6) M, the binding of benoxaprofen decreased to 98.0 +/- 1.6% (p] less than 0.05). Addition of FFA (palmitic acid, 2000 . 10(-6) M) to H SA (580 x 10(-6) M) involved a slight decrease in HSA binding of benoxaprofen: 99.8 +/- 0.1 versus 99.66 +/- 0.03%. Serum binding of benoxaprofen was not affected by therapeutic levels of tolbutamide, was slightly decreased from 99.7 to 9.2% by furosemide, to 99.4% by CPIB, and to 99.4% by salicylic acid. At the reverse, therapeutic plasma levels of benoxaprofen did not displace warfarin and acenocoumarol, but they displaced CPIB from 90.1 to 86.1%, glibenclamide from 95.2 to 94.2% and phenylbutazone 99.6 to 93.0%.

Anti-Inflammatory Agents↗
PubMed1981

[Current trends in the treatment of chronic glomerulonephritis].

The results from the long-term combined anticoagulant, immunesuppressive and corticosteroid treatment of 36 patients with various histological forms of idiopathic and lupus glomerulonephritis are reported. Twenty five of them are with preserved or slightly disturbed renal function, and 11 - with chronic renal insufficiency. The treatment was carried out with heparin, acenocoumarol, azathioprin and to the patients with lupus glomerulonephritis - corticosteroids in the course of 4 to 50 months. The results were "very good", "good", with "no change" and "deterioration" according to clinical and laboratory indices. Very good and good effect was obtained in 18 patients (72%) of the group with preserved or slightly disturbed renal function (25 patients). Five patients were with no change (20%) and 2 patients died of complications in connection with corticosteroid treatment. Very good results was obtained in 2 patients with rapid progressive glomerulonephritis from the group with chronic renal insufficiency (11 patients) and the rest were without effect. The adverse effects are not frequent and are mainly due to corticosteroids. The combined anticoagulant and immunosuppressive treatment is concluded to be indicated in patients, with idiopathic and lupus nephritis with preserved or slightly disturbed renal function, in patients with rapidly-progressive glomerulonephritis but not in case of manifested chronic renal insufficiency. The considerable duration and the systematic follow-up control are of essential importance for the treatment success.

Adolescent↗
PubMed1995

[Subcutaneous recombinant hirudin in the treatment of deep venous thrombosis. A pharmacokinetic study].

Recombinant hirudin (HBW 023) has a pure and specific antithrombotic activity. It could be more effective than heparin in the treatment of deep venous thrombosis. Its half life is about three hours when administered intravenously which requires continuous infusion whereas subcutaneous administration can ensure stable plasma concentrations and antithrombotic activity over a period of approximatively 12 hours. The aim of the study was to check the safety and clinical and radiographic efficacy of recombinant hirudin administered subcutaneously to patients with recent deep venous thrombosis and to analyse the pharmacokinetics of the product and its effects on tests of coagulation. Ten patients were treated with 0.75 mg/kg of subcutaneous recombinant hirudin twice a day for 5 days. Anticoagulation was performed with standard heparin and acenocoumarol. Bilateral phlebography, pulmonary angiography or ventilation and perfusion scintigraphy were carried out before and on the 5th day of recombinant hirudin treatment. The activated cephalin time and standard anticoagulant tests and the plasma kinetics of recombinant hirudin were assayed between the 1st and 12th hour on the first and fifth days of treatment. The clinical course was simple in all but one patient who had a recurrence of pulmonary embolism on the 4th day justifying thrombolytic treatment. No haemorrhagic complications or secondary biological effects were observed. On the 5th day, control phlebography was unchanged or improved in all patients. The peak plasma concentration of recombinant hirudin was observed between the 3rd and the 4th hour following subcutaneous injection. The activated cephalin time was increased in parallel with increased concentrations of recombinant hirudin.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMedDate not supplied

Results of mitral valve reconstruction. Experience of Hôpital Erasme, ULB, Brussels.

BACKGROUND: Reconstructive surgery of the mitral valve has been an alternative to mitral valve replacement in patients with mitral regurgitation. In order to evaluate the early results of mitral valve reconstruction, 38 consecutive cases were analyzed. METHODS: Between January 1985 and May 1993, 38 patients with mitral valve incompetence were treated with a system of reconstructive techniques. Nineteen (52%) of the patients were in NYHA functional class II and seventeen (45%) in class III or IV preoperatively. The cause of the mitral disease was degenerative in 25 (66%), rheumatic in 6 (15%) and ischaemic in 5 (13%) patients. Isolated mitral valve repair was performed in 25 patients (66%); the remainder underwent associated procedures that included a myocardial revascularization in 9 patients (23.6%). Thirty-eight patients (100%) underwent a ring annuloplasty. Resection of the posterior leaflet was performed in 24 patients (63%). RESULTS: There was one operative death (2.6%) and two late deaths (5.3%). Postoperatively, four patients sustained embolic events (incidence 10.5%). Six patients (15.8%) were precociously reoperated within the following month; two patients required valve replacement, one had mediastinitis and three other ones needed a pericardial drainage. Patients routinely received acenocoumarol anticoagulation for two months. Mean follow-up was 33 months (range 6 to 104) and one patient was lost to follow-up. Two years actuarial survival was 91.4%. There were no thromboembolic complications in the follow-up period. No patient was reoperated for valvular insufficiency beyond this time limit. One patient had late endocarditis and has been reoperated for mitral replacement (2.6%). After surgery, 34 survivors (89.5%) were in the NYHA functional class I or II. CONCLUSIONS: These results demonstrate that mitral valvuloplasty is associated with lower operative mortality rates. Preservation of the mitral valve mechanism raised the performance of the left ventricle after reconstructive surgery. The incidence of reoperation and thromboembolism was low.

Cardiac Surgical Procedures↗
PubMed1994

[Effect of large doses of nifedipine on pulmonary hypertension in patients with recurrent pulmonary thromboembolism].

Thromboembolic pulmonary hypertension is an uncommon condition with poor prognosis. Vasodilators may be effective in some patients with that disease. The effect of nifedipine on hemodynamics was investigated in two patients with thromboembolic pulmonary hypertension treated with acenocoumarol. Nifedipine was administered in 20 mg doses hourly during right cardiac catheterization and was repeated after 1 hour until a decrease in systemic pressure occurred. Patients received 80 mg and 120 mg of nifedipine. Pulmonary artery pressures decreased in both cases. An increase of cardiac output and decrease of pulmonary vascular resistance were observed after 60-80 mg of nifedipine and continued to the end of the investigation. No effect on heart rate was observed. We suggest that high doses of nifedipine may be--in some patients--effective in reducing thromboembolic pulmonary hypertension.

Adult↗
PubMed1994

A pilot study of subcutaneous recombinant hirudin (HBW 023) in the treatment of deep vein thrombosis.

BACKGROUND: Recombinant hirudin, a pure, specific antithrombin could be more effective than heparin in the treatment of deep vein thrombosis, but its short half-life requires constant intravenous infusion, whereas subcutaneous administration of recombinant hirudin can ensure stable and prolonged plasma levels. The aim of our study was to assess the pharmacokinetics, the results on the coagulation variables, and the safety of a recombinant hirudin (HBW 023) administered subcutaneously in patients suffering from deep vein thrombosis. METHODS: Recombinant hirudin (HBW 023) was administered subcutaneously to 10 patients with recent deep vein thrombosis, at a dose of 0.75 mg/kg of body weight twice daily for 5 days, after which standard heparin and acenocoumarol were introduced. Bilateral lower limb venography, and pulmonary angiography, and/or ventilation-perfusion lung scan were carried out on day 1 prior to recombinant hirudin injection and repeated on day 5. aPTT and recombinant hirudin plasma levels were serially assessed after the 1st and the 10th injections. Prothrombin fragments 1 + 2, thrombin-antithrombin III complexes, fibrin degradation products were collected on days 1 and 5. RESULTS: Clinical evolution was uneventful in all but one patient who had a probable recurrence of pulmonary embolism on day 4. No hemorrhagic complication, no untoward biological event was observed. On days 5, Marder score was unchanged or had decreased. Plasma levels of recombinant hirudin peaked in between 3 and 4 h following the injection. aPTT values paralleled, and were significantly correlated with plasma levels of recombinant hirudin on day 1 as well on day 5 (r = 0.903, r = 0.948 respectively). Fragment 1 + 2, and thrombin antithrombin complexes non-significantly decreased from day 1 to day 5. CONCLUSIONS: Subcutaneous administration of recombinant hirudin ensures prolonged stable plasma levels of recombinant hirudin which results in efficient anticoagulation. A dose-ranging study conducted with subcutaneous recombinant hirudin in comparison to conventional heparin therapy may answer the question as to efficacy.

Adolescent↗
PubMedDate not supplied

Phenprocoumon therapy during pregnancy: case report and comparison of the teratogenic risk of different coumarin derivatives.

The case report is about an infant suffering from coumarin embryopathy and coumarin syndrome after its mother underwent phenprocoumon treatment (Marcumar, Falithrom) during pregnancy (until 26th week of gestation). Interestingly, a hearing disorder was diagnosed, which had never been described in context with this substance. The coumarin derivatives warfarin, acenocoumarol and phenoprocoumon were compared with regards to spontaneous abortion rate, perinatal mortality and teratogenic risk. Eye anomalies or malformations seem to appear only under warfarin treatment, whereas CNS-malformations are more frequent under phenprocoumon. As a consequence, phenprocoumon treatment of fertile women seems rather doubtful. Upon discovery of a pregnancy under coumarin treatment, vitamin K should immediately be substituted in order to minimize the risk of anomalies and malformation.

Abnormalities, Drug-Induced↗
PubMed1993

[New approaches for treating skin necrosis in protein C deficiency].

A 62-year-old woman with a 8-month-history of recurrent deep and superficial vein thrombosis developed multiple areas of skin necrosis during warfarin treatment initiation. Routine coagulation tests did not revealed any abnormalities. Protein C plasma activity and concentration were significantly decreased (59.9% and 63.3% of the normal value, respectively). Antithrombin III and protein S (total and free) content were in the normal range. Initially, the adjusted dosage of standard heparin and fresh frozen plasma was administered. Thereafter, the treatment with low doses of oral anticoagulant (acenocoumarol) was reinstalled simultaneously with Protein C Concentrate (Immuno, Vienna) intravenous administration. After six days of the oral anticoagulation the therapeutic value of prothrombin time was obtained and administration of Protein C Concentrate could have been discontinued. No adverse reactions and post-transfusions complications were observed.

Female↗