Safety profile of tinzaparin administered once daily at a standard curative dose in two hundred very elderly patients

• Published in: Drug safety Vol. 25; no. 10; pp. 725 - 733
• Main Authors: PAUTAS, Eric, GOUIN, Isabelle, BELLOT, Oliver, ANDREUX, Jean-Paul, SIGURET, Virginie
• Format: Journal Article
• Language: English
• Published: Auckland Adis international 01.01.2002
• Subjects: Age Factors; Aged; Aged, 80 and over; Antithrombin III - analysis; Atrial Fibrillation - drug therapy; Biological and medical sciences; Blood. Blood coagulation. Reticuloendothelial system; Body Weight; Creatine - metabolism; Drug Interactions; Female; Fibrinolytic Agents - administration & dosage; Fibrinolytic Agents - adverse effects; Fibrinolytic Agents - therapeutic use; Heparin, Low-Molecular-Weight - administration & dosage; Heparin, Low-Molecular-Weight - adverse effects; Heparin, Low-Molecular-Weight - therapeutic use; Humans; Male; Medical sciences; Pharmacology. Drug treatments; Platelet Count; Renal Insufficiency; Venous Thrombosis - drug therapy; Human; Kidney disease; Urinary system disease; Toxicity; Low molecular weight heparin; Anticoagulant; Multiple dose; Chemotherapy; Treatment; Surveillance; Tinzaparin sodium; Renal failure; Drug interaction; Safety; High dose; Elderly
• ISSN: 0114-5916
• DOI: 10.2165/00002018-200225100-00005

Too few very elderly patients with an age-related renal impairment are included in clinical trials. We conducted a study in order to evaluate the safety profile of tinzaparin, a low molecular weight heparin (LMWH), given at a curative dose (175 IU/kg once daily) in very elderly patients treated for up to 30 days. An 800-bed geriatric hospital. A 1-year prescribing study. Consecutive in-patients older than age 70, whose creatinine clearance was above 20 ml/min, and requiring full anticoagulation with LMWH were included. Safety parameters (major bleeding/heparin-induced thrombocytopenia/death) were recorded. Plasma anti-Xa activity levels were regularly measured throughout the treatment period. Two-hundred in-patients, mean age 85.2 +/- 6.9 years (70 to 102), mean creatinine clearance 51.2 +/- 22.9 ml/min, were given tinzaparin. Six patients died during the treatment period: only one could be related to the anticoagulation treatment. Three major bleeding episodes (1.5%) were reported. Antithrombotic drug interactions likely contributed to the bleeding event in two of them. Heparin-induced thrombocytopenia was confirmed in two patients (1%). No correlation was found between anti-Xa activity and creatinine clearance or age. Tinzaparin can be used safely at a curative dose in very elderly patients as long as (i) the accurate bodyweight-adjusted dose is given; (ii) platelet counts and anti-Xa levels are regularly monitored and; (iii) the interaction with other antithrombotic drugs is correctly managed.