NEW YORK (MedscapeWire) Nov 30 Pharmacia Corporation has initiated PREVENT (PRospective EValuation of Dalteparin Efficacy for Prevention of VTE in Immobilized PatieNts Trial) to study the safety and efficacy of its antithrombotic agent dalteparin sodium injection (Fragmin) for prophylaxis of venous thromboembolism (VTE) in hospitalized patients who are at significant risk. The study uses clinically relevant combined endpoints of deep vein thrombosis (DVT), pulmonary embolism (PE), and sudden death.
"Patients with acute conditions ranging from GI disorders and arthritis to obesity and cardiovascular disease commonly are hospitalized for prolonged periods, which put them at significant risk for dangerous and sometimes fatal blood clots because they often cannot move easily on their own," said Samuel Z. Goldhaber, MD, director, Venous Thromboembolism Research Group, staff cardiologist, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
For the first time in a clinical trial, in medical patients treated with low molecular weight heparin (LMWH), symptomatic and asymptomatic proximal DVT will be diagnosed primarily using compression ultrasonography (CUS), a noninvasive diagnostic method.
No studies to date, with either unfractionated or LMWH, have evaluated venous thromboembolism (VTE) in hospitalized patients by systematically screening all patients for proximal DVTs (whether thrombosis was suspected or not) with CUS. Venography, the screening evaluation method used in many studies, is invasive and associated with adverse effects, including local pain, in some patients. Furthermore, venograms can be nondiagnostic in many.
Compression ultrasonography, which has become increasingly common for DVT detection in many hospitals, has been documented to have sensitivity and specificity in diagnosis of symptomatic proximal DVT with less risk of complications and improved patient friendliness.
PREVENT is an international, multicenter, randomized, double-blind, placebo-controlled study of more than 3000 patients (3 times the population of earlier studies). The trial is designed to measure the effectiveness and safety of Fragmin vs placebo in reducing symptomatic and asymptomatic VTE and death in hospitalized patients at moderate-to-high risk for VTE. Study patients will receive 5000 IU/day of dalteparin for up to 14 days. In addition to the clinical analysis, the study will include a health economic evaluation to assist in the justification of reimbursement for this type of medication.
DVT and PE are major causes of mortality among hospitalized patients and are often undiagnosed conditions. PE is responsible for up to 10% or approximately 200,000 hospital deaths per year in the United States. Seventy-five percent of the deaths from PE occur in patients with acute medical conditions. The rationale for thromboprophylaxis is based on the high prevalence of VTE in hospitalized patients, the clinically silent nature of the disease in the majority of the patients, and the morbidity, costs, and potential mortality associated with unprevented thrombi.
תגובות רוצה להצטרף לדיון?
יש להתחבר כדי להגיב.
התחבראין תגובות עדיין. היה הראשון להגיב!