warfarin and indobufen

To examine the benefits and risks of long term anticoagulation (warfarin) compared with antiplatelet treatment (aspirin/indobufen) [corrected] in patients with non-rheumatic atrial fibrillation.. Meta-analysis of randomised controlled trials from Cochrane library, Medline, Embase, Cinhal, and Sigle from 1966 to December 1999. Odds ratios (95% confidence intervals) calculated to estimate treatment effects.. Fatal and non-fatal cardiovascular events, reductions of which were classified as benefits. Fatal and major non-fatal bleeding events classified as risks.. No trials were found from before 1989. There were five randomised controlled trials published between 1989-99. There were no significant differences in mortality between the two treatment options (fixed effects model: odd ratio 0.74 (95% confidence interval 0.39 to 1.40) for stroke deaths; 0.86 (0.63 to 1.17) for vascular deaths). There was a borderline significant difference in non-fatal stroke in favour of anticoagulation (0.68 (0.46 to 0.99)); and 0.75 (0.50 to 1.13) after exclusion of one trial with weak methodological design. A random effects model showed no significant difference in combined fatal and non-fatal events (odds ratio 0.79 (0.61 to 1.02)). There were more major bleeding events among patients on anticoagulation than on antiplatelet treatment (odds ratio 1.45 (0.93 to 2.27)). One trial was stopped prematurely after a significant difference in favour of anticoagulation was observed. The only trial to show a significant difference in effect (favouring anticoagulation) was methodologically weaker in design than the others.. The heterogeneity between the trials and the limited data result in considerable uncertainty about the value of long term anticoagulation compared with antiplatelet treatment. The risks of bleeding and the higher cost of anticoagulation make it an even less convincing treatment option.

Topics: Anticoagulants; Aspirin; Atrial Fibrillation; Hemorrhage; Humans; Isoindoles; Phenylbutyrates; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Risk Assessment; Treatment Outcome; Warfarin

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Anticoagulants; Aspirin; Atrial Fibrillation; Clinical Trials as Topic; Consensus Development Conferences as Topic; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Electric Countershock; Female; Hemorrhage; Humans; Incidence; International Normalized Ratio; Isoenzymes; Isoindoles; Male; Membrane Proteins; Middle Aged; Phenylbutyrates; Platelet Aggregation Inhibitors; Prospective Studies; Prostaglandin-Endoperoxide Synthases; Randomized Controlled Trials as Topic; Risk Factors; Stroke; Thromboembolism; Treatment Outcome; Warfarin

The risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrome. This study aimed to compare the efficacy and safety of indobufen with that of warfarin in patients with nephrotic syndrome.. This multicenter, randomized, three-arm, open-label, parallel controlled trial involved a total of 180 adult patients with nephrotic syndrome from four centers in China. Patients were randomly assigned to receive 100 mg indobufen (bid), 200 mg indobufen (bid), and 3 mg warfarin (qd) daily for 12 weeks. The primary endpoints included thromboembolic and bleeding events, while laboratory results and adverse events constituted secondary endpoints.. No thromboembolic events occurred in the high-/low-dose indobufen and warfarin groups. Moreover, the use of a low dose of indobufen significantly reduced the risk of minor bleeding events compared with warfarin use (2% versus 18%,. This study found that indobufen therapy provided equivalent effects in preventing thromboembolic events compared with warfarin therapy, while low dose of indobufen was associated with a reduced risk of bleeding events, thus it should be recommended for the prevention of thromboembolic events in clinical practice in patients with nephrotic syndrome.. ChiCTR-IPR-17013428.

Topics: Adult; Anticoagulants; Atrial Fibrillation; Fibrinolytic Agents; Hemorrhage; Humans; Nephrotic Syndrome; Thromboembolism; Treatment Outcome; Warfarin

The results of a large prospective randomized trial have shown the efficacy of oral anticoagulation in the secondary prevention of major vascular events in patients with nonrheumatic atrial fibrillation (NRAF); less well established is the role of antiplatelet agents. The present study compared the effects of indobufen, a reversible inhibitor of platelet cyclooxygenase, with those of warfarin in this setting.. A total of 916 patients with NRAF and a recent (< or = 15 days) cerebral ischemic episode were admitted to this multicenter, randomized study, during which they were treated with either indobufen (100 or 200 mg BID) or warfarin (to obtain an international normalized ratio of 2.0 to 3.5) for 12 months. The two groups (462 on indobufen and 454 on warfarin) were well balanced in terms of their main baseline characteristics. The primary outcome of the study was the combined incidence of nonfatal stroke (including intracerebral bleeding), pulmonary or systemic embolism, nonfatal myocardial infarction, and vascular death.. At the end of follow-up, the incidence of primary outcome events was 10.6% in the indobufen group (95% confidence interval, 7.7% to 13.5%) and 9.0% in the warfarin group (95% confidence interval, 6.3% to 11.8%), with no statistically significant difference between treatments. The frequency of noncerebral major bleeding complications was low: only four cases (0.9%) of gastrointestinal bleeding were observed, all of them in the warfarin group.. We conclude that, within the limitations of its design, this study may help the medical community in devising appropriate antithrombotic strategies for NRAF patients for whom oral anticoagulants are contraindicated or do not represent a feasible approach to treatment.

Topics: Adult; Aged; Anticoagulants; Atrial Fibrillation; Cyclooxygenase Inhibitors; Female; Follow-Up Studies; Humans; Isoindoles; Male; Middle Aged; Phenylbutyrates; Prospective Studies; Treatment Outcome; Vascular Diseases; Warfarin

Topics: Adult; Aged; Anticoagulants; Aspirin; Atrial Fibrillation; Brain Ischemia; Cerebrovascular Disorders; Embolism; Female; Follow-Up Studies; Humans; Isoindoles; Italy; Male; Middle Aged; Phenylbutyrates; Platelet Aggregation Inhibitors; Risk Factors; Time Factors; Warfarin

Topics: Aspirin; Atrial Fibrillation; Cerebrovascular Disorders; Humans; Isoindoles; Phenylbutyrates; Platelet Aggregation Inhibitors; Warfarin

Non-valvular atrial fibrillation increases the risk of stroke by a factor of 5 and is present in about 15% of patients with acute stroke. Its prevalence in the general population increases from 0.5% at 50-59 years to > 10% at 80-99 years. In patients with non-valvular atrial fibrillation the risk of stroke increases with age, blood pressure and other evidence of cardiac disease. In addition, non-valvular atrial fibrillation is associated with a greater early mortality and a greater risk of recurrent stroke. The anticoagulant therapy to prevent early recurrent embolism is likewise controversial. Anticoagulant therapy appears to reduce this risk, but there is the danger of accentuating hemorrhagic infarction, especially in patients with large strokes. The effectiveness of antiplatelet drugs in patients with cardioembolic stroke is also not defined. The Studio Italiano Fibrillazione Atriale (SIFA) is a multicentric, randomized trial to assess the efficacy and safety of anticoagulant, warfarin, versus antiplatelet treatment, indobufen, a reversible inhibitor of platelet cyclo-oxygenase, in the prevention of recurrent cerebral ischemia and other systemic embolisms in non-valvular atrial fibrillation patients. Patients of both sexes, aged > 30 years with non-valvular atrial fibrillation, who have presented in the last 2 weeks an ischemic cerebral event (transitory ischemic attack or non-disabling stroke) and who have given their informed consent, were eligible. Patients with hemorrhagical diseases or contraindications to anticoagulant therapy were excluded. Patients were randomly given either indobufen (400 mg/die) or oral warfarin to an international normalized ratio of 2.0-3.5. The primary end-points were: recurrence of cerebral ischemia, systemic embolisms, intracranial or fatal hemorrhage, acute myocardial infarction, vascular death.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Atrial Fibrillation; Cerebrovascular Disorders; Female; Humans; Isoindoles; Italy; Male; Middle Aged; Phenylbutyrates; Platelet Aggregation Inhibitors; Warfarin

BACKGROUND Worldwide, the treatment of patients with chronic kidney disease (CKD) remains a challenge as warfarin treatment can be associated with severe adverse events related to bleeding. Alternative anticoagulants that can be used in CKD remain to be identified. This study aimed to compare the effects of indobufen, a new antiplatelet agent, with warfarin in a rat model of adenine-induced CKD. MATERIAL AND METHODS Forty-eight male Wistar rats were treated with intragastric adenine to create the rat model of CKD and were divided into four groups: an untreated control group (N=12), a group treated with dimethyl sulfoxide (DMSO) (N=12), a group treated with indobufen, (N=12) and a group treated with warfarin (N-12). Treatment was given for 4 weeks and 8 weeks. Kidney histology was performed, and the degree of fibrosis was quantified using Masson trichrome staining. RESULTS In the rat model of adenine-induced CKD, Masson trichrome staining showed that the degree of kidney fibrosis in the indobufen group (26%) was significantly reduced (p<0.05) when compared the DMSO group (58%) and the warfarin group (49%). Kidney fibrosis was associated with upregulation of 6-keto-PGI2/TXB2 in the rat kidney tissue. CONCLUSIONS In a rat model of adenine-induced CKD, preliminary findings showed that indobufen was associated with reduced kidney fibrosis when compared with warfarin.

Topics: Adenine; Animals; Anticoagulants; China; Disease Models, Animal; Fibrosis; Isoindoles; Kidney; Kidney Failure, Chronic; Male; Phenylbutyrates; Platelet Aggregation Inhibitors; Rats; Rats, Wistar; Renal Insufficiency, Chronic; Warfarin

Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Aspirin; Atrial Fibrillation; Comorbidity; Diabetes Complications; Double-Blind Method; Fibrinolytic Agents; Heart Valve Diseases; Hemorrhage; Humans; Hypertension; Ischemic Attack, Transient; Isoindoles; Middle Aged; Phenylbutyrates; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic; Risk Factors; Stroke; Thromboembolism; Warfarin