Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: A randomized, double-blind, placebo-controlled trial in asymptomatic antiphospholipid antibody–positive individuals
| العنوان: | Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: A randomized, double-blind, placebo-controlled trial in asymptomatic antiphospholipid antibody–positive individuals |
|---|---|
| المؤلفون: | Lisa R. Sammaritano, Michelle Petri, Roger A. Levy, Michael D. Lockshin, Yusuf Yazici, Margaret G. E. Peterson, Melanie J. Harrison, Aynur Unalp-Arida, Verônica Silva Vilela, Doruk Erkan |
| المصدر: | Arthritis & Rheumatism. 56:2382-2391 |
| بيانات النشر: | Wiley, 2007. |
| سنة النشر: | 2007 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Immunology, Placebo-controlled study, Placebo, Asymptomatic, law.invention, Placebos, Double-Blind Method, Rheumatology, Randomized controlled trial, law, Antiphospholipid syndrome, Internal medicine, Ethnicity, medicine, Humans, Immunology and Allergy, Pharmacology (medical), Aspirin, business.industry, Patient Selection, Anti-Inflammatory Agents, Non-Steroidal, Hazard ratio, Thrombosis, Middle Aged, Antiphospholipid Syndrome, medicine.disease, Surgery, Female, medicine.symptom, business, medicine.drug |
| الوصف: | Objective To determine the efficacy of a daily dose of 81 mg aspirin in primary thrombosis prevention in asymptomatic, persistently antiphospholipid antibody (aPL)–positive individuals (those with positive aPL but no vascular and/or pregnancy events). Methods The Antiphospholipid Antibody Acetylsalicylic Acid (APLASA) study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in which asymptomatic, persistently aPL-positive individuals were randomized to receive a daily dose of 81 mg of aspirin or placebo. In a separate observational and parallel study, asymptomatic, persistently aPL-positive individuals who were taking aspirin or declined randomization were followed up prospectively. Results In the APLASA study, 98 individuals were randomized to receive aspirin or placebo (mean ± SD followup period 2.30 ± 0.95 years), of whom 48 received aspirin and 50 received placebo. In the observational study, 74 nonrandomized individuals were followed up prospectively (mean ± SD followup period 2.46 ± 0.76 years); 61 received aspirin and 13 did not. In the APLASA study, the acute thrombosis incidence rates were 2.75 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for the placebo-treated subjects (hazard ratio 1.04, 95% confidence interval 0.69–1.56) (P = 0.83). Similarly, in the observational study, the acute thrombosis incidence rates were 2.70 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for those not treated with aspirin. All but 1 patient with thrombosis in either study had concomitant thrombosis risk factors and/or systemic autoimmune disease at the time of thrombosis. Conclusion Our results suggest that asymptomatic, persistently aPL-positive individuals do not benefit from low-dose aspirin for primary thrombosis prophylaxis, have a low overall annual incidence rate of acute thrombosis, and develop vascular events when additional thrombosis risk factors are present. |
| تدمد: | 1529-0131 0004-3591 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::689f4e1daa3d4223ab96d69b0b2dc178Test https://doi.org/10.1002/art.22663Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....689f4e1daa3d4223ab96d69b0b2dc178 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15290131 00043591 |
|---|