Safety of Acitrom®
- In studies carried out to evaluate the safety of acenocoumarol, the drug has been shown to be well-tolerated in patients who are well-controlled for the international normalized ratio (INR).43
- Tolerability of acenocoumarol was similar in younger and elderly population (aged >70 years), with acenocoumarol being well-tolerated in both the populations.44
- In children and adolescents (age 5 months-16 years), who had undergone valve replacement surgery, use of acenocoumarol (with aspirin) has been shown to be effective and well-tolerated, without significant hemorrhagic complications (0.74/1000 patient-months).45
Bleeding complications of oral anticoagulant treatment: An inception-cohort, prospective collaborative study (ISCOAT). Italian Study on Complications of Oral Anticoagulant Therapy
Palareti G et al., Lancet. 1996 Aug 17;348(9025):423-8.
To study the frequency of bleeding complications in outpatients treated routinely in anticoagulation clinics.
2745 consecutive patients from 34 Italian anticoagulation clinics.
Oral anticoagulation (warfarin or acenocourmarol) administered as per the INR targets (low intensity INR ≤2.8 in 71% of the patients and high, >2.8 in the remainder). The mean follow-up was 267 days.
Bleeding complications - major and minor.
- Over 2011 patient-years of follow-up, 153 bleeding complications occurred (7.6 per 100 patient years).
- 5 were fatal (all cerebral hemorrhages, 0.25 per 100 patient-years), 23 were major (1.1), and 125 were minor (6.2).
Multivariate analysis of bleeding complications:
- The rate of events was similar between sexes, coumarin type, size of enrolling centre, and target international normalized ratio (INR).
- The rate was higher in older patients, in those with peripheral or cerebrovascular diseases and in the first 90 days of therapy.
- A fifth of the bleeding events occurred at low anticoagulation intensity (INR < 2, rate 7.7 per 100 patient-years of follow-up). The rates were 4.8, 9.5, 40.5, and 200 at INRs 2.0-2.9, 3-4.4, 4.5-6.9, and over 7, respectively (relative risks for INR >4.5, 7.91, 5.44-11.5, p < 0.0001).