Cutaneous Ulcer Caused by Apixaban Treatment Is Resolved after Replacement with Dabigatran.

Nowadays, novel oral anticoagulants (NOACs) have shown improved safety profile and efficacy compared to vitamin K antagonists in the prevention of thromboembolic events occurring during different pathological conditions. However, there are concerns and safety issues, mostly related to adverse events following interactions with other drugs, in real-world practice. We report the case of an 83-year-old woman who developed a non-bleeding leg ulcer not caused by trauma or other evident pathological conditions after 10 days of treatment with apixaban 5 mg/q.d. She was switched from apixaban to dabigatran and the leg ulcer rapidly improved and completely cicatrized in 40 days. The resolution of the ulcer and the toleration of dabigatran therapy suggest an apixaban-specific reaction; however, the pathological mechanism of ulcer onset is currently unclear. Careful evaluation of hospital databases of Molise region (Southern Italy) hospitals identified two similar cases between 2019 and 2021. These cases underline the necessity of careful post-marketing surveillance, considering the rapidly increasing number of patients treated with NOACs and patient's risk factors such as old age, high polypharmacy rate, co-morbidities, and peculiar genetic background related to NOACs pharmacokinetic features.

Adherence to routine use of pharmacological prophylaxis of heterotopic ossification after total hip arthroplasty: results from an Italian multicenter, prospective, observational survey.

BACKGROUND: In spite of the proven efficacy of pharmacological prophylaxis of heterotopic ossification following total hip arthroplasty, its routine use is still debated, and no data are available regarding the adherence to its administration in clinical practice. MATERIALS AND METHODS: In this prospective, observational, multicenter study, 480 consecutive patients operated on for primary total hip arthroplasty during the year 2009 were followed radiographically for 12 months after surgery in order to assess the incidence of periprosthetic heterotopic ossification. Surgeons were free to choose whether to administer pharmacological prophylaxis, and were asked to keep a record of the duration of the prophylaxis (if used) or the reasons for not using it. To facilitate the statistical analysis, all of the participating centers agreed to use only one drug (celecoxib) that had already proven to be effective. RESULTS: 368 patients were administered celecoxib and 112 patients did not receive any prophylaxis. Reported reasons for not administering celecoxib prophylaxis were the surgeon's opinion that prophylaxis was not needed on a routine basis (84/112 patients, 75%), previous history of gastrointestinal bleeding (17.8%), and concomitant cardiorenal pathologies (7.1%). The overall incidence of heterotopic ossification in the celecoxib-treated patients was 23% (no cases of Brooker grade 3 or 4 ossifications), compared to 55% in the untreated patients (Brooker grade 3 and 4: 8.9%). Multivariate analysis showed that celecoxib prophylaxis was the single most important variable when predicting the occurrence of heterotopic ossification. CONCLUSIONS: This study confirms the efficacy and tolerability of celecoxib for the prophylaxis of heterotopic ossification after total hip arthroplasty, and shows how the surgeon's belief that routine prevention is not required still plays an important role in the determination of this complication, together with the fear of possible unwanted side effects.