Self-testing and adjusting of warfarin dosages by patients is an evolving strategy for management of oral anticoagulation. We performed this open, prospective, 3-month pilot study to assess the feasibility of conducting a large, randomized trial comparing self-managed with physician-managed anticoagulation. Ten competent patients with planned anticoagulation for at least 3 months were provided education on warfarin therapy and trained to use an individualized warfarin nomogram. International normalized ratios (INRs) were determined weekly for 12 weeks and reported with warfarin dosages to the investigator for the first 8 weeks only. Eight patients elected to use a home monitor (ProTime) to measure INRs. Patients maintained 76.5% (range 50-91.7%) of INRs within the target range. In 119 dosage adjustment decisions, there were only 3 errors (2.5%). No bleeding or thrombotic complications occurred. To confirm concordance, initial and final INRs were measured concurrently by the ProTime monitor and laboratory. The mean absolute difference for 16 paired INR determinations was 0.33 (range 0.02-0.9). All patients expressed satisfaction and a desire to continue with self-management. This pilot study provides support for conducting a prospective, large-scale, randomized trial.
BACKGROUND: It is common practice to administer acyclovir as prophylaxis to patients with hematologic malignancies during neutropenia; however, effective therapy requires frequent dosing, which is difficult in this setting. Valacyclovir has greater oral bioavailability and requires less frequent dosing. OBJECTIVE: To evaluate the efficacy and safety of valacyclovir compared with acyclovir. METHODS: Patients who had been treated with chemotherapy or stem-cell transplantation were randomized to receive acyclovir 400 mg orally 3 × daily (n = 51), valacyclovir 500 mg orally twice daily (n = 48), or valacyclovir 250 mg orally twice daily (n = 52) during neutropenia. RESULTS: Clinical success, defined as the absence of an active herpes simplex virus (HSV) lesion or asymptomatic viral shedding, was similar between the 3 groups (acyclovir 96%, valacyclovir 500 mg 95%, valacyclovir 250 mg 100%). The overall rates of adverse events were similar in the 3 groups. CONCLUSIONS: Prophylactic treatment with valacyclovir is an effective and safe alternative to acyclovir for the prevention of HSV reactivation in patients with hematologic malignancies.
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