Nau, Karen M.

Background: Lacosamide (LCM) is a newer antiepileptic drug (AED) with favorable properties for hospitalized patients including intravenous formulation, minimal hepatic metabolism, and no adverse respiratory effects. We sought to determine the safety profile of LCM in hospitalized patients. Methods: We performed a retrospective medical record review of patients who received LCM between July 1, 2009, and January 31, 2010, at Mayo Clinic Hospital. Data included demographics, LCM dosing, concomitant AED therapy, documented seizure activity, hemodynamic variables, electrocardiogram (ECG), and laboratory data. Adverse drug reaction and drug–drug interactions were reviewed. Results: Thirty-two patients were identified. No major hypotension or serious cardiac arrhythmias occurred. Heart rate increased, however, in seizure group compared with the prophylaxis group 2 hours postdrug infusion (median heart rate = 86 vs 164). The ECGs demonstrated a mean PR interval prolongation of about 6 milliseconds (ms) after LCM initiation (mean PR 185.5 ms, compared with baseline ECG mean of 179.3 ms). Laboratory data revealed no clinically significant changes 24 hours after LCM initiation. Three patients developed adverse events (9.4%): One with altered mental state and exceptionally prolonged ECG PR interval (212 vs 178 ms baseline); One with unexplained thrombocytopenia; and a third patient with dizziness, all of which resolved after drug discontinuation. Conclusion: The LCM demonstrated ECG PR prolongation as previously reported without systemic hypotension, with no discernable drug–drug interactions in hospitalized patients. About 9% of patients had transient adverse drug reactions after LCM, namely alteration in mental state, unexplained thrombocytopenia, and dizziness, which stopped after discontinuation of the drug.

Purpose. Oral mucositis is a serious problem that affects a significant number of hematopoietic cell transplant (HCT) patients. There are many gaps in management, and evidence-based guidelines do not provide consistent recommendations. The purpose of this pilot study was to develop a mucositis oral care protocol for the prevention and management of mucositis in the HCT patient and to evaluate the clinical impact of its implementation. Methods. After receipt of Institutional Review Board approval, all patients admitted to the Hematology—Oncology service for high-dose chemotherapy followed by an autologous or allogeneic HCT were eligible for the study. As part of a change in practice, a new mucositis protocol consisting of a specific oral care regimen was instituted for prevention and treatment of mucositis. Assessment of mucositis began upon admission to the hospital and the patient was evaluated using a mucositis grading scale on a daily basis by the physician and nursing staff. The new mucositis protocol was a part of the HCT service admission orders for each patient. The group of patients treated according to the new mucositis protocol were compared with a retrospective control group consisting of patients who had undergone management of oral mucositis under the previous standard of care. The primary endpoints were to evaluate incidence, severity, and duration of oral mucositis. Secondary endpoints included days requiring narcotics; days of parenteral nutrition, febrile neutropenia, antimicrobial therapy, and length of hospital stay. Results. There were 13 patients enrolled in the control group and 12 patients in the new protocol group. The new protocol resulted in a decreased incidence (100% vs. 75%) and duration (19.2 vs. 8.3 days) of mucositis. Days of maximum grade one and three mucositis were decreased by 56%, and 70%, respectively. Days of maximum grade two mucositis, however increased by 22%. The days of narcotic use were reduced by 19% in the new protocol group (15.8 vs. 12.8 days). All patients in the new protocol group required parenteral nutrition, but days of use were reduced by 41% (17 vs. 10.2 days). The incidence of infection measured by days of febrile neutropenia and antimicrobial therapy were reduced by 35% (10.2 vs. 6.5 days) and 33% (17 vs. 11.4 days). Finally, the overall length of hospital stay was reduced by 7 days (30 vs. 23 days). Conclusion. Implementation of a standardized oral care protocol for mucositis management resulted in a decreased incidence, duration and severity of mucositis, and also reduced the global negative impact of mucositis. Future studies may further evaluate the global impact by adjusting for confounding factors. J Oncol Pharm Practice (2010) 16: 195—204.