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• W2507367761 abstract "Objective: Evaluate Trokendi XR (Supernus Pharmaceuticals, Inc.) use in clinical practice. Background: Available in the US for >2 decades, topiramate (TPM) has a unique profile with demonstrated efficacy in epilepsy, migraine, and obesity. Based on its bioequivalence to immediate-release TPM (TPM-IR, Topamax), Trokendi XR is currently approved for epilepsy. A medical record review was undertaken to provide stakeholders with information about Trokendi XR in the real-world clinical setting. Methods: Retrospective, HIPAA-compliant review of de-identified chart data of patients prescribed Trokendi XR. Study approved by central IRB. Inclusion: Trokendi XR initiated between 08/2013 and 09/2014 in patients ≥6 yrs; record of initiating visit and ≥1 post-initiation visit. Key data: primary diagnosis, patient characteristics; dosage; adverse events (AEs). Subset analysis also examined AEs in patient cohort previously treated with TPM-IR. Results: Primary diagnosis associated with Trokendi XR treatment (n=485): Epilepsy, n=83; Migraine, n=285; Obesity, n=117. Age (median), yrs: Epilepsy, 23; Migraine, 41; Obesity, 43.5. Female: Epilepsy, 61[percnt]; Migraine, 90[percnt]; Obesity, 89[percnt]. Dosage, mg/day (median): Epilepsy, 200 mg; Migraine, 100 mg; Obesity, 50 mg. Data from previous TPM-IR treatment were available for a subset analysis of AEs (N=187: Epilepsy, n=42; Migraine, n=112; Obesity, n=33). Overall mean dosage, mg/day: TPM-IR, 237; Trokendi XR, 201. Notable between-treatment differences (≥2[percnt]) in AEs: fewer patients reported cognitive dysfunction (2[percnt] vs. 7[percnt]), paresthesia (3[percnt] vs. 6[percnt]), or somnolence (0 vs. 3[percnt]) during Trokendi XR vs. TPM-IR treatment; more patients reported fatigue (4[percnt] vs. 2[percnt]) during Trokendi XR treatment. Conclusions: Use of Trokendi XR (eg, target disorder, age/gender, dosage) in clinical practice was consistent with empirical evidence from randomized controlled trials evaluating TPM in Epilepsy, Migraine, and Obesity. Use of Trokendi XR skewed towards younger patients in Epilepsy; lower dosages were used in Migraine and Obesity. Subset analysis suggested fewer AEs with Trokendi XR. Study sponsor: Supernus Pharmaceuticals, Inc. Disclosure: Dr. O9Neal has received personal compensation for activities with Supernus Pharmaceuticals, Inc. as an employee. Dr. Hur has received personal compensation for activities with Supernus Pharmaceuticals, Inc. as an employee. Dr. Liranso has received personal compensation for activities with Supernus Pharmaceuticals, Inc. as an employee. Dr. Barr has received personal compensation fro activities with Indegene TTM as an employee." @default.
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• W2507367761 date "2016-04-05" @default.
• W2507367761 modified "2023-09-28" @default.
• W2507367761 title "Pragmatic Assessment of Trokendi XR (Extended-Release Topiramate) Use in Clinical Practice (P2.256)" @default.
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