Dataset Information

PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy.

ABSTRACT:

Objective

To assess retention, dosing, efficacy, and safety of perampanel in a large cohort of patients with epilepsy during routine clinical care.

Methods

PROVE was a retrospective, non-interventional Phase IV study (NCT03208660). Data were obtained retrospectively from the medical records of patients in the United States initiating perampanel after January 1, 2014, according to treating clinicians' recommendation. Retention rate was the primary efficacy endpoint. Secondary efficacy endpoints included median percent changes in seizure frequency per 28 days from baseline, seizure-freedom rate, and overall investigator impression of seizure effect. Safety endpoints included incidence of treatment-emergent adverse events (TEAEs). Efficacy and safety were also assessed according to baseline use of enzyme-inducing antiseizure medications (EIASMs).

Results

Overall, 1703 patients were enrolled and included in the Safety Analysis Set (SAS; ≥1 baseline EIASMs, n = 358 [21.0%]; no baseline EIASMs, n = 1345 [79.0%]). Mean (standard deviation [SD]) cumulative duration of exposure to perampanel was 17.4 (15.7) months; mean (SD) daily perampanel dose was 5.6 (2.7) mg. The most frequent perampanel titration intervals were weekly (23.4%) and every 2 weeks (24.7%). Across the SAS, 24-month retention rate was 48.1% (n = 501/1042). Based on overall investigator impression at the end of treatment, 51.9%, 35.8%, and 12.3% of patients in the SAS experienced improvement, no change, or worsening of seizures, respectively. TEAEs occurred in 704 (41.3%) patients; 79 (4.6%) had serious TEAEs. The most common TEAE was dizziness (7.3%). There was some variation in efficacy according to EIASM use, while retention rates and safety were generally consistent.

Significance

In this final analysis of >1700 patients with epilepsy receiving perampanel in routine clinical care, favorable retention and sustained efficacy were demonstrated for ≥12 months.

SUBMITTER: Wechsler RT

PROVIDER: S-EPMC9159249 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy.

Wechsler Robert T RT Wheless James J Zafar Muhammad M Huesmann Graham R GR Lancman Marcelo M Segal Eric E Chez Michael M Aboumatar Sami S Patten Anna A Salah Alejandro A Malhotra Manoj M

Epilepsia open 20220320 2

<h4>Objective</h4>To assess retention, dosing, efficacy, and safety of perampanel in a large cohort of patients with epilepsy during routine clinical care.<h4>Methods</h4>PROVE was a retrospective, non-interventional Phase IV study (NCT03208660). Data were obtained retrospectively from the medical records of patients in the United States initiating perampanel after January 1, 2014, according to treating clinicians' recommendation. Retention rate was the primary efficacy endpoint. Secondary effic ...[more]

PMID: 34942053

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Project description:Objectives(1) To evaluate risk of hospitalization following initiation of perampanel (pre- and post-analysis) and (2) to compare hospitalization rates following initiation of perampanel vs lacosamide.MethodsPatients were identified from Symphony Health's Patient Integrated Database if they had a prescription for perampanel (July 1, 2014-June 30, 2016). Patients 4-11 years of age with any partial-onset seizure (POS) or ≥12 years of age with any POS or primary generalized tonic-clonic seizure (GTCS) (pre-post); or ≥12 years of age (perampanel vs lacosamide). The first fill of perampanel ("index date") marked the start of the analysis period. Patients had ≥1 additional fill for perampanel and ≥2 diagnoses for epilepsy or nonfebrile convulsion diagnosis during pre-index (based on ICD-9/ICD-10 codes). Patients were matched using a 1:1 propensity scoring method for the perampanel vs lacosamide analysis. Primary outcome was hospitalization during the one year following medication initiation.ResultsPre- and post-perampanel: N = 1771 (mean age 34 years, 55% female). One-year all-cause hospitalization risk ratio was 0.76 (P < .05) and 36.2% with hospitalization during the pre-period vs 29.5% in the follow-up. One-year epilepsy-related inpatient hospitalization risk ratio was 0.72 (P < .05) and 30.8% with hospitalization during the pre-period vs 23.9% during follow-up. In the perampanel and lacosamide cohorts, N = 1717 per cohort after matching, most baseline demographics were balanced. A higher percentage of subjects were prescribed ≥3 anti-seizure medications for perampanel vs lacosamide (60.5% vs 57.7%, P < .001). The perampanel cohort had a 9.6% reduction in all-cause hospitalizations vs 5.8% for the lacosamide cohort (P < .05). Epilepsy-related hospitalizations decreased from the pre-index rate by 9.9% for perampanel and 8.3% for lacosamide (P < .05). Among those with baseline hospitalizations, perampanel was associated with a 59.9% reduction in all-cause hospitalizations vs 48.6% for lacosamide (P < .05), and for epilepsy-related hospitalizations, a reduction of 65.0% vs 58.9%, respectively (P < .05).SignificancePerampanel was associated with a significant reduction in one-year hospitalization risk.

Project description:PurposeTo investigate whether there exists a statistically significant distinction between the effectiveness and tolerance of perampanel (PER) and the number of antiseizure medications (ASMs) that were tried prior to administering PER.MethodA prospective, observational study was performed at West China Hospital of Sichuan University. The study included patients diagnosed with epilepsy who were prescribed PER and were monitored for a minimum of 6 months. The efficacy of PER was evaluated at 1, 3, 6, and 12-month intervals by examining the retention rate and the 50% response rate. All statistical analyses were conducted using IBM SPSS Statistics version 25 (IBM Corporation, Armonk, New York).ResultsA total of 1,025 patients were identified, of which 836 were included in the analysis. Seven hundred and eighty-nine patients (94.4%) were followed up for a year. The median age of the patients was 29.32 ± 14.06 years, with 45.81% of the patients being male and 17.0% being adolescents. The average duration of epilepsy was 11.22 ± 8.93 years. Overall, PER was discontinued in 49.5% of patients, with the most common reasons being inadequate therapeutic effect and treatment-emergent adverse events (TEAEs). At the 6-month follow-up, the retention rate was 54.2% (454/836), and 39.6% of patients had a 50% response. At the 12-month follow-up, the retention rate was 49.4% (340/789), and 44.5% of patients had a 50% response. Patients who received PER as monotherapy had the highest retention rates (P = 0.034) and 50% response rates (P < 0.001) at any follow-up point. TEAEs were reported in 32.0% of patients, and these led to discontinuation in 15.4% of patients. The most common TEAEs were dizziness and somnolence. There was no significant difference between subgroups (P = 0.57), but there was a significant difference between the dosage of PER and TEAEs (P < 0.001).Main findingsThe study concludes that PER is effective in treating both focal and generalized tonic-clonic seizures. Patients who had fewer previous exposures to ASMs exhibited higher response rates to PER. TEAEs related to PER dosage were more prevalent during the first 3 months of treatment and tended to improve with continued use, ultimately demonstrating favorable long-term tolerability.

Dataset Information

PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy.

Objective

Methods

Results

Significance

Publications

PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy.

Similar Datasets

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