■抗癫痫药物会对血浆脂质水平产生负面影响。
评估在III期期间接受醋酸埃司卡西平(ESL)或卡马西平控释(CBZ-CR)单药治疗的新诊断局灶性癫痫患者的血脂变化,随机化,双盲(DB)试验和2年的开放标签扩展(OLE)ESL治疗。
■III期试验和OLE研究的事后分析。
■在DB基线时评估总胆固醇和低密度脂蛋白(LDL)胆固醇水平升高的患者的比例,OLE基线(DB试验的最后一次访问),和OLE的结束。
■在OLE期间,共有184例患者接受了ESL单药治疗:在DB试验中,有96例患者接受了ESL单药治疗,有88例患者接受了CBZ-CR单药治疗。在使用CBZ-CR单药治疗的患者中,在DB试验期间,总胆固醇和LDL胆固醇升高的患者比例显着增加[总胆固醇,+14.9%(p<0.001);低密度脂蛋白胆固醇,+11.5%(p=0.012)],但在OLE[总胆固醇,-15.3%(p=0.008);低密度脂蛋白胆固醇,-11.1%(p=0.021)]。在DB试验和OLE期间,用ESL单药治疗的患者未观察到显着变化。在DB试验结束时,总胆固醇和LDL胆固醇升高的患者比例的组间差异(ESL-CBZ-CR)分别为-13.6%(p=0.037)和-12.3%(p=0.061),分别;在OLE的末尾,这些组间差异是-6.0%(p=0.360)和-0.6%(p=1.000),分别。
■新诊断的局灶性癫痫患者总胆固醇和低密度脂蛋白胆固醇水平升高的比例较低,与基线相比,ESL与CBZ-CR单药治疗后;从CBZ-CR转换为ESL后,水平升高的患者比例显着下降。
■ClinicalTrials.govNCT01162460/NCT02484001;EudraCT2009-011135-13/2015-001243-36。
醋酸艾司卡西平或控释卡马西平治疗对新诊断局灶性癫痫患者胆固醇水平的影响癫痫患者患心血管和脑血管疾病的风险增加(例如,心肌梗塞和中风)。抗癫痫药物治疗可能对血液胆固醇水平产生负面影响[如总胆固醇和低密度脂蛋白(LDL)胆固醇]。会进一步增加患心脑血管疾病的风险。我们检查了单一疗法治疗的影响(即,在184例新诊断的局灶性癫痫患者(ESL,96例患者;CBZ-CR,88名患者)。在III期临床试验中,患者接受ESL或CBZ-CR单药治疗约1年。在这之后,患者可以继续进行为期2年的延长研究,在此期间他们都接受了ESL单药治疗.我们评估了在III期试验开始和结束时总胆固醇和LDL胆固醇水平升高的患者比例,在扩展研究结束时。在第三阶段审判开始时,治疗组之间总胆固醇升高和LDL胆固醇升高的患者比例相似.在第三阶段审判期间,在接受CBZ-CR单药治疗的患者中,总胆固醇升高和LDL胆固醇升高的患者比例增加(总胆固醇,+14.9%;低密度脂蛋白胆固醇,+11.5%),但在扩展研究中改用ESL单一疗法后下降(总胆固醇,−15.3%;低密度脂蛋白胆固醇,−11.1%)。相比之下,在III期试验和扩展研究期间,在接受ESL单药治疗的患者中,总胆固醇和LDL胆固醇水平升高的患者比例保持相对稳定.这些结果表明,ESL单药治疗可能是新诊断的局灶性癫痫患者的适当治疗选择,或者有发展风险的人,高胆固醇水平,因为这可能会降低他们患心脑血管疾病的可能性。
UNASSIGNED: Antiseizure medications can have negative effects on plasma lipid levels.
UNASSIGNED: To evaluate plasma lipid changes in patients with newly diagnosed focal epilepsy treated with eslicarbazepine acetate (ESL) or controlled-release carbamazepine (CBZ-CR) monotherapy during a phase III, randomized, double-blind (DB) trial and 2 years of ESL treatment in an open-label extension (OLE).
UNASSIGNED: Post hoc analysis of a phase III
trial and OLE
study.
UNASSIGNED: Proportions of patients with elevated levels of total cholesterol and low-density lipoprotein (LDL) cholesterol were assessed at DB baseline, OLE baseline (last visit of DB trial), and end of OLE.
UNASSIGNED: A total of 184 patients received ESL monotherapy during the OLE: 96 received ESL monotherapy in the DB trial and 88 patients received CBZ-CR monotherapy. The proportions of patients with elevated total cholesterol and LDL cholesterol increased significantly during the DB trial in those treated with CBZ-CR monotherapy [total cholesterol, +14.9% (p < 0.001); LDL cholesterol, +11.5% (p = 0.012)] but decreased significantly after switching to ESL monotherapy in the OLE [total cholesterol, -15.3% (p = 0.008); LDL cholesterol, -11.1% (p = 0.021)]. No significant changes were observed in those treated with ESL monotherapy during the DB trial and OLE. At the end of the DB trial, between-group differences (ESL-CBZ-CR) in the proportions of patients with elevated total and LDL cholesterol were -13.6% (p = 0.037) and -12.3% (p = 0.061), respectively; at the end of the OLE, these between-group differences were -6.0% (p = 0.360) and -0.6% (p = 1.000), respectively.
UNASSIGNED: A lower proportion of patients with newly diagnosed focal epilepsy had increased levels of total and LDL cholesterol, compared to baseline, following monotherapy with ESL versus CBZ-CR; after switching from CBZ-CR to ESL, the proportions of patients with increased levels decreased significantly.
UNASSIGNED: ClinicalTrials.gov NCT01162460/NCT02484001; EudraCT 2009-011135-13/2015-001243-36.
The impact of treatment with either eslicarbazepine acetate or controlled-release carbamazepine on cholesterol levels in patients with newly diagnosed focal epilepsy Patients with epilepsy have an increased risk of having cardiovascular and cerebrovascular diseases (e.g., myocardial infarction and stroke). Treatment with antiseizure medications can have a negative effect on blood cholesterol levels [such as total cholesterol and low-density lipoprotein (LDL) cholesterol], which can further increase the risk of cardiovascular and cerebrovascular diseases. We examined the impact of monotherapy treatment (i.e., treatment with only one antiseizure medication) using either eslicarbazepine acetate (ESL) or a controlled-release formulation of carbamazepine (CBZ-CR) in 184 patients with newly diagnosed focal epilepsy (ESL, 96 patients; CBZ-CR, 88 patients). Patients received monotherapy with ESL or CBZ-CR for approximately 1 year in a phase III clinical trial. After this, the patients could continue into a 2-year extension
study during which they all received monotherapy with ESL. We assessed the proportions of patients with elevated levels of total cholesterol and LDL cholesterol at the beginning and end of the phase III trial, and at the end of the extension
study. At the beginning of the phase III trial, the proportions of patients with elevated total cholesterol and elevated LDL cholesterol were similar between treatment groups. During the phase III trial, the proportions of patients with elevated total cholesterol and elevated LDL cholesterol increased in those treated with CBZ-CR monotherapy (total cholesterol, +14.9%; LDL cholesterol, +11.5%) but decreased after switching to ESL monotherapy in the extension
study (total cholesterol, −15.3%; LDL cholesterol, −11.1%). By contrast, the proportions of patients with elevated levels of total cholesterol and LDL cholesterol remained relatively stable in those treated with ESL monotherapy during the phase III trial and extension
study. These findings indicate that ESL monotherapy may be an appropriate treatment option for patients with newly diagnosed focal epilepsy who either already have, or who are at risk of developing, high levels of cholesterol, since this may reduce their likelihood of having cardiovascular and cerebrovascular diseases.