Adverse effects of carbamazepine, phenytoin, valproate and lamotrigine monotherapy in epileptic adult Chinese patients.
OBJECTIVE
Antiepileptic drugs (AEDs) have been widely used in patients with epilepsy but the adverse effects in adult Chinese patients have not been investigated. This study evaluated the adverse effects of four commonly prescribed AED monotherapies with carbamazepine (CBZ), phenytoin (PHT), valproate (VPA), and lamotrigine (LTG) in adult Chinese patients with epilepsy.


METHODS
The prospective open-label clinical trial was conducted at the Chongqing Epilepsy Center. The study enrolled 505 adults with newly diagnosed epilepsy, including generalized tonic-clonic (n=110), partial and partial secondarily generalized (n=395) seizures. Patients were evaluated by two clinicians at the Center and were prescribed one type of AED monotherapy with CBZ, PHT, VPA or LTG for a 24-month period. An adverse effect profile, as well as efficacy of monotherapy, was obtained through a face-to-face interview with the patient at each visit. A physical examination and routine laboratory tests were performed during a clinical screening.


RESULTS
A total of 62.6% (316/505) patients successfully completed the AED monotherapy study: 64.3% of those receiving CBZ, 55.9%--PHT, 61.5%--VPA, and 66.2%--LTG. However, 34.7% of the patients discontinued the AED monotherapy because of unsatisfactory seizure control. Overall, 18% of patients experienced adverse effects: for CBZ (25/168; 14.9%), PHT (18/59; 30.5%), VPA (32/192; 16.7%) and LTG (16/86; 18.6%). The most common drug-related adverse events included gastrointestinal disturbances, loss of appetite and nausea, weight gain and fatigue/tiredness. Tremor and nystagmus occurred in some patients receiving PHT and VPA. Two CBZ, one PHT and four LTG patients (n=7) discontinued the study due to rash.


CONCLUSIONS
Adult Chinese patients with epilepsy accepted and tolerated monotherapy with CBZ, PHT, VPA, and LTG. No fatal adverse events occurred. Unsatisfactory seizure control was a primary reason for withdrawal from the AED monotherapy study.
Zeng
Kebin
K
Department of Neurology, First Affiliated Hospital, Chongqing Medical University, Chongqing Key Laboratories of Neurology, 1 Youyi Road, Yuzhong County, Chongqing 400016, PR China.
Wang
Xuefeng
X
Xi
Zhiqing
Z
Yan
Yong
Y
D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use; D002220:Carbamazepine / Q000009:adverse effects / Q000627:therapeutic use; D002681:China / Q000453:epidemiology; D003875:Drug Eruptions / Q000453:epidemiology; D004827:Epilepsy / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010672:Phenytoin / Q000009:adverse effects / Q000627:therapeutic use; D016019:Survival Analysis; D017211:Treatment Failure; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use; D055815:Young Adult
D000927:Anticonvulsants; D014227:Triazines; D002220:Carbamazepine; D014635:Valproic Acid; D010672:Phenytoin; D000077213:Lamotrigine