Comparison of the efficacy of Tegatard and Tegretol as a monotherapy in patients with focal seizure with or without secondary generalization.

Background: Carbamazepine is a first line treatment for focal epilepsy. Tegretol and Tegatard are two trade name of Carbamazepine. Tegretol is produced by Novartis Pharmaceutical Company, Switzerland. Recently, Raha pharmaceutical Company in Iran has produced CBZ which trade named is Tegatard. Extended usage of Tegatard instead of Tegretol has economic benefits for Iranian families. In this clinical trial, we aimed to compare therapeutic efficacy and safety of Tegretol and Tegatard in patients suffering from focal seizures with or without secondary generalization.

Methods: 200 patients with provoked or non-provoked focal seizure with or without secondary generalization were screened and 180 patients were fulfilled the criteria to enter this double blinded clinical trial study. Patients were divided into two groups, the first group (A) received Tegretol and the second group (B) Tegatard. Carbamazepine (CBZ) was prescribed with doses 10-20 mg/kg every 12 hours by neurologists. The patients were visited after 1, 3 and 6 months and the side effects and lab data in patients were investigated.

Results: Patients were divided into two groups, 88 patients in group A (Tegretol) (50 males and 38 females) and 92 in group B (Tegatard) (51 males and 41 females). Mean age of patients was 35.39±11.17 years. There was no significant difference according to age and gender, Carbamazepine dosage, EEG recording, neuroimaging change and adverse effects of antiepileptic drug between two groups (P>0.05). Regarding the drug efficacy, in group A and B, 60 (68%) and 58 (63%) patients were seizure free after 6 month follow up; respectively. The differences between two groups were not statistically significant (P value =0.46).

Conclusion: Tegatard is an effective drug with similar efficacy, similar side effects and cost-effectiveness compared with Tegretol and could be used widely when indicated.