Comparison of effectiveness and safety of Iranian-made vs. Indian-made imatinib in treatment of chronic myeloid leukemia.

BACKGROUND

Currently, imatinib is the drug of choice for initiation of medical treatment of chronic myeloid leukemia (CML) in the chronic phase. The current study was carried out to compare effectiveness and safety of Iranian vs. Indian imatinib.

MATERIALS AND METHODS

The clinical study was performed on newly diagnosed CML patients in Seyyed-oShohada Hospital (Isfahan) and Khansari Hospital (Arak) from January to June 2011. The control group consisted of CML patients who received Indian imatinib previously. The drug was initiated with the dose of 400 mg daily. The patients were followed for six months, and the treatment outcomes (WBC <10(4)) and molecular response. Finally, the two groups were compared in these respects.

RESULT

We evaluated 43 patients in each group. The hematological and molecular responses for the Iranian Imatinib were respectively 86.0% and 46.5%, while the rates were respectively 86.0 and 44.2% for the Indian imatinib. The two groups were similar with regard to the treatment outcome. The two groups were not significantly different with regard to the drug adverse effects.

CONCLUSION

According to the findings, the Iranian imatinib is not different from the Indian drug in the hematological and molecular responses in treatment of the chronic phase of CML patients. Furthermore, the adverse effects of the two kinds were not significantly different. Compared with the results of other studies, the effectiveness of Iranian imatinib is equivalent to the Indian drug can be employed for treatment of CML patients in the chronic phase.