A randomized, open-label study to evaluate the efficacy and safety of liposomal amphotericin B (Ambisome) versus miltefosine in patients with post-kala-azar dermal leishmaniasis

Title : A randomized, open-label study to evaluate the efficacy and safety of liposomal amphotericin B (Ambisome) versus miltefosine in patients with post-kala-azar dermal leishmaniasis

Abstract:

BACKGROUND: Treatment of post-kala-azar dermal leishmaniasis cases is of paramount importance for kala-azar elimination; however, limited treatment regimens are available as of now.
AIM: To compare the effectiveness of liposomal amphotericin B vs miltefosine in post-kala-azar dermal leishmaniasis patients.
METHODOLOGY: This was a randomized, open-label, parallel-group study. A total of 100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group A (liposomal amphotericin B) and B (miltefosine). Patients were randomized to receive either liposomal amphotericin B (30 mg/kg), six doses each 5 mg/kg, biweekly for 3 weeks or miltefosine 2.5 mg/kg or 100 mg/day for 12 weeks. All the patients were followed at 3^rd, 6^th and 12^th months after the end of the treatment.
RESULTS: In the liposomal amphotericin B group, two patients were lost to follow-up, whereas four patients were lost to follow-up in the miltefosine group. The initial cure rate by “intention to treat analysis” was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively. The final cure rate by “per protocol analysis” was 74.5% and 86.9% in liposomal amphotericin B and miltefosine, respectively. Twelve patients (25.5%) in the liposomal amphotericin B group and six patients (13%) in the miltefosine group relapsed. None of the patients in either group developed any serious adverse events.
LIMITATIONS: Quantitative polymerase chain reaction was not performed at all the follow-up visits and sample sizes.
CONCLUSION: Efficacy of miltefosine was found to be better than liposomal amphotericin B, hence, the use of miltefosine as first-line therapy for post-kala-azar dermal leishmaniasis needs to be continued. However, liposomal amphotericin B could be considered as one of the treatment options for the elimination of kala-azar from the Indian subcontinent.

Audience Take Away Notes:

• Comparative assessment of the two treatment regimens for post-kala-azar dermal leishmaniasis
• Clinical management of PKDL patients of Indian sub-continent
• Researchers from other endemic regions may ratify the findings of thisstudy

Biography:

Dr. Krishna Pandey obtained MBBS and MD-General Medicine degreesfromPatna Medical College Hospital in 1988 and 1995, respectively. He did his Senior Residency in Neurology at Indira Gandhi Institute of Medical Sciences, Patna. He joined ICMR-Rajendra Memorial Research Institute of Medical Sciences, Patna in 2000 and continued working and subsequently promoted to his current designation of Scientist-G & Director. He has published more than 170 research articles in SCI(E) journals.