Table 1.  Drugs for the Treatment of Visceral Leishmaniasis [Download PDF]

 

 Dose

 Duration (days)

 Route

Proved efficacy and available

 

 

 

Antimony

20 mg/kg/day

28 or >

i.m., i.v.

Amphotericin B

1 mg/kg/day

20

i.v. (slow)

Liposomal amphotericin B

3-4 mg/kg/day

D 1-5 +10

i.v.

Lipid associated amphotericin B

2-3 mg/kd/day

5

i.v.

 

Miltefosine

<25 kg 50mg/d

>25 kg 100-150 mg/d

28

Oral

Of proved efficacy but not (yet) available)

 

 

 

 Aminosidin1

16-20 mg/kg/day

21-28

i.m.

Efficacy less certain

 

 

 

 Pentamidine

3-4 mg/kg/day

15 inj.

i.m., i.v.

1Combination treatment advised

 
 

Table 2. Adverse Events During Antimony Treatment as Reported in Different Studies

 

Author

Llanos-Cuentas113

 

Aronson18

Soto274

Country/ Year

Peru

 

1997

 

USA 1998

Colombia/Bolivia 2004

Disease/

Parasite

MCL

 

L.b. complex

CL                 VL

CL

Treatment

 

Sb

Sb +

A

Sb                   Sb

Gluc*  Pent*  SSG*

Dose mg/kg/d

Duration

20/28

20/28

20/28

20/20           20/30  

 20/20   20/20       20/20

Number

 

41

 

40

83                   13

50         16       48

EVENT

n

%

n

                %

n (%)           n (%)

n (%)    n (%)   n (%)

Headache

32

78

34

85              

19 (23)        2 (17)

16 (32)   5 (31)     9 (19)

Arthralgia

32

78

29

72.4           

49 (60)        7 (58)

 

Myalgia

31

75.6

24

60              

45 (45)        6 (50)

23(46)   9 (56)     14 (29)

Abdominal

Pain

14

34.1

13

32.5           

24 (29)        4 (33)

8 (16)    4 (25)        2 (4)

Anorexia

9

22

12

30             

20 (24)        2 (17)

 

Haematologic

Toxicity

11

26.8

12

 30           

           (44,of 96)

11 (22)   3 (19)      5 (10)

Hepatic

Toxicity

6

14.6

5

12.5           

(>60)          (>60)

27 (54)   12 (75)   21(44)

Renal

Abnormality*

9

22

8

 20             

 

 

Pancreatic toxicity

 

 

 

≥ 84%          ≥84%

32 (64)  11 (69)  22 (46)

ECG

Abnormality

 

not done

 

         20 p (21%)

          (of 96)

19 (38)   5 (31)    16 (33)

  MCL:                      mucocutaneous leishmaniasis          * Gluc: GlucantimeŽ

  CL:                          cutaneous leishmaniasis                    * Pent: PentostamŽ

  VL:                          visceral leishmaniasis                         * SSG: sodium stibogluconate, generic

  Sb:                           pentavalent antimony

  A:                            allopurinol

  L.b. complex          Leishmania ‑braziliensis complex;

  * Serum creatinine at least 0.3 mg/1 higher than base line value              

         

Table 3.    Results of Treatment of Mucosal Leishmaniasis with Pentavalent Antimony Alone or Pentavalent Antimony plus Allopurinol in One Study113 . 

 

severe disease

moderate disease

treatment

Sb

Sb + A

Sb

Sb + A

number

11

11

30

29

clinical cure

2

0

21 (75%)

14 (63.6%)

failure

8 (80%)

10 (90.1%)

7

8

withdrawn

1

1

2

7

   Sb: pentavalent antimony 20 mg/kg/d x 28 days

   A: allopurinol 20 mg/kg/d in 4 doses x 28 days