Abstract
Miltefosine (MIL)–allopurinol combination therapy administered at standard dosage is effective to treat canine leishmaniosis, nevertheless for some dogs the digestive tolerance of MIL is not acceptable. This study evaluates an alternative therapeutic protocol by using a modified dosage of MIL to increase its effectiveness and improve the digestive tolerance. Thirty-four Leishmania infantum owned naturally infected dogs were included and monitored for 180 days. The dogs were allocated in two randomized groups: Group X−18 dogs treated with MIL registered dose of 2 mg/kg, oral administration, once daily, for 28 days; Group Y−16 dogs treated with 1.2 mg/kg for 5 days followed by 2.5 mg/kg for 25 days. Both groups were also treated with allopurinol. Digestive tolerance was monitored by adverse events observation. Treatments effectiveness was evaluated by monitoring the reduction of clinical score, the improvement of clinicopathological abnormalities, the reduction of parasitological load by PCR and the number of relapses. 16.6% dogs of group X and 12.5% dogs of group Y showed treatment associated adverse events. The reduction of clinical score was 61.7% for group X and 71.6% for group Y. All dogs showed an improvement of laboratory parameters after treatment. Quantitative PCR showed better results in group Y compared to group X; relapses were only registered in four dogs of group X. The modified protocol demonstrates a better trend of results in term of tolerance, clinical effectiveness, parasitological load reduction and relapses control, suggesting it could be considered for new large-scale studies.
Highlights
Canine leishmaniosis (CanL), caused by the protozoan parasite Leishmania infantum, is endemic in southern Italy [1]
Dogs presenting the following characteristics were not included in the trial: females known to be pregnant or lactating; dogs treated with drugs of known efficacy against CanL within 3 months prior to inclusion; dogs treated with systemic long-acting corticosteroids and other immunomodulatory drugs within 1 month prior to inclusion; dogs with concomitant disorders that may interfere with the evaluation of response to treatment; dogs with life-threatening diseases
Real Time-PCR was performed on a total of 66 bone marrow (BM) samples due to an unsuitable material obtained from two dogs of group X at D60
Summary
Canine leishmaniosis (CanL), caused by the protozoan parasite Leishmania infantum, is endemic in southern Italy [1]. Adverse reactions associated with MIL treatment have been reported in 11.7% (11/94) to 100% (17/17) of treated dogs [19, 25]. The authors hypothesize that a particular therapeutic scheme that considers an initial lower dosage followed by an higher one, may allow a better drug tolerance in the reduction of side effects and a better efficacy on parasite load. The aim of this pilot study is to compare the tolerance and efficacy of two different dose rates of MIL (Milteforan R , Virbac, France) in dogs with CanL exhibiting moderate to severe clinical signs of the disease
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