Clinical field efficacy and safety of pyrantel pamoate paste (19.13% w/w pyrantel base) against Anoplocephala spp. in naturally infected horses.

Clinical field trials were conducted at five geographical locations in the USA (Oklahoma, Wisconsin, Tennessee, Virginia and Idaho) to evaluate the efficacy and safety of pyrantel pamoate paste (19.13%, w/w, pyrantel base) administered at the recommended dosage of 13.2 mg pyrantel base/kg (6.0 mg pyrantel base/lb) body weight (b.w.) against tapeworm infections of Anoplocephala spp. in naturally infected horses. Horses at each study site were allocated by restricted randomization based on the cestode status (positive or negative) of pre-treatment fecal egg counts to complete sets of four animals each or incomplete sets of fewer than four animals. Within sets comprising of two to four horses, one animal was randomly allocated to receive placebo vehicle paste and the remaining horse(s) received pyrantel pamoate paste administered orally at a minimum dosage of 13.2 mg pyrantel base/kg b.w. on Test Day (TD) 0. Single animal sets received pyrantel pamoate paste. Fecal samples of horses were collected and examined for equine tapeworm (Anoplocephala spp.) eggs a minimum of four times (once or thrice between TD -28 and -14, twice between TD -14 and -7, and once on TD 0) prior to treatment on TD 0. Fecal samples of horses that were positive for cestode infection pre-treatment were examined for cestode eggs on TD 7, 8, 9, 14, 15 and 16. Cestode-negative pre-treatment horses were not sampled again after treatment. A total of 241 horses (141 mares, 16 stallions and 84 geldings; 6 months-30 yrs of age; 173-646 kg; 13 recognized breeds and various crossbreds) were evaluated. The prevalence of Anoplocephala spp. determined by pre-treatment fecal examination ranged from 38.3% in Idaho to 68.1% in Tennessee with an overall prevalence of 52.3%. Ninety cestode-positive and 88 cestode-negative horses were treated with pyrantel pamoate paste, 36 cestode-positive and 27 cestode-negative horses were treated with placebo vehicle paste. Overall, 178 horses were treated with pyrantel pamoate paste, and 63 horses were treated with placebo paste. Of the 178 horses treated with pyrantel pamoate paste, no drug related, adverse clinical or neurological health events were observed. No doses of pyrantel pamoate paste were refused or lost during dosing. At each post-treatment time sampling interval, significantly fewer cestode eggs (P < 0.0115) were passed by cestode-positive horses treated with pyrantel pamoate paste compared to cestode-positive horses that received placebo paste. Efficacy of the pyrantel pamoate paste treatment ranged from 92 to 96% from TD 7 to TD 16 with an overall efficacy of 95%. The results of these trials demonstrated that pyrantel pamoate paste (19.13%, w/w, pyrantel base) administered orally at a dosage of 13.2 mg pyrantel base/kg b.w. is highly efficacious (95%) against Anoplocephala spp. and safe for use in horses with no adverse clinical or neurological health events observed under field use conditions.