Neurological, cardiovascular and metabolic effects of mefloquine in healthy volunteers: a double‐blind, placebo‐controlled trial

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Abstract
1To assess neurological, cardiovascular, metabolic and other side‐effects of mefloquine given in conventional prophylactic dose to healthy volunteers, a double‐blind, randomized, placebo‐controlled trial was conducted. In addition, the identity of the active drug was concealed until the end of the trial. 2A total of 106 healthy adults were recruited, of whom 95 (mean age 24 years; 45% males) completed the full study protocol. 3Subjects had a baseline assessment, received placebo as first dose, were randomized to mefloquine 250 mg or placebo weekly for 4 weeks starting a week later, and were reassessed after the 2nd and 4th active/placebo doses. Subjects kept a daily symptom diary from 2 weeks before until 2 weeks after the dosing period. 4Plasma mefloquine assay suggested compliance in all 46 subjects allocated active treatment (week 5 mean±s.d.; 2.35±0.94 μmol l−1). Mefloquine did not alter calcium homoeostasis but produced a mean 0.5 mmol l−1 fall in serum glucose over the study period (Pc interval prolongation and diarrhoea were mild but transient side‐effects of mefloquine (P5Mefloquine prophylaxis does not appear to produce low‐grade but debilitating neurological symptoms or to alter the results of sensitive tests of cerebral function. However, there may be situations in which mefloquine might contribute to hypoglycaemia and cardiac dysrhythmias.