Study population. Patients were recruited and screened in April 2007 and began treatment in July 2007. On the basis of the screening results, 51 eligible patients were identified and randomized to receive standard, annual therapy or high‐dose, twice‐yearly therapy. Seven patients (3 in the annual group and 4 in the twice‐yearly group) declined to participate before enrollment, and 2 (1 in each group) signed consent but refused to undergo venipuncture at the baseline visit, leaving 42 patients (22 in the annual group and 20 in the twice‐yearly group) in the treatment portion of the study. There were no significant differences between the 2 groups at baseline with respect to median age, sex distribution, eosinophil count, W. bancrofti microfilarial or circulating antigen levels, or the prevalence of worm nests detected by ultrasonography. Clinical disease associated with lymphatic filariasis was uncommon in both groups, with hydrocele found in only 3 patients (2 in the annual group and 1 in the twice‐yearly group) and a history of lymphedema in only 1 subject (in the annual group). Sixteen patients (8 in each group) reported a history of lymphangitis occurring >1 month before the study. As has been reported in previous studies in this region of Mali, most W. bancrofti–infected patients (38 [90%] of 42) were coinfected with Mansonella perstans.
Adverse events. A total of 12 adverse events were reported by 9 study patients (17%). Mild‐to‐moderate adverse events were reported in both treatment groups and included gastrointestinal symptoms, urticaria, and localized angioedema, all of which are consistent with known effects of anthelmintic (albendazole‐ivermectin) therapy. None of the patients with angioedema demonstrated respiratory or laryngeal symptoms. The only serious adverse event, an incarcerated hernia requiring surgical intervention, was categorized as unrelated to the study procedures.
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Efficacy. As expected, microfilarial levels decreased significantly in both groups after albendazole‐ivermectin treatment. Nevertheless, the percentages of pretreatment W. bancrofti microfilarial levels were significantly decreased in the high‐dose, semiannual group at 12, 18, and 24 months compared with the group receiving annual, standard‐dose treatment. More importantly, complete W. bancrofti microfilarial clearance was significantly more common in the high‐dose biannual group, with no patients having results positive for circulating microfilariae at 12, 18, or 24 months, compared with 12 of 21, 6 of 19, and 5 of 18 patients with positive results in the annual treatment group. Because all patients in the twice‐yearly group cleared at the 3 time points, the odds ratio estimates and upper confidence limits are infinite, whereas the lower 95% confidence limits are 5.05 (12 months), 1.52 (18 months), and 1.28 (24 months). Even the conservative sensitivity analysis at 12 months showed highly significant results ( , by 2‐sided Fisher’s exact after imputing missing responses in each group in proportion to the overall response rate).