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Abstract
Background: Very few trials of hydroxyurea efficacy and safety have been conducted in sub-Saharan Africa. We aimed to evaluate the efficacy and safety of hydroxyurea and its utility in low-resource settings. Methods: We conducted a prospective comparative trial in patients with SCA. 128 patients were enrolled and divided into two groups. 68 patients were treated with hydroxyurea at a dose of 10-20 mg/kg/day and 62 patients in a control group without hydroxyurea. The endpoints evaluated were feasibility, safety, and benefit (laboratory variables, sickle cell-related events, transfusions). Results: The patients assigned to hydroxyurea treatment had a lower annual rate of crises than the control group (median 2.9 vs. 5.3 crises per year, p=0.001), a lower annual rate of hospitalizations (median 2.2 vs. 4.7, p=0.002), and a lower annual rate of transfusions (median 1.3 vs. 5.1, p=0.001). We observed a significant increase in Hb F from 11.77% to 14.6% (p=0.001) in patients treated with hydroxyurea. We also observed a significant increase in the mean Hb level from 7.3 g/dL to 9.2 g/dL in patients treated with hydroxyurea (p=0.004). Patients treated with hydroxyurea also have a beneficial effect on WBC and platelet levels by reducing leukocytosis and thrombocytosis. The annual number of infectious complications was significantly lower in the group of patients treated with hydroxyurea. Conclusion: Hydroxyurea has an important clinical benefit by reducing the incidence of vaso-occlusive events, infections, and transfusions, which translates into fewer hospitalizations. The main problem is that it is not accessible to most of our patients who live in poor socioeconomic conditions.
Published Version
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