A comparative clinical study was conducted to evaluate the safety and tolerability of two commonly used fixed dose artemisinin-based combinations for the treatment of uncomplicated Plasmodium falciparum malaria in the second and third trimester of pregnancy. To achieve this, a total of 155 participants were recruited for the study. Eighty of these were drawn from pregnant women who came for routine antenatal care while 40 nonpregnant participants were recruited from apparently healthy females in the community. Eighty pregnant participants with uncomplicated P. falciparum malaria were randomized into artesunate/amodiaquine (AA) and artemether/lumefantrine (AL) treatment arms while 40 nonpregnant and 35 nonmalarious pregnant women were used as control. The interventional groups received standard fixed dose combinations of AA (100/270 mg) daily or AL (20/120 mg) twice daily for 3 days. Blood samples were collected on day 4 and patients were followed-up closely to ascertain the safety of the drugs. The study showed a significant (p<0.0001) elevation of alkaline phosphatase in the AA and AL group compared to the nonpregnant control and a significant (p<0.05) elevation of alanine transaminase and aspartate transaminase level in the AL combination group when compared with the AA group. The elevated hepatic enzymes were within the normal range for pregnancy and were not clinically significant. Adverse event rate was higher in the AA group (n=28 [70%]) when compared to the AL group (n=4 [10%]) although the drugs were well-tolerated in both treatment arms. In conclusion, the use of these combinations is safe in the second and third trimester of pregnancy. However, we recommend active pharmacovigilance and spontaneous drug reporting of the agents in order to continuously monitor safety in the vastly heterogeneous population.
Objectives The objectives of this study were to determine the safety of the use of nonfixed-dose combination of artesunate (AS) and amodiaquine (AQ) in the treatment of uncomplicated falciparum malaria in pregnancy. In this regard, the focus was on the possible effects of the combination on biochemical and haematological parameters as well as other adverse drug reactions associated with the use of the drugs. Methods Ninety subjects were recruited from pregnant women on antenatal care visit to a busy hospital in Esan West Local Government Area, Edo State Nigeria. Fifty met the criteria for the diagnosis of uncomplicated malaria. They were placed on treatment with standard doses of AS 4 mg/kg and AQ 10 mg/kg daily for 3 days. Forty apparently healthy pregnant women and 30 nonpregnant women were used as control. Patients on AS + AQ combination were monitored closely for 28 days. Key findings There was a significant reduction in high-density lipoprotein cholesterol-C: 24.60 AE 1.20 mg/dl) in the test group (P < 0.05) when compared with pregnant control (27.57 AE 0.89 mg/dl) and a nonsignificant reduction (P > 0.05) in low-density lipoprotein cholesterol-C: 83.55 AE 6.10 mg/dl) levels compared with control (87.82 AE 4.88 mg/dl). Additionally, there was a nonsignificant elevation (P > 0.05) of conjugated bilirubin in the test group (0.48 AE 0.06 mg/dl) when compared with pregnant control (0.40 AE 0.04 mg/dl). Changes in haemoglobin concentration (10.45 AE 0.23 g/dl) and packed cell volume (31.37 AE 0.70%) in patients treated with AS + AQ combination were not significant compared with pregnant control (10.18 AE 0.27 g/dl and 31.17 AE 0.55% respectively). Alkaline phosphatase (120.27 AE 7.81 IU/l) was not significantly elevated (P > 0.05) in patients treated with AS + AQ combination compared with pregnant control (117.81 AE 10.61 IU/l). Conclusion We conclude that the use of this combination is safe and well tolerated in pregnant women with uncomplicated falciparum malaria.
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