TY - JOUR
T1 - Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: A randomized trial: A randomized trial
AU - Kamya, Moses R.
AU - Yeka, Adoke
AU - Bukirwa, Hasifa
AU - Lugemwa, Myers
AU - Rwakimari, John B.
AU - Staedke, Sarah
AU - Talisuna, Ambrose O.
AU - Greenhouse, Bryan
AU - Nosten, François
AU - Rosenthal, Philip J.
AU - Wabwire-Mangen, Fred
AU - Dorsey, Grant
PY - 2007/5/18
Y1 - 2007/5/18
N2 - Objectives: To compare the efficacy and safety of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treating uncomplicated falciparum malaria in Uganda. Design: Randomized single-blinded clinical trial. Setting: Apac, Uganda, an area of very high malaria transmission intensity. Participants: Children aged 6 mo to 10 y with uncomplicated falciparum malaria. Intervention: Treatment of malaria with AL or DP, each following standard 3-d dosing regimens. Outcome measures: Risks of recurrent parasitemia at 28 and 42 d, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections. Results: Of 421 enrolled participants, 417 (99%) completed follow-up. The unadjusted risk of recurrent falciparum parasitemia was significantly lower for participants treated with DP than for those treated with AL after 28 d (11 % versus 29%, risk difference [RD] 18%, 95% confidence interval [CI] 11%-26%) and 42 d (43% versus 53%; RD 9.6%, 95% CI 0%-19%) of follow-up. Similarly, the risk of recurrent parasitemia due to possible recrudescence (adjusted by genotyping) was significantly lower for participants treated with DP than for those treated with AL after 28 d (1.9% versus 8.9%; RD 7.0%, 95% CI 2.5%-12%) and 42 d (6.9% versus 16%; RD 9.5%,95% CI 2.8%-16%). Patients treated with DP had a lower risk of recurrent parasitemia due to non-falciparum species, development of gametocytemia, and higher mean increase in hemoglobin compared to patients treated with AL. Both drugs were well tolerated; serious adverse events were uncommon and unrelated to study drugs. Conclusion: DP was superior to AL for reducing the risk of recurrent parasitemia and gametocytemia, and provided improved hemoglobin recovery. DP thus appears to be a good alternative to AL as first-line treatment of uncomplicated malaria in Uganda. To maximize the benefit of artemisinin-based combination therapy in Africa, treatment should be integrated with aggressive strategies to reduce malaria transmission intensity.
AB - Objectives: To compare the efficacy and safety of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treating uncomplicated falciparum malaria in Uganda. Design: Randomized single-blinded clinical trial. Setting: Apac, Uganda, an area of very high malaria transmission intensity. Participants: Children aged 6 mo to 10 y with uncomplicated falciparum malaria. Intervention: Treatment of malaria with AL or DP, each following standard 3-d dosing regimens. Outcome measures: Risks of recurrent parasitemia at 28 and 42 d, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections. Results: Of 421 enrolled participants, 417 (99%) completed follow-up. The unadjusted risk of recurrent falciparum parasitemia was significantly lower for participants treated with DP than for those treated with AL after 28 d (11 % versus 29%, risk difference [RD] 18%, 95% confidence interval [CI] 11%-26%) and 42 d (43% versus 53%; RD 9.6%, 95% CI 0%-19%) of follow-up. Similarly, the risk of recurrent parasitemia due to possible recrudescence (adjusted by genotyping) was significantly lower for participants treated with DP than for those treated with AL after 28 d (1.9% versus 8.9%; RD 7.0%, 95% CI 2.5%-12%) and 42 d (6.9% versus 16%; RD 9.5%,95% CI 2.8%-16%). Patients treated with DP had a lower risk of recurrent parasitemia due to non-falciparum species, development of gametocytemia, and higher mean increase in hemoglobin compared to patients treated with AL. Both drugs were well tolerated; serious adverse events were uncommon and unrelated to study drugs. Conclusion: DP was superior to AL for reducing the risk of recurrent parasitemia and gametocytemia, and provided improved hemoglobin recovery. DP thus appears to be a good alternative to AL as first-line treatment of uncomplicated malaria in Uganda. To maximize the benefit of artemisinin-based combination therapy in Africa, treatment should be integrated with aggressive strategies to reduce malaria transmission intensity.
U2 - 10.1371/journal.pctr.0020020
DO - 10.1371/journal.pctr.0020020
M3 - Article
VL - 2
JO - PLoS Clinical Trials
JF - PLoS Clinical Trials
IS - 5
M1 - e20
ER -
