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Table 2 Comparison of hematological changes and prevalence of other adverse events following administration of SLD primaquine

From: Is it time for Africa to adopt primaquine in the era of malaria control and elimination?

Author, country

G6PD deficiency vs normal

Hb changes and other AEs

Prevalence of AEs

SAE

Treatment required

Gonçalves et al. 2016 [75], Burkina Faso

No

The mean relative percentage Hb drop (− 7.8 g/dL in AL + PQ, − 5.7 g/dL in AL) was more pronounced in individuals receiving 0.25 mg/kg PQ than in those who received AL alone but was not statistically significant. Other observed AEs were mild or moderate and were not different between treatment groups

A total number of subjects with AEs was not reported

18 AEs occurred in the ACT + PQ arm

15 AEs occurred in AL alone

None

None

Mwaiswelo et al. 2016 [10], Tanzania

Yes

Mean absolute Hb drop (−1.48 g/dL in G6PD deficient, − 0.74 in G6PD normal) was statistically significantly different between G6PD status, but relative percentage Hb drop (− 12.6 g/dL in G6PD deficient, − 6.2 in G6PD normal) was not significantly different between G6PD deficient and G6PD normal subjects treated with PQ. The majority of the AEs were mild and self-limiting

42.7% (47/110) in ACT + PQ

40.9% (45/110) in ACT alone

None

None

Bancone et al. 2016 [79], Thailand

Yes

Mean relative Hb drop (− 5.2 g/dL in G6PD deficient, − 3.2 g/dL in G6PD normal) were significantly greater in G6PD deficient than G6PD normal subjects in the PQ arm but normalized during follow-up

A total number of subjects with AEs was not reported

Dizziness occurred in 4.8% (79/1659) of subjects

  

Dicko et al. 2016 [13], Mali

No

Within person changes in Hb concentration were not significant in any of the treatment groups at any time point

40.0% (6/15) in ACT + PQ

40.0% (6/15) in ACT alone

None

None

Tine et al,. 2017 [11], Senegal

Yes

The mean absolute Hb drop (-1.8 g/dL in G6PD deficient, -1.4 g/dL in G6PD normal) was significantly greater in G6PD deficient than G6PD normal treated with PQ. Only one patient developed moderately severe anemia. Dark urine was more frequent in patients who received PQ. Incidences of AEs were similar in both treatment groups

A total number of subjects with AEs was not reported

205 AEs occurred in the ACT + PQ arm

180 AEs occurred in ACT alone

None

None

Bastiaens et al. 2018 [12], Burkina Faso and

The Gambia

Yes

The mean absolute Hb drop was significant in G6PD deficient than in G6PD normal patients in Burkina Faso (− 0.92 g/dL in G6PD deficient, − 0.64 in G6PD normal), but was not significant in The Gambia (− 0.99 g/dL in G6PD deficient, − 1.1 g/dL in G6PD normal). PQ was well tolerated with the majority of observed AEs being mild

43.3% (13/30) in ACT + PQ

40.0% (4/10) in AL alone

None

None

Dicko et al., 2018 [76], Mali

No

Within person change in relative percentage of Hb was not significantly different between treatment arms

65.0% (13/20) in SP + AQ + PQ

55.0% (11/20) in DP alone

None

None

Raman et al. 2019 [14], South Africa

Yes

Mean Hb drop (values not indicated) was more prevalent in G6PD deficient than G6PD normal individuals. Anemia during follow-up was more prevalent in G6PD normal than in G6PD deficient. Other observed AEs were common in both groups, and the majority was mild

31.4% (22/70) in ACT + PQ

26.0% (18/69) in ACT alone

Renal impairment in PQ arm. But the patient failed to disclose a history of renal impairment

None

  1. AQ amodiaquine, AL artemether-lumefantrine, ACT artemisinin-based combination therapy, DP dihydroartemisinin-piperaquine, PQ primaquine, SP sulfadoxine-amodiaquine