Atovaquone‐proguanil for treating uncomplicated malaria

Alex Osei‐Akoto; Lois C Orton; Shirley Owusu‐Ofori

doi:10.1002/14651858.CD004529.pub2

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Analysis 1.1

Comparison 1 Atovaquone‐proguanil (AP) versus chloroquine, Outcome 1 Treatment failure on or by day 28.

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Analysis 1.2

Comparison 1 Atovaquone‐proguanil (AP) versus chloroquine, Outcome 2 Parasite clearance time (mean; h).

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Analysis 1.3

Comparison 1 Atovaquone‐proguanil (AP) versus chloroquine, Outcome 3 Fever clearance time (mean; h).

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Analysis 1.4

Comparison 1 Atovaquone‐proguanil (AP) versus chloroquine, Outcome 4 Adverse events.

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Analysis 2.1

Comparison 2 Atovaquone‐proguanil (AP) versus amodiaquine, Outcome 1 Treatment failure on or by day 28.

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Analysis 2.2

Comparison 2 Atovaquone‐proguanil (AP) versus amodiaquine, Outcome 2 Treatment failure on or by day 14.

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Analysis 2.3

Comparison 2 Atovaquone‐proguanil (AP) versus amodiaquine, Outcome 3 Parasite clearance time (mean; h).

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Analysis 2.4

Comparison 2 Atovaquone‐proguanil (AP) versus amodiaquine, Outcome 4 Fever clearance time (mean; h).

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Analysis 2.5

Comparison 2 Atovaquone‐proguanil (AP) versus amodiaquine, Outcome 5 Adverse events.

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Analysis 3.1

Comparison 3 Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP), Outcome 1 Treatment failure on or by day 28.

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Analysis 3.2

Comparison 3 Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP), Outcome 2 Parasite clearance time (mean; h).

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Analysis 3.3

Comparison 3 Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP), Outcome 3 Fever clearance time (mean; h).

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Analysis 3.4

Comparison 3 Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP), Outcome 4 Progression to severe disease.

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Analysis 3.5

Comparison 3 Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP), Outcome 5 Adverse events.

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Analysis 4.1

Comparison 4 Atovaquone‐proguanil (AP) versus quinine plus tetracycline (Q plus T), Outcome 1 Treatment failure on or by day 28.

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Analysis 4.2

Comparison 4 Atovaquone‐proguanil (AP) versus quinine plus tetracycline (Q plus T), Outcome 2 Parasite clearance time (mean; h).

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Analysis 4.3

Comparison 4 Atovaquone‐proguanil (AP) versus quinine plus tetracycline (Q plus T), Outcome 3 Fever clearance time (mean; h).

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Analysis 4.4

Comparison 4 Atovaquone‐proguanil (AP) versus quinine plus tetracycline (Q plus T), Outcome 4 Adverse events.

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Analysis 5.1

Comparison 5 Atovaquone‐proguanil (AP) versus halofantrine, Outcome 1 Treatment failure on or by day 28.

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Analysis 5.2

Comparison 5 Atovaquone‐proguanil (AP) versus halofantrine, Outcome 2 Parasite clearance time (mean; h).

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Analysis 5.3

Comparison 5 Atovaquone‐proguanil (AP) versus halofantrine, Outcome 3 Fever clearance time (mean; h).

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Analysis 5.4

Comparison 5 Atovaquone‐proguanil (AP) versus halofantrine, Outcome 4 Adverse events.

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Analysis 6.1

Comparison 6 Atovaquone‐proguanil (AP) versus mefloquine, Outcome 1 Treatment failure on or by day 28.

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Analysis 6.2

Comparison 6 Atovaquone‐proguanil (AP) versus mefloquine, Outcome 2 Parasite clearance time (mean; h).

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Analysis 6.3

Comparison 6 Atovaquone‐proguanil (AP) versus mefloquine, Outcome 3 Fever clearance time (mean; h).

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Analysis 6.4

Comparison 6 Atovaquone‐proguanil (AP) versus mefloquine, Outcome 4 Adverse events.

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Analysis 7.1

Comparison 7 Atovaquone‐proguanil (AP) versus artesunate plus mefloquine (AS plus MQ), Outcome 1 Treatment failure on or by day 14.

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Analysis 7.2

Comparison 7 Atovaquone‐proguanil (AP) versus artesunate plus mefloquine (AS plus MQ), Outcome 2 Treatment failure on or by day 28 adjusted by PCR.

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Analysis 7.3

Comparison 7 Atovaquone‐proguanil (AP) versus artesunate plus mefloquine (AS plus MQ), Outcome 3 Adverse events.

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Analysis 8.1

Comparison 8 Atovaquone‐proguanil (AP) versus dihydroartemisinin, piperaquine, trimethoprim, and primaquine (CV8), Outcome 1 Treatment failure on or by day 28.

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Analysis 8.2

Comparison 8 Atovaquone‐proguanil (AP) versus dihydroartemisinin, piperaquine, trimethoprim, and primaquine (CV8), Outcome 2 Parasite clearance time (mean; h).

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Analysis 8.3

Comparison 8 Atovaquone‐proguanil (AP) versus dihydroartemisinin, piperaquine, trimethoprim, and primaquine (CV8), Outcome 3 Fever clearance time (mean; h).

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Analysis 8.4

Comparison 8 Atovaquone‐proguanil (AP) versus dihydroartemisinin, piperaquine, trimethoprim, and primaquine (CV8), Outcome 4 Adverse events.

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Table 1. Risk of bias assessment

Trial	Allocation sequence generation	Allocation concealment	Blinding	Inclusion^a
Anabwani 1999	Unclear	Unclear	None	Adequate
Borrmann 2003	Adequate	Adequate	None	Inadequate
Bouchaud 2000	Unclear	Unclear	None	Inadequate
De Alencar 1997	Unclear	Unclear	None	Inadequate
Giao 2004	Adequate	Adequate	None	Adequate
Llanos‐Cuentas 2001	Unclear	Unclear	None	Adequate
Looareesuwan 1999a	Unclear	Unclear	None	Inadequate
Mulenga 1999	Unclear	Unclear	None	Adequate
Radloff 1996	Adequate	Unclear	None	Inadequate
Van Vugt 2002	Adequate	Adequate	None	Adequate
^aSee the 'Characteristics of included studies' for details. ^bInclusion of all randomized participants in the final analysis.

Table 1. Risk of bias assessment

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Comparison 1. Atovaquone‐proguanil (AP) versus chloroquine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Parasite clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3 Fever clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Abdominal pain	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Chills/rigors	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Dizziness	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 Headache	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 Insomnia	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.6 Nausea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.7 Palpitations	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.8 Pruritus	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.9 Severe	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.10 Vomiting	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.11 Weakness	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Atovaquone‐proguanil (AP) versus chloroquine

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Comparison 2. Atovaquone‐proguanil (AP) versus amodiaquine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	2	342	Risk Ratio (M‐H, Fixed, 95% CI)	0.22 [0.13, 0.36]

2 Treatment failure on or by day 14 Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Parasite clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Fever clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5 Adverse events Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Abdominal pain	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	2.8 [1.07, 7.31]
5.2 Diarrhoea	2	326	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.57, 1.61]
5.3 Dizziness	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	0.27 [0.08, 0.93]
5.4 Insomnia	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	0.29 [0.12, 0.75]
5.5 Nausea	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	2.63 [1.26, 5.48]
5.6 Pruritus	1	126	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.04, 0.35]
5.7 Respiratory infections	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	3.0 [0.62, 14.51]
5.8 Vomiting	2	326	Risk Ratio (M‐H, Fixed, 95% CI)	1.39 [0.80, 2.41]
5.9 Weakness	2	326	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.02, 0.64]
5.10 Any event	1	200	Risk Ratio (M‐H, Fixed, 95% CI)	1.12 [0.82, 1.51]

Comparison 2. Atovaquone‐proguanil (AP) versus amodiaquine

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Comparison 3. Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Parasite clearance time (mean; h) Show forest plot	2	174	Mean Difference (IV, Fixed, 95% CI)	11.23 [5.43, 17.03]

3 Fever clearance time (mean; h) Show forest plot	2	156	Mean Difference (IV, Fixed, 95% CI)	‐13.73 [‐21.31, ‐6.16]

4 Progression to severe disease Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

5 Adverse events Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Abdominal pain	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	0.85 [0.58, 1.24]
5.2 Chills/rigors	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.06, 32.05]
5.3 Diarrhoea	1	160	Risk Ratio (M‐H, Fixed, 95% CI)	43.0 [2.65, 697.91]
5.4 Dizziness	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.06, 32.05]
5.5 Headache	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.81, 1.67]
5.6 Insomnia	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.09, 1.21]
5.7 Nausea	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	2.25 [0.31, 16.59]
5.8 Orthostatic hypotension	1	160	Risk Ratio (M‐H, Fixed, 95% CI)	0.03 [0.00, 0.57]
5.9 Pruritus	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.16 [0.01, 3.56]
5.10 Raised liver enzymes	1	160	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.25, 1.79]
5.11 Severe	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.06, 32.05]
5.12 Vomiting	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.50, 1.90]
5.13 Weakness	2	189	Risk Ratio (M‐H, Fixed, 95% CI)	1.47 [0.82, 2.62]

Comparison 3. Atovaquone‐proguanil (AP) versus sulfadoxine‐pyrimethamine (SP)

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Comparison 4. Atovaquone‐proguanil (AP) versus quinine plus tetracycline (Q plus T)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Parasite clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3 Fever clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Abdominal pain	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Anorexia	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Diarrhoea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 Dizziness	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 Headache	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.6 Nausea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.7 Pruritus	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.8 Tinnitus	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.9 Vomiting	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.10 Weakness	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 4. Atovaquone‐proguanil (AP) versus quinine plus tetracycline (Q plus T)

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Comparison 5. Atovaquone‐proguanil (AP) versus halofantrine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Parasite clearance time (mean; h) Show forest plot	2	205	Mean Difference (IV, Fixed, 95% CI)	14.76 [10.41, 19.10]

3 Fever clearance time (mean; h) Show forest plot	2	205	Mean Difference (IV, Fixed, 95% CI)	‐1.70 [‐9.41, 6.02]

4 Adverse events Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Abdominal pain	2	216	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.14, 4.68]
4.2 Chills/Rigors	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.11, 3.89]
4.3 Cough	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.34, 1.52]
4.4 Diarrhoea	2	216	Risk Ratio (M‐H, Random, 95% CI)	0.57 [0.23, 1.39]
4.5 Headache	2	216	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.17, 6.84]
4.6 Insomnia	2	216	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.15, 2.60]
4.7 Moderate or severe	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.15, 0.91]
4.8 Myalgia	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.14 [0.01, 2.72]
4.9 Nausea	1	48	Risk Ratio (M‐H, Random, 95% CI)	2.76 [0.62, 12.33]
4.10 Palpitations	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.5 [0.05, 5.41]
4.11 Pruritus	2	216	Risk Ratio (M‐H, Random, 95% CI)	1.20 [0.51, 2.87]
4.12 Vomiting	2	216	Risk Ratio (M‐H, Random, 95% CI)	3.47 [0.66, 18.43]
4.13 Weakness	1	168	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.03, 2.19]

Comparison 5. Atovaquone‐proguanil (AP) versus halofantrine

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Comparison 6. Atovaquone‐proguanil (AP) versus mefloquine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Parasite clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3 Fever clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Abdominal pain	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Anaemia	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Diarrhoea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 Dizziness	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 Headache	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.6 Insomnia	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.7 Nausea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.8 Raised liver enzymes	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.9 Sore throat	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.10 Vomiting	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.11 Any event	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 6. Atovaquone‐proguanil (AP) versus mefloquine

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Comparison 7. Atovaquone‐proguanil (AP) versus artesunate plus mefloquine (AS plus MQ)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 14 Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Treatment failure on or by day 28 adjusted by PCR Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3.1 Anorexia	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Dizziness	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Nausea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 Palpitations	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.5 Skin rash	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 Sleeping disorders	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.7 Tremor	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.8 Vomiting	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 7. Atovaquone‐proguanil (AP) versus artesunate plus mefloquine (AS plus MQ)

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Comparison 8. Atovaquone‐proguanil (AP) versus dihydroartemisinin, piperaquine, trimethoprim, and primaquine (CV8)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Treatment failure on or by day 28 Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Parasite clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3 Fever clearance time (mean; h) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4.1 Diarrhoea	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Dry mouth	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Headache	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.4 Itch	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.5 Vomiting	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 8. Atovaquone‐proguanil (AP) versus dihydroartemisinin, piperaquine, trimethoprim, and primaquine (CV8)

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