Fluvastatin for lowering lipids

Stephen P Adams; Sarpreet S Sekhon; Michael Tsang; James M Wright

doi:10.1002/14651858.CD012282.pub2

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Figure 1

Fluvastatin flow diagram

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Figure 2

Number of included studies according to publication year

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Figure 3

Log dose fluvastatin response curve for total cholesterol

Values represent the results of each trial for each dose comparison. The standard error bars cannot be seen because they all lie within the points

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Figure 4

Log dose fluvastatin response curve for LDL cholesterol

Values represent the results of each trial for each dose comparison. The standard error bars cannot be seen because they all lie within the points

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Figure 5

Log dose fluvastatin response curve for triglycerides

Values represent the results of each trial for each dose comparison. The standard error bars cannot be seen because they all lie within the points

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Figure 6

'Risk of bias' graph: Summary of overall risk of bias for the lipid parameters according to each item.

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Analysis 1.1

Comparison 1 2.5 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 1.2

Comparison 1 2.5 mg vs control, Outcome 2 WDAEs.

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Analysis 2.1

Comparison 2 5 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 2.2

Comparison 2 5 mg vs control, Outcome 2 LDL‐cholesterol.

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Analysis 2.3

Comparison 2 5 mg vs control, Outcome 3 WDAEs.

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Analysis 3.1

Comparison 3 10 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 3.2

Comparison 3 10 mg vs control, Outcome 2 Total cholesterol.

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Analysis 3.3

Comparison 3 10 mg vs control, Outcome 3 HDL‐cholesterol.

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Analysis 3.4

Comparison 3 10 mg vs control, Outcome 4 Triglycerides.

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Analysis 3.5

Comparison 3 10 mg vs control, Outcome 5 WDAEs.

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Analysis 4.1

Comparison 4 20 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 4.2

Comparison 4 20 mg vs control, Outcome 2 Total cholesterol.

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Analysis 4.3

Comparison 4 20 mg vs control, Outcome 3 HDL‐cholesterol.

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Analysis 4.4

Comparison 4 20 mg vs control, Outcome 4 Triglycerides.

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Analysis 4.5

Comparison 4 20 mg vs control, Outcome 5 LDL‐cholesterol.

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Analysis 4.6

Comparison 4 20 mg vs control, Outcome 6 Total cholesterol.

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Analysis 4.7

Comparison 4 20 mg vs control, Outcome 7 HDL‐cholesterol.

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Analysis 4.8

Comparison 4 20 mg vs control, Outcome 8 Triglycerides.

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Analysis 4.9

Comparison 4 20 mg vs control, Outcome 9 WDAE.

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Analysis 5.1

Comparison 5 30 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 5.2

Comparison 5 30 mg vs control, Outcome 2 Total cholesterol.

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Analysis 5.3

Comparison 5 30 mg vs control, Outcome 3 HDL‐cholesterol.

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Analysis 6.1

Comparison 6 40 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 6.2

Comparison 6 40 mg vs control, Outcome 2 Total cholesterol.

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Analysis 6.3

Comparison 6 40 mg vs control, Outcome 3 HDL‐cholesterol.

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Analysis 6.4

Comparison 6 40 mg vs control, Outcome 4 Triglycerides.

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Analysis 6.5

Comparison 6 40 mg vs control, Outcome 5 LDL‐cholesterol.

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Analysis 6.6

Comparison 6 40 mg vs control, Outcome 6 Total cholesterol.

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Analysis 6.7

Comparison 6 40 mg vs control, Outcome 7 HDL‐cholesterol.

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Analysis 6.8

Comparison 6 40 mg vs control, Outcome 8 Triglycerides.

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Analysis 6.9

Comparison 6 40 mg vs control, Outcome 9 WDAE.

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Analysis 7.1

Comparison 7 80 mg vs control, Outcome 1 LDL‐cholesterol.

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Analysis 7.2

Comparison 7 80 mg vs control, Outcome 2 Total cholesterol.

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Analysis 7.3

Comparison 7 80 mg vs control, Outcome 3 HDL‐cholesterol.

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Analysis 7.4

Comparison 7 80 mg vs control, Outcome 4 Triglycerides.

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Analysis 7.5

Comparison 7 80 mg vs control, Outcome 5 LDL‐cholesterol.

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Analysis 7.6

Comparison 7 80 mg vs control, Outcome 6 Total cholesterol.

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Analysis 7.7

Comparison 7 80 mg vs control, Outcome 7 HDL‐cholesterol.

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Analysis 7.8

Comparison 7 80 mg vs control, Outcome 8 Triglycerides.

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Analysis 7.9

Comparison 7 80 mg vs control, Outcome 9 WDAEs.

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Analysis 8.1

Comparison 8 all doses vs control, Outcome 1 WDAEs.

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LDL cholesterol lowering efficacy of fluvastatin

Patient or population: participants with normal or abnormal lipid profiles

Settings: ambulatory care

Intervention: fluvastatin

Comparison: LDL cholesterol percentage change from baseline for all trials

Outcomes

Anticipated absolute effects

mmol/L (95%CI)

Percent reduction
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Before exposure to fluvastatin¹

After exposure to fluvastatin

LDL‐cholesterol

fluvastatin

10 mg/day

4.81

(4.44 to 5.17)

4.08

(3.98 to 4.16)

15.2

(17.1 to 13.4)

595
(6)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 14.8%.

Randomised and before and after design not different P = 0.94.

LDL‐cholesterol fluvastatin

20 mg/day

4.87

(4.54 to 5.21)

3.90

(3.88 to 3.91)

20.0

(19.7 to 20.3)

9010
(55)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 20.8%.

Randomised and before and after design not different P = 0.16.

LDL‐cholesterol

fluvastatin

40 mg/day

4.74

(4.41 to 5.06)

3.51

(3.48 to 3.54)

25.9

(25.3 to 26.5)

3658
(57)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 26.8%.

Randomised and before and after design not different P = 0.58.

LDL‐cholesterol

fluvastatin

80 mg/day

4.80

(4.47 to 5.13)

3.13

(3.10 to 3.15)

34.9

(35.5 to 34.3)

4928
(32)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 32.8%.

Randomised and before and after design not different P = 0.07.

CI: Confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1. Mean baseline values.

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Total cholesterol lowering efficacy of fluvastatin

Patient or population: participants with normal or abnormal lipid profiles

Settings: ambulatory care

Intervention: fluvastatin

Comparison: Total cholesterol percentage change from baseline for all trials

Outcomes

Anticipated absolute effects

mmol/L (95%CI)

Percent reduction
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Before exposure to fluvastatin¹

After exposure to fluvastatin

Total cholesterol

fluvastatin

10 mg/day

6.90

(6.47 to 7.33)

6.16

(6.02 to 6.30)

10.7

(12.7 to 8.6)

287
(4)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 10.9%.

Randomised and before and after design not different P = 0.86.

Total cholesterol

fluvastatin

20 mg/day

6.99

(6.61 to 7.37)

5.96

(5.94 to 5.98)

14.8

(15.1 to 14.5)

6309
(50)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 15.2%.

Randomised versus before and after design borderline different P = 0.044.

Total cholesterol

fluvastatin

40 mg/day

6.91

(6.54 to 7.27)

5.60

(5.57 to 5.64)

18.9

(19.3 to 18.4)

2966
(55)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 19.4%.

Randomised and before and after design not different P = 0.106.

Total cholesterol

fluvastatin

80 mg/day

6.97

(6.62, 7.32)

5.24

(5.12 to 5.27)

24.9

(25.5 to 24.4)

3943
(27)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 23.6%.

Randomised and before and after design not different P = 0.595.

CI: Confidence interval

1. Mean baseline values.

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Triglyceride lowering efficacy of fluvastatin

Patient or population: participants with normal or abnormal lipid profiles

Settings: ambulatory care

Intervention: fluvastatin

Comparison: Triglyceride percentage change from baseline for all trials

Outcomes

Anticipated absolute effects

mmol/L (95%CI)

Percent Reduction
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Before exposure to fluvastatin¹

After exposure to fluvastatin

Triglycerides

fluvastatin

10 mg/day

1.93

(1.63 to 2.22)

1.87

(1.73 to 2.01)

3.0

(10.1 to ‐4.2)

259
(3)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 5.2%.

Only RCT data.

Triglycerides

fluvastatin

20 mg/day

1.98

(1.68 to 2.28)

1.76

(1.74 to 1.77)

11.1

(11.8 to 10.3)

7510
(39)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 9.4%.

Randomised and before and after design not different P = 0.277.

Triglycerides

fluvastatin

40 mg/day

1.94

(1.70 to 2.17)

1.72

(1.69 to 1.75)

11.1

(12.6 to 9.6)

2646
(48)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 13.6%

Randomised and before and after design not different P = 0.186.

Triglycerides

fluvastatin

80 mg/day

1.92

(1.67 to 2.17)

1.59

(1.56 to 1.62)

17.5

(19.1 to 15.9)

3623
(23)

⊕⊕⊕⊕
high

Effect predicted from log dose‐response equation is 17.7%

Randomised and before and after design not different P = 0.496.

CI: Confidence interval

1. Mean baseline values.

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Withdrawal due to adverse events due to fluvastatin
Patient or population: participants with normal or abnormal lipid profiles Settings: ambulatory care Intervention: fluvastatin Comparison: WDAEs fluvastatin versus placebo
Outcomes	*Illustrative Comparative Risks (95%CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	placebo	fluvastatin
WDAEs within 3‐12 weeks			RR 1.52 (0.94 to 2.45)	3023 (16)	⊕⊝⊝⊝ very low^1,2	only 16 out of 36 placebo controlled trials reported withdrawals due to adverse effects.
	18 per 1000	27 per 1000 (17 to 44)




The basis for the assumed risk* is the measure of absolute effect with the placebo group. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1. Downgraded 2 levels due to high risk of selective reporting and other biases. 2. Downgraded 1 level due to wide confidence intervals.

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Table 1. Fluvastatin Overall Efficacy

Fluvastatin dose (mg/day)	2.5	5	10	20	30	40	80
Total Cholesterol (mean percentage change from control)	‐9.8	‐11.7	‐10.7	‐14.8	‐18.0	‐18.85	‐24.9
95% confidence interval	(‐12.0 to ‐7.7)	(‐14.2 to ‐9.2)	(‐12.7 to ‐8.6)	(‐15.1 to ‐14.5)	(‐19.2 to ‐16.7)	(‐19.3 to ‐18.4)	(‐25.4 to ‐24.4)
LDL‐C^a (mean percentage change from control)	‐12.1	‐14.5	‐15.2	‐20.0	‐25.3	‐25.9	‐34.9
95% confidence interval	(‐14.2 to ‐10.1)	(‐16.3 to ‐12.7)	(‐17.1 to ‐13.3)	(‐20.3 to ‐19.7)	(‐26.9 to ‐23.7)	(‐26.5 to ‐25.3)	(‐35.5 to ‐34.3)
Triglycerides (mean percentage change from control)	‐3.3	‐5.3	‐3.0	‐11.1	‐5.9	‐11.1	‐17.5
95% confidence interval	(‐14.6 to 8.0)	(‐13.1 to 2.5)	(‐10.1 to 4.2)	(‐11.8 to ‐10.3)	(‐20.1 to 8.3)	(‐12.6 to ‐9.6)	(‐19.1 to ‐15.9)
^aLDL‐C: low‐density lipoprotein cholesterol

Table 1. Fluvastatin Overall Efficacy

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Comparison 1. 2.5 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	2	338	Mean Difference (IV, Fixed, 95% CI)	‐11.91 [‐14.14, ‐9.69]

2 WDAEs Show forest plot	1	173	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 7.98]

Comparison 1. 2.5 mg vs control

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Comparison 2. 5 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	2	332	Mean Difference (IV, Fixed, 95% CI)	‐15.76 [‐18.91, ‐12.60]

2 LDL‐cholesterol Show forest plot	2	91	Mean Difference (Fixed, 95% CI)	‐13.85 [‐16.02, ‐11.69]

3 WDAEs Show forest plot	1	171	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.16]

Comparison 2. 5 mg vs control

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Comparison 3. 10 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	5	570	Mean Difference (IV, Random, 95% CI)	‐14.49 [‐17.95, ‐11.02]

2 Total cholesterol Show forest plot	3	259	Mean Difference (IV, Random, 95% CI)	‐8.44 [‐13.95, ‐2.93]

3 HDL‐cholesterol Show forest plot	3	259	Mean Difference (IV, Fixed, 95% CI)	1.86 [‐1.28, 5.00]

4 Triglycerides Show forest plot	3	259	Mean Difference (IV, Fixed, 95% CI)	‐2.96 [‐10.19, 4.28]

5 WDAEs Show forest plot	2	211	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.16]

Comparison 3. 10 mg vs control

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Comparison 4. 20 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	14	2329	Mean Difference (IV, Fixed, 95% CI)	‐20.82 [‐21.88, ‐19.77]

2 Total cholesterol Show forest plot	12	2023	Mean Difference (IV, Fixed, 95% CI)	‐15.81 [‐16.75, ‐14.88]

3 HDL‐cholesterol Show forest plot	10	1727	Mean Difference (IV, Fixed, 95% CI)	2.33 [0.90, 3.77]

4 Triglycerides Show forest plot	10	1712	Mean Difference (IV, Fixed, 95% CI)	‐9.67 [‐12.61, ‐6.73]

5 LDL‐cholesterol Show forest plot	41	6681	Mean Difference (Random, 95% CI)	‐20.92 [‐21.83, ‐20.02]

6 Total cholesterol Show forest plot	38	4286	Mean Difference (Random, 95% CI)	‐15.68 [‐16.67, ‐14.68]

7 HDL‐cholesterol Show forest plot	32	6239	Mean Difference (Random, 95% CI)	5.34 [4.51, 6.17]

8 Triglycerides Show forest plot	29	5798	Mean Difference (Random, 95% CI)	‐9.15 [‐11.36, ‐6.94]

9 WDAE Show forest plot	7	1060	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.14, 5.46]

Comparison 4. 20 mg vs control

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Comparison 5. 30 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	7	336	Mean Difference (Random, 95% CI)	‐24.03 [‐27.72, ‐20.34]

2 Total cholesterol Show forest plot	6	285	Mean Difference (Random, 95% CI)	‐17.23 [‐19.68, ‐14.78]

3 HDL‐cholesterol Show forest plot	2	47	Mean Difference (Random, 95% CI)	7.86 [‐0.36, 16.07]

Comparison 5. 30 mg vs control

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Comparison 6. 40 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	11	1275	Mean Difference (IV, Random, 95% CI)	‐27.04 [‐30.69, ‐23.40]

2 Total cholesterol Show forest plot	11	1276	Mean Difference (IV, Random, 95% CI)	‐18.21 [‐21.17, ‐15.26]

3 HDL‐cholesterol Show forest plot	6	716	Mean Difference (IV, Fixed, 95% CI)	5.14 [2.86, 7.41]

4 Triglycerides Show forest plot	10	1198	Mean Difference (IV, Fixed, 95% CI)	‐13.53 [‐17.27, ‐9.78]

5 LDL‐cholesterol Show forest plot	46	2383	Mean Difference (Random, 95% CI)	‐26.41 [‐27.67, ‐25.14]

6 Total cholesterol Show forest plot	44	1690	Mean Difference (Random, 95% CI)	‐19.52 [‐20.60, ‐18.45]

7 HDL‐cholesterol Show forest plot	35	1354	Mean Difference (Random, 95% CI)	3.87 [2.06, 5.68]

8 Triglycerides Show forest plot	38	1448	Mean Difference (Random, 95% CI)	‐11.23 [‐14.07, ‐8.40]

9 WDAE Show forest plot	4	236	Risk Ratio (M‐H, Fixed, 95% CI)	3.47 [0.75, 16.11]

Comparison 6. 40 mg vs control

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Comparison 7. 80 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 LDL‐cholesterol Show forest plot	10	2727	Mean Difference (IV, Random, 95% CI)	‐34.62 [‐38.60, ‐30.64]

2 Total cholesterol Show forest plot	10	2757	Mean Difference (IV, Random, 95% CI)	‐25.76 [‐28.10, ‐23.41]

3 HDL‐cholesterol Show forest plot	9	2644	Mean Difference (IV, Random, 95% CI)	1.06 [‐2.26, 4.38]

4 Triglycerides Show forest plot	10	2756	Mean Difference (IV, Fixed, 95% CI)	‐17.28 [‐19.63, ‐14.92]

5 LDL‐cholesterol Show forest plot	22	2201	Mean Difference (Random, 95% CI)	‐33.04 [‐35.17, ‐30.90]

6 Total cholesterol Show forest plot	17	1186	Mean Difference (Random, 95% CI)	‐23.27 [‐24.99, ‐21.55]

7 HDL‐cholesterol Show forest plot	13	828	Mean Difference (Random, 95% CI)	3.36 [‐0.50, 7.22]

8 Triglycerides Show forest plot	13	867	Mean Difference (Random, 95% CI)	‐20.04 [‐26.35, ‐13.73]

9 WDAEs Show forest plot	4	1430	Risk Ratio (M‐H, Fixed, 95% CI)	1.33 [0.71, 2.51]

Comparison 7. 80 mg vs control

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Comparison 8. all doses vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 WDAEs Show forest plot	16	3023	Risk Ratio (M‐H, Fixed, 95% CI)	1.52 [0.94, 2.45]

Comparison 8. all doses vs control

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