Pitavastatin for lowering lipids

Stephen P Adams; Nima Alaeiilkhchi; James M Wright

doi:10.1002/14651858.CD012735.pub2

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Figure 1

Study flow diagram for pitavastatin.

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Figure 2

Number of included trials according to publication year

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Figure 3

Log dose pitavastatin 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 4

Log dose pitavastatin 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 5

Log dose pitavastatin 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 summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1: 1 mg vs control, Outcome 1: LDL cholesterol RCTs

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Analysis 1.2

Comparison 1: 1 mg vs control, Outcome 2: Total cholesterol RCTs

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Analysis 1.3

Comparison 1: 1 mg vs control, Outcome 3: HDL cholesterol RCTs

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Analysis 1.4

Comparison 1: 1 mg vs control, Outcome 4: Triglycerides RCTs

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Analysis 1.5

Comparison 1: 1 mg vs control, Outcome 5: LDL‐cholesterol non‐RCTs

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Analysis 1.6

Comparison 1: 1 mg vs control, Outcome 6: Total cholesterol non‐RCTs

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Analysis 1.7

Comparison 1: 1 mg vs control, Outcome 7: HDL‐cholesterol non‐RCTs

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Analysis 1.8

Comparison 1: 1 mg vs control, Outcome 8: Triglycerides non‐RCTs

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Analysis 1.9

Comparison 1: 1 mg vs control, Outcome 9: WDAE

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Analysis 2.1

Comparison 2: 2 mg vs control, Outcome 1: LDL cholesterol RCTs

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Analysis 2.2

Comparison 2: 2 mg vs control, Outcome 2: Total cholesterol RCTs

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Analysis 2.3

Comparison 2: 2 mg vs control, Outcome 3: HDL cholesterol RCTs

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Analysis 2.4

Comparison 2: 2 mg vs control, Outcome 4: Triglycerides RCTs

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Analysis 2.5

Comparison 2: 2 mg vs control, Outcome 5: LDL‐cholesterol non‐RCTs

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Analysis 2.6

Comparison 2: 2 mg vs control, Outcome 6: Total cholesterol non‐RCTs

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Analysis 2.7

Comparison 2: 2 mg vs control, Outcome 7: HDL‐cholesterol non‐RCTs

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Analysis 2.8

Comparison 2: 2 mg vs control, Outcome 8: Triglycerides non‐RCTs

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Analysis 2.9

Comparison 2: 2 mg vs control, Outcome 9: WDAE

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Analysis 3.1

Comparison 3: 4 mg vs control, Outcome 1: LDL‐cholesterol RCTs

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Analysis 3.2

Comparison 3: 4 mg vs control, Outcome 2: Total cholesterol RCTs

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Analysis 3.3

Comparison 3: 4 mg vs control, Outcome 3: HDL cholesterol RCTs

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Analysis 3.4

Comparison 3: 4 mg vs control, Outcome 4: Triglycerides RCTs

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Analysis 3.5

Comparison 3: 4 mg vs control, Outcome 5: LDL‐cholesterol non‐RCTs

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Analysis 3.6

Comparison 3: 4 mg vs control, Outcome 6: Total cholesterol non‐RCTs

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Analysis 3.7

Comparison 3: 4 mg vs control, Outcome 7: HDL‐cholesterol non‐RCTs

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Analysis 3.8

Comparison 3: 4 mg vs control, Outcome 8: Triglycerides non‐RCTs

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Analysis 3.9

Comparison 3: 4 mg vs control, Outcome 9: WDAE

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Analysis 4.1

Comparison 4: 8 mg vs control, Outcome 1: LDL cholesterol RCTs

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Analysis 4.2

Comparison 4: 8 mg vs control, Outcome 2: Total cholesterol RCTs

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Analysis 4.3

Comparison 4: 8 mg vs control, Outcome 3: HDL cholesterol RCTs

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Analysis 4.4

Comparison 4: 8 mg vs control, Outcome 4: Triglycerides RCTs

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Analysis 5.1

Comparison 5: 16 mg vs control, Outcome 1: LDL cholesterol RCTs

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Analysis 6.1

Comparison 6: All doses of pitavastatin vs placebo, Outcome 1: WDAE

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Summary of findings 1. Low‐density lipoprotein (LDL) cholesterol‐lowering efficacy of pitavastatin

pitavastatin dose	Anticipated absolute effects mmol/L (95%CI)		Percentage change from baseline (95% CI)	No of participants (trials)	Certainty of the evidence (GRADE)	Comments
Low‐density lipoprotein (LDL) cholesterol‐lowering efficacy of pitavastatin
Patient or population: participants with normal or abnormal lipid profiles Settings: ambulatory clinics Intervention: different fixed doses of pitavastatin Comparison: placebo or baseline

	LDL‐cholesterol before exposure to pitavastatin^a	LDL‐cholesterol after exposure to pitavastatin
1 mg/day	5.06 (4.39 to 5.74)	3.38 (3.32 to 3.44)	‐33.2 (‐34.3 to ‐32.1)	759 (10)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response curve, ‐33.3%
2 mg/day	4.51 (4.24 to 4.79)	2.77 (2.75 to 2.79)	‐38.65 (‐39.1 to ‐38.2)	3847 (36)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response curve, ‐38.6%
4 mg/day	5.04 (4.24 to 5.85)	2.82 (2.73 to 2.91)	‐44.0 (‐45.8 to ‐42.3)	469 (7)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response curve, ‐44.0%
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.
^aMean baseline values.

Summary of findings 1. Low‐density lipoprotein (LDL) cholesterol‐lowering efficacy of pitavastatin

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Summary of findings 2. Total cholesterol‐lowering efficacy of pitavastatin

Pitavastatin dose	Anticipated absolute effects mmol/L (95%CI)		Percentage change from baseline (95% CI)	№ of participants (trials)	Certainty of the evidence (GRADE)	Comments
Total cholesterol‐lowering efficacy ofpitavastatin
Patient or population: participants with normal or abnormal lipid profiles Settings: ambulatory clinics Intervention: different fixed doses of pitavastatin Comparison: placebo or baseline

	Total cholesterol before exposure to pitavastatin^a	Total cholesterol after exposure to pitavastatin
1 mg/day	7.24 (6.67 to 7.82)	5.55 (5.49 to 5.60)	‐23.4 (‐24.2 to ‐22.7)	777 (10)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response equation is ‐23.3%
2 mg/day	6.65 (6.33 to 6.97)	4.84 (4.81 to 4.87)	‐27.25 (‐27.65 to ‐26.84)	2789 (32)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response equation is ‐27.3%
4 mg/day	7.21 (6.49 to 7.94)	4.97 (4.87 to 5.07)	‐31.1 (‐32.4 to ‐29.7)	477 (7)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response equation is ‐31.2%
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.
^aMean baseline values.

Summary of findings 2. Total cholesterol‐lowering efficacy of pitavastatin

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Summary of findings 3. Triglyceride‐lowering efficacy of pitavastatin

Pitavastatin dose	Anticipated absolute effects mmol/L (95%CI)		Percentage change from baseline (95% CI)	№ of participants (trials)	Certainty of the evidence (GRADE)	Comments
Triglyceride‐lowering efficacy of pitavastatin
Patient or population: participants with normal or abnormal lipid profiles Settings: ambulatory clinics Intervention: different fixed doses of pitavastatin Comparison: placebo or baseline

	Triglycerides before exposure to pitavastatin^a	Triglycerides after exposure to pitavastatin
1 mg/day	1.71 (1.27 to 2.15)	1.49 (1.45 to 1.52)	‐13.1 (‐15.4 to ‐10.85)	673 (8)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response equation is ‐13.0%
2 mg/day	1.88 (1.75 to 2.02)	1.56 (1.54 to 1.59)	‐16.8 (‐18.2 to ‐15.5)	2035 (26)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response equation is ‐16.8%
4 mg/day	2.04 (1.29 to 2.79)	1.67 (1.57 to 1.77)	‐18.0 (‐23.0 to ‐13.0)	424 (6)	⊕⊕⊕⊕ high	Effect predicted from log dose‐response equation is ‐20.6%
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.
^aMean baseline values.

Summary of findings 3. Triglyceride‐lowering efficacy of pitavastatin

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Table 1. Pitavastatin overall efficacy

Pitavastatin dose mg/day

Mean percentage

change from control

of LDL‐C^a

(95% confidence interval)

‐33.2

(‐34.3 to ‐32.1)

‐38.65

(‐39.1 to ‐38.2)

‐44.0

(‐45.8 to ‐42.3)

‐48.7

(‐52.4 to ‐45.0)

‐54.5

(‐59.4 to ‐49.6)

Mean percentage

change from

control of total

cholesterol

(95% confidence interval)

‐23.4

(‐24.2 to ‐22.7)

‐27.25

(‐27.65 to ‐26.84)

‐31.1

(‐32.4 to ‐29.7)

‐37.0

(‐41.4 to ‐32.6)

Mean percentage

change from

control

of triglycerides

(95% confidence interval)

‐13.1

(‐15.4 to ‐10.85)

‐16.8

(‐18.2 to ‐15.5)

‐18.0

(‐23.0 to ‐13.0)

‐32.9

(‐45.0 to ‐20.8)

^aLDL‐C: low‐density lipoprotein cholesterol

Table 1. Pitavastatin overall efficacy

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Comparison 1. 1 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 LDL cholesterol RCTs Show forest plot	3	255	Mean Difference (IV, Fixed, 95% CI)	‐26.85 [‐29.89, ‐23.81]

1.2 Total cholesterol RCTs Show forest plot	3	255	Mean Difference (IV, Fixed, 95% CI)	‐19.43 [‐21.90, ‐16.97]

1.3 HDL cholesterol RCTs Show forest plot	2	202	Mean Difference (IV, Fixed, 95% CI)	6.28 [3.36, 9.20]

1.4 Triglycerides RCTs Show forest plot	2	202	Mean Difference (IV, Fixed, 95% CI)	‐19.22 [‐28.52, ‐9.91]

1.5 LDL‐cholesterol non‐RCTs Show forest plot	7	504	Mean Difference (IV, Random, 95% CI)	‐33.37 [‐35.87, ‐30.86]

1.6 Total cholesterol non‐RCTs Show forest plot	7	522	Mean Difference (IV, Random, 95% CI)	‐23.51 [‐25.98, ‐21.04]

1.7 HDL‐cholesterol non‐RCTs Show forest plot	5	402	Mean Difference (IV, Random, 95% CI)	3.71 [‐1.29, 8.70]

1.8 Triglycerides non‐RCTs Show forest plot	6	471	Mean Difference (IV, Fixed, 95% CI)	‐12.72 [‐15.05, ‐10.38]

1.9 WDAE Show forest plot	2		Risk Ratio (IV, Fixed, 95% CI)	Totals not selected

Comparison 1. 1 mg vs control

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Comparison 2. 2 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 LDL cholesterol RCTs Show forest plot	3	253	Mean Difference (IV, Fixed, 95% CI)	‐31.00 [‐34.09, ‐27.90]

2.2 Total cholesterol RCTs Show forest plot	3	253	Mean Difference (IV, Fixed, 95% CI)	‐22.77 [‐25.32, ‐20.22]

2.3 HDL cholesterol RCTs Show forest plot	2	200	Mean Difference (IV, Fixed, 95% CI)	6.25 [3.32, 9.19]

2.4 Triglycerides RCTs Show forest plot	2	200	Mean Difference (IV, Fixed, 95% CI)	‐24.63 [‐33.45, ‐15.80]

2.5 LDL‐cholesterol non‐RCTs Show forest plot	33	3594	Mean Difference (IV, Random, 95% CI)	‐37.97 [‐39.53, ‐36.41]

2.6 Total cholesterol non‐RCTs Show forest plot	29	2536	Mean Difference (IV, Fixed, 95% CI)	‐27.36 [‐27.77, ‐26.96]

2.7 HDL‐cholesterol non‐RCTs Show forest plot	28	1996	Mean Difference (IV, Random, 95% CI)	3.98 [2.40, 5.55]

2.8 Triglycerides non‐RCTs Show forest plot	24	1835	Mean Difference (IV, Fixed, 95% CI)	‐16.66 [‐18.00, ‐15.31]

2.9 WDAE Show forest plot	2		Risk Ratio (IV, Fixed, 95% CI)	Totals not selected

Comparison 2. 2 mg vs control

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Comparison 3. 4 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 LDL‐cholesterol RCTs Show forest plot	4	315	Mean Difference (IV, Fixed, 95% CI)	‐39.97 [‐42.86, ‐37.08]

3.2 Total cholesterol RCTs Show forest plot	4	315	Mean Difference (IV, Random, 95% CI)	‐28.09 [‐32.73, ‐23.46]

3.3 HDL cholesterol RCTs Show forest plot	3	264	Mean Difference (IV, Fixed, 95% CI)	6.65 [3.57, 9.73]

3.4 Triglycerides RCTs Show forest plot	3	264	Mean Difference (IV, Fixed, 95% CI)	‐24.81 [‐32.20, ‐17.41]

3.5 LDL‐cholesterol non‐RCTs Show forest plot	3	154	Mean Difference (IV, Fixed, 95% CI)	‐46.39 [‐48.54, ‐44.24]

3.6 Total cholesterol non‐RCTs Show forest plot	3	162	Mean Difference (IV, Fixed, 95% CI)	‐32.28 [‐33.95, ‐30.60]

3.7 HDL‐cholesterol non‐RCTs Show forest plot	4	319	Mean Difference (IV, Random, 95% CI)	6.69 [‐1.04, 14.43]

3.8 Triglycerides non‐RCTs Show forest plot	3	160	Mean Difference (IV, Fixed, 95% CI)	‐12.00 [‐18.87, ‐5.14]

3.9 WDAE Show forest plot	3		Risk Ratio (IV, Fixed, 95% CI)	Totals not selected

Comparison 3. 4 mg vs control

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Comparison 4. 8 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 LDL cholesterol RCTs Show forest plot	2	256	Mean Difference (IV, Random, 95% CI)	‐48.96 [‐54.93, ‐43.00]

4.2 Total cholesterol RCTs Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	‐37.00 [‐41.46, ‐32.54]

4.3 HDL cholesterol RCTs Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	6.00 [0.44, 11.56]

4.4 Triglycerides RCTs Show forest plot	1	100	Mean Difference (IV, Fixed, 95% CI)	‐32.90 [‐45.17, ‐20.63]

Comparison 4. 8 mg vs control

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Comparison 5. 16 mg vs control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 LDL cholesterol RCTs Show forest plot	1	156	Mean Difference (IV, Fixed, 95% CI)	‐54.50 [‐59.47, ‐49.53]

Comparison 5. 16 mg vs control

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Comparison 6. All doses of pitavastatin vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 WDAE Show forest plot	3	371	Risk Ratio (IV, Fixed, 95% CI)	1.35 [0.15, 12.04]

Comparison 6. All doses of pitavastatin vs placebo

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