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. 2020 Jun 19;2020(6):CD012735. doi: 10.1002/14651858.CD012735.pub2

Stender 2013.

Study characteristics
Methods Study design: Historically controlled trial
Study grouping: Parallel group
Method: 6 to 8‐week washout/dietary period; 12‐week before‐and‐after study
Participants Baseline Characteristics
1 mg

  • n: 207

  • Age (years): 70

  • Males (n): 89

  • Females (n): 118

  • Total cholesterol: 253.4 mg/dL (6.55 mmol/L)

  • LDL cholesterol: 164.4 mg/dL (4.25 mmol/L)

  • HDL cholesterol: 60.8 mg/dL (1.57 mmol/L)

  • Triglycerides: 141.2 mg/dL (1.59mmol/L)


2 mg

  • n: 224

  • Age (years): 70.5

  • Males (n): 100

  • Females (n): 124

  • Total cholesterol: 250.5 mg/dL (6.48 mmol/L)

  • LDL cholesterol: 162.8 mg/dL (4.21 mmol/L)

  • HDL cholesterol: 60.2 mg/dL (1.56 mmol/L)

  • Triglycerides: 137.2 mg/dL (1.55 mmol/L)


2 mg then titrated to 4 mg at 4 weeks

  • n: 210

  • Age (years): 70.2

  • Males (n): 89

  • Females (n): 121

  • Total cholesterol: 250.7 mg/dL (6.48 mmol/L)

  • LDL cholesterol: 163.5 mg/dL (4.23 mmol/L)

  • HDL cholesterol: 58.1 mg/dL (1.50 mmol/L)

  • Triglycerides: 145.4 mg/dL (1.64 mmol/L)


Included criteria: Enroled patients were at least 65 years of age with a diagnosis of primary hypercholesterolaemia or combined (mixed) dyslipidaemia [plasma LDL‐C between 3.4 mmol/L (130 mg/dL) and 5.7 mmol/L (220 mg/dL) despite dietary therapy, and moderately elevated triglyceride levels ≤ 4.6 mmol/L (400 mg/dL)] at two consecutive assessments during a washout and dietary lead‐in period.
Excluded criteria: Exclusion criteria included homozygous familial hypercholesterolaemia or condition(s) that could cause secondary dyslipidaemia; uncontrolled medical conditions, including diabetes mellitus (glycated haemoglobin > 8%), uncontrolled hypothyroidism, defined as concentrations of thyroid‐stimulating hormone above the upper limit of the reference range (ULRR); and poorly controlled or uncontrolled hypertension (systolic blood pressure > 160 mmHg and diastolic blood pressure > 90 mmHg) with or without antihypertensive therapy; gastrointestinal conditions that may have interfered with drug absorption; impaired liver or renal function; serum creatine kinase (CK) more than five times the ULRR; or significant CVD, such as MI, coronary or peripheral artery angioplasty, bypass graft surgery, or severe or unstable angina pectoris.
Baseline Group Characteristics: Groups were well matched in terms of their demographic and other baseline characteristics.
Interventions Intervention Characteristics
1 mg
2 mg
2 mg then titrated to 4 mg at 4 weeks
Outcomes Total cholesterol

  • Outcome type: Continuous

  • Reporting: Partially reported

  • Unit of measure: Percentage change from baseline

  • Direction: Lower is better


LDL cholesterol

  • Outcome type: Continuous

  • Reporting: Partially reported

  • Unit of measure: Percentage change from baseline

  • Direction: Lower is better


HDL cholesterol

  • Outcome type: ContinuousOutcome

  • Reporting: Partially reported

  • Unit of measure: Percentage change from baseline

  • Direction: Higher is better


Triglycerides

  • Outcome type: Continuous

  • Reporting: Partially reported

  • Unit of measure: Percentage change from baseline

  • Direction: Lower is better
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Judgement Comment: Controlled before‐and‐after design
Allocation concealment (selection bias) High risk Judgement Comment: Controlled before‐and‐after design
Blinding of participants and personnel (performance bias)
All outcomes Low risk Judgement Comment: Lipid parameter measurements unlikely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement Comment: Lipid parameters were measured in a remote laboratory.
Selective reporting (reporting bias) Low risk Judgement Comment: LDL‐cholesterol outcome was reported.
Other bias High risk Judgement Comment: This study was supported by Kowa Research Europe.
Incomplete outcome data (attrition bias) Total cholesterol Low risk [(209 ‐ 207)/209]*100 = 1.0% participants were not included in the efficacy analysis for 1 mg/day dose; [(226 ‐ 224)/226]*100 = 0.9% participants were not included in the efficacy analysis for 2 mg/day dose.
Incomplete outcome data (attrition bias) LDL cholesterol) Low risk Pitavastatin 1 mg/day: 4 weeks [(209 ‐ 197)/209]*100 = 5.7%, 8 weeks [(209 ‐ 192)/209]*100 = 8.1%, 12 weeks [(209 ‐ 188)/209]*100 = 10.0% participants were not included in the efficacy analysis.
Pitavastatin 2 mg/day: 4 weeks [(226 ‐ 217)/226]*100 = 4.0%, 8 weeks [(226 ‐ 214)/226]*100 = 5.3%, 12 weeks [(226 ‐ 208)/226]*100 = 8.0% participants were not included in the efficacy analysis.
Pitavastatin 2 mg/day at 4 weeks then uptitrated to 4 mg/day from 8‐12 weeks: [(216 ‐ 203)/216]*100 = 6.0% participants were not included in the efficacy analysis.
Incomplete outcome data (attrition bias) HDL cholesterol Low risk [(209 ‐ 207)/209]*100 = 1.0% participants were not included in the efficacy analysis for 1 mg/day dose; [(226 ‐ 224)/226]*100 = 0.9% participants were not included in the efficacy analysis for 2 mg/day dose.
Incomplete outcome data (attrition bias) Triglycerides Low risk [(209 ‐ 207)/209]*100 = 1.0% participants were not included in the efficacy analysis for 1 mg/day dose; [(226 ‐ 224)/226]*100 = 0.9% participants were not included in the efficacy analysis for 2 mg/day dose.
Blinding of outcome assessment (detection bias)WDAEs High risk No comparison possible
Selective reporting (reporting bias) for WDAEs High risk No WDAE outcome reported