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Table 1 Key characteristics of included studies.

From: The impact of statins on psychological wellbeing: a systematic review and meta-analysis

Lead author, year, reference

Study design

Agent/dosage

Sample

Measure

Presentation of results

Key finding

Muldoon 2000 [28]

Double-blind, randomized, placebo-controlled trial

Lovastatin (20 mg)/placebo

209 generally healthy adults with LDL cholesterol level of 160 mg/dl or higher were randomized (complete data: drug, n = 98; placebo, n = 96)

Hamilton Depression Rating Scale; NEO-Depression

Means and SDs

24-week treatment of hypercholesterolemia with lovastatin did not cause psychological distress

Wardle 1996 [23]

Randomized, placebo-controlled trial

Simvastatin 20 mg or 40 mg daily/placebo

621 individuals greater higher than average risk of CHD based on medical history (total cholesterol of ≥3.5 mmol/l) were randomized (complete data: drug, n = 334; placebo, n = 157)

Shortened profile of Mood States Questionnaire

Medians and IQRs

152 weeks of cholesterol-lowering treatment did not cause mood disturbance

Hyyppa 2003c

Two separate randomizations, Double-blind, crossover design

Simvastatin 20 mg/day plus dietary intervention/placebo

120 hypercholesterolemic but otherwise healthy middle-aged men (complete data: drug, n = 60; placebo, n = 60)

Brief Symptom Inventory

Mean difference in change scores between groups, SEM

12 weeks of simvastatin resulted in a statistically significant increase in depression

Harrison 1994 [24]

Randomized, crossover design

Sequential placebo, pravastatin 40 mg day/simvastatin 40 mg day, in separate 4-week treatment phases

25 healthy volunteers (17 male, 8 female), average age 23.8 years. Drug, n = 25/n = 25; placebo, n = 25. HADS score for pravastatin was 1.5 (0.6 to 2.4).

HADS, BDI (baseline only)

Means and CIs

No association between simvastatin and depression or anxiety at 4 weeks

Gengo 1995 [25]

Randomized, cross over design

Placebo, lovastatin (40 mg), and pravastatin (40 mg) for 4 weeks

36 patients between the ages of 40 and 60 years with moderate hypercholesterolemia. Drug, n = 24/n = 24; placebo, n = 24. Mood scores for pravastatin 4.8 (6.5).

Profile of Mood States (fatigue/inertia)

Means and SDs

After 4 weeks, no statistically significant differences between lovastatin in changes from baseline were observed on any parameter

Stewart 2000 [26]

Randomized, double-blind, placebo-controlled trial

Pravastatin sodium (40 mg/day) for 4 years

1130 with stable CAD. Drug, n = 559; placebo, n = 571.

General Health Questionnaire (depression and anxiety domains)

Means and SDs

After 4 years no significant increases in self-reported depression, anxiety

Morales 2006 [27]

Randomized, placebo-controlled trial

Simvastatin up to 20 mg/day or placebo for 15 weeks

80 older volunteers, average age 70 years, with high normal/mildly elevated serum cholesterol (placebo, n = 39; drug completers, n = 33)

Center for Epidemiology Studies Depression Scale

Mean and SDs

After 3 months, drug group reported decrease in positive affect