Supplementary Digital Content 2. Potential risks of statin therapy in trials of statin vs placebo and more intensive vs less intensive statin
therapy
Study
No. of trials
included
Comparison
No of subjects
Population/age
Follow up
Results/Outcomes
Conclusions
134,537
Primary and secondary
prevention
Median: 4.8y
Risk of Cancer Incidence:
No effect on cancer incidence or
cancer mortality irrespective of age.
Meta-analyses of individual participant data from RCTs
Cancer
**CTT
Collaborators
2012 Plos One
[1]
Individual patient
data from 27 RCTS
Statin vs. control
RR 1.00, 95% CI 0.96-1.05
More intensive vs.
less intensive
39,612
Mean age: 63y
Age<60y RR 1.00, 95% CI 0.89-1.12
statin therapy
Age 60-70y RR 0.97 95% CI 0.90-1.03
Age 70-75y RR 1.01 95% CI 0.91-1.13
Age ≥75y RR 1.05 95% CI 0.92-1.21
Risk of Cancer mortality:
RR 1.00, 95% CI 0.93-1.08
Age<60y RR 0.94, 95% CI 0.76-1.17
Age 60-70y RR 0.99 95% CI 0.87-1.13
Age 70-75y RR 1.03 95% CI 0.87-1.22
Age ≥75y RR 0.91 95% CI 0.74-1.12
Meta-analyses of published tabular data from RCTs
Myopathy
*Alberton et al
2012 Q J Med
[2]
36 RCTs
(rhabdomylosis)
Statin vs. control
139,029
(rhabdomylosis)
Mean age 59.8y
Range 0.5-6.1 y
Risk of rhabdomyolysis (36 RCTs):
Mean 2.7y
OR 1.05, 95% CI 0.84-1.31
26 RCTs (creatinine
kinase)
Statins were not associated with a
significant increase in risk of
rhabdomyolysis or rise in CK
Atorvastatin OR 1.38, 95% CI 0.61-3.13
Pravastatin OR 1.08, 95% CI 0.82-1.41
Fluvastatin OR (4 RCTs) 2.68, 95% CI 0.68-10.56
Lovastatin OR (3 RCTs) 1.33, 95% CI 0.27-6.58
Rosuvastatin OR (5 RCTs) 0.73, 95% CI 0.17-3.09
Simvastatin OR (3 RCTs) 1.84, 95% CI 0.50-6.79
Risk of increased creatinine kinase 10x (26 RCTs):
OR 1.09, 95% CI0.85-1.41
Atorvastatin OR 1.21, 95% CI 0.19-7.90
Pravastatin OR 1.21, 95% CI 0.96-1.54
Fluvastatin OR (6 RCTs) 0.60, 95% CI 0.18-2.03
Lovastatin OR (2 RCTs) 0.85, 95% CI 0.52-1.41
Rosuvastatin OR (4 RCTs) 0.52, 95% CI 0.16-1.64
Simvastatin OR (2 RCTs) 2.28, 95% CI 0.92-5.69
*Naci H et al
2013 Circ
Cardiovasc Qual
Outcomes [3]
135 RCTs
55 two-armed
placebo-controlled
trials, 80 twoarmed or multiarmed active
comparator trials
Statins vs. placebo
Placebo controlled
trial 43,531
Network meta analysis
84,391
Dose level network
meta analysis 99,433
A range of populations
eligible for statin therapy.
average 68 weeks
Myalgia incidence:
Placebo controlled trials: Statins vs. controls: OR 1.07; 95%
CI, 0.89–1.29; I2, 22.1%
Simvastatin vs Atorvastatin: OR 0.56; 95% CI, 0.42–0.75; I2,
0.0%
Statins were not associated with a
significant increase in risk of
myalgia or rise in CK
Network meta-analysis : no significant differences between
individual statins
Dose-level network meta-analysis: lack of an apparent dose–
response relationship, no statistically detectable differences
between individual statin–dose combinations and control
treatment
Creatine Kinase Elevations
Pairwise meta-analysis placebo-controlled trials (N=
101,324): OR 1.13; 95% CI, 0.85–1.51; I2, 20.4%.
Network meta-analysis individual statins (N= 127,571):
Pitavastatin vs control OR 3.63; 95% CrI, 1.10–14.10
Fluvastatin significantly lower odds compared with all other
statins except lovastatin
Dose-level network meta-analysis (N= 137,980): Simvastatin
>40 mg/d vs control OR 4.14; 95% CrI, 1.08–16.24.
Small dose–response relationship higher doses lovatatin
Myopathy
Network meta-analysis:
Atorvastatin vs control OR 1.21; 95% CrI, 0.25–4.95
Pravastatin vs control OR 1.06; 95% CrI, 0.18–4.81
Rosuvastatin vs control OR 0.91; 95% CrI, 0.12–4.43
Simvastatin vs control OR 1.23; 95% CrI, 0.29–4.21
Rhabdomyosis
Network meta-analysis:
Atorvastatin vs control OR 1.33; 95% CrI, 0.31–6.92
Pravastatin vs control OR 0.20; 95% CrI, 0.00–11.15
Rosuvastatin vs control OR 0.19; 95% CrI, 0.00–9.22
Simvastatin vs control OR 2.03; 95% CrI, 0.40–14.81
Palmer et al
2012 Ann Int
Med [4]
17 RCTs (myalgia)
Statin vs control
15 RCTs (Creatine
kinase)
21,502 (myalgia)
People with chronic kidney
disease
NA
Risk of myalgia (17 RCTs):
RR 0.99, 95% CI 0.94 – 1.04
17,273 (creatinine
kinase)
Statins were not associated with
associated with a significant increase
in risk of myalgia or elevated
creatinine kinase
Risk of elevated creatine kinase levels (15 RCTs):
RR 1.11, 95% CI 0.80 – 1.56
Hou et al 2013
Eur Heart J [5]
7 RCTs (muscle
pain)
Statin vs control
14,482 (muscle pain)
19,881 (creatinine
kinase)
11 RCTs (Creatine
kinase)
People with chronic kidney
disease
NA
Risk of muscle pain (7 RCTs):
RR 1.02, 95% CI 0.95-1.09
Range of mean age for
included trials: 57-66y
Statins were not associated with a
significant increase in risk of muscle
pain or elevated creatinine kinase
Risk of increased creatinine kinase (11 RCTs):
RR 1.18, 95% CI0.89-1.55
Cancer
Alberton et al
2012 Q J Med
[2]
33 RCTs
Statin vs. control
159,458
Mean age 59.8y
Range 0.5-6.1 y
Risk of incident cancer (33 RCTs)
Mean 2.7y
OR 0.99, 95% CI 0.94-1.04
Statins were not associated with
cancer incidence.
Atorvastatin OR 0.90, 95% CI 0.74-1.11
Pravastatin OR1.03, 95% CI 0.95-1.11
Fluvastatin OR (4 RCTs) 0.89, 95% CI 0.75-1.05
Lovastatin OR (2 RCTs) 0.97, 95% CI 0.82-1.17
Rosuvastatin OR (3 RCTs) 0.97, 95% CI 0.86-1.09
Simvastatin OR (4 RCTs) 1.00, 95% CI 0.91-1.10
Naci H et al
2013 Circ
Cardiovasc Qual
Outcomes [3]
Palmer et al
2012 Ann Int
Med [4]
135 RCTs
6 RCTs
55 two-armed
placebo-controlled
trials, 80 twoarmed or multiarmed active
comparator trials
Statins vs. placebo
placebo-controlled
trials 100,523
Statin vs control
20,957
A range of populations
eligible for statin therapy.
average 68 weeks
Cancer
Pairwise meta-analysis placebo-controlled trials (N=
100,523): OR, 0.96; 95% CrI, 0.91–1.02; I2, 0.0%
Network meta analysis
105,450
No evidence of potential head-tohead differences between individual
statins
Network meta-analyses: individual statins vs. Control no
evidence
People with chronic kidney
disease
NA
Risk of cancer (6 RCTs):
RR 0.96, 95% CI 0.89-1.05
Statins were not associated with
adverse events including cancer
Hou et al 2013
4 RCTs
Statin vs control
17,260
People with chronic kidney
disease
NA
Eur Heart J [5]
Risk of cancer morbidity (4 RCTs):
Statins were not associated with
cancer morbidity
RR 0.95, 95% CI 0.87-1.05
Range of mean age for
included trials: 57-66y
Diabetes
Alberton et al
2012 Q J Med
[2]
16 RCTs
Statin vs. control
118,240
Mean age 59.8y
Range 0.5-6.1 y
Risk of incident diabetes (16 RCTs; 118,240 patients):
Mean 2.7y
OR 1.09, 95% CI 1.02-1.16
Statins significantly increased risk of
incident diabetes
Pravastatin OR (9 RCTS) 1.04, 95% CI 0.91-1.19
Rosuvastatin OR (4 RCTs)1.14, 95% CI 1.01-1.29
Simvastatin OR (2 RCTs)1.10, 95% CI 0.97-1.25
Naci H et al
2013 Circ
Cardiovasc Qual
Outcomes [3]
135 RCTs
55 two-armed
placebo-controlled
trials, 80 twoarmed or multiarmed active
comparator trials
Statins vs. placebo
Placebo controlled
trials 113,698
A range of populations
eligible for statin therapy.
average 68 weeks
Risk of new onset DM:
Placebo controlled trials (N= 113,698)
Network meta analysis
NA
Statins vs. controls: OR 1.09; 95% CrI, 1.02-1.16, I2, 2.8%
Rosuvastatin vs control OR 1.16; 95% CI, 1.02–1.31; I2, 0.0%
Network meta-analysis: not statistically significant for any
statin. No statistically detectable differences between
individual statins
Navarese et al
2013 Am J
Cardiol [6]
17 RCTs
Statin vs placebo
(14 RCTs)
113,394
Mean age range: 55-76 years
Mean: 1.9-6.0
years
Risk of new onset DM (Adjusted for percentage of lowdensity lipoprotein cholesterol reduction as
Covariate:
High-dose vs
moderate-dose
statin therapy (3
RCTs)
In placebo-controlled trials,
rosuvastatin resulted in significantly
Atorvastatin 10 mg/d vs placebo OR 1.04 95% CrI 0.74-1.48
Atorvastatin 80 mg/d vs placebo OR 1.15, 95% CrI 0.90-1.51
Pravastatin 20 mg vs placebo OR 0.99 95% CrI 0.68-1.41
Pravastatin 40 mg vs placebo OR 1.06, 95% CrI 0.85-1.30
higher odds of diabetes mellitus
compared with control.
In the drug-level
network meta-analysis the result did
not achieve statistical significance
for any of the individual statins
Different types and doses of statins
show different potential to increase
the risk of DM.
Rosuvastatin 10 mg vs placebo OR 1.10 95% CrI 0.78-1.58
Rosuvastatin 20 mg vs placebo: OR 1.25, 95% CrI 0.82-1.90.
Simvastatin 40 mg vs placebo OR 1.21 95% CrI 0.93-1.57
Lovastatin 40 mg vs placebo OR 0.97 95% CrI 0.58-1.61
Zhou Y et al
2013 Expert
Opin
Pharmacother
[7]
26 RCTs
Statin vs. placebo
(22) or no
treatment (4)
3,232
Mean age patients with Type
2 diabetes ranged from 49.965 years.
4 weeks to 4 years
HbA1c: Weighted Mean Difference (WMD) 0.04%, 95% CI 0.08 - 0.16, I² = 45.7%, n = 3070
FPG: WMD 2.25 mg/dl, 95% CI -3.50 to 7.99, I² = 46%, n =
1176)
Statin therapy showed nonsignificant effect on glycaemic
control among patients with type 2
diabetes. However, atorvastatin
demonstrated a small but significant,
detrimental effect on HbA1c.
BMI, fasting insulin: no significant influence
Subgroup analysis
Atorvastatin on HbA1c: WMD 0.20% (0.08, 0.31)
Simvastatin on HbA1c: WMD -0.26 (-0.48, -0.04)
Pancreatitis
Preiss et al 2012
JAMA [8]
16 RCTs
Statin vs
placebo/standard
care
113,800
Patients with norma l or
mildly elevated triglyceride
levels
Mean 4.1y
Risk of incident pancreatitis:
RR 0.77, 95% CI 0.62-0.97
Across all trials statin therapy was
associated with a lower risk of
incident pancreatitis in patients with
normal or mildly elevated TG levels
Mean age range: 46-75y
5 RCTs
Intensive vs.
moderate dose
39,614
Mean 4.8y
Risk of incident pancreatitis:
RR 0.82, 95% CI 0.59-1.12
All trials
Risk of incident pancreatitis (21 RCTs):
RR 0.79, 95% CI 0.65-0.95
Cognitive function
*McGuinness et
al 2013 Int J
3 double blind RCTs
Statin vs. placebo
748
Secondary prevention
People with a diagnosis of
dementia (probable or
At least 6 months
Outcome: Assessment of change in ADAS-Cog from
baseline (3 rcts)
No effect on cognitive function.
Geriar
Psychiatry [9]
possible Alzheimer’s disease
according to standard
criteria)
No significant difference in ADAS-Cog between statin group
and placebo group (mean difference: -1.12, 95% CI -3.99 to
1.75)
Age range 50-90 years
Outcome: Change in MMSE from baseline (3 rcts)
Mean ages for included
RCTs: 68-78 years
No significant benefit from statins (mean difference: -1.53,
95% CI -3.28 to 0.21)
Outcome: Change in Alzheimer’s Disease Cooperative
Study Clinical Global Impression of Change (2 rcts)
No significant difference between the statin and placebo
groups (mean difference - 0.02; 95% CI - 0.14 to, 0.10)
Liver Function
Alberton et al
2012 Q J Med
[2]
22 RCTs (AST)
20 RCTs (ALT)
Statin vs. control
NA
Mean age 59.8y
Range 0.5-6.1 y
Risk of elevated AST (22 RCTs):
Mean 2.7y
OR 1.31, 95% CI 1.04-1.66
Atorvastatin OR 2.27, 95% CI 1.19-4.30
Pravastatin OR1.03, 95% CI 0.96-1.23
Fluvastatin OR (3 RCTs) 2.46, 95% CI 0.93-6.52
Lovastatin OR (3 RCTs) 1.22, 95% CI 0.86-1.74
Risk of increased ALT levels (20 RCTs):
OR 1.28, 95% CI 1.11-1.48
Atorvastatin OR 1.74, 95% CI 0.50-6.07
Pravastatin OR 1.09, 95% CI 0.85-1.39
Fluvastatin OR (3 RCTs) 1.38, 95% CI 0.62-3.07
Lovastatin OR (2 RCTs) 1.54, 95% CI 1.15-2.07
Rosuvastatin OR (5 RCTs) 1.17, 95% CI 0.79-1.72
Simvastatin OR (2 RCTs) 1.42, 95% CI 1.03-1.96
Statin treatments significantly
increased the risk of elevated AST
and increased ALT.
Palmer et al
2012 Ann Int
Med[4]
16 RCTs
Hou et al 2013
Eur Heart J [5]
7 RCTs
Statin vs control
20,996
People with chronic kidney
disease
NA
Risk of abnormal liver function (16 RCTs):
Statins were not associated with
abnormal liver function.
RR 0.99, 95%CI 0.70 – 1.40
Statin vs control
21,811
People with chronic kidney
disease
NA
Risk of hepatic impairment (7 RCTs):
Statins did not significantly increase
adverse events
RR 1.13, 95% CI 0.92-1.39
Range of mean age for
included trials: 57-66y
Naci H et al
2013 Circ
Cardiovasc Qual
Outcomes [3]
135 RCTs
55 two-armed
placebo-controlled
trials, 80 twoarmed or multiarmed active
comparator trials
Statins vs. placebo
246,955.
A range of populations
eligible for statin therapy.
average 68 weeks
Transaminase Elevations:
Placebo-controlled trials (N=122,665) : Statins vs. controls:
OR 1.51; 95% CI, 1.24-1.84
Atorvastatin vs. Pravastatin: OR, 0.27; 95% CI, 0.10–0.74; I2,
61.3%).
Network meta-analysis (N=165,534):
Individual statins: Atorvastatin OR, 2.55; 95% CrI, 1.71–3.74,
fluvastatin OR, 5.18; 95% CrI, 1.89–15.55)
Head-to-head comparisons: Pravastatin OR 0.39; 95% CrI,
0.24–0.65, rosuvastatin OR 0.63; 95% CrI, 0.42–0.94, and
simvastatin OR 0.45; 95% CrI, 0.28–0.73.
Fluvastatin vs. pravastatin OR 5.19; 95% CrI, 1.75–16.73,
Fluvastatin vs. rosuvastatin OR 3.25; 95% CrI, 1.08–10.50
Fluvastatin vs. simvastatin OR 4.50; 95% CrI,1.49–14.19
Dose-level network meta-analysis (N= 188,503): Simvastatin
≤10 mg/d vs. control OR 0.41; 95% CrI, 0.18–0.85.
Atorvastatin >20 to ≤40 mg/d vs control: OR 2.42; 95% CrI,
1.10–5.55,
Atorvastatin >40 mg/d vs control: OR 5.25; 95% CrI, 3.89–
7.24
Fluvastatin >40 mg/d vs control: OR 4.16; 95% CrI, 1.60–
14.36
Simvastatin >40 mg/d vs control: OR 2.83; 95% CrI, 1.47–
5.87
Higher doses of some statins are
associated with larger transaminase
and creatine kinase elevations
Meta-analyses including observational studies
Cognitive function
*Pandey et al
2013 Int J
Neurosci [10]
4 RCTs: ADASCoG
Placebo vs.
Statins
1,154: ADAS-CoG
ADAS-CoG: Mean age >2668 years
0.5 -3.2y
CGIC: mean difference −0.26, 95% CI: −3.10 to 2.58, p
>0.05
6,317: MMSE
4 RCTs: MMSE
704: CGIC
MMSE: Mean age >26- >70
years
MMSE: mean difference −0.921, 95% CI: −1.84 to 0.0055, p
< 0.05
CGIC: Mean age >50- >51
years Patients with
Alzheimer’s disease
ADAS-CoG: mean difference −0.18, 95% CI: −1.03 to 0.66, p
> 0.05.
2 RCTS: CGIC
*Richardson et
al 2013 Ann
Intern Med [11]
Qualitative
synthesis:
Statin vs. control
3 RCTs: 1064
Adult patients receiving
statin therapy
0.8 – 60 months
Incidence of dementia:
Cohort studies RR 0.87, 95% CI 0.82-0.92
19 rcts
Case control studies RR 0.25, 95% CI 0.14-0.46
26 cohort
Cross sectional studies RR 0.54, 95% CI 0.22-1.33
6 case control
Incidence of Alzheimer’s disease
6 cross sectional
Cohort studies RR 0.79, 95% CI 0.63-0.99
Case control studies RR 0.56, 95% CI 0.41-0.78
Quantitative
synthesis:
Cross sectional studies RR 0.45, 95% CI 0.35-0.58
3 rcts
Incidence of mild cognitive impairment
16 cohort
Cohort studies RR 0.66, 95% CI 0.51-0.86
4 case control
Case control studies RR 0.37, 95% CI 0.16-0.84
4 cross sectional
Cross sectional studies RR 0.97, 95% CI 0.87-1.09
(ADAS-Cog) score in cognitively impaired patients:
change in score of for pooled analysis of 3 RCTs
0.11 [CI, -1.76 to 1.97]
Only MMSE score showed a
significant difference in favour of
statins.
Highly heterogeneous distribution
was seen for MMSE score.
No adverse effect of statins on
cognition. The strength of available
evidence is limited, especially for
high-dose statins
*Swiger et al
2013 Mayo Clin
Proc [12]
16 (qualitative
synthesis)
Statin vs. placebo
11 (quantitative
synthesis)
Short term cognition:
296
Long term cognition:
23,443
Primary prevention
Adults with no history of
cognitive dysfunction
Short term: < 1
year after drug
initiation
Long term: ≥1
year after drug
initiation (range of
mean exposures in
trials 3 to 24.9
years)
Cognition (Digit Symbol Substitution Test ):
Short term use of statin did not
significantly impair cognition.
Quantitative synthesis (3 rcts) : mean change 1.65, 95% CI 0.03 to 3.32)
Prevention of dementia (risk of incident dementia):
Long-term use may prevent
dementia
Quantitative synthesis (8 studies): HR 0.71, 95%CI 0.61-0.82)
RCT sub-group analyses
Ridker et al 2012
Lancet [13]
Subgroup analysis
of the JUPITER
RCT: stratified by
baseline risk of
diabetes
Rosuvastatin vs
placebo
17,802
Primary prevention
Median: 1.9y
Risk of diabetes:
No major diabetes risk factors HR 0.99, 95% CI 0.45-2.21
Median age: 66y
One or more major diabetes risk factors HR 1.28, 95% CI
1.07-1.54
38% women
No major diabetes risk factors
Risk of muscular weakness, stiffness or pain:
Rosuvastatin 8.72 per 100 py
Placebo 8.53 per 100 py
Myopathy
Rosuvastatin 0.06 per 100 py
Placebo 0.06 per 100 py
Rhabdomyolosis
Rosuvastatin 0.02 per 100 py
Placebo 0.0 per 100 py
Cancer
Rosuvastatin 1.98 per 100 py
Placebo 1.70 per 100 py
Participants had similar adverse
event rates attributable to statins if
they had diabetes risk factors or not.
Renal disorders
Rosuvastatin 3.10 per 100 py
Placebo 2.65 per 100 py
Bleeding
Rosuvastatin 1.32 per 100 py
Placebo 1.52 per 100 py
Hepatic disorders
Rosuvastatin 1.12 per 100 py
Placebo 1.08 per 100 py
Haemorrhagic stroke
Rosuvastatin 0.03 per 100 py
Placebo 0.03 per 100 py
One or more major diabetes risk factors
Risk of muscular weakness, stiffness or pain:
Rosuvastatin 8.20 per 100 py
Placebo 7.75 per 100 py
Myopathy
Rosuvastatin 0.05 per 100 py
Placebo 0.04 per 100 py
Rhabdomyolosis
Rosuvastatin 0.0 per 100 py
Placebo 0.0 per 100 py
Cancer
Rosuvastatin 1.38 per 100 py
Placebo 1.61 per 100 py
Renal disorders
Rosuvastatin 2.77 per 100 py
Placebo 2.52 per 100 py
Bleeding
Rosuvastatin 1.41 per 100 py
Placebo 1.42 per 100 py
Hepatic disorders
Rosuvastatin 1.14 per 100 py
Placebo 0.93 per 100 py
Haemorrhagic stroke
Rosuvastatin 0.02 per 100 py
Placebo 0.05 per 100 py
ADAS-Cog Alzheimer’s disease assessment scale cognitive subscale; BMI Body mass index; CHD coronary heart disease; CI confidence
interval; CGIC Clinical Global Impression of Change; CTT Cholesterol Treatment Trialists’ Collaboration, CVD cardiovascular disease; DM
diabetes mellitus; FPG fasting plasma glucose; HbA1c glycated haemoglobin; JUPITER Justification for the Use of Statins in Prevention:
an Intervention Trial Evaluating Rosuvastatin; MI myocardial infarction; MMSE mini-mental state examination; MVE major vascular
events; OR odds ratio; RR rate ratio, risk ratio; PY per-year; WMD Weighted mean difference
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