Electronic searches

Unless otherwise stated, search terms are free text terms; MeSH = Medical subject heading (Medline medical index term); exp = exploded MeSH; the dollar sign ($) stands for any character(s); the question mark (?) = to substitute for one or no characters; tw = text word; pt = publication type; sh = MeSH; adj = adjacent.

Phase I: Ezetimibe

1 ezetimib*[tw]
2 ezetrol [tw]
3 Azetidines [MeSH‐Terms]
4 azetidines [tw]
5 vytorin [tw]
6 or/ 1‐5

Phase II: Hypercholesterolemia.

7 hypercholesterol?emia* [tw]
8 hyperlipid?emia*[tw]
9 Hyperlipidemia [MeSH‐Terms]
10 cholesterol [MeSH‐Terms]
11 cholesterol [tw]
12 or/ 7‐11

Phase III: Study‐design

13 (randomized controlled trial [pt]
14 controlled clinical trial [pt]
15 randomized controlled trials [MeSH‐Terms]
16 random allocation [MeSH‐Terms]
17 double‐blind method [MeSH‐Terms]
18 single‐blind method [MeSH‐Terms]
19 clinical trial [pt]
20 clinical trials [MeSH‐Terms]
21 ("clinical trial" [tw])
22 ((singl* OR doubl* OR trebl* OR tripl*) AND (mask* OR blind* )) [tw]
23 placebos [MeSH‐Terms]
24 placebo* [tw]
25 random* [tw]
26 research design [MeSH‐Terms]
27 comparative study [MeSH‐Terms]
28 evaluation studies [MeSH‐Terms]
29 follow‐up studies [MeSH‐Terms]
30 prospective studies [MeSH‐Terms]
31 (control* OR prospectiv* OR volunteer*) [tw]
32 or/13‐32
33 #32 limit to animal
34 #32 limit to human
35 #34 not #33
36 #33 not #35

All phases

37 #6 and #12 and #36

Dose

Atorvastatin

Lovastatin

Pravastatin

Simvastatin

Fluvastatin

Rosuvastatin

1

10 mg

40 mg

40 mg

20 mg

80 mg

5 mg

2

20 mg

80 mg

80 mg

40 mg

160 mg

10 mg

3

40 mg

160 mg

160 mg

80 mg

320 mg

20 mg

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1:
I2:
C1: Placebo

Randomised controlled clinical trial (RCT)

Non‐inferiority / equivalence trial

Controlled clinical trial

Design: parallel, crossover, factorial RCT

Design: crossover study

Design: factorial study

Crossover study: wash‐out phase

Crossover study: carryover effect tested

Crossover study: period effect tested

Method of randomisation

Unit of randomisation (individuals, cluster ‐ specify)

Randomisation stratified for centres

Randomisation ratio

Concealment of allocation

Stated blinding (open; single, double, triple blind)

Actual blinding: participant

Actual blinding: caregiver / treatment administrator

Actual blinding: outcome assessor

Actual blinding: others

Blinding checked: participant

Blinding checked: caregiver / treatment administrator

Primary endpoint defined

[n] of primary endpoint(s)

[n] of secondary endpoints

Total [n] of endpoints

Prior publication of study design

Outcomes of prior / current publication identical

Power calculation

[n] participants per group calculated

Non‐inferiority trial: interval for equivalence specified

Intention‐to‐treat analysis (ITT)

Per‐protocol‐analysis

ITT defined

Analysis stratified for centres

Missing data: last‐observation‐carried‐forward (LOCF)

Missing data: other methods

LOCF defined

[n] of screened participants (I1/ I2 / C1 / total)

[n] of randomised participants (I1/ I2 / C1 / total)

I1:
I2:
C1:
Total:

[n] of participants finishing the study (I1/ I2 / C1 / total)

[n] of patients analysed (I1/ I2 / C1 / total)

Description of discontinuing participants

Drop‐outs (reasons explained)

Withdrawals (reasons explained)

Losses‐to‐follow‐up (reasons explained)

[n] of participants who discontinued (I1/ I2 / C1 / total)

[%] discontinuation rate (I1/ I2 / C1 / total)

Discontinuation rate similar between groups

[%] crossover between groups

Differences [n] calculated to analysed patients

[n] of subgroups

Subgroups: pre‐defined

Subgroups: post‐hoc

[n] of statistical comparisons

Adjustment for multiple outcomes / repeated measurements

Baseline characteristics: clinically relevant differences

Treatment identical (apart from intervention)

Timing of outcomes' measurement comparable between groups

Compliance measured

Other important covariates measured (specify)

Co‐morbidities measured

Co‐medications measured

Specific doubts about study quality

Funding: commercial

Funding: non‐commercial

Publication status: peer review journal

Publication status: journal supplement

Publication status: abstract

Publication status: other

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1:
I2:
C1: Placebo

[n] (I1/ I2 / C1 / total)

Sex [n,%] (I1/ I2 / C1 / total)

Age [years] mean (SD) (I1/ I2 / C1 / total)

I1:
I2:
C:
Total:

Ethnic groups [%] (I1/ I2 / C1 / total)

Duration of disease [years] mean (SD) (I1/ I2 / C1 / total)

Body mass index [kg/m2] mean (SD) (I1/ I2 / C1 / total)

Pharmaco‐naive patients [n,%] (I1/ I2 / C1 / total)

Co‐morbidity [%] (I1/ I2 / C1 / total)

Co‐medication [%] (I1/ I2 / C1 / total)

HbA1c [%] mean (SD) (I1/ I2 / C1 / total)

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear
I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1:
I2:
C1: Placebo

[n] of participants who died

[n] adverse events (I1/ I2 / C1 / total)

[%] adverse events (I1/ I2 / C1 / total)

[n] serious adverse events (I1/ I2 / C1 / total)

[%] serious adverse events (I1/ I2 / C1 / total)

[n] drop‐outs due to adverse events (I1/ I2 / C1 / total)

I1:
I2:
C1:
Total:

[%] drop‐outs due to adverse events (I1/ I2 / C1 / total)

[n] hospitalisation (I1/ I2 / C1 / total)

[%] hospitalisation (I1/ I2 / C1 / total)

[n] out‐patient treatment (I1/ I2 / C1 / total)

[%] out‐patient treatment (I1/ I2 / C1 / total)

[n] hypoglycaemic episodes (I1/ I2 / C1 / total)

[%] hypoglycaemic episodes (I1/ I2 / C1 / total)

[n] severe hypoglycaemic episodes (I1/ I2 / C1 / total)

[%] severe hypoglycaemic episodes (I1/ I2 / C1 / total)

[n] nocturnal hypoglycaemic episodes (I1/ I2 / C1 / total)

[%] nocturnal hypoglycaemic episodes (I1/ I2 / C1 / total)

[n] with symptoms (I1/ I2 / C1 / total)

[%] with symptoms (I1/ I2 / C1 / total)

Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1:
I2:
C1: Placebo

All‐cause mortality: [n] of participants who died
(I1/ I2 / C1 / total)"

I1:
I2:
C1:
Total:

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1:
I2:
C1: Placebo

Weight change [kg] at 12 weeks (mean/SD)
(I1/ I2 / C1 / total)

I1:
I2:
C1:
Total:

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear; I = intervention; C = control