About Randomised Clinical Trials Related to Lipoproteins in Diabetes Mellitus

 

Number of patients

Treatment comparison (mg/day)

Median follow-up in survivors (years)a

Mean age (years)

Baseline LDL-C (mmol/L)

Prior CHDb

Other vascular diseasec

No prior vascular disease

Women

LDL-C difference at 1 year (mmol/L)

Statin vs. control

SSSS

4,444

S20-40 vs. placebo

5.4

59

4.88

4,444 (100 %)

126 (3 %)

0 (0 %)

827 (19 %)

−1.77

WOSCOPS

6,595

P40 vs. placebo

4.8

55

4.96

338 (5 %)

193 (3 %)

6,096 (92 %)

0 (0 %)

−1.07

CARE

4,159

P40 vs. placebo

5.0

59

3.58

4,159 (100 %)

0 (0 %)

0 (0 %)

576 (14 %)

−1.03

Post CABG

1,351

L40-80 vs. L2.5-5

4.3

61

4.02

1,351 (100 %)

37 (3 %)

0 (0 %)

102 (8 %)

−1.07

AFCAPS/TexCaps

6,605

L20-40 vs. placebo

5.2

58

3.89

10 (1 %)

9 (0 %)

6,586(0.99 %)

997 (15 %)

−0.94

LIPID

9,014

P40 vs. placebo

6.0

61

3.88

9,014 (100 %)

905 (10 %)

0 (0 %)

1,516 (17 %)

−1.03

GISSI-P

4,271

P20 vs. no treatment

2.0

59

3.92

4,271 (100 %)

179 (4 %)

0 (0 %)

587 (14 %)

−0.35

LIPS

1,677

F80 vs. placebo

3.9

60

3.42

1,677 (100 %)

142 (8 %)

0 (0 %)

271 (16 %)

−0.92

HPS

20,536

S40 vs. placebo

5.4

63

3.38

13,386 (65 %)

8,865 (43 %)

3,161 (15 %)

5,082 (25 %)

−1.29

PROSPER

5,804

P40 vs. placebo

3.3

75

3.79

1,881 (32 %)

1,026 (18 %)

3,254 (56 %)

3,000 (52 %)

−1.04

ALLHAT-LLT

10,355

P40 vs. usual care

4.9

67

3.76

1,188 (11 %)

1,788 (17 %)

8,037 (78 %)

5,051 (49 %)

−0.54

ASCOT-LLA

10,305

A10 vs. placebo

3.3

63

3.44

15 (1 %)

1,435 (14 %)

8,860 (86 %)

1,942 (19 %)

−1.07

ALERT

2,102

F40 vs. placebo

5.5

50

4.14

400 (19 %)

241 (11 %)

1,702 (81 %)

715 (34 %)

−0.84

CARDS

2,838

A10 vs. placebo

4.1

62

3.03

9 (1 %)

97 (3 %)

2,738 (96 %)

909 (32 %)

−1.14

ALLIANCE

2,442

A10-80 vs. usual care

4.7

61

3.80

2,442 (100 %)

162 (7 %)

0 (0 %)

434 (18 %)

−1.16

4D

1,255

A20 vs. placebo

4.0

66

3.25

630 (50 %)

666 (53 %)

344 (27 %)

578 (46 %)

−0.89

ASPEN

2,410

A10 vs. placebo

4.0

61

2.93

578 (24 %)

302 (13 %)

1,663 (69 %)

811 (34 %)

−0.99

MEGAd

8,214

P10-20 vs. usual care

5.0

58

4.05

42 (1 %)

53 (1 %)

8,119 (99 %)

5,547 (68 %)

−0.67

JUPITER

17,802

R20 vs. placebo

2.0

66

2.70

0 (0 %)

0 (0 %)

17,802 (100 %)

6,801 (38 %)

−1.09

GISSI-HF

4,574

R10 vs. placebo

4.2

67

3.06

1,797 (39 %)

4,574 (100 %)

0 (0 %)

1,032 (23 %)

−0.92

AURORA

2,773

R10 vs. placebo

4.6

64

2.58

659 (24 %)

743 (27 %)

1,663 (60 %)

1,050 (38 %)

−0.99

CORONA

5,011

R10 vs. placebo

3.0

73

3.55

4,377 (87 %)

5,011 (100 %)

0 (0 %)

1,180 (24 %)

−1.19

Subtotal (22 trials)

134,537


4.8e

63e

3.70e

52,668 (39 %)

26,554 (20 %)

70,025 (52 %)

39,008 (29 %)

−1.08||

More vs. less statin
          
PROVE-IT

4,162

A80 vs. P40

2.1

58

2.62f

4,162 (100 %)

328 (8 %)

0 (0 %)

911 (22 %)

−0.65

A to Z

4,497

S40 then S80 vs.

2.0

60

2.09f

4,497 (100 %)

479 (11 %)

0 (0 %)

1,100 (24 %)

−0.30
  
placebo then S20
        
TNT

10,001

A80 vs. A10

5.0

61

2.52

10,001 (100 %)

1,537 (15 %)

0 (0 %)

1,902 (19 %)

−0.62

IDEAL

8,888

A40-80 vs. S20-40

4.8

62

2.64f

8,888 (100 %)

971 (11 %)

0 (0 %)

1,702 (19 %)

−0.55

SEARCH

12,064

S80 vs. S20

7.0

64

2.50

12,064 (100 %)

1,062 (9 %)

0 (0 %)

2,052 (17 %)

−0.39

Subtotal (5 trials)

39,612


5.1e

62e

2.53e

39,612 (100 %)

4,377 (11 %)

0 (0 %)

7,667 (19 %)

−0.51||

Total (27 trials)

174,149


4.9e

63e


92,280 (53 %)

30,931 (18 %)

70,025 (40 %)

46,675 (27 %)



Trials are ordered by their date of publication A atorvastatin, F fluvastatin, L lovastatin, P pravastatin, R rosuvastatin, S simvastatin, LDL-C LDL cholesterol, CHD coronary heart disease, 4D Die Deutsche Diabetes Dialyse Studie, A to Z Aggrastat to Zocor, AFCAPS/TexCAPS Air Force/Texas Coronary Atherosclerosis Prevention Study, ALERT Assessment of Lescol in Renal Transplantation, ALLHAT-LLT Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial, ALLIANCE Aggressive Lipid-Lowering Initiation Abates New Cardiac Events, ASCOT-LLA Anglo-Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm, ASPEN Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus, AURORA A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events, CARDS Collaborative Atorvastatin Diabetes Study, CARE Cholesterol And Recurrent Events, GISSI-HF Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza cardiac, GISSI–P Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico, HPS Heart Protection Study, IDEAL Incremental Decrease in End Points Through Aggressive Lipid Lowering Study Group, JUPITER Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin study group, LIPID Long–term Intervention with Pravastatin in Ischaemic Disease, LIPS Lescol Intervention Prevention Study, MEGA Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group, Post-CABG Post-Coronary Artery Bypass Graft, PROSPER PROspective Study of Pravastatin in the Elderly at Risk, PROVE-IT Pravastatin or Atorvastatin Evaluation and Infection Therapy, SEARCH Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine, SSSS Scandinavian Simvastatin Survival Study, TNT Treating to New Targets, WOSCOPS West of Scotland Coronary Prevention Study a Estimated with standard Kaplan–Meier methods, with patients censored at their date of death b History of MI or other symptomatic CHD c History of intracerebral bleed, transient ischaemic attack, ischaemic stroke, unknown stroke, peripheral artery disease or heart failure (if known) dIncludes 382 randomised patients who were excluded from the trialists’ primary publication e Median follow-up, and mean age, baseline LDL-C and LDL-C difference at 1 year are weighted by the trial-specific variances of the observed logrank (o-e) statistic for major vascular events f These three trials did not have active run-in periods; the values shown are the estimated on-treatment LDL cholesterol levels in the standard statin group




Table 17.2
Number of participants with diabetes by trial











 
Diabetes mellitus

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Apr 14, 2017 | Posted by in ENDOCRINOLOGY | Comments Off on About Randomised Clinical Trials Related to Lipoproteins in Diabetes Mellitus

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