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Table 4 Summary of changes from baseline in fasting plasma lipids at Week 26 (LOCF) *

From: Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies

 

Patients <65 y

Patients ≥65 y

 

PBO

CANA 100 mg

CANA 300 mg

PBO

CANA 100 mg

CANA 300 mg

Triglycerides, n

446

614

610

118

139

131

  Mean ± SD baseline, mmol/L

2.2 ± 1.4

2.1 ± 1.5

2.1 ± 1.5

1.8 ± 0.8

1.9 ± 1.1

1.7 ± 0.9

  LS mean ± SE change

0.01 ± 0.05

-0.10 ± 0.04

-0.23 ± 0.04

-0.05 ± 0.05

-0.14 ± 0.05

-0.16 ± 0.05

  Median (IQR) percent change

-1.6

-6.0

-9.3

-3.2

-7.4

-9.2

(-22.1, 28.8)

(-26.4, 24.4)

(-28.6, 19.8)

(-20.4, 16.3)

(-21.9, 10.6)

(-25.8, 10.2)

  LS mean ± SE percent change

9.1 ± 2.2

3.7 ± 2.0

0.6 ± 2.0

2.6 ± 3.0

-2.4 ± 2.8

-2.5 ± 2.9

  Difference versus PBO (95% CI)

 

-5.4 (-11.1, 0.3)

-8.5 (-14.2, -2.8)

 

-5.0 (-13.0, 3.1)

-5.1 (-13.3, 3.1)

LDL-C, n

444

609

601

118

137

129

  Mean ± SD baseline, mmol/L

2.9 ± 1.0

2.8 ± 0.9

2.7 ± 0.9

2.7 ± 1.0

2.6 ± 0.9

2.7 ± 1.0

  LS mean ± SE change

-0.05 ± 0.03

0.06 ± 0.03

0.17 ± 0.03

-0.07 ± 0.06

0.04 ± 0.05

0.07 ± 0.06

 Median (IQR) percent change

-2.3

2.0

6.5

-1.5

1.9

2.0

(-16.9, 11.3)

(-10.7, 19.4)

(-7.8, 23.9)

(-9.8, 12.2)

(-7.1, 15.5)

(-10.5, 17.9)

  LS mean ± SE percent change

1.5 ± 1.4

6.3 ± 1.2

9.8 ± 1.2

0.7 ± 2.1

3.5 ± 1.9

6.8 ± 2.0

  Difference versus PBO (95% CI)

 

4.8 (1.2, 8.4)

8.3 (4.7, 11.9)

 

2.7 (-2.9, 8.4)

6.1 (0.4, 11.8)

HDL-C, n

446

612

606

118

138

129

  Mean ± SD baseline, mmol/L

1.2 ± 0.3

1.2 ± 0.3

1.2 ± 0.3

1.2 ± 0.3

1.3 ± 0.3

1.3 ± 0.3

  LS mean ± SE change

0.03 ± 0.01

0.09 ± 0.01

0.10 ± 0.01

0.03 ± 0.02

0.12 ± 0.02

0.12 ± 0.02

  Median (IQR) percent change

3.2

7.3

9.5

3.9

9.2

9.7

(-6.0, 13.6)

(-2.6, 19.6)

(-0.7, 20.0)

(-4.7, 11.8)

(0.0, 17.6)

(-0.8, 21.2)

  LS mean ± SE percent change

4.0 ± 0.8

9.2 ± 0.7

10.2 ± 0.7

3.6 ± 1.4

9.8 ± 1.3

10.8 ± 1.4

  Difference versus PBO (95% CI)

 

5.2 (3.1, 7.3)

6.1 (4.1, 8.2)

 

6.2 (2.4, 9.9)

7.2 (3.4, 11.0)

LDL-C/HDL-C, n

444

609

601

118

137

129

  Mean ± SD baseline, mol/mol

2.6 ± 1.1

2.5 ± 1.0

2.4 ± 0.9

2.3 ± 1.0

2.2 ± 0.9

2.2 ± 0.8

  LS mean ± SE change

-0.13 ± 0.03

-0.12 ± 0.03

-0.07 ± 0.03

-0.10 ± 0.05

-0.15 ± 0.05

-0.11 ± 0.05

  Median (IQR) percent change

-6.8

-5.4

-1.5

-4.4

-3.3

-7.3

(-19.3, 9.3)

(-19.0, 10.9)

(-16.3, 14.1)

(-19.8, 12.8)

(-17.4, 7.8)

(-21.9, 11.8)

  LS mean ± SE percent change

-0.5 ± 1.4

-0.7 ± 1.2

1.3 ± 1.2

-1.4 ± 2.3

-4.2 ± 2.2

-1.2 ± 2.3

  Difference versus PBO (95% CI)

 

-0.2 (-3.8, 3.4)

1.8 (-1.8, 5.4)

 

-2.8 (-9.1, 3.4)

0.2 (-6.2, 6.5)

Non–HDL-C, n

446

609

602

117

138

127

  Mean ± SD baseline, mmol/L

3.9 ± 1.1

3.8 ± 1.1

3.6 ± 1.0

3.5 ± 1.2

3.5 ± 1.1

3.5 ± 1.1

  LS mean ± SE change

-0.04 ± 0.04

0.00 ± 0.03

0.10 ± 0.03

-0.09 ± 0.07

-0.02 ± 0.06

-0.02 ± 0.06

  Median (IQR) percent change

-2.3

-0.7

2.4

-2.6

0.0

0.0

(-13.6, 9.7)

(-10.2, 13.1)

(-8.6, 14.9)

(-10.6, 9.5)

(-6.3, 11.5)

(-12.6, 13.5)

  LS mean ± SE percent change

1.1 ± 1.0

2.6 ± 0.9

4.7 ± 0.9

-0.5 ± 1.8

0.8 ± 1.7

2.8 ± 1.8

  Difference versus PBO (95% CI)

 

1.4 (-1.3, 4.1)

3.6 (0.8, 6.3)

 

1.3 (-3.6, 6.2)

3.3 (-1.7, 8.3)

  1. LOCF, last observation carried forward; PBO, placebo; CANA, canagliflozin; SD, standard deviation; LS, least squares; SE, standard error; IQR, interquartile range; CI, confidence interval; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol.
  2. *All fasting plasma lipids parameters are reported for regardless of rescue medication.