Niacin (Page 5 of 7)

14.2 Niacin Extended-Release Clinical Studies

Placebo-Controlled Clinical Studies in Patients with Primary Hyperlipidemia and Mixed Dyslipidemia: In two randomized, double-blind, parallel, multi-center, placebo-controlled trials, niacin extended-release dosed at 1000, 1500 or 2000 mg daily at bedtime with a low-fat snack for 16 weeks (including 4 weeks of dose escalation) favorably altered lipid profiles compared to placebo (Table 3). Women appeared to have a greater response than men at each niacin extended-release dose level (see Gender Effect , below).

Table 3. Lipid Response to Niacin Extended-Release Therapy

Mean Percent Change from Baseline to Week 16*

Treatment

n

TC

LDL-C

HDL-C

TG

Apo B

Niacin Extended-Release 1000 mg at

41

-3

-5

+18

-21

-6

bedtime

Niacin Extended-Release 2000 mg at

41

-10

-14

+22

-28

-16

bedtime

Placebo

40

0

-1

+4

0

+1

Niacin Extended-Release 1500 mg at

76

-8

-12

+20

-13

-12

bedtime

Placebo

73

+2

+1

+2

+12

+1

n = number of patients at baseline;

* Mean percent change from baseline for all niacin extended-release doses was significantly different ( p < 0.05) from placebo.

In a double-blind, multi-center, forced dose-escalation study, monthly 500 mg increases in niacin extended-release dose resulted in incremental reductions of approximately 5% in LDL-C and Apo B levels in the daily dose range of 500 mg through 2000 mg (Table 4). Women again tended to have a greater response to niacin extended-release than men (see Gender Effect , below).

Table 4. Lipid Response in Dose-Escalation Study

Mean Percent Change from Baseline*

Treatment

n

TC

LDL- C

HDL-C

TG

Apo B

Placebo

44

-2

-1

+5

-6

-2

Niacin Extended-Release

87

500 mg at bedtime

-2

-3

+10

-5

-2

1000 mg at bedtime

-5

-9

+15

-11

-7

1500 mg at bedtime

-11

-14

+22

-28

-15

2000 mg at bedtime

-12

-17

+26

-35

-16

n = number of patients enrolled;

Placebo data shown are after 24 weeks of placebo treatment.

* For all niacin extended-release doses except 500 mg, mean percent change from baseline was significantly different ( p < 0.05) from placebo for all lipid parameters shown.

Pooled results for major lipids from these three placebo-controlled studies are shown below (Table 5).

Table 5. Selected Lipid Response to Niacin Extended-Release in Placebo-Controlled Clinical Studies*

Mean Baseline and Median Percent Change from Baseline

(25th, 75th Percentiles)

Niacin Extended-Release Dose

n

LDL-C

HDL-C

TG

1000 mg at bedtime

104

Baseline (mg/dL)

218

45

172

Percent Change

-7 (-15, 0)

+14 (+7, +23)

-16 (-34, +3)

1500 mg at bedtime

120

Baseline (mg/dL)

212

46

171

Percent Change

-13 (-21, -4)

+19 (+9, +31)

-25 (-45, -2)

2000 mg at bedtime

85

Baseline (mg/dL)

220

44

160

Percent Change

-16 (-26, -7)

+22 (+15, +34)

-38 (-52, -14)

* Represents pooled analyses of results; minimum duration on therapy at each dose was 4 weeks.

Gender Effect: Combined data from the three placebo-controlled niacin extended-release studies in patients with primary hyperlipidemia and mixed dyslipidemia suggest that, at each niacin extended-release dose level studied, changes in lipid concentrations are greater for women than for men (Table 6).

Table 6. Effect of Gender on Niacin Extended-Release Dose Response

Mean Percent Change from Baseline

Niacin Extended-Release

N

LDL-C

HDL-C

TG

Apo B

Dose

(M/F)

M

F

M

F

M

F

M

F

500 mg at bedtime

50/37

-2

-5

+11

+8

-3

-9

-1

-5

1000 mg at bedtime

76/52

-6*

-11*

+14

+20

-10

-20

-5*

-10*

1500 mg at bedtime

104/59

-12

-16

+19

+24

-17

-28

-13

-15

2000 mg at bedtime

75/53

-15

-18

+23

+26

-30

-36

-16

-16

n = number of male/female patients enrolled.

* Percent change significantly different between genders ( p < 0.05).

Other Patient Populations: In a double-blind, multi-center, 19-week study the lipid-altering effects of niacin extended-release (forced titration to 2000 mg at bedtime) were compared to baseline in patients whose primary lipid abnormality was a low level of HDL-C (HDL-C ≤40 mg/dL, TG ≤400 mg/dL, and LDL-C ≤160, or <130 mg/dL in the presence of CHD). Results are shown below (Table 7).

Table 7. Lipid Response to Niacin Extended-Release in Patients with Low HDL-C

Mean Baseline and Mean Percent Change from Baseline*

n

TC

LDL-C

HDL-C

TG

Apo B

Baseline

88

190

120

31

194

106

(mg/dL)

Week 19

71

-3

0

+26

-30

-9

(% Change)

n = number of patients

* Mean percent change from baseline was significantly different ( p < 0.05) for all lipid parameters shown except LDL-C.

n = 72 at baseline and 69 at week 19.


At niacin extended-release 2000 mg/day, median changes from baseline (25th, 75th percentiles) for LDL-C, HDL-C, and TG were -3% (-14, +12%), +27% (+13, +38%), and -33% (-50, -19%), respectively.

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