Niacin: Package Insert and Label Information (Page 3 of 4)

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.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.