Table F-17

Longer-term outcomes (clinical outcomes, serious adverse events and cancer) using niacin plus statin therapy compared with statin monotherapy

TrialPopulationCombination Statin Dose (mg/day)NiacinCombo NMonotherapy Statin Dose (mg/day)Mono NFollow up (wk)Trial Baseline LDL-c (mg/dL)Difference (95% CI) [combo-mono]AACJadad ScoreITTA
All-cause mortality – patients requiring intensive lipid lowering therapy
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152892/1 1.84 (0.16, 20.76)yes5No
All-cause mortality
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152892/1 1.84 (0.16, 20.76)yes5No
Kos Pharm (MA-06)105
MA-06 North America Multicenter
Participants with hyperlipidemi a type IIa or IIb, Statin naïveLovastatin 40Ext Rls114Lovastatin 4061281891/1 0.53 (0.03, 8.64)yes5No
Kos Pharm (MA-14)104
MA-14 North America Multicenter
Participants with combined dyslipidemia (Fredrickson’s type IIb or IV hyperlipidemia) ; Statin naïve.Lovastatin 10Ext Rls100Lovastatin 4033201980/0yes4No
Stein (1996)170
North America Pharm. Fund Multicenter
Participants with elevated low-density lipoprotein cholesterol, high triglycerides, and low high-density lipoprolein cholesteroLSimvastatin 10Imm Rls60Simvastatin 1060171760/0unclear2No
Ballantyne (2008_a)150
North America, South America, Europe Pharm. Fund Multicenter
Participants with increased ATP III risk adjusted non-HDL-c but on target LDL-c on run-in simvastatin 20 mg/daySimvastatin 20Ext Rls 1000–2000187Simvastatin 20114240/0unclear3No
Ballantyne (2008_b)171
North America, South America, Pharm. Fund Multicenter
Participants with elevated non-HDL-c level desipte run-in simvastatin 40 mg/daySimvastatin 40Ext Rls 1000–2000216Simvastatin 80119240/0adequate3No
All-cause mortality – Adequate Allocation Concealment
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152892/1 1.84 (0.16, 20.76)yes5No
Kos Pharm (MA-06)105
MA-06 North America Multicenter
Participants with hyperlipidemia type IIa or IIb, Statin naïveLovastatin 40Ext Rls114Lovastatin 4061281891/1 0.53 (0.03, 8.64)yes5No
Kos Pharm (MA-14)104
MA-14 North America Multicenter
Participants with combined dyslipidemia (Fredrickson’s type IIb or IV hyperlipidemia) ; Statin naïve.Lovastatin 10Ext Rls100Lovastatin 4033201980/0yes4No
Ballantyne (2008_b)171
North America, South America, Pharm. Fund Multicenter
Participants with elevated non-HDL-c level desipte run-in simvastatin 40 mg/daySimvastatin 40Ext Rls216Simvastatin 80119240/0adequate3No
All-cause mortality – patients with vascular disease
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152892/1 1.84 (0.16, 20.76)yes5No
Vascular death – patients requiring intensive lipid lowering therapy
Kuvin (2006)197
North America Pharm. Fund Single center
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 100 mg/dLMixedExt Rls27Mixed2712790/0unclear1No
Vascular death
Hunninghake (2003)128
North America Pharm. Fund Multicenter
Participants with type IIA hyperlipidemia or type IIB hyperlipidemiaLovastatin 40Ext Rls114Lovastatin 4061281891/1 0.53 (0.03, 8.64)unclear4Yes
Kuvin (2006)197
North America Pharm. Fund Single center
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 100 mg/dLMixedExt Rls27Mixed2712790/0unclear1No
Vascular death – patients with vascular disease
Kuvin (2006)197
North America Pharm. Fund Single center
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 100 mg/dLMixedExt Rls27Mixed2712790/0unclear1No
Fatal myocardial infarction
Kos Pharm (MA-06)105
MA-06 North America Multicenter
Participants with hyperlipidemia type IIa or IIb, Statin naïveLovastatin 40Ext Rls114Lovastatin 4061281891/0 1.63 (0.07, 40.51)yes5No
Kuvin (2006)197
North America Pharm. Fund Single center
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 100 mg/dLMixedExt Rls27Mixed2712790/0unclear1No
Any stroke
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152890/1 0.12 (0.00, 6.21)yes5No
Acute coronary syndrome
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152892/2 0.91 (0.12, 6.62)yes5No
Percutaneous coronary intervention
Taylor (2004)196
ARBITER North America Single centre
Participants with coronary artery disease, and currently treated with a statin drug, with LDL-C < 130 mg/dL and HDL-C < 45 mg/dLMixed >20Ext Rls78Mixed >207152894/1 3.78 (0.41, 34.68)yes5No
Serious adverse events
Kos Pharm (MA-06)105
MA-06 North America Multicenter
Participants with hyperlipidemia type IIa or IIb, Statin naïveLovastatin 20–40Ext Rls114Lovastatin 4061281895/2 1.35 (0.25, 7.19)yes5No
Kos Pharm (MA-14)104
MA-14 North America Multicenter
Participants with combined dyslipidemia (Fredrickson’s type IIb or IV hyperlipidemia) ; Statin naïve.Lovastatin 10–40Ext Rls100Lovastatin 4033201985/1 1.68 (0.19, 14.96)yes4No
Stein (1996)170
North America Pharm. Fund Multicentre
Participants with elevated low-density lipoprotein cholesterol, high triglycerides, and low high-density lipoprolein cholesteroLSimvastatin 10Imm Rls60Simvastatin 1060171761/0 3.05 (0.12, 76.39)unclear2No
Ballantyne (2008_a)150
North America, South America, Europe Pharm. Fund Multicenter
Participants with increased ATP III risk adjusted non-HDL-c but on target LDL-c on run-in simvastatin 20 mg/daySimvastatin 20Ext Rls187Simvastatin 20114241/0 1.84 (0.07, 45.60)unclear3No
Ballantyne (2008_b)171
North America, South America, Pharm. Fund Multicenter
Participants with elevated non-HDL-c level desipte run-in simvastatin 40 mg/daySimvastatin 40Ext Rls216Simvastatin 80119241040/1 0.18 (0.01, 4.51)adequate3No
Cancer
Kos Pharm (MA-06)105
MA-06 North America Multicenter
Participants with hyperlipidemia type IIa or IIb, Statin naïveLovastatin 20–40Ext Rls114Lovastatin 4061281890/2 0.10 (0.00, 2.2)yes5No

From: Appendix F, Included Evidence

Cover of Comparative Effectiveness of Lipid-Modifying Agents
Comparative Effectiveness of Lipid-Modifying Agents [Internet].
Comparative Effectiveness Reviews, No. 16.
Sharma M, Ansari MT, Soares-Weiser K, et al.

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