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* CONCLUSION: Low HDL-C levels strongly and independently predict the occurrence of coronary events which were reduced by treatment with gemfibrozil.<ref name="pmid18356553">{{cite journal |author=Robins SJ, Collins D, Nelson JJ, Bloomfield HE, Asztalos BF |title=Cardiovascular events with increased lipoprotein-associated phospholipase A(2) and low high-density lipoprotein-cholesterol: the Veterans Affairs HDL Intervention Trial |journal=Arterioscler. Thromb. Vasc. Biol. |volume=28 |issue=6 |pages=1172–8 |year=2008 |month=June |pmid=18356553 |doi=10.1161/ATVBAHA.107.160739 |url=}}</ref><ref name="pmid18078862">{{cite journal |author=Asztalos BF, Collins D, Horvath KV, Bloomfield HE, Robins SJ, Schaefer EJ |title=Relation of gemfibrozil treatment and high-density lipoprotein subpopulation profile with cardiovascular events in the Veterans Affairs High-Density Lipoprotein Intervention Trial |journal=Metab. Clin. Exp. |volume=57 |issue=1 |pages=77–83 |year=2008 |month=January |pmid=18078862 |pmc=2194640 |doi=10.1016/j.metabol.2007.08.009 |url=}}</ref><ref name="pmid20855565">{{cite journal |author=Peloso GM, Demissie S, Collins D, ''et al.'' |title=Common genetic variation in multiple metabolic pathways influences susceptibility to low HDL-cholesterol and coronary heart disease |journal=J. Lipid Res. |volume=51 |issue=12 |pages=3524–32 |year=2010 |month=December |pmid=20855565 |pmc=2975725 |doi=10.1194/jlr.P008268 |url=}}</ref><ref name="pmid17335828">{{cite journal |author=Robins SJ, Collins D, McNamara JR, Bloomfield HE |title=Body weight, plasma insulin, and coronary events with gemfibrozil in the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT) |journal=Atherosclerosis |volume=196 |issue=2 |pages=849–55 |year=2008 |month=February |pmid=17335828 |doi=10.1016/j.atherosclerosis.2007.01.029 |url=}}</ref>
* CONCLUSION: Low HDL-C levels strongly and independently predict the occurrence of coronary events which were reduced by treatment with gemfibrozil.<ref name="pmid18356553">{{cite journal |author=Robins SJ, Collins D, Nelson JJ, Bloomfield HE, Asztalos BF |title=Cardiovascular events with increased lipoprotein-associated phospholipase A(2) and low high-density lipoprotein-cholesterol: the Veterans Affairs HDL Intervention Trial |journal=Arterioscler. Thromb. Vasc. Biol. |volume=28 |issue=6 |pages=1172–8 |year=2008 |month=June |pmid=18356553 |doi=10.1161/ATVBAHA.107.160739 |url=}}</ref><ref name="pmid18078862">{{cite journal |author=Asztalos BF, Collins D, Horvath KV, Bloomfield HE, Robins SJ, Schaefer EJ |title=Relation of gemfibrozil treatment and high-density lipoprotein subpopulation profile with cardiovascular events in the Veterans Affairs High-Density Lipoprotein Intervention Trial |journal=Metab. Clin. Exp. |volume=57 |issue=1 |pages=77–83 |year=2008 |month=January |pmid=18078862 |pmc=2194640 |doi=10.1016/j.metabol.2007.08.009 |url=}}</ref><ref name="pmid20855565">{{cite journal |author=Peloso GM, Demissie S, Collins D, ''et al.'' |title=Common genetic variation in multiple metabolic pathways influences susceptibility to low HDL-cholesterol and coronary heart disease |journal=J. Lipid Res. |volume=51 |issue=12 |pages=3524–32 |year=2010 |month=December |pmid=20855565 |pmc=2975725 |doi=10.1194/jlr.P008268 |url=}}</ref><ref name="pmid17335828">{{cite journal |author=Robins SJ, Collins D, McNamara JR, Bloomfield HE |title=Body weight, plasma insulin, and coronary events with gemfibrozil in the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT) |journal=Atherosclerosis |volume=196 |issue=2 |pages=849–55 |year=2008 |month=February |pmid=17335828 |doi=10.1016/j.atherosclerosis.2007.01.029 |url=}}</ref>


===AIM-HIGH Trial===<ref name="pmid22085343">{{cite journal |author=Boden WE, Probstfield JL, Anderson T, ''et al.'' |title=Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy |journal=N. Engl. J. Med. |volume=365 |issue=24 |pages=2255–67 |year=2011 |month=December |pmid=22085343 |doi=10.1056/NEJMoa1107579 |url=}}</ref>
===AIM-HIGH Trial<ref name="pmid22085343">{{cite journal |author=Boden WE, Probstfield JL, Anderson T, ''et al.'' |title=Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy |journal=N. Engl. J. Med. |volume=365 |issue=24 |pages=2255–67 |year=2011 |month=December |pmid=22085343 |doi=10.1056/NEJMoa1107579 |url=}}</ref>===
* OBJECTIVE: To assess if [[niacin]] + [[simvastatin]] combination is superior to simvastatin alone in raising low levels of [[high density lipoprotein]] ([[HDL]]).
* OBJECTIVE: To assess if [[niacin]] + [[simvastatin]] combination is superior to simvastatin alone in raising low levels of [[high density lipoprotein]] ([[HDL]]).
* METHOD: AIM-HIGH is a randomized trial wherein 3414 patients randomly received either extended release niacin (1500 to 2000 md per day) or a matching [[placebo]]. All patients received simvastatin 40 to 80 mg daily to maintain an [[LDL]]-C level in the range of 40-80 mg/dL. [[Ezetimibe]] 10 mg daily was added, if needed, to achieve the LDL goal. The primary end point was the first event of the composite of death from [[coronary heart disease]], nonfatal [[myocardial infarction]], [[ischemic stroke]], hospitalization for an [[acute coronary syndrome]], or symptom-driven coronary or cerebral revascularization.
* METHOD: AIM-HIGH is a randomized trial wherein 3414 patients randomly received either extended release niacin (1500 to 2000 md per day) or a matching [[placebo]]. All patients received simvastatin 40 to 80 mg daily to maintain an [[LDL]]-C level in the range of 40-80 mg/dL. [[Ezetimibe]] 10 mg daily was added, if needed, to achieve the LDL goal. The primary end point was the first event of the composite of death from [[coronary heart disease]], nonfatal [[myocardial infarction]], [[ischemic stroke]], hospitalization for an [[acute coronary syndrome]], or symptom-driven coronary or cerebral revascularization.

Revision as of 16:00, 17 April 2013

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aarti Narayan, M.B.B.S [2]; Raviteja Guddeti, M.B.B.S. [3]

Landmark Trials

VA-HIT Trial

  • OBJECTIVE: To conclude if changes in plasma lipid levels due to gemfibrozil is the cause for reduction in major cardiovascular events in VA-HIT trial.
  • METHOD: VA-HIT (Veterans Affairs HDL Intervention Trial) trial is a multicentered, randomized, double-blinded, placebo-controlled trial wherein 2531 patients with CAD along with LDL levels ≤140 mg/dL (mean 111 mg/dL) and HDL ≤40 mg/dL (mean 32 mg/dL) were randomly assigned to treatment with gemfibrozil or placebo.
  • RESULTS: At one year the following findings were noted in the group treated with gemfibrozil:
    • Mean HDL-C level was higher by 6%
    • 31% lower mean TG concentration
    • Mean total cholesterol was 4% lower

At five years, the combined primary end point of cardiac death and non-fatal myocardial infarction occurred in 17.3% versus 21.7% in the placebo group. Acute coronary events reduced by 11% with gemfibrozil for every 5 mg/dL rise in HDL-C, but the reduction was independent of changes in LDL-C and triglyceride levels.

  • CONCLUSION: Low HDL-C levels strongly and independently predict the occurrence of coronary events which were reduced by treatment with gemfibrozil.[1][2][3][4]

AIM-HIGH Trial[5]

  • OBJECTIVE: To assess if niacin + simvastatin combination is superior to simvastatin alone in raising low levels of high density lipoprotein (HDL).
  • METHOD: AIM-HIGH is a randomized trial wherein 3414 patients randomly received either extended release niacin (1500 to 2000 md per day) or a matching placebo. All patients received simvastatin 40 to 80 mg daily to maintain an LDL-C level in the range of 40-80 mg/dL. Ezetimibe 10 mg daily was added, if needed, to achieve the LDL goal. The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
  • RESULTS: The trial was stopped prematurely for futility after a follow-up of 36 months. At two years compared to placebo, niacin increased HDL-C levels and reduced triglyceride and LDL-C levels but there was no reduction in the rate of primary endpoint or all-cause mortality with niacin. Moreover, there was a trend towards more ischemic strokes in the niacin group. This led to the decision to halt the trial prematurely.
  • CONCLUSION: No incremental clinical benefit was observed from addition of niacin to simvastatin during a 36 month follow-up. Also, elevations in HDL-C levels in the placebo group were higher than expected which may have reduced the competency of the trial to detect a real benefit with niacin therapy.[6][7][8][9]

References

  1. ↑ Robins SJ, Collins D, Nelson JJ, Bloomfield HE, Asztalos BF (2008). "Cardiovascular events with increased lipoprotein-associated phospholipase A(2) and low high-density lipoprotein-cholesterol: the Veterans Affairs HDL Intervention Trial". Arterioscler. Thromb. Vasc. Biol. 28 (6): 1172–8. doi:10.1161/ATVBAHA.107.160739. PMID 18356553. Unknown parameter |month= ignored (help)
  2. ↑ Asztalos BF, Collins D, Horvath KV, Bloomfield HE, Robins SJ, Schaefer EJ (2008). "Relation of gemfibrozil treatment and high-density lipoprotein subpopulation profile with cardiovascular events in the Veterans Affairs High-Density Lipoprotein Intervention Trial". Metab. Clin. Exp. 57 (1): 77–83. doi:10.1016/j.metabol.2007.08.009. PMC 2194640. PMID 18078862. Unknown parameter |month= ignored (help)
  3. ↑ Peloso GM, Demissie S, Collins D; et al. (2010). "Common genetic variation in multiple metabolic pathways influences susceptibility to low HDL-cholesterol and coronary heart disease". J. Lipid Res. 51 (12): 3524–32. doi:10.1194/jlr.P008268. PMC 2975725. PMID 20855565. Unknown parameter |month= ignored (help)
  4. ↑ Robins SJ, Collins D, McNamara JR, Bloomfield HE (2008). "Body weight, plasma insulin, and coronary events with gemfibrozil in the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT)". Atherosclerosis. 196 (2): 849–55. doi:10.1016/j.atherosclerosis.2007.01.029. PMID 17335828. Unknown parameter |month= ignored (help)
  5. ↑ Boden WE, Probstfield JL, Anderson T; et al. (2011). "Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy". N. Engl. J. Med. 365 (24): 2255–67. doi:10.1056/NEJMoa1107579. PMID 22085343. Unknown parameter |month= ignored (help)
  6. ↑ Michos ED, Sibley CT, Baer JT, Blaha MJ, Blumenthal RS (2012). "Niacin and statin combination therapy for atherosclerosis regression and prevention of cardiovascular disease events: reconciling the AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial with previous surrogate endpoint trials". J. Am. Coll. Cardiol. 59 (23): 2058–64. doi:10.1016/j.jacc.2012.01.045. PMID 22520249. Unknown parameter |month= ignored (help)
  7. ↑ Brinton EA (2012). "Search and rescue for hypotheses surviving AIM-HIGH, the niacin therapy earthquake: still problematic after the primary publication". J Clin Lipidol. 6 (4): 312–7. doi:10.1016/j.jacl.2012.03.005. PMID 22836067.
  8. ↑ Nicholls SJ (2012). "The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) trial: to believe or not to believe?". J. Am. Coll. Cardiol. 59 (23): 2065–7. doi:10.1016/j.jacc.2012.02.021. PMID 22520248. Unknown parameter |month= ignored (help)
  9. ↑ Nicholls SJ (2012). "Is niacin ineffective? Or did AIM-HIGH miss its target?". Cleve Clin J Med. 79 (1): 38–43. doi:10.3949/ccjm.79a.11166. PMID 22219232. Unknown parameter |month= ignored (help)

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