[Viva] Fwd: FW: CATIE News - Is there a link between niacin and stroke?
Denise Becker
dbecker106 at gmail.com
Tue Jul 12 12:31:47 PDT 2011
---------- Forwarded message ----------
From: Ross Harvey <rossh at positivelivingbc.org>
Date: Tue, Jul 12, 2011 at 11:50 AM
Subject: FW: CATIE News - Is there a link between niacin and stroke?
To: Positive Living BC Group <group at positivelivingbc.org>
FYI****
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Ross Harvey****
Executive Director****
Positive Living BC****
1107 Seymour Street, 2nd Floor****
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t. 604.893.2252****
f. 604.893.2251****
c.604.788.9111****
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www.positivelivingbc.org <http://www.bcpwa.org/>****
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*From:* mailing at mercury.catie.ca [mailto:mailing at mercury.catie.ca]
*Sent:* July-12-11 11:26 AM
*To:* Ross Harvey
*Subject:* CATIE News - Is there a link between niacin and stroke?****
** **
*CATIE News - Is there a link between niacin and stroke?*****
A large American-Canadian study called Aim-High was halted 18 months ahead
of schedule. Aim-High compared the effects of a cholesterol-lowering
medicine called simvastatin (Zocor) against a combination of simvastatin and
an extended-release formulation of the B-vitamin niacin (high doses of
niacin can help to normalize cholesterol levels). Since the combination of
simvastatin and extended-release niacin did not provide any additional
benefit compared to simvastatin alone, the trial was stopped. Also, there
was a relatively small increase in the number of people who developed stroke
among niacin users. So far only limited information about Aim-High has been
released. As some HIV-positive people use niacin as part of a strategy to
help manage cholesterol levels, in this *CATIE News* bulletin, we provide
background information about niacin and the general implications of the
results of Aim-High.****
*About niacin*
High doses of the B-complex vitamin niacin (vitamin B3, nicotinic acid,
niacinamide) have been used for over 50 years to treat people with abnormal
levels of lipids—cholesterol and triglycerides—in the blood. Emerging
research suggests that niacin has modest anti-inflammatory activity and may
affect some hormones used by fat cells.****
Immediate-release formulations of niacin can cause a temporary and harmless
flushing effect on the skin, resulting in warmth, itching and redness. Some
users of high doses of niacin can experience headache, nausea or diarrhea.
In people who have diabetes or pre-diabetes, increased blood sugar levels
can sometimes occur when large doses of niacin are used.****
Due to the potential for immediate-release niacin to cause a flushing
reaction, an extended-release formulation (ER) of niacin, available with a
prescription under the brand name Niaspan, has been developed and approved
in some high-income countries. The ER formulation of niacin has much less
potential for a flushing reaction. In clinical trials, at doses of 2,000 mg
per day, ER niacin can significantly help to reduce levels of bad
cholesterol (LDL-C) and triglycerides and raise good cholesterol (HDL-C).***
*
ER niacin has been found to reduce the risk of cardiovascular disease when
taken with cholesterol-lowering medicines called statins. Examples of
statins include the following:****
- atorvastatin (Lipitor)****
- rosuvastatin (Crestor)****
- simvastatin (Zocor)****
*HIV infection*
Infection with HIV alters lipid levels and so do many treatments for this
virus. Some physicians therefore prescribe niacin as part of an overall plan
to help normalize lipid levels in their HIV-positive patients. Clinical
trials of niacin in HIV-positive people have found that high doses can help
improve the ability of blood vessels to move blood and reduce levels of
LDL-C and triglycerides and raise HDL-C.****
*Why combinations?*
Statins are powerful drugs that not only improve abnormal lipid levels but
also have anti-inflammatory effects on the cardiovascular system. However,
statins do not entirely remove the risk of worsening cardiovascular disease.
As there is still a residual risk of cardiovascular disease in some statin
users, researchers have been conducting studies that combine statins with
high-dose niacin.****
*Study details*
Researchers in Canada and the U.S. enrolled 3,414 volunteers for Aim-High.
Although participants were apparently not screened for HIV infection, it is
likely that they were HIV negative. The average profile of participants at
the start of the study was as follows:****
- age – 64 years****
- 92% had coronary artery disease****
- 81% had the metabolic syndrome (a combination of risk factors for heart
disease)****
- 71% had higher-than-normal blood pressure****
- 34% had diabetes****
Additionally, many participants had a history of heart attack, stroke, heart
pain or peripheral artery disease.****
All participants received simvastatin at whatever dose was necessary to keep
their LDL-C within a target range between 1 and 2 mmol/L. Also, 515
participants for whom simvastatin was insufficiently potent received another
medicine, ezetimibe (Ezetrol, Zetia), which reduces the absorption of
cholesterol.****
All participants in Aim-High were randomly assigned to one of two groups
where they received the following:****
- extended-release niacin (Niaspan), given in increasing doses until the
target dose of 2,000 mg per day was achieved****
- placebo (fake niacin)****
Participants were monitored for about three years.****
*Results—Overall*
Analyses of Aim-High’s data found that the combination of ER niacin and
simvastatin increased levels of HDL-C in the blood but did not significantly
decrease rates of heart attack and other cardiovascular events. Moreover,
statistical projections suggested that had the trial continued for two or
three years, as originally planned, it was not expected to show any benefit
for combination therapy (simvastatin and niacin).****
*Results—Death*
A total of 145 participants (about 4%) died during the study. Importantly, *
no* deaths were attributed to the study medication(s), including niacin.****
*Results—Stroke*
Overall, about 1% of participants developed a stroke during the study. The
distribution of stroke was as follows:****
- simvastatin + ER niacin: 28 strokes (1.6%)****
- simvastatin + placebo: 12 strokes (0.7%)****
This finding of a small but excess number of strokes among niacin users was
unexpected and played a role in the decision to halt Aim-High. However, 33%
of the strokes in the niacin group occurred in participants who had stopped
taking niacin “at least two months and up to four years before their
stroke,” noted the American National Heart, Lung and Blood Institute
(NHLBI). Due to this time lag between the use of niacin and the development
of stroke in some Aim-High participants, the U.S. Food and Drug
Administration (FDA) stated: “It is unclear, what role, if any, niacin
contributed to this imbalance in stroke.”****
*Niacin in perspective*
- It is important to bear in mind that Aim-High is just one study.****
- Based on the interim data released by the Aim-High researchers, the FDA
sees no reason to issue any warning about the use of ER niacin.****
- Previous clinical trials have found that high doses of niacin are
generally safe and effective when used under medical supervision as part of
a larger strategy to reduce abnormal lipid levels in the blood. None of
these other trials have found any link between the use of niacin and an
increased risk of stroke. Moreover, some researchers have considered that
niacin is sufficiently beneficial that it be considered for use in clinical
trials to assess its ability to prevent strokes.****
- The NHLBI has stated that it is not clear if the association between
exposure to niacin and a small increase in the risk of stroke was caused by
chance or some other issue.****
- Dr. William Boden, co-principal investigator for Aim-High, warned that
the results from the present study should not be presumed to be relevant to
other people who are at even greater risk for serious cardiovascular events
and who were not in Aim-High. In other words, other patients may benefit
from medically supervised use of niacin.****
- An even larger study, similar in design to Aim-High, was *not* stopped
because of concern about any association between niacin and stroke.****
*Supplements*
The amount of niacin normally found in multivitamins or B-complex
formulations is usually between 5 mg and 100 mg. At such doses there is no
evidence that niacin is unsafe for adults. People who have concerns about
the use of niacin arising from the preliminary results from the Aim-High
study should speak to their doctor.****
*High-dose niacin study continues*
Oxford University is coordinating a study called HPS2-Thrive (commonly
called Thrive by researchers), which is similar in design to Aim-High.
However, Thrive is much larger and as of July 2010 enrolled more than 25,000
men and women from China, Scandinavia and the U.K. Regardless of the results
of Aim-High, the researchers who run Thrive plan to continue their study,
which will hopefully yield valuable information about ER niacin and
cardiovascular health in the years ahead.****
*—Sean R. Hosein*****
REFERENCES:****
**1. **National Heart, Lung and Blood Institute. NIH stops clinical
trial on combination cholesterol treatment: lack of efficacy in reducing
cardiovascular events prompts decision. *Press release*. 26 May, 2011.
Available at: www.nih.gov/news/health/may2011/nhlbi-26.htm****
**2. **Food and Drug Administration. FDA statement on the Aim-High
trial. *Press release*. 26 May, 2011. Available at:
www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm256841.htm
****
**3. **The Aim-High investigators. The role of niacin in raising
high-density lipoprotein cholesterol to reduce cardiovascular events in
patients with atherosclerotic cardiovascular disease and optimally treated
low-density lipoprotein cholesterol: baseline characteristics of study
participants. The Atherothrombosis Intervention in Metabolic syndrome with
low HDL/high triglycerides: Impact on Global Health outcomes (AIM-HIGH)
trial. *American Heart Journal*. 2011 Mar;161(3):538-43.****
**4. **Ruparelia N, Digby JE, Choudhury RP. Effects of niacin on
atherosclerosis and vascular function. *Current Opinion in Cardiology*. 2011
Jan; 26(1):66.****
**5. **Villines TC, Stanek EJ, Devine PJ, et al. The ARBITER 6-HALTS
Trial (Arterial Biology for the Investigation of the Treatment Effects of
Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis):
final results and the impact of medication adherence, dose, and treatment
duration. *Journal of the American College of Cardiology*. 2010 Jun
15;55(24):2721-6.****
**6. **Taylor AJ, Villines TC, Stanek EJ, et al. Extended-release niacin
or ezetimibe and carotid intima-media thickness. *New England Journal of
Medicine*. 2009 Nov 26;361(22):2113-22.****
**7. **Canner PL, Furberg CD, McGovern ME. Benefits of niacin in
patients with versus without the metabolic syndrome and healed myocardial
infarction (from the Coronary Drug Project). *American Journal of Cardiology
*. 2006 Feb 15;97(4):477-9.****
**8. **Keener A, Sanossian N. Niacin for stroke prevention: evidence and
rationale. *CNS Neuroscience and Therapeutics*. 2008 Winter;14(4):287-94.***
*
**9. **Karas RH, Kashyap ML, Knopp RH, et al. Long-term safety and
efficacy of a combination of niacin extended release and simvastatin in
patients with dyslipidemia: the OCEANS study. *American Journal of
Cardiovascular Drugs*. 2008;8(2):69-81.****
**10. **Digby JE, Lee JM, Choudhury RP. Nicotinic acid and the prevention
of coronary artery disease. *Current Opinion in Lipidology*. 2009
Aug;20(4):321-6.****
**11. **Lee JM, Robson MD, Yu LM, et al. Effects of high-dose
modified-release nicotinic acid on atherosclerosis and vascular function: a
randomized, placebo-controlled, magnetic resonance imaging study. *Journal
of the American College of Cardiology*. 2009 Nov 3;54(19):1787-94.****
**12. **Chow DC, Stein JH, Seto TB, et al. Short-term effects of
extended-release niacin on endothelial function in HIV-infected patients on
stable antiretroviral therapy. *AIDS*. 2010 Apr 24;24(7):1019-23.****
**13. **Dubé MP, Wu JW, Aberg JA, et al. Safety and efficacy of
extended-release niacin for the treatment of dyslipidaemia in patients with
HIV infection: AIDS Clinical Trials Group Study A5148. *Antiviral Therapy*.
2006;11(8):1081-9.****
****
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