The safety of niacin in the US Food and Drug Administration adverse event reporting database. Re: Re: The Only Double Blind Study In Non-Drug Treatment Of Heart Disease

[Guest guest]

The safety of niacin in the US Food and Drug Administration adverse

event reporting database.

Alsheikh-Ali AA, Karas RH.

Institute for Clinical Research and Health Policy Studies and Molecular

Cardiology Research Institute, Department of Medicine, Tufts-New England

Medical Center and Tufts University School of Medicine, Boston,

Massachusetts 02111, USA.

Of currently approved drugs, niacin is the most effective in raising

high-density lipoprotein cholesterol levels, either as monotherapy or in

combination with other agents. The US Food and Drug Administration's

(FDA) Adverse Event Reporting System provides 1 mechanism to evaluate

the safety of niacin as it is used in common clinical practice. In this

report, the authors review recent analyses of adverse events reported to

the FDA demonstrating that the extended-release formulation of niacin

(niacin-ER) has a significantly better safety profile compared with

other niacin formulations and compares favorably with other commonly

used lipid-altering drugs, including 3-hydroxy-3-methylglutaryl coenzyme

A reductase inhibitors (statins) and fibrates. In addition, analyses of

FDA adverse event reports of the pill combining lovastatin and niacin-ER

suggest that the safety of combination therapy with niacin-ER and a

statin is comparable with the safety of each of the drugs alone. These

analyses should encourage the use of niacin-ER in patients at high risk

for cardiovascular disease, as recommended by current national

guidelines for cardiovascular prevention.

PMID: 18375244 [PubMed - indexed for MEDLINE]

There are also quite a few combination studies that show no increase in

adverse effects.

Steve

bill morris wrote:

>

>

> Hi Bobby,

> This is Bill. I would like to know were you heard that you should not

> take niacin with a statin. My doctors have me taking niaspan and

> simvastatin. Thanks. Bill

>

> Re: The Only Double Blind Study In

> Non-Drug Treatment Of Heart Disease

>

> Kay, mixing a statin with niacin is a dangerous mixture as it is

> high risk of severe myopathy. This has been known for years. I am

> surprised anyone would do that now.

>

> Bobby

>

>

> >

> > I love you Steve...you got the guts to speak how you see it.....I

> was asked to participate in a study on Zocor and Niacin....the

> first appt showed my glucose level too high so they asked me to

> cheat and take insulin before they tested me again to bring glucose

> level down... I SAID NO WAY...YOU GOT A 5 MILLION DOLLAR GRANT TO

> CHEAT ....so I dont have too much faith in these studies....This

> afternoon I had the sum up interview regarding a study that was

> trying to see if over six months being assigned a buddy would help

> elieviate depression. I filled out the questionairre then pointed

> out how bloody useless this study was...as you said one cant control

> what outside influences affect the patient...the loss of 3 friends

> in a short space of time will cause depression no matter how many

> assigned buddies you have...anyway just another way to get funding

> for assinine studies...I am just getting ready to copy an article

> from our newspaper that blew me

> > away .....will send later....Kay

>

--

Steve - dudescholar4@...

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