News 06/03/2551

News 06/03/2551

Pfizer Pulls Lipitor Ads With Heart Expert Jarvik
Pfizer Inc said on Monday it was voluntarily withdrawing advertising for
its Lipitor cholesterol drug featuring Dr. Robert Jarvik, inventor of
the Jarvik artificial heart, because its ads led to "misimpressions."
Reuters Health Information 2008

FDA Approves Combination Niacin and Simvastatin
The US Food and Drug Administration has approved a combination of niacin
and simvastatin for patients with lipid disorders in which treatment
with niacin or simvastatin alone is not sufficient.
Medscape Medical News 2008

Pfizer Pulls Lipitor Ads With Heart Expert Jarvik

Reuters Health Information 2008. ©2008 Reuters Ltd.

NEW YORK (Reuters) Feb 25 - Pfizer Inc said on Monday it was voluntarily withdrawing advertising for its Lipitor cholesterol drug featuring Dr. Robert Jarvik, inventor of the Jarvik artificial heart, because its ads led to "misimpressions."

The ads involving Jarvik had come under scrutiny, including from a U.S. House of Representative Committee as part of an investigation into celebrity endorsements of prescription medicines.

Democratic lawmakers had voiced concern that Jarvik's qualifications were misrepresented in widely seen television commercials touting the blockbuster drug. They said he seemed to be dispensing medical advice even though he is not a practicing physician.

On his Web site, Jarvik describes himself as a medical scientist who has worked in the field of artificial hearts for 36 years and does not practice clinical medicine or treat individual patients.

"The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world -- cardiovascular disease. We regret this," Ian Read, Pfizer's president of worldwide pharmaceutical operations, said in a statement.

"Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople," Read said.

(Reporting by Lewis Krauskopf and Lisa Richwine; editing by Jeffrey Benkoe)

FDA Approves Combination Niacin and Simvastatin

News Author: Michael O'Riordan
from Heartwire — a professional news service of WebMD

February 28, 2008 — The US Food and Drug Administration (FDA) has approved a fixed-dose combination of extended-release (ER) niacin (Niaspan, Abbot) and simvastatin for use in patients with complex lipid abnormalities where treatment with niacin or simvastatin alone is not sufficient.

The drug, known as Simcor (Abbott, Abbott Park, IL), is approved to lower total- and low-density lipoprotein (LDL)-cholesterol levels and triglycerides and to raise high-density lipoprotein (HDL)-cholesterol levels. The approval is based on safety and efficacy data from 641 patients with mixed dyslipidemia and type 2 dyslipidemia, a study in which patients treated with Simcor 1000/20 mg achieved significantly better improvements in cholesterol end points than simvastatin 20 mg. Also, compared with simvastatin 20 mg, the fixed-dose combination reduced triglyceride levels an additional 27%.

The drug, which is composed of the nicotinic acid form of niacin, was generally well tolerated, with flushing the most commonly reported side effect.

The US National Institutes of Health (NIH) is also sponsoring a trial that is evaluating the merits of simultaneously lowering LDL and raising HDL. The trial, known as Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes (AIM-HIGH), will compare the incidence of major cardiovascular events in patients randomized to niacin plus simvastatin or simvastatin alone.

The trial, which will enroll 3300 patients with established vascular disease, is run by Drs William Boden (Hartford Hospital, CT) and Greg Brown (University of Washington School of Medicine, Seattle), but full results are not expected until 2011. In addition to the NIH, Abbott is a cosponsor of the AIM-HIGH study.

The Clinical Trials Service Unit (CTSU) of Oxford University is also in on the HDL-cholesterol show. That group is running a study, known as Heart Protection Study 2 Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE), that will assess whether a new combination tablet, containing extended-release niacin and a specific blocker of prostaglandin D2 to prevent flushing, prevents myocardial infarction (MI), stroke, or revascularization procedures in patients.

http://www.fda.gov/cder/foi/label/2008/022078lbl.pdf

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Study Highlights

The approval of combination therapy with ER niacin plus simvastatin was based on data from a double-blind, randomized, multicenter, multinational, active-controlled, 24-week study that evaluated the lipid effects of ER niacin plus simvastatin tablets vs simvastatin 20 and 80 mg in 641 patients with type 2 hyperlipidemia or mixed dyslipidemia.
In group A, patients with elevated non-HDL and LDL cholesterol levels who were taking low-dose (20 mg) simvastatin monotherapy were randomized to continue this treatment or to receive ER niacin/simvastatin 1000/20 mg or 2000/20 mg.
In group B, patients with elevated non-HDL levels who were taking high-dose (40 mg) simvastatin monotherapy were randomized (regardless of attainment of LDL cholesterol goals) to receive 80 mg of simvastatin or to receive ER niacin/simvastatin 1000/40 mg or 2000/40 mg.
Combination therapy was initiated at the 500-mg dose of ER niacin and increased by 500 mg every 4 weeks to achieve a dose of 1000 mg after 4 weeks and 2000 mg after 12 weeks.
All patients randomized to simvastatin monotherapy received 50 mg of immediate-release niacin daily in an attempt to keep the study from being unblinded because of niacin-related flushing.
Group A results showed that patients receiving combination treatment with ER niacin/simvastatin 1000/20 mg and 2000/20 mg achieved significant decreases of 13.6% and 19.5%, respectively, in non-HDL cholesterol levels vs a 5% decrease for those receiving simvastatin 20 mg (P < .05). Significant improvements were also observed in HDL cholesterol (+20.7% and +29.0%, respectively, vs +7.8%) and triglyceride levels (–26.5% and –38.0%, respectively, vs –15.3%).
Group B results showed that combination therapy with ER niacin/simvastatin 1000/40 mg and 2000/40 mg was noninferior to simvastatin 80 mg alone for reducing non-HDL cholesterol levels (–6.7% and –7.6%, respectively, vs –6.0%). However, significant improvements were observed in HDL cholesterol (+15.4% and +24.4%, respectively, vs +0.1%) and triglyceride levels (–22.8% and –31.8%, respectively, vs +0.3%).
Although beneficial for improving HDL cholesterol and triglyceride levels, combination therapy was not superior to simvastatin for lowering LDL cholesterol levels in either group
(–11.9% and –14.3%, respectively, vs –6.7%; – 7.1% and –5.1%, respectively, vs –11.4%).
Flushing was the most commonly reported adverse event overall, occurring in 59% of patients receiving combination therapy with ER niacin/simvastatin (discontinuation rate, 6.0%).
Other adverse events reported in patients receiving combination therapy vs simvastatin alone included headache (4.5% vs 4.6%), pruritus (3.2% vs 0.0%), nausea (3.2% vs 4.2%), back pain (3.2% vs 2.1%), and diarrhea (3.0% vs 2.9%).
The frequency and severity of flushing may be reduced by taking aspirin or a nonsteroidal anti-inflammatory drug approximately 30 minutes before a dose. Flushing, pruritus, and gastrointestinal tract distress are also reduced by gradually increasing the dose of niacin and avoiding administration on an empty stomach.

Pearls for Practice

The FDA has approved a fixed-dose tablet formulation of ER niacin plus simvastatin for the treatment of primary hypercholesterolemia or mixed dyslipidemia and hypertriglyceridemia when use of either agent alone is not sufficient.
The tablet is available in strengths of 500 mg of niacin ER/20 mg of simvastatin, 750 mg of niacin ER/20 mg of simvastatin, and 1000 mg of niacin ER/20 mg of simvastatin. The initial dose of ER niacin for patients naive to or switching from niacin products other than the ER formulation is 500 mg once daily and should not be increased by more than 500 mg every 4 weeks. Maintenance doses range from 1000 to 2000 mg of ER niacin per day, depending on tolerance and lipid levels. Niacin plus simvastatin should be taken at bedtime after a low-fat snack.

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