Featured Research

from universities, journals, and other organizations

New Combination Drug Improves Multiple Cholesterol Disorders In Single Pill

Date:
November 7, 2007
Source:
Methodist Hospital, Houston
Summary:
Patients treated with a new investigational combination pill showed significant improvements in cholesterol, triglycerides and other key lipids that lead to heart disease. Simcor combines prescription niacin and simvastatin, two FDA-approved medications with established safety profiles, to target good cholesterol (HDL), bad cholesterol (LDL), and triglycerides in a single pill.

Patients treated with a new investigational combination pill showed significant improvements in cholesterol, triglycerides and other key lipids that lead to heart disease.

Simcor combines prescription niacin and simvastatin, two FDA-approved medications with established safety profiles, to target good cholesterol (HDL), bad cholesterol (LDL), and triglycerides in a single pill.

“These results indicate that Simcor can go beyond what simvastatin alone can provide,” said principal investigator Dr. Christie Ballantyne, medical director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center in Houston. “This type of combination approach could be an important tool in treating the increasing number of patients with complex lipid disorders, the metabolic syndrome and heart disease.”

Treatment of high cholesterol has historically centered on the use of statins, including simvastatin, to lower LDL cholesterol, which has been the primary target of therapy.

“We now place more importance on comprehensive cholesterol management, including management of HDL levels, in impacting cardiovascular risk,” Ballantyne said. “Medications like Simcor can help patients address multiple problems with one pill.”

Abbott’s Simcor, an investigational, fixed-dose combination of Niaspanฎ, Abbott’s extended-release niacin, and simvastatin, met its primary endpoint of lowering non-HDL cholesterol and demonstrating improvements on LDL, HDL and triglycerides. Niacin is known to raise HDL and statins are known to reduce LDL cholesterol and triglycerides.

Research was conducted at the Methodist DeBakey Heart Center and other sites across the nation. Patients in the study treated with a Simcor combination containing 20 mg simvastatin had significantly better reductions in non-HDL (total cholesterol minus HDL) compared to 20 mg simvastatin therapy alone, as well as significant improvements in HDL and triglyceride levels. Patients receiving a Simcor combination with 40 mg simvastatin experienced reductions in non-HDL comparable to 80 mg high-dose simvastatin alone, and significant improvements in HDL and triglycerides.

In April, Abbott submitted its New Drug Application to the Food and Drug Administration for Simcor including includes data from this Phase III pivotal Seacoast trial.

Seacoast Studies

This 24-week double-blind, randomized, controlled trial in more than 600 patients with elevated non-HDL (type II hyperlipidemia or mixed dyslipidemia) compared simvastatin alone to a combination of Abbott's extended-release niacin combined with simvastatin. The SEACOAST study was designed to evaluate the safety and efficacy of the Simcor combination following simvastatin monotherapy.

Patients enrolled in the trial were assigned to either a low-dose (20 mg) or high-dose (40 mg) simvastatin group. Patients in the low-dose group were randomized to receive Niaspan 2000 mg/simvastatin 20 mg, Niaspan 1000 mg/simvastatin 20 mg, or simvastatin 20 mg. Patients in the high-dose group were randomized to receive Niaspan 2000 mg/simvastatin 40 mg, Niaspan 1000 mg/simvastatin 40 mg or simvastatin 80 mg. Those in the simvastatin control groups received a 50 mg dose of immediate-release niacin to maintain blinding.

Patients in the low dose group receiving combination treatment achieved 14 percent (1000 mg/20 mg) and 23 percent (2000 mg/20 mg) reductions in non HDL compared to a 7 percent reduction with 20 mg simvastatin therapy alone. Additionally, combination treatment resulted in significant improvements in HDL of 18 percent (1000 mg/20 mg) and 25 percent (2000 mg/20 mg) compared to 7 percent with 20 mg simvastatin alone. Similarly, significant reductions in triglycerides of 26 percent (1000 mg/20 mg) and 38 percent (2000 mg/20 mg) were seen in those treated with combination therapy compared to a 15 percent reduction with simvastatin monotherapy.

In the high-dose group, patients treated with Simcor combination therapy showed similar (non-inferior) improvements in non-HDL of 11 percent (1000 mg/40 mg) and 17 percent (2000 mg/40 mg) compared to a 10 percent improvement with 80mg simvastatin therapy alone. Additionally, the high-dose combination group demonstrated significant improvements in HDL of 15 percent (1000 mg/40 mg) and 22 percent (2000 mg/40 mg) compared to a one percent decrease among those receiving 80 mg simvastatin monotherapy. Triglyceride levels among the high-dose combinations groups dropped 23 percent and 32 percent, respectively, in contrast to a 0.3 percent increase in those randomized to 80 mg simvastatin monotherapy.

Treatment with four different doses of Niaspan combined with simvastatin for 24 weeks was well tolerated. There was no evidence for increased risk of hepatotoxicity or myopathy with the combination. Six percent of patients on Simcor therapy discontinued due to flushing compared to 0.8 percent with simvastatin alone.

This research was presented November 4 at the American Heart Association’s Scientific Sessions.


Story Source:

The above story is based on materials provided by Methodist Hospital, Houston. Note: Materials may be edited for content and length.


Cite This Page:

Methodist Hospital, Houston. "New Combination Drug Improves Multiple Cholesterol Disorders In Single Pill." ScienceDaily. ScienceDaily, 7 November 2007. <www.sciencedaily.com/releases/2007/11/071106091509.htm>.
Methodist Hospital, Houston. (2007, November 7). New Combination Drug Improves Multiple Cholesterol Disorders In Single Pill. ScienceDaily. Retrieved September 19, 2014 from www.sciencedaily.com/releases/2007/11/071106091509.htm
Methodist Hospital, Houston. "New Combination Drug Improves Multiple Cholesterol Disorders In Single Pill." ScienceDaily. www.sciencedaily.com/releases/2007/11/071106091509.htm (accessed September 19, 2014).

Share This



More Health & Medicine News

Friday, September 19, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Could Grief Affect The Immune Systems Of Senior Citizens?

Could Grief Affect The Immune Systems Of Senior Citizens?

Newsy (Sep. 19, 2014) — The study found elderly people are much more likely to become susceptible to infection than younger adults going though a similar situation. Video provided by Newsy
Powered by NewsLook.com
Jury Delivers Verdict in Salmonella Trial

Jury Delivers Verdict in Salmonella Trial

AP (Sep. 19, 2014) — A federal jury has convicted three people in connection with an outbreak of salmonella poisoning five years ago that sickened hundreds of people and was linked to a number of deaths. (Sept. 19) Video provided by AP
Powered by NewsLook.com
How The 'Angelina Jolie Effect' Increased Cancer Screenings

How The 'Angelina Jolie Effect' Increased Cancer Screenings

Newsy (Sep. 19, 2014) — Angelina's Jolie's decision to undergo a preventative mastectomy in 2013 inspired many women to seek early screenings for the disease. Video provided by Newsy
Powered by NewsLook.com
The Cost of Ebola

The Cost of Ebola

Reuters - Business Video Online (Sep. 18, 2014) — As Sierra Leone prepares for a three-day "lockdown" in its latest bid to stem the spread of Ebola, Ciara Lee looks at the financial implications of fighting the largest ever outbreak of the disease. Video provided by Reuters
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins