Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading cause of death in the United States. Unstable plaques often have more fat than stable plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising compared with LDL-lowering alone would more effectively reduce the plaque fat content assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and strokes.

开始日期2008-03-01

申办/合作机构

University of Washington

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100 项与辛伐他汀/烟酸相关的临床结果

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100 项与辛伐他汀/烟酸相关的转化医学

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100 项与辛伐他汀/烟酸相关的专利（医药）

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项与辛伐他汀/烟酸相关的文献（医药）

2019-12-01·Trials4区 · 医学

The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial

4区 · 医学

ArticleOA

作者: Krysiński, Jerzy ; Niezgoda, Anna ; Kowaliszyn, Bogna ; Czajkowski, Rafał ; Kosmalski, Tomasz ; Winnicki, Andrzej

BACKGROUND:

Vitiligo is a chronic skin disorder presenting with depigmentation, the pathogenesis of which is complex but the autoimmune theory is now preferred. Multiple immunologic processes, including stimulation of the T-helper (Th)1 response, formation of autoreactive melanocyte-specific CD8⁺ T lymphocytes, a decrease in the blood concentration of T regulatory (Treg) cells, and an increase in interleukin (IL)-17 and interferon (IFN) concentration, have been shown to contribute to vitiligo progression and maintenance. The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with nonsegmental vitiligo (NSV). According to available data, statins act through several immunological pathways, potentially reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis.

METHODS/DESIGN:

A study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of at least 24 active NSV patients presenting with vitiligous lesions on both upper and lower limbs. The clinical effects of ointments containing 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb will be assessed in comparison with vehicle ointment applied on the opposite limb. All study participants will undergo clinical evaluation using body surface area (BSA) and Vitiligo Area Scoring Index (VASI) scales at baseline and at weeks 4, 8, and 12 time points. A precise assessment of skin lesions will be performed using photographic documentation obtained during each study visit and processed with NIS-Elements software.

DISCUSSION:

Currently available vitiligo topical therapeutic approaches including calcineurin inhibitors and corticosteroids remain poorly effective and are associated with either relatively high cost or potentially dangerous adverse effects. The clinical application of orally administrated statins, widely used as systemic cholesterol-lowering agents, in vitiligous patients has only been tested in two clinical trials; however, data on their potential usefulness is scarce. Moreover, due to a high risk of clinically significant toxicity, topical administration was recommended by researchers. This study is the first to evaluate safety and efficacy of the topical use of statins in patients presenting with NSV.

TRIAL REGISTRATION:

Clinicaltrials.gov, NCT03247400 . Registered on 05 August 2017.

2011-09-01·Geriatric nursing (New York, N.Y.)3区 · 医学

Focus on Statin Safety Concerns

3区 · 医学

Article

作者: Zarowitz, Barbara ; Lefkovitz, Allen

Muscle complaints, including rhabdomyolysis (severe muscle damage), related to the cholesterol-lowering medications known as statins, are a class effect. Following preliminary data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial showing increased muscle injuries, the Food and Drug Administration (FDA) began reviewing the safety of simvastatin, particularly the high-dose 80-mg simvastatin, in March 2010. On June 8, 2011, the Food and Drug Administration (FDA) released the updated product information with revised safety warnings regarding myopathy and rhabdomyolysis associated with products for high cholesterol that contain simvastatin. Simvastatin is the generic form of Zocor and is the statin contained in both Vytorin (simvastatin and ezetimibe) and Simcor (simvastatin and niacin extended-release). From the SEARCH trial and analysis of the FDA’s Adverse Event Reporting System (AERS) database, the FDA found that fatal rhabdomyolysis was significantly more common with 80 mg compared with 20 mg of simvastatin, and that overall rates of myopathy and rhabdomyolysis were higher in simvastatin 80 mg versus lower doses of simvastatin or other statins (e.g., atorvastatin, pravastatin, etc.). The risks for both myopathy and rhabdomyolysis were highest for 80 mg simvastatin during the first 12 months of treatment and are shown in Table 1. Both older age and female sex were seen as risk factors for

2010-11-01·Drugs in R&D4区 · 医学

Niacin Extended Release (ER)/Simvastatin (Simcor®)

4区 · 医学

ReviewOA

作者: Lyseng-Williamson, Katherine A

Oral fixed-dose niacin extended release/simvastatin is associated with clinically relevant improvements in plasma lipid profiles, including lowering of non-high-density lipoprotein cholesterol levels, relative to simvastatin monotherapy in patients with mixed dyslipidemias who had not responded fully to simvastatin monotherapy, and is generally well tolerated.

项与辛伐他汀/烟酸相关的新闻（医药）

2007-04-20

·BioSpace

Abbott Laboratories Submits New Drug Application for Combination Niaspan(R)/Simvastatin Tablet

ABBOTT PARK, Ill., April 20 /PRNewswire-FirstCall/ -- Abbott submitted its New Drug Application to the Food and Drug Administration for a fixed-dose combination (Simcor) of Niaspan(R) (extended-release niacin) and simvastatin. This product seeks to target multiple lipid parameters in a single pill. Niaspan and simvastatin are two widely prescribed medications for treating cholesterol. Niaspan is used to raise HDL "good" cholesterol levels, and simvastatin is effective in reducing LDL "bad" cholesterol levels. This combination is being submitted for FDA approval to address LDL, HDL and triglycerides in a single pill, which may lead to improved patient convenience and outcomes. The Niaspan/simvastatin application includes data from two large clinical studies, composed of more than 1,150 randomized patients, which evaluated safety and efficacy of the combination of Niaspan and simvastatin in patients with mixed dyslipidemia. These studies measured the additional impact of combining Niaspan and simvastatin on key lipid parameters. According to the American Heart Association (AHA), more than 38 million Americans have complex lipid disease. Combination therapy makes up 15 percent of the more than $17 billion U.S. cholesterol management market and represents the fastest-growing segment. "The Niaspan/simvastatin combination tablet is a promising next step in our efforts to develop therapies that support more comprehensive cholesterol management with one pill," said Eugene Sun, M.D., vice president of Global Clinical Development, Abbott. "Combination lipid therapies are an increasing trend to help physicians reach their patients' treatment goals." Treatment guidelines endorsed by the National Cholesterol Education Panel (NCEP), the American College of Cardiology and AHA have called for more aggressive treatment of lipids, including a lower LDL goal for many patients, as well as more aggressive treatment of HDL and triglycerides. Elevated cholesterol can build up in the bloodstream, forming plaque and restricting blood flow, which can lead to heart disease. According to the NCEP guidelines, reducing LDL cholesterol by 1 percent is associated with a 1 percent reduction of the risk of coronary events, and improving HDL by an increase of one point is associated with a 2 percent reduction in the risk of coronary events. "More and more, physicians and their patients understand that good cholesterol management means trying to bring multiple parameters into optimal levels for improved cardiovascular health," said James M. McKenney, PharmD, president and CEO of National Clinical Research, and professor emeritus, Virginia Commonwealth University School of Pharmacy in Richmond, VA. "Continued study of managing key lipid parameters is important to advancing heart health." About Niaspan Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels. Niaspan Indications Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone have been inadequate, to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. In patients with a history of myocardial infarction and hyper-cholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction or in patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. Important Safety Information About Niaspan Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash. Important Safety Information About Simvastatin Simvastatin is a prescription tablet and isn't right for everyone, including women who are nursing or pregnant or who may become pregnant, and anyone with liver problems. Unexplained muscle pain or weakness could be a sign of rhabdomyolysis, a rare but serious side effect and should be reported to your doctor right away. Simvastatin may interact with certain foods or other medicines including lipid-lowering medications called fibrates or niacin, increasing your risk of getting this serious side effect. So tell your doctor about any other medications you are taking. The most common side effects are headache, abdominal pain, and constipation. About Abbott Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries Abbott's news releases and other information are available on the company's Web site at . Abbott CONTACT: Media, DeAnna DuBose, +1-847-938-9002, or Laureen Cassidy,+1-847-938-7743, or Financial, Lawrence J. Peepo, +1-847-935-6772, all ofAbbott Web site:

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100 项与辛伐他汀/烟酸相关的药物交易

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