An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.

Start Date01 Oct 2004

Sponsor / Collaborator

Medical Research Laboratories International, Inc.

NCT00079859 / TerminatedPhase 2

Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).

Start Date01 Oct 2003

Sponsor / Collaborator

Medical Research Laboratories International, Inc.

NCT00079846 / TerminatedPhase 2

Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

Start Date01 Sep 2003

Sponsor / Collaborator

Medical Research Laboratories International, Inc.

100 Clinical Results associated with Medical Research Laboratories International, Inc.

0 Patents (Medical) associated with Medical Research Laboratories International, Inc.

Literatures (Medical) associated with Medical Research Laboratories International, Inc.

01 Apr 2003·Clinical CardiologyQ3 · MEDICINE

The power of statins: Aggressive lipid lowering

Q3 · MEDICINE

ReviewOA

Author: Stein, Evan A

A large body of evidence has demonstrated that reductions in low-density lipoprotein cholesterol (LDL-C) decrease the risk of coronary heart disease (CHD) and related adverse events. The greatest reductions in morbidity and mortality are attained in higher-risk patients, suggesting that targeting this group can maximize the cost-effectiveness of statins, since fewer patients need to be treated to prevent one event. High-risk individuals (those with preexisting CHD or CHD risk equivalents) require aggressive lipid lowering to achieve the stringent LDL-C goal levels established by the third report of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III). The hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins, have assumed the central role in this setting because of their superior ability to reduce LDL-C across the spectrum of CHD risk. Rosuvastatin, a new agent in this class, reduces LDL-C to a significantly greater degree than atorvastatin, pravastatin, or simvastatin. The more aggressive goals put forward since ATP I (1987) have heightened interest in more efficacious statins. As a result, simvastatin, atorvastatin, and now rosuvastatin have been developed, adding sequentially greater LDL-C-reducing capacity for the physician. Substantially more patients, particularly high-risk patients, are thereby able to achieve NCEP ATP III target LDL-C levels with rosuvastatin. Other cholesterol-lowering drugs (bile acid sequestrants, niacin, plant stanols, and fibrates) are much less effective at lowering LDL-C and are much less well tolerated but may be useful when combined with statins. A novel class of agents, cholesterol transport inhibitors, have recently become available. These and other new agents hold promise to help achieve ATP III goals when used in combination regimens initiated with a statin.

01 Mar 2002·The American Journal of CardiologyQ3 · MEDICINE

Managing dyslipidemia in the high-risk patient

Q3 · MEDICINE

Review

Author: Stein, Evan A

Lipid-lowering agents have been shown to reduce morbidity and mortality associated with coronary artery disease (CAD) in all patients. However, these agents are more cost-effective in high-risk patients whose absolute risk of CAD is greater than that of low-risk patients. Furthermore, from preliminary data, it appears that there is greater risk reduction in those subjects achieving lower low-density lipoprotein cholesterol (LDL-C) levels (ie, lower is better). The identification and aggressive treatment of these patients should therefore be a high priority for clinicians. Guidelines from medical organizations, such as the Adult Treatment Panel (ATP) III of the US National Cholesterol Education Program (NCEP), emphasize that patients with CAD, diabetes, or global risk of CAD >20% over 10 years and LDL-C levels >130 mg/dL should receive drug therapy with a goal of reducing LDL-C levels to <100 mg/dL. The recent results of the United Kingdom's Heart Protection Study (HPS) strongly suggest that even those with CAD or who are at high risk and LDL-C levels >100 mg/dL would benefit from drug therapy. Although optimal LDL-C levels have been set at <100 mg/dL for high-risk patients, recent studies show only about 20% of such patients meet these goals. Thus, a large treatment gap remains that needs to be overcome if we are to continue to make significant inroads into preventing further morbidity and mortality in these high-risk subjects. Of therapeutic options available currently and for the near future, statins remain the most effective and well-tolerated form of lipid-lowering therapy. Other therapies include bile acid sequestrants, niacin, and plant stanols. However, none of these is, in general, sufficiently effective as an initial agent to achieve these more aggressive LDL-C goals in the high-risk patient. However, combination therapy with a statin and 1 of these other lipid-lowering agents is useful in patients who are unable to achieve lipid goals on monotherapy. A number of agents for reducing LDL-C levels currently in development may be available in the near future, including 2 new statins: pitavastatin and rosuvastatin. Rosuvastatin, which is in the later stages of the US Food and Drug Administration (FDA) approval process, has been shown to produce significantly greater reductions in LDL-C levels compared with atorvastatin, simvastatin, and pravastatin, and allows more patients to meet lipid goals. Ezetimibe, the first of an entirely new class of LDL-C-lowering agents that inhibit intestinal cholesterol absorption, also appears to offer significant therapeutic value. It is anticipated that these new options will allow clinicians to optimize the management of dyslipidemia in high-risk patients, thereby further reducing the morbidity and mortality of CAD.

01 Jan 2002·Current Atherosclerosis ReportsQ2 · MEDICINE

A general assessment of the safety of HMG CoA reductase inhibitors (statins)

Q2 · MEDICINE

Review

Author: Black, Donald M

Few principles in medicine today are as well accepted as the benefits of using statins to reduce cardiovascular risk factors and to prevent cardiovascular disease. The recent withdrawal of a statin (cerivastatin) has lead to a re-examination of all statins, and an attempt to better assess the risk-benefit ratio of this class of drugs. Although the benefits of statin treatment are well known from a myriad of clinical trials, the safety of these compounds has not been an issue since lovastatin was first introduced in 1987. This report provides a brief review of statin safety, and reiterates the excellent profile of this class of drugs.

100 Deals associated with Medical Research Laboratories International, Inc.

100 Translational Medicine associated with Medical Research Laboratories International, Inc.

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