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Current Drug Targets - Cardiovascular & Haematological Disorders, Volume 5, Number 2, 2005

 

Contents

 

Statins: Effects Beyond Cholesterol Lowering

Guest Editor: Garry X. Shen

 

Editorial

Garry X. Shen

[Abstract]

 

Statins and Thrombin Pp.115-120

J.W. Fenton II, D.V. Brezniak, F.A. Ofosu, G.X. Shen, J.R. Jacobson, J.G.N.Garcia

[Abstract]

 

Mechanisms for Antiplatelet Action of Statins Pp.121-126

Luca Puccetti, Anna Laura Pasqui, Alberto Auteri and Fulvio Bruni

[Abstract]

 

Cholesterol-independent Effects of Statins in Inflammation, Immunomodulation and Atherosclerosis Pp.127-134

Claire Arnaud, Niels R. Veillard and Francois Mach

[Abstract]

 

Statin-induced Vascular Smooth Muscle Cell Apoptosis: A Possible Role in the Prevention of Restenosis? Pp.135-144

Wolfgang Erl

[Abstract]

 

Three’s Company: Regulation of Cell Fate by Statins Pp.145-163

Joannis E. Vamvakopoulos

[Abstract]

 

The Role of Statins in Oxidative Stress and Cardiovascular Disease Pp.165-175

Dominic S. Ng

[Abstract]

 

General Articles

 

Biological Properties of Baicalein in Cardiovascular System Pp.177-184

Yu Huang, Suk-Ying Tsang, Xiaoqiang Yao and Zhen-Yu Chen

[Abstract]

 

Common Therapeutic Strategies in the Management of Sexual Dysfunction and Cardiovascular Disease Pp.185-195

T.M. Hale, J.L. Hannan, J.P.W. Heaton, and M.A. Adams

[Abstract]

 

Abstracts

 

[Back to top]  Editorial

Garry X. Shen

 

Introduction

 

Within last 30 years, 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) have become one of the most common classes of prescripted drugs in routine clinical practice. The original purpose for developing statins was to reduce cholesterol synthesis. All available statins are able to inhibit the activity of HMG-CoA reductase, a rate limiting cholesterol synthetic enzyme, which directly results in decreased generation of mevalonate from acetyl CoA. Mevalonate is a precursor of a group of active intracellular mediators (farnesyl and geranyl pyrophosphates) in addition to cholesterol [1]. Treatment with statins not only reduces the levels of cholesterol in the body, but also affects a variety of biological activities which are either dependent on or independent to cholesterol lowering. Results from a recent meta-analysis demonstrated that statin-treatment significantly reduced coronary events by 27%, stroke by 18%, and all-causes mortality by 15% compared to placebo controls [2]. The beneficial effects of statins have also been seen in hypercholesterolemic patients with diabetes or hypertension, and even those with normal cholesterol levels [3]. Accumulating lines of evidence demonstrated that statin-treatment is helpful in the management of a wide range of pathological conditions, including thrombotic, inflammatory, autoimmune, and neurodegenerative diseases as well as organ transplantation, in addition to atherosclerotic cardiovascular diseases. This hot topic issue aims to help in the translation of our current knowledge of statins and the expanded clinical applications of statins.

 

Coagulation, fibrinolysis and platelet activation

 

Thrombosis at sites of atherosclerotic lesion formation is the most common cause of acute coronary syndromes, the leading cause of morbidity and mortality in North America [4]. A number of studies have examined the effects of statins on markers of coagulation, fibrinolysis and platelet activation in experimental or clinical studies. In hypercholesterolemic or diabetic patients receiving statins, reduced levels of tissue factor, fibrinogen, prothrombin fragments 1 and 2 (F1+2), tissue plasminogen activator, plasminogen activator inhibitor-1 (PAI-1) or platelet aggregation have been detected after the treatment [5-8]. The changes in many of the coagulationor fibrinolysis-related factors do not correlate with the reduction of cholesterol by statins [7]. In a recent study in our group, correlations between total or low density lipoprotein-cholesterol with the levels of PAI-1, but not F1+2, have been observed in type 2 diabetic patients treated with simvastatin [8]. The findings suggest that some of anti-thrombotic activities of statins may be secondary to the cholesterol lowering effects of statins at least in certain populations. The effects of statins on coagulation or fibrinolytic factors have not been verified in large-scale clinical trials to our knowledge. The mechanism for statin-induced anti-thrombotic effects also remains uncertain. Preliminary studies suggest that Ras and other prenylated proteins, including Rho, Rac and Rap, may be implicated in statins mediated biological processes [9-11], which possibly contribute to changes in the regulation of coagulation/fibrinolytic and thrombotic factors associated with statin treatment. Relevant progresses in this field have been summarized in the reviews by Dr. J.W. Fenton et al. and Dr. L. Puccette et al. in following sections of this issue.

 

Inflammation and immunomodulation

 

A recent meta-analysis has demonstrated that the most consistent and significant effects of statins on non-lipid serum markers is a decrease of C-reactive protein (CRP) [7]. CRP is an acute phase reactant synthesized in the liver. The levels of CRP in blood circulation have been considered as an integrated assessment of the activation of inflammation system in the body [12]. Although the biological activity of CRP remains unclear, the level of CRP using highly sensitive analyses has been considered as a reliable predicator for cardiovascular prognosis [13]. Inflammation plays a central role in atherogenesis [14]. The production of CRP is regulated by cytokines, particularly interleukin-6 (IL-6). Statins affects signaling pathway of IL-6 through suppressing isoprenylation of Rac-1 [15], which may affect the formation of CRP. Statins also regulate the expression of major histocompatibility complex II (MHC-II). MHC-II plays a crucial role in T-cell-mediated immunomodulation and the pathogenesis of autoimmune disease and transplantation rejection [16]. Recent studies has demonstrated that statins are potential treatment for multiple sclerosis and neurodegenerative disease [17,18]. More autoimmune and inflammation-related diseases are expected to be beneficial by statin treatment. Dr. F. Mach and his colleagues have highlighted the recent progresses on the impact of statins on inflammation and immunomodulation in this issue.

 

Cell growth and apoptosis

 

Multiple lines of evidence suggest that statin-treatment inhibits cell proliferation and promotes apoptosis. Smooth muscle cell (SMC) proliferation is one of major pathological findings in progressive atherosclerotic plaques as well as restenosis. Restenosis occurs in 20-40% of patients received angioplasty or stent [19]. Statin treatment has the potential to reduce the development of atherosclerosis plaque or stenosis. This hypothesis remains to be confirmed by experimental and clinical studies. Anti-proliferation effects of statins have been found in SMC, endothelial cells, fibroblasts and myoblasts [20]. Inhibition of cell growth or increase in apoptosis in atherosclerotic or restenotic lesions will be beneficial to the management of ischemic heart disease. A retrospective study has demonstrated that statin treatment was associated with lower rates of choroidal neovascularization among patients with age-related macular degeneration in elders [21]. However, the findings on the effects of statins on cell proliferation or apoptosis have not been consistent in previous studies. Effects of statins on cancers remain inconclusive [22]. Relevant progress in this field has been reviewed by Dr. W. Erl and J. Vamvakopoulos.

 

Oxidative stress and metabolic syndrome

 

Oxidative stress causes tissue injury and also mediates the effects of several biological activators in cells. Dyslipidemia, hyperglycemia, obesity and angiotension II increase endogenous oxidative stress in tissues through enhancing the generation of reactive oxygen species (ROS) [23]. ROS plays an important role in the crosslink between the components of metabolic syndrome (diabetes, hypertension, obesity and dyslipidemia). Statin treatment reduces the activities of enzymes mediating the generation of ROS or their metabolism, which reduces endogenous oxidative stress [24]. Angiotensin II is a key mediator for the development of hypertension and increases the production of ROS in the body. The biological activity of angiotensin II is mainly mediated through its receptor (AT1). Statins down-regulate the density of AT1 in platelets in hypercholesterolemic patients, ameliorates their dyslipidemia and helps to control high blood pressure [25]. Statin treatment has been proposed for use in diabetic patients with and without hypercholesterolemia [26]. A review provided by Dr. D. Ng provides an update on recent progress in this field.

 

Non-LDL-cholesterol lipids

 

Statins not only reduces the levels of cholesterol, but also the levels of triglycerides in blood circulation. Moderate increases of HDL-cholesterol (5-15%) have been observed in trials of statin treatment [27,28]. These findings imply that the lipid effects of statins are not limited to cholesterol or LDL-cholesterol lowering. The mechanism for non-cholesterol lowering effects on lipoproteins and atherogenesis remains to be determined. The levels of HDL-cholesterol independently correlate to extent of atherosclerotic lesions detected by angiography [29,30]. The moderate increases in HDL-cholesterol by statins may have meaningful impact on the development of atherosclerosis. HDL reduces the susceptibility of LDL to oxidation. The antioxidant effect of HDL partially results from paraoxonase (PON) associated with HDL. A recent study has demonstrated that simvastatin upregulated the expression of PON1 in HepG2 hepatocyptes [31]. Increases of triglyceride-rich lipoproteins are evident in diabetic patients or patients with metabolic syndrome. Growing evidence suggests that patients with hypertriglyceridemia associated with metabolic syndrome have increased risk for or ischemic heart disease [32]. Although statin-treatment has effectively decreased triglyceride levels in hypercholesterolemic and diabetic patients [33], clinical benefits of statin-induced triglyceride lowering have mainly been seen in individuals with high baseline levels [34]. Triglyceride-lowering as well as HDL-rising effects of statins likely plays important role in the beneficial effects of statins in patients with cardiovascular diseases and diabetes.

 

Safety concerns for statin treatment

 

Low incidence of adverse effects have been described in large-scale clinical trials using statins. The major adverse effects of statins are myotoxicity and moderate liver toxicity. Fatal rhadomyolysis associated with statins is less than one death per million prescriptions of all statins, except cerivastatin. Cerivastatin has been withdrawn from market in 2001 for this complication. The majority of myotoxicity caused by statins were related to drug/drug interference with the P450 system [35]. A meta-analysis of liver toxicity of statins indicated that low doses of pravastatin, simvastatin and lovastatin did not increase the rates of liver function abnormalities compared to placebo in 13 trials [36]. Non-life threatening side effects of statins may occur in up to 15% of receivers, including mood alterations [35]. Statin treatment has been considered as safe in general. Limited side effects may be reduced to minimal by avoiding drug/drug interference.

 

Conclusion and Perspectives

 

Statin treatment effectively lowers cardiovascular risks in hyper- and normocholesterolemic individuals with ischemic heart disease, hypertension, diabetes, nephrotic disease, and may improve the outcome of autoimmune diseases or organ transplantation. The beneficial effects of statins may be mediated via multiple mechanisms including cholesterol lowering, regulation of the coagulation/fibrinolysis balance, platelet inactivation, inhibition of inflammation, immunomodulation, anti-oxidative effects, reduced cell proliferation and improved endothelial function. The excellent safety profile allows statins to be used as primary and/or secondary intervention agents. Further researches on non-cholesterol lowering effects of statins are expected to expand their growing clinical applications.

 

Acknowledgements

 

The author is grateful to Drs. J.W. Fenton II, F.A. Ofosu, S. Luwig, H. te Vethuis, and Mr. S. Nelson for their helps in relevant studies, and grant supports from Canadian Institute of Health Reseaarch and from Canadian Diabetes Association.

 

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[Back to top] Statins and Thrombin

J.W. Fenton II, D.V. Brezniak, F.A. Ofosu, G.X. Shen, J.R. Jacobson, J.G.N.Garcia

 

L-Mevalonic acid is the distant precursor of cholesterol, in contrast to cholesterol, L-mevalonic acid, its distant precursor gives rise to farnesyl and geranylgeranyl pyrophosphates in relatively few metabolic steps. These isoprenyl pyrophophates covalently conjugate with specific G-proteins and serve as membrane anchors enabling them to carry out their function. Although farnesyl-proteins may participate in signal transduction, geranylgeranyl-proteins (e.g., Rho GTP binding proteins) are well known to downregulate signaling pathways by inhibiting L-mevalonic acid synthesis. Such inhibitors include 3-hydroxy-3-methylglutaryl CoA reductase inhibitors, drugs (statins) and isoprenoids of dietary origins, where Rho protein activation appears to be necessary for cellular-mediated thrombin generation. Thrombin and other proteases (e.g., coagulation factor Xa, tryptase) upregulate protease-activated receptor (PAR) synthesis and PAR activation promotes synthesis and expression of other proteins [e.g., tissue factor (TF) and plasminogen activator inhibitor-1 (PAI-1)]. With the PAR-1 activating peptide SSFLRNP, we found that either cerivastatin or atorvastatin mitigated platelet stimulation in a time- and dose-dependent manner, as predicted if a statin-mediated Rho pathway is required. We also found that simvastatin decreased prothrombin fragments F1+2 in plasma from type 2 diabetics, demonstrating that statins downregulate thrombin generation. Thus, independent of cholesterol, statins and dietary isoprenoids behave as inhibitors of TF-dependent thrombin generation. Because thrombin has multiple physiological functions, the 20 pleiotropic effects reported for statins may reflect a common mechanism for downregulation of thrombin-mediated events, in particular at the cellular level.

 

[Back to top] Mechanisms for Antiplatelet Action of Statins

Luca Puccetti, Anna Laura Pasqui, Alberto Auteri and Fulvio Bruni

 

Hydroxymethyl-glutaryl coenzyme A reductase inhibitors (statins) offer important benefits for the large populations of individuals at high risk for coronary heart and cerebrovascular disease. the overall clinical benefits observed with statin therapy appear to be greater than what might be expected from changes in lipid profile alone, suggesting that the beneficial effects of such drugs may extend beyond their effects on serum cholesterol. Platelet hyperactivity is a key step in atherothrombosis and experimental data suggest that statins could exert an antiplatelet effect which could be involved in their protective action. In the present review we report of the major studies in humans showing the effect of statins on platelets, especially by the more sensitive methods to explore platelet function such as cytofluorymetric detection of specific proteins. Moreover we describe the putative mechanisms involved in platelet deactivation with particular regard to the effects related to cholesterol reduction or beyond lipid-lowering. Indeed, data from several studies suggest some differences among compounds in terms of timing of action by modulation of several activating pathways which could take part either in the early, cholesterol-lowering independent, effects in the acute phase of vascular disease or during chronic treatment.

 

[Back to top] Cholesterol-independent Effects of Statins in Inflammation, Immunomodulation and Atherosclerosis

Claire Arnaud, Niels R. Veillard and Francois Mach

 

Atherosclerosis and its complications still represent the major cause of death in developed countries. Statins have revolutionized the treatment of dyslipidemia and demonstrated their ability to reduce and prevent coronary morbidity and mortality. Statins inhibit 3-hydroxyl-3-methylglutaryl coenzyme A (HMG-CoA) reductase, an enzyme crucial to cholesterol synthesis. The effectiveness and rapidity of statin-induced decreases in coronary events led to the speculation that statins possess cholesterol-independent effects. Since mevalonate produced by the HMG-CoA reductase is not only the precursor of cholesterol, but also of non steroidal isoprenoid compounds, such as the farnesyl pyrophosphate and the geranylgeranyl pyrophosphate, statins also regulate the small signaling proteins, Ras and Rho. Thus, inhibition of these prenylated proteins might account for the non-lipid lowering effects of statins. In this review, we describe the numerous beneficial pleiotropic effects of statins that could modulate atherogenesis.

 

[Back to top] Statin-induced Vascular Smooth Muscle Cell Apoptosis: A Possible Role in the Prevention of Restenosis?

Wolfgang Erl

 

Growing evidence suggests that statins are more than simple lipid-lowering drugs. The so called pleiotropic effects of statins include multiple actions on cells of the vasculature. A large number of studies have confirmed that these compounds exert beneficial effects by mechanisms unrelated to cholesterol metabolism. For example, statins have been shown to inhibit the migration and proliferation of vascular smooth muscle cells (VSMC), and to induce apoptosis in this cell type. It is not yet clear if the induction of apoptosis in VSMC by statins is beneficial or detrimental. In the context of post-angioplasty restenosis, recurrent plaque growth after intervention, the inhibition of neointimal proliferation as well as a reduction of neointimal cell numbers by apoptosis is appealing. Multiple animal studies and clinical trials have therefore been undertaken to investigate effects of statin treatment on the development of restenosis, with very controversial results. Conversely, in advanced atherosclerotic lesions VSMC in the intima may stabilize the plaque and prevent plaque rupture by synthesizing collagen. VSMC in media adjacent to plaque areas or restenotic lesions should not be exposed to apoptosis promoting agents. In this context, recent evidence suggests that pravastatin protects such lesions by inhibiting inflammation and macrophage activation Our recent findings together with observations from other groups suggest that neointima cells are more sensitive to the induction of apoptosis than media VSMC. Importantly, statins were found to preferentially induce apoptosis in neointimal VSMC in our study. The purpose of the present review is to summarize statin effects on proliferation and apoptosis in VSMC in vitro and in vivo. Furthermore, the development of drug-coated stents may help to deliver high local doses of statins to enhance their effectiveness in the treatment of post-angioplasty restenosis.

 

[Back to top] Three’s Company: Regulation of Cell Fate by Statins

Joannis E. Vamvakopoulos

 

Inhibitors of 3-hydroxy-3-methylglutaryl-CoA reductase (statins), the rate-limiting enzyme of the mevalonate biosynthetic pathway, are currently the leading prescription drugs worldwide. Programmed cell death (apoptosis) is a powerful physiological regulator of cellular development, function and dynamics. Statins are known to induce cellular apoptosis in vitro; however, the clinical relevance of this action remains controversial. This paper draws from 15 years’ worth of research to explore the impact of statin treatment on cell fate, as represented by the interlinked processes of cellular growth, differentiation and apoptosis. In particular, I outline our current understanding of the pertinent molecular mechanisms; and discuss the evidence for clinical relevance of statin-induced apoptosis.

 

[Back to top] The Role of Statins in Oxidative Stress and Cardiovascular Disease

Dominic S. Ng

 

Statins have emerged as a highly efficacious class of drugs in the prevention of cardiovascular events. The primary mechanism of its cardioprotective effect is likely through its effectiveness in lowering serum lipids, particularly the low density lipoprotein (LDL) fractions. Recent studies suggest that statins also confer direct beneficial effects on the vascular cells in the attenuation of the atherogenic process through a variety of mechanisms. It remains the current dogma that oxidative modification of the LDL particles in the vessel wall plays a critical role for these lipoprotein particles to intiate the atherogenic cascade. The current failure of a number of antioxidants, which includes vitamin E, to favorably impact on the cardiovascular outcome in large scale clinical trials attests to the complexity of the oxidation processes in biological systems. In this review, we will highlight the current advances in a number of endogenous pro-oxidative and anti-oxidative systems in how they contribute to the net oxidative stress and how statin drugs may modulate this complex array of pro- and anti-oxidative processes.

 

[Back to top] Biological Properties of Baicalein in Cardiovascular System

Yu Huang, Suk-Ying Tsang, Xiaoqiang Yao and Zhen-Yu Chen

 

The dried roots of Scutellaria baicalensis (S. baicalensis) Georgi (common name: Huangqin in China) have been widely employed for many centuries in traditional Chinese herbal medicine as popular antibacterial and antiviral agents. They are effective against staphylococci, cholera, dysentery, pneumococci and influenza virus. Baicalein, one of the major flavonoids contained in the dried roots, possesses a multitude of pharmacological activities. The glycoside of baicalein, baicalin is a potent anti-inflammatory and anti-tumor agent. This review describes the biological properties of baicalein (Table 1), which are associated with the prevention and treatment of cardiovascular diseases. Baicalein is a potent free radical scavenger and xanthine oxidase inhibitor, thus improving endothelial function and conferring cardiovascular protective actions against oxidative stress-induced cell injury. Baicalein lowers blood pressure in renin-dependent hypertension and the in vivo hypotensive effect may be partly attributed to its inhibition of lipoxygenase, resulting in reduced biosynthesis and release of arachidonic acid-derived vasoconstrictor products. On the other hand, baicalein enhances vasoconstricting sensitivity to receptor-dependent agonists such as noradrenaline, phenylephrine, serotonin, U46619 and vasopressin in isolated rat arteries. The in vitro effect is likely caused by inhibition of an endothelial nitric oxide-dependent mechanism. The anti-thrombotic, anti-proliferative and anti-mitogenic effects of the roots of S. baicalensis and baicalein are also reported. Baicalein inhibits thrombin-induced production of plasminogen activator inhibitor-1, and interleukin-1ß- and tumor necrosis factor-a-induced adhesion molecule expression in cultured human umbilical vein endothelial cells. The pharmacological findings have highlighted the therapeutic potentials of using plant-derived baicalein and its analogs for the treatment of arteriosclerosis and hypertension.

 

[Back to top] Common Therapeutic Strategies in the Management of Sexual Dysfunction and Cardiovascular Disease

T.M. Hale, J.L. Hannan, J.P.W. Heaton, and M.A. Adams

 

Sexual dysfunction is a frequent complication of treated and untreated cardiovascular disease. In fact, ~30% of hypertensives have been found to suffer from erectile dysfunction (ED) resulting from arterial dysfunction. Recent evidence has suggested that ED may be an early indicator of subclinical cardiovascular disease. In women, the evidence is similar, but more limited, showing that in hypertensive patients there is an increased prevalence of sexual dysfunction involving decreased vaginal lubrication, decreased orgasm, and increased pain. Clouding the issue, however, is that some antihypertensive agents may induce sexual dysfunction in hypertensives with normal sexual function. In contrast to the chronic treatments used in hypertension, therapies for ED involve acute treatments (none currently approved for women) targeting vasodilation of penile arteries, resulting in erection. Common to the treatment of hypertension and ED is that the current therapies were not designed to target underlying disorders of local, neural, vascular, or endocrine origin. In fact, while blood pressure is lowered, and erectile responses are improved with the respective therapies, the causal abnormalities may progress thereby limiting the long-term effectiveness of the medication. Some antihypertensive agents have been shown to have additional effects beyond blood pressure reduction and their impact on sexual function is a key focus of this review. This review examines the current and future strategies for treatments of male and female sexual dysfunction and the potential for therapeutic modalities that go beyond the recovery of the responses by targeting the fundamental mechanisms common to both sexual dysfunction and cardiovascular disease.