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Dyslipidemia: Opportunities in Cardiovascular Risk Reduction

Published by: Biophoenix Limited

Published: Jul. 15, 2008 - 210 Pages


Table of Contents


Executive Summary


Chapter 1 Introduction


1.0 Executive summary

1.1 Dyslipidemia and atherosclerosis

1.2 Atherosclerotic vascular diseases

1.3 Background on lipids and lipoproteins

1.3.1 Lipids

1.3.2 Lipoproteins

1.3.2.1 Apolipoproteins

1.3.3 Association with atherosclerosis

1.3.4 Lipid metabolism

1.4 Atherosclerosis

1.4.1 Overview

1.4.2 Plaque evolution

1.4.2.1 Role of apoB-containing lipoproteins

1.4.3 Vulnerable plaques

1.4.4 Diagnosis and treatment

1.5 Hyperlipidemia

1.6 Atherogenic dyslipidemia

1.7 Lipids, CVD risk and treatment goals

1.7.1 Targeting elevated LDL-C

1.7.2 Targeting elevated triglycerides

1.7.3 Targeting low HDL-C

1.7.4 Targeting the metabolic syndrome


Chapter 2 Biomarkers and surrogates of atherosclerosis


2.0 Executive summary

2.1 Introduction

2.2 Vascular imaging technologies

2.2.1 Quantitative coronary angiography

2.2.1.1 Brown-Dodge system

2.2.1.2 Edge detection systems

2.2.1.3 Videodensitometric methods

2.2.1.4 Problems and disadvantages

2.2.1.5 Predicting lesion progression

2.2.2 B-Mode ultrasound

2.2.2.1 Principle of B-mode imaging

2.2.2.2 Carotid intimal-medial thickness (CIMT)

2.2.2.3 Risk factors for CIMT and its progression

2.2.2.4 Lipid lowering and CIMT trials

2.2.2.5 Effect of other interventions on CIMT

2.2.3 Intravascular ultrasound (IVUS)

2.2.3.1 Overview of the technique

2.2.3.2 Advantages and disadvantages

2.2.3.3 IVUS trials

2.2.3.4 Intravascular ultrasound elastography

2.2.3.5 Integrated backscatter IVUS

2.2.4 Coronary angioscopy

2.2.5 Optical coherence tomography

2.2.6 Intravascular thermography

2.2.7 Regulatory status of vascular imaging

2.3 Plasma biomarkers

2.3.1 Diagnosis of dyslipidemia

2.3.1.1 Fasting lipid panel tests

2.3.1.2 apoB and apoAI

2.3.1.3 Lp(a)

2.3.1.4 Small dense LDL particles

2.3.2 Emerging biomarkers of risk

2.3.2.1 OxLDL

2.3.2.2 Lp-PLA2

2.3.2.3 CRP

2.3.2.4 Myeloperoxidase

2.3.2.5 Homocysteine

2.3.2.6 PAPP-A

2.3.2.7 CD40L

2.3.2.8 IL-18

2.3.2.9 Other biomarkers


Chapter 3 Improving mainstay therapies


3.0 Executive summary

3.1 Introduction

3.2 Dietary manipulations

3.2.1 Plant sterols and stanols

3.2.2 Soy-derived isoflavones

3.2.3 Red yeast rice

3.2.4 Essential fatty acids

3.2.5 Omega-3 products

3.2.5.1 Dietary supplements

3.2.5.2 Prescription products on the market

3.2.5.3 Prescription drugs in development

3.3 Statins

3.3.1 Overview

3.3.2 Mode of action

3.3.3 Statins on the market

3.3.3.1 Lovastatin and simvastatin

3.3.3.2 Pravastatin

3.3.3.3 Atorvastatin

3.3.3.4 Fluvastatin

3.3.3.5 Rosuvastatin

3.3.3.6 Other agents and indications

3.3.4 Pharmacogenomics of statin efficacy

3.4 Cholesterol absorption inhibitors

3.4.1 Ezetimibe

3.4.2 Drugs in development

3.5 Niacin

3.6 Fibrates

3.7 Bile acid sequestrants

3.8 Combination therapies

3.8.1 Statin + ezetimibe

3.8.2 Statin + niacin

3.8.3 Statin + fibrate

3.8.4 Other combination products

3.8.5 Statin-containing "polypills"


Chapter 4 Focus on HDL


4.0 Executive summary

4.1 HDL-C levels and cardiovascular risk

4.1.1 Prevalence of low HDL-C

4.2 Background on HDL

4.2.1 Structure

4.2.2 Metabolism

4.2.3 Lab measurements

4.2.4 Antiatherogenic activities

4.2.4.1 Cellular cholesterol efflux

4.2.4.2 Antioxidative action

4.2.4.3 Anti-inflammatory activity

4.2.5 HDL in dyslipidemic and inflammatory states

4.3 Current treatments which increase HDL

4.3.1 Niacin

4.3.2 Fibrates

4.3.3 Statins

4.3.4 Combination therapies

4.4 Novel therapies in commercial development

4.4.1 HDL mimetics

4.4.2 ApoAI mimetics

4.4.3 ApoAI-boosting therapies

4.4.4 ABCA1-boosting therapies

4.4.5 CETP-suppressing therapies

4.4.6 Niacin receptor agonists


Chapter 5 Other lipid modulators in development


5.0 Executive summary

5.1 Introduction

5.2 PPAR agonists

5.2.1 PPAR alpha agonists

5.2.1.1 Agents in development

5.2.2 PPAR gamma agonists

5.2.2.1 TZDs

5.2.2.2 Agents in development

5.2.3 Dual PPAR alpha/gamma agonists

5.2.4 PPAR delta agonists

5.2.5 PPAR pan agonists

5.2.6 Other insulin sensitizers

5.3 Anti-obesity therapies

5.3.1 Obesity and dyslipidemia

5.3.2 Approved therapies

5.3.3 Drugs in development

5.4 Thyroid hormone function agonists

5.5 MTP inhibitors

5.6 Leukotriene antagonists

5.6.1 Targeting Lp-PLA2

5.6.2 Targeting 5-LO and LTA4H

5.7 Succinobucol

5.8 ApoB inhibitors

5.9 Kinase modulators

5.9.1 Targeting MAPK14

5.9.2 Targeting other kinases

5.10 Miscellaneous drugs targeting lipid metabolism

5.11 Miscellaneous drugs targeting inflammation


Chapter 6 Market outlook


6.0 Executive summary

6.1 Introduction

6.2 The broad spectrum of dyslipidemia

6.3 The dyslipidemia market by therapy

6.3.1 Statins

6.3.1.1 Overview

6.3.1.2 Lipitor

6.3.1.3 Crestor

6.3.1.4 Lescol

6.3.1.5 Livalo

6.3.1.6 Generic statins: lovastatin, simvastatin, and pravastatin

6.3.1.7 Statin-containing ""polypills""

6.3.2 Ezetimibe

6.3.3 CETP Inhibitors

6.3.4 Niacin-based Combination Therapy

6.3.5 Fibrates

6.3.6 Bile acid sequestrants

6.3.7 Omega-3 fatty acid derivatives

6.3.8 Other Agents

6.4 Forecasts


Chapter 7 Market potential


7.0 Executive summary

7.1 Introduction

7.2 New therapies

7.2.1 Investing in biopharmaceuticals

7.3 Reaching more patients

7.3.1 Introduction

7.3.2 Maximising statin treatment

7.3.3 Focusing on undertreated populations

7.3.3.1 Targeting hypertensives

7.3.3.2 Targeting women

7.3.3.3 Targeting the elderly

7.3.3.4 Targeting the obese

7.3.3.5 Targeting diabetics

7.3.3.6 Targeting rheumatoid arthritis patients

7.3.3.7 Targeting HIV patients

7.3.3.8 Targeting renal insufficiency patients

7.3.3.9 Targeting schizophrenia patients

7.4 Increasing patient compliance

7.5 Promoting combination therapies


Appendix 1 Cholesterol Value Reporting


Appendix 2 Abbreviations and Acronyms

A2.1 Scientific/medical terms

A2.2 Institutions

A2.3 Clinical trials


Appendix 3 Research Methodology


List of Tables and Figures


Fig. 1.1 LDL-C and relative risk of CHD

Table 1.1 Findings of the INTERHEART Study

Table 1.2 First presentation of CHD in the UK

Table 1.3 European Society of Cardiology Lipid Guidelines (2003)

Table 1.4 European Society of Cardiology Lipid Guidelines (2007)

Table 1.5 NCEP ATP III Lipid Goals and Cut-Points (2001)

Table 1.6 Revised NCEP ATP III Lipid Goals and Cut-Points (2004)

Table 1.7 Classification of fasting triglyceride levels in adults

Table 1.8 Metabolic Syndrome Criteria

Table 1.9 Therapeutic goals for LDL-C and potential goals for non-HDL-C and total apo B

Table 2.1 LDL-C and atheroma volume in several IVUS trials

Table 2.2 Ongoing Clinical Trials in Dyslipidemia Using a CIMT Endpoint

Table 2.3 Ongoing Clinical Trials in Dyslipidemia Using an IVUS Endpoint

Table 2.4 Ongoing Clinical Trials in Dyslipidemia Using Lp(a) as an Endpoint

Table 2.5 Ongoing Clinical Trials in Dyslipidemia Using Oxidized DL as an Endpoint

Table 2.6 Ongoing Clinical Trials in Dyslipidemia Using CRP as an Endpoint

Fig. 3.1 Relative LDL Lowering Potencies of Five Marketed Statins

Table 3.1 Some Landmark Trials in Dyslipidemia

Table 3.2 Patent Data for Launched Statin Products

Table 3.3 Suppliers of Off-Patent and Near Off-Patent Statins

Table 3.4 Crestor Trial Programme (GALAXY)

Table 3.5 Fixed Dose Combination Products On The Market Or In Development

Table 3.6 Ongoing Clinical Trials in Dyslipidemia Using Statin/Ezetimibe Combinations

Table 3.7 Ongoing Clinical Trials in Dyslipidemia Using Niacin Combinations

Table 3.8 Ongoing Clinical Trials in Dyslipidemia Using Statin/Fibrate and Other Statin Combinations

Table 3.9 Other Ongoing Clinical Trials in Dyslipidemia Using Combined Agents

Table 4.1 At-a-glance guide to experimental therapies which may boost HDL levels and/or function

Table 5.1 At-a-glance guide to experimental therapies targeting lipid metabolism and/or inflammation

Table 5.2 Ongoing Clinical Trials in Hypertriglyceridemia

Table 6.1 Worldwide Sales of Branded Statins in 2007

Table 6.2 Worldwide Sales of Branded Non-Statin Antidyslipidemics in 2007

Table 6.3 Statin Sales Analysis and Forecasts, 2007-2012

Table 6.4 Statin Prescription Analysis and Forecasts, 2007-2012

Table 6.5 Dyslipidemia Market by Drug Class, 2007-2012

Table 6.6 Dyslipidemia Market by Prescriptions, 2007-2012

Table 6.7 Dyslipidemia Market by Country, 2007-2012

Table 7.1 Cancer and Cardiovascular Pipelines by Type of Agent

Table 7.2 Dyslipidemia Market by Patient Numbers, 2007-2012

Table 7.3 Ongoing Clinical Trials in Metabolic Syndrome

Abstract

This report examines trends in the $36 billion dyslipidemia market, which is poised for transformation with the advent of novel combination products and biopharmaceuticals. Cholesterol (LDL and HDL) and triglycerides need to be controlled in individuals at risk of developing new or worsening cardiovascular disease (primary and secondary prevention). Antidyslipidemics on the market include statins, ezetimibe, fibrates, niacin products, bile acid sequestrants, and prescription omega-3 products. Many clinical trials over the past 30 years or so have shown that treatment with these drugs substantially reduces cardiovascular risk. The report reviews current approaches to treatment, drugs on the market, marketing strategies, lessons learnt from landmark clinical trials, biomarkers, surrogates of atherosclerosis for drug development, and over 150 products in commercial development. It also derives market forecasts (for the period 2008 to 2012) and assesses market potential.

Why buy this report?

1. gain an insight into the performance of statins and other lipid-modulating drugs and commercial implications of post-marketing clinical trials such as ASTEROID and ENHANCE

2. identify biomarkers and surrogates of atherosclerosis, their potential and limitations in drug development

3. obtain market forecasts for the dyslipidemia market to 2012 by major market segments and geographic areas

4. discover why much of the growth in the dyslipidemia market is forecast to come from non-statin segments, in particular niacins and fibrates

5. be alerted to opportunities presented by the growing challenges of mixed dyslipidemias and undertreated patient subpopulations

6. identify companies developing novel lipid-modulating drugs

7. identify the most promising classes of drugs under development, together with their targets.

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