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Cardiovascular Drug Delivery - technologies, markets and companies
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Summary
Drug delivery to the cardiovascular system is different from delivery to other systems because of the anatomy and physiology of the vascular system; it supplies blood and nutrients to all organs of the body. Drugs can be introduced into the vascular system for systemic effects or targeted to an organ via the regional blood supply. In addition to the usual formulations of drugs such as controlled release, devices are used as well. This report starts with an introduction to molecular cardiology and discusses its relationship to biotechnology and drug delivery systems.
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Drug delivery to the cardiovascular system is approached at three levels: (1) routes of drug delivery; (2) formulations; and finally (3) applications to various diseases. Formulations for drug delivery to the cardiovascular system range from controlled release preparations to delivery of proteins and peptides. Cell and gene therapies, including antisense and RNA interference, are described in full chapters as they are the most innovative methods of delivery of therapeutics. Various methods of improving systemic administration of drugs for cardiovascular disorders are described including use of nanotechnology.
Cell-selective targeted drug delivery has emerged as one of the most significant areas of biomedical engineering research, to optimize the therapeutic efficacy of a drug by strictly localizing its pharmacological activity to a pathophysiologically relevant tissue system. These concepts have been applied to targeted drug delivery to the cardiovascular system. Devices for drug delivery to the cardiovascular system are also described.
Role of drug delivery in various cardiovascular disorders such as myocardial ischemia, hypertension and hypercholesterolemia is discussed. Cardioprotection is also discussed. Some of the preparations and technologies are also applicable to peripheral arterial diseases. Controlled release systems are based on chronopharmacology, which deals with the effects of circadian biological rhythms on drug actions. A full chapter is devoted to drug-eluting stents as treatment for restenosis following stenting of coronary arteries. Fifteen companies are involved in drug-eluting stents.
New cell-based therapeutic strategies are being developed in response to the shortcomings of available treatments for heart disease. Potential repair by cell grafting or mobilizing endogenous cells holds particular attraction in heart disease, where the meager capacity for cardiomyocyte proliferation likely contributes to the irreversibility of heart failure. Cell therapy approaches include attempts to reinitiate cardiomyocyte proliferation in the adult, conversion of fibroblasts to contractile myocytes, conversion of bone marrow stem cells into cardiomyocytes, and transplantation of myocytes or other cells into injured myocardium.
Advances in molecular pathophysiology of cardiovascular diseases have brought gene therapy within the realm of possibility as a novel approach to treatment of these diseases. It is hoped that gene therapy will be less expensive and affordable because the techniques involved are simpler than those involved in cardiac bypass surgery, heart transplantation and stent implantation. Gene therapy would be a more physiologic approach to deliver vasoprotective molecules to the site of vascular lesion. Gene therapy is not only a sophisticated method of drug delivery; it may at time need drug delivery devices such as catheters for transfer of genes to various parts of the cardiovascular system.
The cardiovascular drug delivery markets are estimated for the years 2009 to 2019 on the basis of epidemiology and total markets for cardiovascular therapeutics. The estimates take into consideration the anticipated advances and availability of various technologies, particularly drug delivery devices in the future. Markets for drug-eluting stents are calculated separately. Role of drug delivery in developing cardiovascular markets is defined and unmet needs in cardiovascular drug delivery technologies are identified.
Selected 95 companies that either develop technologies for drug delivery to the cardiovascular system or products using these technologies are profiled and 72 collaborations between companies are tabulated. The bibliography includes 200 selected references from recent literature on this topic. The report is supplemented with 27 tables and 6 figures
TABLE OF CONTENTS
0.Executive Summary11
1.Cardiovascular Diseases13
Introduction13
History of cardiovascular drug delivery13
Overview of cardiovascular disease14
Coronary artery disease14
Angina pectoris14
Limitations of current therapies for myocardial ischemic disease14
Cardiomyopathies14
Cardiac arrhythmias15
Congestive heart failure15
Peripheral arterial disease15
Current management16
Atherosclerosis16
The endothelium as a target for cardiovascular therapeutics16
Molecular cardiology17
Cardiogenomics17
Cardioproteomics17
Personalized cardiology18
Pharmacogenomics of cardiovascular disorders18
Modifying the genetic risk for myocardial infarction19
Management of heart failure19
Management of hypertension20
Pharmacogenomics of diuretic drugs20
Pharmacogenomics of ACE inhibitors20
Management of hypertension by personalized approach21
Pharmacogenetics of lipid-lowering therapies21
Polymorphisms in genes involved in cholesterol metabolism21
Role of eNOS gene polymorphisms22
Important advances in cardiovascular therapeutics22
Drug delivery, biotechnology and the cardiovascular system23
Role of cardiovascular imaging in cardiovascular therapeutics23
Chronopharmacotherapy of cardiovascular diseases23
2.Methods for Drug Delivery to the Cardiovascular System25
Introduction25
Routes of drug delivery to the cardiovascular system25
Local administration of drugs to the cardiovascular system25
Intramyocardial drug delivery25
Drug delivery via coronary venous system26
Intrapericardial drug delivery26
Formulations for drug delivery to the cardiovascular system26
Sustained and controlled release27
Programming the release at a defined time27
Dosage formulation of calcium channel blockers28
Sustained and controlled release verapamil28
Methods of administration of proteins and peptides28
Delivery of peptides by subcutaneous injection29
Depot formulations and implants29
Poly(ethylene glycol) technology29
Microencapsulation for protein delivery30
Localized delivery of biomaterials for tissue engineering30
Oral delivery of proteins and peptides30
DDS to improve systemic delivery of cardiovascular drugs31
Nanotechnology-based drug delivery32
Controlled delivery of nanoparticles to injured vasculature33
Nanoparticles for cardiovascular imaging and targeted drug delivery34
Nanofiber-based scaffolds with drug-release properties34
Targeted drug delivery to the cardiovascular system34
Immunotargeting of liposomes to activated vascular endothelial cells35
PEGylated biodegradable particles targeted to inflamed endothelium36
Devices for cardiovascular drug delivery36
Local drug delivery by catheters37
Microneedle for periarterial injection38
Nanotechnology-based devices for the cardiovascular system38
Liposomal nanodevices for targeted cardiovascular drug delivery39
Nanotechnology approach to the problem of "vulnerable plaque"39
Drug delivery in the management of cardiovascular disease40
Drug delivery in the management of hypertension40
Transnasal drug delivery for hypertension40
Transdermal drug delivery for hypertension41
Oral extended and controlled release preparations for hypertension41
Long-acting hypertensives for 24 h blood pressure control42
Drug delivery to control early morning blood pressure peak42
Role of drug delivery in improving compliance with antihypertensive therapy43
Drug delivery for congestive heart failure43
Oral human brain-type natriuretic peptide43
Nitric oxide-based therapies for congestive heart failure43
Automated drug delivery system for cardiac failure44
DDS in the management of ischemic heart disease44
Intravenous emulsified formulations of halogenated anesthetics45
Injectable peptide nanofibers for myocardial ischemia45
Delivery of angiogenesis-inducing agents for myocardial ischemia45
Drug delivery for cardioprotection46
Drug delivery for cardiac rhythm disorders47
Drug delivery in the treatment of angina pectoris48
Sustained and controlled-release nitrate for angina pectoris48
Transdermal nitrate therapy48
Controlled release calcium blockers for angina pectoris49
Vaccines for hypertension50
Drug delivery in the management of pulmonary hypertension50
Prostacyclin by inhalation51
Endothelin receptor antagonist treatment of PAH51
Anticoagulation in cardiovascular disease51
Oral heparin51
Low molecular weight heparin-loaded polymeric nanoparticles52
Transdermal anticoagulants52
Thrombolysis for cardiovascular disorders52
Use of ultrasound to facilitate thrombolysis52
Delivery of alteplase through the AngioJet rheolytic catheter53
Drug delivery for peripheral arterial disease53
Delivery of thrombolytic agent to the clot through a catheter53
Delivery of growth factors to promote angiogenesis in ischemic limbs54
Immune modulation therapy for PAD54
NO-based therapies for peripheral arterial disease54
Drug delivery in the management of hypercholesterolemia55
Controlled/sustained release formulations of statins55
Combinations of statins with other drugs to increase efficacy55
Controlled release fenofibrate56
Extended release nicotinic acid57
Intravenous infusion of lipoprotein preparations to raise HDL57
Innovative approaches to hypercholesterolemia58
Single dose therapy for more than one cardiovascular disorder58
3.Cell Therapy for Cardiovascular Disorders61
Introduction61
Inducing the proliferation of cardiomyocytes61
Role of stem cells in repair of the heart61
Cell-mediated immune modulation for chronic heart disease61
Cell therapy for atherosclerotic coronary artery disease62
Transplantation of myoblasts for myocardial infarction62
MyoCell(TM) (Bioheart)63
Transplantation of cardiac progenitor cells for revascularization of myocardium64
Methods of delivery of cells to the heart64
Cellular cardiomyoplasty64
IGF-1 delivery by nanofibers to improve cell therapy for MI65
Intracoronary infusion of bone marrow-derived cells for AMI65
Non-invasive delivery of cells to the heart by Morph®guide catheter65
Transplantation of stem cells for myocardial infarction66
Transplantation of embryonic stem cells66
Transplantation of hematopoietic stem cells66
Transplantation of cord blood stem cells for myocardial infarction66
Intracoronary infusion of mobilized peripheral blood stem cells67
Human mesenchymal stem cells for cardiac regeneration67
Cytokine preconditioning of human fetal liver CD133+ SCs68
Transplantation of expanded adult SCs derived from the heart68
Transplantation of endothelial cells68
Transplantation of genetically modified cells69
Transplantation of cells secreting vascular endothelial growth factor69
Transplantation of genetically modified bone marrow stem cells69
Cell transplantation for congestive heart failure69
Myoblasts for treatment of congestive heart failure69
Injection of adult stem cells for congestive heart failure70
Role of cell therapy in cardiac arrhythmias70
Atrioventricular conduction block71
Ventricular tachycardia71
ESCs for correction of congenital heart defects72
Cardiac progenitors cells for treatment of heart disease in children72
Stem cell therapy for peripheral arterial disease72
Targeted delivery of endothelial progenitor cells labeled with nanoparticles73
Clinical trials of cell therapy in cardiovascular disease73
A critical evaluation of cell therapy for heart disease75
Publications of clinical trials of cell therapy for CVD75
Future directions for cell therapy of CVD76
4.Gene Therapy for Cardiovascular Disorders79
Introduction79
Techniques of gene transfer to the cardiovascular system80
Direct plasmid injection into the myocardium80
Catheter-based systems for vector delivery80
Ultrasound microbubbles for cardiovascular gene delivery81
Vectors for cardiovascular gene therapy81
Adenoviral vectors for cardiovascular diseases81
Plasmid DNA-based delivery in cardiovascular disorders82
Intravenous rAAV vectors for targeted delivery to the heart82
Hypoxia-regulated gene therapy for myocardial ischemia82
Angiogenesis and gene therapy of ischemic disorders83
Therapeutic angiogenesis vs. vascular growth factor therapy83
Gene painting for delivery of targeted gene therapy to the heart84
Gene delivery to vascular endothelium84
Targeted plasmid DNA delivery to the cardiovascular system with nanoparticles84
Gene delivery by vascular stents85
Gene therapy for genetic cardiovascular disorders85
Genetic disorders predisposing to atherosclerosis85
Familial hypercholesterolemia86
Apolipoprotein E deficiency87
Hypertension88
Genetic factors for myocardial infarction88
Acquired cardiovascular diseases88
Coronary artery disease with angina pectoris89
Ad5FGF-489
Ischemic heart disease with myocardial infarction89
Angiogenesis for cardiovascular disease90
Myocardial repair with IGF-1 therapy90
Congestive heart failure91
Rationale of gene therapy in CHF91
-ARKct gene therapy91
Intracoronary adenovirus-mediated gene therapy for CHF92
AAV-mediated gene transfer for CHF92
AngioCell gene therapy for CHF92
nNOS gene transfer in CHF93
Gene therapy for cardiac arrhythmias93
Gene transfer for biological pacemakers93
Management of arrhythmias due to myoblast transplantation94
Genetically engineered cells as biological pacemakers95
Gene therapy and heart transplantation95
Gene therapy for peripheral arterial disease96
Angiogenesis by gene therapy96
HIF-1? gene therapy for peripheral arterial disease96
HGF gene therapy for peripheral arterial disease97
Ischemic neuropathy secondary to peripheral arterial disease97
Maintaining vascular patency after surgery97
Antisense therapy for cardiovascular disorders98
Antisense therapy for hypertension98
Antisense therapy for hypercholesterolemia99
RNAi for cardiovascular disorders99
RNAi for hypercholesterolemia100
microRNA and the cardiovascular system101
Role of miRNAs in angiogenesis101
Role of miRNAs in cardiac hypertrophy and failure101
Role of miRNAs in conduction and rhythm disorders of the heart102
miRNA-based approach for reduction of hypercholesterolemia102
miRNAs as therapeutic targets for cardiovascular diseases102
Future prospects of miRNA in the cardiovascular therapeutics103
Future prospects of gene therapy of cardiovascular disorders103
Companies involved in gene therapy of cardiovascular disorders104
5.Drug-Eluting Stents105
Introduction105
Percutaneous transluminal coronary angioplasty105
Stents105
Restenosis105
Pathomechanism105
Treatment106
Nitric oxide-based therapies for restenosis106
Carbon monoxide inhalation for preventing restenosis107
Antisense approaches for prevention of restenosis after angioplasty107
miRNA-based approach for restenosis following angioplasty109
Gene therapy to prevent restenosis after angioplasty109
Techniques of gene therapy for restenosis110
NOS gene therapy for restenosis111
Non-viral gene therapy to prevent intimal hyperplasia111
HSV-1 gene therapy to prevent intimal hyperplasia111
Drug delivery devices for restenosis112
Local drug delivery by catheter112
Absorbable metal stents113
Drug-eluting stents113
Various types of DES113
CYPHER® sirolimus-eluting coronary stent113
Sirolimus-eluting vs paclitaxel-eluting stents114
Paclitaxel-eluting stents114
Dexamethasone-eluting stents115
NO-generating stents115
Dexamethasone-eluting stents116
Novel technologies for DES116
Stents for delivery of gene therapy116
Stem cell-based stents116
Drug-eluting stents coated with polymer surfaces117
Absorbable DES117
Endeavour DES117
Bio-absorbable low-dose DES118
VAN 10-4 DES119
Nanotechnology-based stents119
Drugs encapsulated in biodegradable nanoparticles119
Magnetic nanoparticle-coated DES119
Nanocoated DES120
Nanopores to enhance compatibility of DES121
The ideal DES121
Companies developing drug-eluting stents121
Clinical trials of drug-eluting stents122
Measurements used in clinical trials of DES122
TAXUS paclitaxel-eluting stents123
XIENCE(TM) V everolimus-eluting coronary stent124
COSTAR II clinical trial125
Endeavor RESOLUTE zotarolimus-eluting stent system125
CUSTOM I clinical trial126
NOBORI CORE Trial126
LEADERS trial126
Comparison of DES in clinical trials127
Comparison of DES with competing technologies127
DES versus coronary artery bypass graft127
DES versus bare metal stents128
Guidelines for DES vs BMS130
DES vs BMS for off-label indications131
Role of DES in cases of bare-metal in-stent restenosis131
DES versus balloon catheter coated with paclitaxel131
DES versus intracoronary radiation therapy for recurrent stenosis132
Cost-effectiveness of DES132
Safety issues of DES133
Adverse reactions to DES133
Endothelial vascular dysfunction due to sirolismus133
Risk of clotting with DES133
Clopidogrel use and long-term outcomes of patients receiving DES135
Effect of blood clot on release of drug from DES135
Use of magnetized cell lining to prevent clotting of DES136
Long-term safety studies of DES136
Regulatory issues of DES137
Future prospects for treatment of restenosis by DES138
Future role of DES in management of cardiovascular diseases138
Stent cost and marketing strategies139
Improvements in stent technology139
Bioabsorbale stent140
6.Markets for Cardiovascular Drug Delivery141
Introduction141
Epidemiology of cardiovascular disease141
Cost of care of cardiovascular disorders142
Cardiovascular markets according to important diseases143
Antithrombotics143
Anticholesterol agents143
Antihypertensive agents144
Drugs for congestive heart failure144
Markets for innovative technologies for cardiovascular disorders144
Markets for cell therapy of cardiovascular disorders144
Markets for gene therapy of cardiovascular disorders145
Markets for drug-eluting stents145
Major players in DES market145
Impact of safety issues on future markets for DES145
DES market in Asia146
Patenting and legal issues of DES147
The financial impact of DES on cardiovascular markets147
Unmet needs for cardiovascular drug delivery148
Role of DDS in developing cardiovascular markets149
Markets for cardiovascular devices149
Marketing of innovative cardiovascular drug delivery devices149
Direct to consumer advertising of DES150
Future trends in the integration of drug delivery with therapeutics150
Future prospects of cardiovascular drug delivery150
7.Companies involved in Cardiovascular Drug Delivery153
Profiles of companies153
Collaborations255
8.References259
Tables
Table 1 1: Landmarks in the historical evolution of cardiovascular drug delivery13
Table 1 2: Gene polymorphisms that alter cardiovascular response to drugs18
Table 2 1: Routes of drug delivery used for treatment of cardiovascular disorders25
Table 2 2: Formulations for drug delivery to the cardiovascular system26
Table 2 3: Improved methods of systemic drug delivery of cardiovascular drugs32
Table 2 4: Targeted delivery of therapeutic substances to the cardiovascular system35
Table 2 5: Classification of devices for drug delivery to the cardiovascular system36
Table 2 6: Various methods of delivery of therapeutic agents for hypertension40
Table 2 7: Marketed controlled/ extended release preparation for hypertension42
Table 2 8: Drug delivery in ischemic heart disease44
Table 2 9: Methods of delivery of nitrate therapy in angina pectoris48
Table 2 10: Drug delivery for peripheral arterial disorders53
Table 3 1: Clinical trials of cell therapy in cardiovascular disease73
Table 4 1: Cardiovascular disorders for which gene therapy is being considered.79
Table 4 2: Catheter-based systems for vector delivery to the cardiovascular system80
Table 4 3: Potential applications of antisense in cardiovascular disorders98
Table 4 4: Companies involved in gene therapy of cardiovascular diseases104
Table 5 1: Treatment of restenosis106
Table 5 2: Devices used for drug delivery in restenosis112
Table 5 3: Companies involved in drug-eluting stents122
Table 6 1: Prevalence of cardiovascular disorders in major markets: US 2009-2019142
Table 6 2: Prevalence of cardiovascular disorders in major markets: Europe 2009-2019142
Table 6 3: Prevalence of cardiovascular disorders in major markets: Japan 2009-2019142
Table 6 4: Values of cardiovascular DDS in major markets 2009-2019143
Table 6 5: Markets for innovative technologies for cardiovascular disorders 2009-2019144
Table 7 1: Top 5 companies in cardiovascular drug delivery153
Table 7 2: Collaborations in cardiovascular drug delivery255
Figures
Figure 1 1: Drug delivery, biotechnology and cardiovascular diseases23
Figure 2 1: Microneedle for periarterial injection38
Figure 5 1: Vicious circle of vascular occlusion following angioplasty and stenting107
Figure 5 2: Medtronic's Endeavour drug-eluting stent118
Figure 5 3: Magnetic nanoparticle-coated stent120
Figure 6 1: Unmet needs for cardiovascular drug delivery148
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