Effects of Thiazolidinedione and New Antidiabetic Agents on Stroke
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Patients with hyperglycemia are at a high risk of cardio- and cerebrovascular diseases. Diabetes patients also have poor outcomes after cerebrovascular disease development. Several classes of drugs are used for diabetes management in clinical practice. Thiazolidinedione (TZD) was introduced in the late 1990s, and new antidiabetic agents have been introduced since 2000. After issues with rosiglitazone in 2007, the U.S. Food and Drug Administration strongly recommended that trials investigating cardiovascular risk associated with new antidiabetic medications should be conducted before drug approval in the United States, to prove the safety of these new drugs and to determine their superiority to previous medications. Currently, results are available from two studies with TZD focusing on cardiovascular diseases, including stroke, and from 12 cardiovascular outcome trials focusing on major adverse cardiovascular events associated with new antidiabetic agents (four with dipeptidyl peptidase-4 inhibitors, three with sodium-glucose cotransporter-2 inhibitors, and five with glucagon-like peptide-1 analogues). These studies showed different results for primary cardiovascular outcomes and stroke prevention. It is important to determine whether prescription of TZD or new antidiabetic medications compared to conventional treatment, such as sulfonylurea or insulin, is better for stroke management. Furthermore, it is unclear whether drugs in the same class show greater safety and efficacy than other drugs for stroke management.
Abstract
Patients with hyperglycemia are at a high risk of cardio- and cerebrovascular diseases. Diabetes patients also have poor outcomes after cerebrovascular disease development. Several classes of drugs are used for diabetes management in clinical practice. Thiazolidinedione (TZD) was introduced in the late 1990s, and new antidiabetic agents have been introduced since 2000. After issues with rosiglitazone in 2007, the U.S. Food and Drug Administration strongly recommended that trials investigating cardiovascular risk associated with new antidiabetic medications should be conducted before drug approval in the United States, to prove the safety of these new drugs and to determine their superiority to previous medications. Currently, results are available from two studies with TZD focusing on cardiovascular diseases, including stroke, and from 12 cardiovascular outcome trials focusing on major adverse cardiovascular events associated with new antidiabetic agents (four with dipeptidyl peptidase-4 inhibitors, three with sodium-glucose cotransporter-2 inhibitors, and five with glucagon-like peptide-1 analogues). These studies showed different results for primary cardiovascular outcomes and stroke prevention. It is important to determine whether prescription of TZD or new antidiabetic medications compared to conventional treatment, such as sulfonylurea or insulin, is better for stroke management. Furthermore, it is unclear whether drugs in the same class show greater safety and efficacy than other drugs for stroke management.
참고문헌 (84)
- Gaede P, "Effect of a multifactorial intervention on mortality in type 2 diabetes", N Engl J Med, 358, pp.580~591 (2008)
- Yang Y, "Primary prevention of macroangiopathy in patients with short-duration type 2 diabetes by intensified multifactorial intervention: seven-year follow-up of diabetes complications in Chinese", Diabetes Care, 36, pp.978~984 (2013)
- Griffin SJ, "Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe):a cluster-randomised trial", Lancet, 378, pp.156~167 (2011)
- Stead LG, "Hyperglycemia as an independent predictor of worse outcome in non-diabetic patients presenting with acute ischemic stroke", Neurocrit Care, 10, pp.181~186 (2009)
- Emerging Risk Factors Collaboration, "Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies", Lancet, 375, pp.2215~2222 (2010)
- Saxena A, "Prognostic significance of hyperglycemia in acute intracerebral hemorrhage: the INTERACT2 study", Stroke, 47, pp.682~688 (2016)
- Luchsinger JA, "Diabetes mellitus and risk of Alzheimer’s disease and dementia with stroke in a multiethnic cohort", Am J Epidemiol, 154, pp.635~641 (2001)
- Schmidt AM, "Activation of receptor for advanced glycation end products: a mechanism for chronic vascular dysfunction in diabetic vasculopathy and atherosclerosis", Circ Res, 84, pp.489~497 (1999)
- Baynes JW, "Role of oxidative stress in diabetic complications: a new perspective on an old paradigm", Diabetes, 48, pp.1~9 (1999)
- Idris I, "Protein kinase C activation: isozyme-specific effects on metabolism and cardiovascular complications in diabetes", Diabetologia, 44, pp.659~673 (2001)
- Rösen P, "The role of oxidative stress in the onset and progression of diabetes and its complications: a summary of a Congress Series sponsored by UNESCO-MCBN, the American Diabetes Association and the German Diabetes Society", Diabetes Metab Res Rev, 17, pp.189~212 (2001)
- Hennes MM, "Insulin-resistant lipolysis in abdominally obese hypertensive individuals. Role of the renin-angiotensin system", Hypertension, 28, pp.120~126 (1996)
- Beckman JA, "Diabetes and atherosclerosis:epidemiology, pathophysiology, and management", JAMA, 287, pp.2570~2581 (2002)
- Ishii H, "Amelioration of vascular dysfunctions in diabetic rats by an oral PKC beta inhibitor", Science, 272, pp.728~731 (1996)
- Guerrero-Romero F, "Proteinuria is an independent risk factor for ischemic stroke in non-insulindependent diabetes mellitus", Stroke, 30, pp.1787~1791 (1999)
- Töyry JP, "Autonomic neuropathy predicts the development of stroke in patients with non-insulin-dependent diabetes mellitus", Stroke, 27, pp.1316~1318 (1996)
- Cheung N, "Is diabetic retinopathy an independent risk factor for ischemic stroke?", Stroke, 38, pp.398~401 (2007)
- Gaede P, "Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes", N Engl J Med, 348, pp.383~393 (2003)
- Ueki K, "Effect of an intensified multifactorial intervention on cardiovascular outcomes and mortality in type 2 diabetes (J-DOIT3): an open-label, randomised controlled trial", Lancet Diabetes Endocrinol, 5, pp.951~964 (2017)
- Bree AJ, "Diabetes increases brain damage caused by severe hypoglycemia", Am J Physiol Endocrinol Metab, 297, pp.E194~E201 (2009)
- Lee M, "Effect of pre-diabetes on future risk of stroke: meta-analysis", BMJ, 344, pp.e3564~ (2012)
- Sidhu JS, "Effect of rosiglitazone on common carotid intima-media thickness progression in coronary artery disease patients without diabetes mellitus", Arterioscler Thromb Vasc Biol, 24, pp.930~934 (2004)
- Langenfeld MR, "Pioglitazone decreases carotid intima-media thickness independently of glycemic control in patients with type 2 diabetes mellitus: results from a controlled randomized study", Circulation, 111, pp.2525~2531 (2005)
- Dormandy JA, "Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomized controlled trial", Lancet, 366, pp.1279~1289 (2005)
- Wilcox R, "Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspective pioglitAzone Clinical Trial In macro-Vascular Events 04)", Stroke, 38, pp.865~873 (2007)
- Kernan WN, "Pioglitazone after ischemic stroke or transient ischemic attack", N Engl J Med, 374, pp.1321~1331 (2016)
- Liu J, "Peroxisome proliferator-activated receptor gamma agonists for preventing recurrent stroke and other vascular events in patients with stroke or transient ischaemic attack", Cochrane Database Syst Rev, (10), pp.CD010693~ (2015)
- Yusta B, "GLP-1 receptor activation improves beta cell function and survival following induction of endoplasmic reticulum stress", Cell Metab, 4, pp.391~406 (2006)
- Nauck MA, "Cardiovascular actions and clinical outcomes with glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors", Circulation, 136, pp.849~870 (2017)
- Scirica BM, "Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus", N Engl J Med, 369, pp.1317~1326 (2013)
- White WB, "Alogliptin after acute coronary syndrome in patients with type 2 diabetes", N Engl J Med, 369, pp.1327~1335 (2013)
- Green JB, "Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes", N Engl J Med, 373, pp.232~242 (2015)
- Rosenstock J, "Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial", JAMA, 321, pp.69~79 (2019)
- Kalra S, "Sodium glucose co-transporter-2 (SGLT2) inhibitors: a review of their basic and clinical pharmacology", Diabetes Ther, 5, pp.355~366 (2014)
- Zinman B, "Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes", N Engl J Med, 373, pp.2117~2128 (2015)
- Neal B, "Canagliflozin and cardiovascular and renal events in type 2 diabetes", N Engl J Med, 377, pp.644~657 (2017)
- Wiviott SD, "Dapagliflozin and cardiovascular outcomes in type 2diabetes", N Engl J Med, 380, pp.347~357 (2019)
- Birkeland KI, "Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic): a multinational observational analysis", Lancet Diabetes Endocrinol, 5, pp.709~717 (2017)
- Guo M, "SGLT2 inhibitors and risk of stroke in patients with type 2 diabetes: a systematic review and meta-analysis", Diabetes Obes Metab, 20, pp.1977~1982 (2018)
- Marso SP, "Liraglutide and cardiovascular outcomes in type 2 diabetes", N Engl J Med, 375, pp.311~322 (2016)
- Marso SP, "Semaglutide and cardiovascular outcomes in patients with type 2 diabetes", N Engl J Med, 375, pp.1834~1844 (2016)
- Hernandez AF, "Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial", Lancet, 392, pp.1519~1529 (2018)
- Pfeffer MA, "Lixisenatide in patients with type 2 diabetes and acute coronary syndrome", N Engl J Med, 373, pp.2247~2257 (2015)
- Holman RR, "Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes", N Engl J Med, 377, pp.1228~1239 (2017)
- Pérez MJ, "Therapeutic actions of the thiazolidinediones in Alzheimer’s disease", PPAR Res, 2015, pp.957248~ (2015)
- Barbier O, "Pleiotropic actions of peroxisome proliferatoractivated receptors in lipid metabolism and atherosclerosis", Arterioscler Thromb Vasc Biol, 22, pp.717~726 (2002)
- Shimazu T, "A peroxisome proliferator-activated receptor-gamma agonist reduces infarct size in transient but not in permanent ischemia", Stroke, 36, pp.353~359 (2005)
- Zhao X, "Neuronal PPARgamma deficiency increases susceptibility to brain damage after cerebral ischemia", J Neurosci, 29, pp.6186~6195 (2009)
- Li AC, "Peroxisome proliferator-activated receptor gamma ligands inhibit development of atherosclerosis in LDL receptordeficient mice", J Clin Invest, 106, pp.523~531 (2000)
- Lim S, "Effect of a new PPAR-gamma agonist, lobeglitazone, on neointimal formation after balloon injury in rats and the development of atherosclerosis", Atherosclerosis, 243, pp.107~119 (2015)
- Calkin AC, "Rosiglitazone attenuates atherosclerosis in a model of insulin insufficiency independent of its metabolic effects", Arterioscler Thromb Vasc Biol, 25, pp.1903~1909 (2005)
- Wang N, "Role of peroxisome proliferator-activated receptor-γ in atherosclerosis: an update", Circ J, 75, pp.528~535 (2011)
- Quinn CE, "Effect of pioglitazone on endothelial function in impaired glucose tolerance", Diabetes Obes Metab, 12, pp.709~715 (2010)
- Zeng Y, "The DPP-4 inhibitor sitagliptin attenuates the progress of atherosclerosis in apolipoprotein-E-knockout mice via AMPK- and MAPKdependent mechanisms", Cardiovasc Diabetol, 13, pp.32~ (2014)
- Matsubara J, "A dipeptidyl peptidase-4 inhibitor, desfluoro-sitagliptin, improves endothelial function and reduces atherosclerotic lesion formation in apolipoprotein E-deficient mice", J Am Coll Cardiol, 59, pp.265~276 (2012)
- Mita T, "Sitagliptin attenuates the progression of carotid intima-media thickening in insulin-treated patients with type 2 diabetes: the sitagliptin preventive study of intima-media thickness evaluation (SPIKE). A randomized controlled trial", Diabetes Care, 39, pp.e104~e105 (2016)
- Mita T, "Alogliptin, a dipeptidyl peptidase 4 inhibitor, prevents the progression of carotid atherosclerosis in patients with type 2 diabetes: the study of preventive effects of alogliptin on diabetic atherosclerosis (SPEAD-A)", Diabetes Care, 39, pp.139~148 (2016)
- Oyama J, "The effect of sitagliptin on carotid artery atherosclerosis in type 2 diabetes: the PROLOGUE randomized controlled trial", PLoS Med, 13, pp.e1002051~ (2016)
- Darsalia V, "The DPP-4 inhibitor linagliptin counteracts stroke in the normal and diabetic mouse brain: a comparison with glimepiride", Diabetes, 62, pp.1289~1296 (2013)
- Hu Y, "GLP-1-dependent and independent effects and molecular mechanisms of a dipeptidyl peptidase 4 inhibitor in vascular endothelial cells", Mol Biol Rep, 40, pp.2273~2279 (2013)
- Ishibashi Y, "Sitagliptin augments protective effects of GLP-1 against advanced glycation end product receptor axis in endothelial cells", Horm Metab Res, 43, pp.731~734 (2011)
- Zhou Y, "Cardiovascular effects of sitagliptin:an anti-diabetes medicine", Clin Exp Pharmacol Physiol, 45, pp.628~635 (2018)
- Fadini GP, "Cardiovascular effects of DPP-4 inhibition: beyond GLP-1", Vascul Pharmacol, 55, pp.10~16 (2011)
- Chiazza F, "The effect of DPP-4 inhibition to improve functional outcome after stroke is mediated by the SDF-1α", CXCR4 pathway, 2018, pp.17, 60~
- Ferrannini E, "SGLT2 inhibition in diabetes mellitus: rationale and clinical prospects", Nat Rev Endocrinol, 8, pp.495~502 (2012)
- Inzucchi SE, "SGLT-2 inhibitors and cardiovascular risk: proposed pathways and review of ongoing outcome trials", Diab Vasc Dis Res, 12, pp.90~100 (2015)
- Han JH, "The beneficial effects of empagliflozin, an SGLT2 inhibitor, on atherosclerosis in ApoE (-", -) mice fed a western diet, 2017, pp.60, 364~376
- Lin B, "Glycemic control with empagliflozin, a novel selective SGLT2 inhibitor, ameliorates cardiovascular injury and cognitive dysfunction in obese and type 2 diabetic mice", Cardiovasc Diabetol, 13, pp.148~ (2014)
- Ferrannini E, "CV protection in the EMPAREG OUTCOME trial: a “thrifty substrate” hypothesis", Diabetes Care, 39, pp.1108~1114 (2016)
- Rahman M, "The β-hydroxybutyrate receptor HCA2activates a neuroprotective subset of macrophages", Nat Commun, 5, pp.3944~ (2014)
- Bazzigaluppi P, "Imaging the effects of β-hydroxybutyrate on peri-infarct neurovascular function and metabolism", Stroke, 49, pp.2173~2181 (2018)
- Lim S, "Clinical implications of current cardiovascular outcome trials with sodium glucose cotransporter-2 (SGLT2) inhibitors", Atherosclerosis, 272, pp.33~40 (2018)
- Arakawa M, "Inhibition of monocyte adhesion to endothelial cells and attenuation of atherosclerotic lesion by a glucagon-like peptide-1 receptor agonist, exendin-4", Diabetes, 59, pp.1030~1037 (2010)
- Gaspari T, "A GLP-1 receptor agonist liraglutide inhibits endothelial cell dysfunction and vascular adhesion molecule expression in an ApoE-", - mouse model, 2011, pp.8, 117~124
- Lim S, "Attenuation of carotid neointimal formation after direct delivery of a recombinant adenovirus expressing glucagon-like peptide-1 in diabetic rats", Cardiovasc Res, 113, pp.183~194 (2017)
- Nagashima M, "Native incretins prevent the development of atherosclerotic lesions in apolipoprotein E knockout mice", Diabetologia, 54, pp.2649~2659 (2011)
- Li Y, "GLP-1 receptor stimulation preserves primary cortical and dopaminergic neurons in cellular and rodent models of stroke and Parkinsonism", Proc Natl Acad Sci U S A, 106, pp.1285~1290 (2009)
- Sato K, "Neuroprotective effects of liraglutide for stroke model of rats", Int J Mol Sci, 14, pp.21513~21524 (2013)
- 김수진, "Anti-inflammatory Effect of Glucagon Like Peptide-1 Receptor Agonist, Exendin-4, through Modulation of IB1", JIP1 Expression and JNK Signaling in Stroke, 2017, pp.26(4), 227~239[DOI]
- Lim S, "Glucagon-like peptide-1 receptor agonists and cardiovascular events: class effects versus individual patterns", Trends Endocrinol Metab, 29, pp.238~248 (2018)
- American Diabetes Association, "6. Glycemic targets", Diabetes Care, 40(Suppl 1), pp.S48~S56 (2017)
- Garber AJ, "Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm: 2017 executive summary", Endocr Pract, 23, pp.207~238 (2017)
- Franchi F, "Pharmacodynamic comparison of prasugrel versus ticagrelor in patients with type 2 diabetes mellitus and coronary artery disease: the OPTIMUS (Optimizing Antiplatelet Therapy in Diabetes Mellitus)-4 Study", Circulation, 134, pp.780~792 (2016)
- Kim JB, "Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial", Trials, 17, pp.422~ (2016)
