Evidence-based practice use of quick-release bromocriptine across the natural history of type 2 diabetes mellitus

References

• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012;35 Suppl 1:S64–S71.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013;36:1033–1046.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. National diabetes statistics report, 2014. Atlanta (GA): US Department of Health and Human Services; 2014.
   Google Scholar
• Schwartz SS, Epstein S, Corkey BE, et al. The time is right for a new classification system for diabetes: rationale and implications of the β-cell-centric classification schema. Diabetes Care. 2016;39:179–186.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Standards of medical care in diabetes–2014. Diabetes Care. 2014;37 Suppl 1:S14–S80.
   PubMed Web of Science ®Google Scholar
• Lorenzo C, Okoloise M, Williams K, et al. The metabolic syndrome as predictor of type 2 diabetes: The San Antonio heart study. Diabetes Care. 2003;26:3153–3159.
   PubMed Web of Science ®Google Scholar
• DeFronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773–795.
   PubMed Web of Science ®Google Scholar
• DeFronzo RA, Ferrannini E. Insulin resistance. A multifaceted syndrome responsible for NIDDM, obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Diabetes Care. 1991;14:173–194.
   PubMed Web of Science ®Google Scholar
• Ginsberg HN. Insulin resistance and cardiovascular disease. J Clin Invest. 2000;106:453–458.
   PubMed Web of Science ®Google Scholar
• DeFronzo RA. Bromocriptine: a sympatholytic, d2-dopamine agonist for the treatment of type 2 diabetes. Diabetes Care. 2011;34:789–794.
   PubMed Web of Science ®Google Scholar
• Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:2117–2128.
   PubMed Web of Science ®Google Scholar
• Marso SP, Daniels GH, Brown-Frandsen K, et al. LEADER steering committee on behalf of the LEADER trial investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016. [ Epub ahead of print].
   PubMed Web of Science ®Google Scholar
• Kernan WN, Viscoli CM, Furie KL, et al. Pioglitazone after ischemic stroke or transient ischemic attack. N Engl J Med. 2016;374:1321–1331.
   PubMed Web of Science ®Google Scholar
• Krumholz HM. Patient-centered medicine: the next phase in health care. Circ Cardiovasc Qual Outcomes. 2011;4:374–375.
   PubMed Web of Science ®Google Scholar
• Schwartz SS. Optimizing glycemic control and minimizing the risk of hypoglycemia in patients with type 2 diabetes. Drugs Context. 2013;2013:212255.
   PubMedGoogle Scholar
• Sniderman AD, LaChapelle KJ, Rachon NA, et al. The necessity for clinical reasoning in the era of evidence-based medicine. Mayo Clin Proc. 2013;88:1108–1114.
   PubMed Web of Science ®Google Scholar
• Colagiuri S, Brand MJ. The ‘carnivore connection’–evolutionary aspects of insulin resistance. Eur J Clin Nutr. 2002;56 Suppl 1:S30–S35.
   PubMed Web of Science ®Google Scholar
• Fernandez-Real JM, Ricart W. Insulin resistance and inflammation in an evolutionary perspective: the contribution of cytokine genotype/phenotype to thriftiness. Diabetologia. 1999;42:1367–1374.
   PubMed Web of Science ®Google Scholar
• Kalsbeek A, la Fleur S, Fliers E. Circadian control of glucose metabolism. Mol Metab. 2014;3:372–383.
   PubMed Web of Science ®Google Scholar
• Yamamoto H, Nagai K, Nakagawa H. Role of SCN in daily rhythms of plasma glucose, FFA, insulin and glucagon. Chronobiol Int. 1987;4:483–491.
   PubMed Web of Science ®Google Scholar
• Cincotta AH. Hypothalamic role in the insulin resistance syndrome. In: Hansen B, Shafrir E, editors. Insulin resistance and insulin resistance syndrome (frontiers in animal diabetes research series). 1st ed. London (UK): Taylor and Francis; 2002. p. 271–312.
   Google Scholar
• Scheer FAJL, Hilton MF, Mantzoros CS, et al. Adverse metabolic and cardiovascular consequences of circadian misalignment. Proc Natl Acad Sci U S A. 2009;106:4453–4458.
   PubMed Web of Science ®Google Scholar
• Kroenke CH, Spiegelman D, Manson J, et al. Work characteristics and incidence of type 2 diabetes in women. Am J Epidemiol. 2007;165:175–183.
   PubMed Web of Science ®Google Scholar
• Meisinger C, Heier M, Loewel H. Sleep disturbance as a predictor of type 2 diabetes mellitus in men and women from the general population. Diabetologia. 2005;48:235–241.
   PubMed Web of Science ®Google Scholar
• Meier AH, Cincotta AH. Circadian rhythms regulate the expression of the thrifty genotype/phenotype. Diabetes Rev. 1996;4:464–487.
   Google Scholar
• Pijl H. Reduced dopaminergic tone in hypothalamic neural circuits: expression of a “thrifty” genotype underlying the metabolic syndrome? Eur J Pharmacol. 2003;480:125–131.
   PubMed Web of Science ®Google Scholar
• Weiss HJ, Aledort LM, Kochwa S. The effect of salicylates on the hemostatic properties of platelets in man. J Clin Invest. 1968;47:2169–2180.
   PubMed Web of Science ®Google Scholar
• Luo S, Luo J, Cincotta AH. Suprachiasmatic nuclei monoamine metabolism of glucose tolerant versus intolerant hamsters. Neuroreport. 1999;10:2073–2077.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Luo S, Ezrokhi M, et al. Identification of a novel hypothalamic circuit regulating energy balance: dopaminergic projection from supramammillary nucleus (SuM) to suprachiasmatic nucleus (SCN). Diabetes. 2013;62:A525.
   Web of Science ®Google Scholar
• Coomans CP, van den Berg SAA, Lucassen EA, et al. The suprachiasmatic nucleus controls circadian energy metabolism and hepatic insulin sensitivity. Diabetes. 2013;62:1102–1108.
   PubMed Web of Science ®Google Scholar
• Luo S, Luo J, Meier AH, et al. Dopaminergic neurotoxin administration to the area of the suprachiasmatic nuclei induces insulin resistance. Neuroreport. 1997;8:3495–3499.
   PubMed Web of Science ®Google Scholar
• Cincotta A, Ezrokhi M, Trubitsyna Y, et al. Lesion of dopaminergic afferent neurons communicating with the biological clock induces metabolic syndrome in rats. Diabetes. 2015;64:A540.
   Web of Science ®Google Scholar
• Luo S, Ezrokhi M, Trubitsyna Y, et al. One minute of circadian-timed daily dopamine (DA) administration at the biological clock for 2 weeks ameliorates metabolic syndrome in spontaneously hypertensive rats (SHR) held on a high fat diet (HFD). Diabetes. 2015;64:A523.
   Web of Science ®Google Scholar
• Luo S, Meier AH, Cincotta AH. Bromocriptine reduces obesity, glucose intolerance and extracellular monoamine metabolite levels in the ventromedial hypothalamus of Syrian hamsters. Neuroendocrinology. 1998;68:1–10.
   PubMed Web of Science ®Google Scholar
• Ezrokhi M, Luo S, Trubitsyna Y, et al. Neuroendocrine and metabolic components of dopamine agonist amelioration of metabolic syndrome in SHR rats. Diabetol Metab Syndr. 2014;6:104.
   PubMed Web of Science ®Google Scholar
• Boundy VA, Cincotta AH. Hypothalamic adrenergic receptor changes in the metabolic syndrome of genetically obese (ob/ob) mice. Am J Physiol Regul Integr Comp Physiol. 2000;279:R505–R514.
   PubMed Web of Science ®Google Scholar
• Cincotta AH, Luo S, Zhang Y, et al. Chronic infusion of norepinephrine into the VMH of normal rats induces the obese glucose-intolerant state. Am J Physiol Regul Integr Comp Physiol. 2000;278:R435–R444.
   PubMed Web of Science ®Google Scholar
• Liang Y, Luo S, Cincotta AH. Long-term infusion of norepinephrine plus serotonin into the ventromedial hypothalamus impairs pancreatic islet function. Metabolism. 1999;48:1287–1289.
   PubMed Web of Science ®Google Scholar
• Luo S, Luo J, Cincotta AH. Chronic ventromedial hypothalamic infusion of norepinephrine and serotonin promotes insulin resistance and glucose intolerance. Neuroendocrinology. 1999;70:460–465.
   PubMed Web of Science ®Google Scholar
• Mancia G, Bousquet P, Elghozi JL, et al. The sympathetic nervous system and the metabolic syndrome. J Hypertens. 2007;25:909–920.
   PubMed Web of Science ®Google Scholar
• Cree MG, Paddon-Jones D, Newcomer BR, et al. Twenty-eight-day bed rest with hypercortisolemia induces peripheral insulin resistance and increases intramuscular triglycerides. Metabolism. 2010;59:703–710.
   PubMed Web of Science ®Google Scholar
• Licht CMM, Vreeburg SA, van Reedt Dortland AKB, et al. Increased sympathetic and decreased parasympathetic activity rather than changes in hypothalamic-pituitary-adrenal axis activity is associated with metabolic abnormalities. J Clin Endocrinol Metab. 2010;95:2458–2466.
   PubMed Web of Science ®Google Scholar
• Reynolds RM, Labad J, Strachan MWJ, et al. Elevated fasting plasma cortisol is associated with ischemic heart disease and its risk factors in people with type 2 diabetes: the Edinburgh type 2 diabetes study. J Clin Endocrinol Metab. 2010;95:1602–1608.
   PubMed Web of Science ®Google Scholar
• Lambert GW, Straznicky NE, Lambert EA, et al. Sympathetic nervous activation in obesity and the metabolic syndrome–causes, consequences and therapeutic implications. Pharmacol Ther. 2010;126:159–172.
   PubMed Web of Science ®Google Scholar
• Straznicky NE, Grima MT, Sari CI, et al. Neuroadrenergic dysfunction along the diabetes continuum: a comparative study in obese metabolic syndrome subjects. Diabetes. 2012;61:2506–2516.
   PubMed Web of Science ®Google Scholar
• Bhardwaj S, Verma N, Anjum B, et al. Variations in 7-day/24-h circadian pattern of ambulatory blood pressure and heart rate of type 2 diabetes patients. J Diabetes Investig. 2014;5:728–733.
   PubMed Web of Science ®Google Scholar
• Rubí B, Ljubicic S, Pournourmohammadi S, et al. Dopamine D2-like receptors are expressed in pancreatic beta cells and mediate inhibition of insulin secretion. J Biol Chem. 2005;280:36824–36832.
   PubMed Web of Science ®Google Scholar
• Simpson N, Maffei A, Freeby M, et al. Dopamine-mediated autocrine inhibitory circuit regulating human insulin secretion in vitro. Mol Endocrinol. 2012;26:1757–1772.
   PubMed Web of Science ®Google Scholar
• Cycloset^® (bromocriptine mesylate) tablets, oral. Tiverton (RI): VeroScience, LLC; 2010.
   Google Scholar
• Cincotta AH, Schiller BC, Meier AH. Bromocriptine inhibits the seasonally occurring obesity, hyperinsulinemia, insulin resistance, and impaired glucose tolerance in the Syrian hamster, Mesocricetus auratus. Metabolism. 1991;40:639–644.
   PubMed Web of Science ®Google Scholar
• Moore M, Smith M, Farmer B, et al. Timed daily bromocriptine mesylate (bc) administration improves glucose disposal in a canine diet-induced model of impaired glucose tolerance [abstract 860]. Diabetologia. 2014;57:S350.
   Web of Science ®Google Scholar
• Luo S, Liang Y, Cincotta AH. Intracerebroventricular administration of bromocriptine ameliorates the insulin-resistant/glucose-intolerant state in hamsters. Neuroendocrinology. 1999;69:160–166.
   PubMed Web of Science ®Google Scholar
• Ezrokhi M, Luo S, Trubitsyna Y, et al. Weighted effects of bromocriptine treatment on glucose homeostasis during hyperglycemic versus euglycemic clamp conditions in insulin resistant hamsters: bromocriptine as a unique postprandial insulin sensitizer. J Diabetes Metab. 2014;S2:007.
   Google Scholar
• Kamath V, Jones CN, Yip JC, et al. Effects of a quick-release form of bromocriptine (Ergoset) on fasting and postprandial plasma glucose, insulin, lipid, and lipoprotein concentrations in obese nondiabetic hyperinsulinemic women. Diabetes Care. 1997;20:1697–1701.
   PubMed Web of Science ®Google Scholar
• Cincotta AH, Meier AH, Taylor E, et al. Bromocriptine (ErgosetTM) reduces body fat, hyperinsulinemia, and glucose intolerance in obese subjects. Diabetes. 1995;44:168A.
   Web of Science ®Google Scholar
• Luo S, Ezrokhi M, Trubitsyna Y, et al. Intrahypothalamic circuitry regulating hypothalamic fuel sensing to induce insulin sensitivity or insulin resistance [abstract 128]. Diabetologia. 2008;51:S59.
   Web of Science ®Google Scholar
• Bina KG, Cincotta AH. Dopaminergic agonists normalize elevated hypothalamic neuropeptide Y and corticotropin-releasing hormone, body weight gain, and hyperglycemia in ob/ob mice. Neuroendocrinology. 2000;71:68–78.
   PubMed Web of Science ®Google Scholar
• Cincotta AH, Meier AH, Cincotta JM. Bromocriptine improves glycaemic control and serum lipid profile in obese Type 2 diabetic subjects: a new approach in the treatment of diabetes. Expert Opin Investig Drugs. 1999;8:1683–1707.
   PubMedGoogle Scholar
• Levin BE. Glucosensing neurons do more than just sense glucose. Int J Obes Relat Metab Disord. 2001;25 Suppl 5:S68–S72.
   PubMed Web of Science ®Google Scholar
• Lam TKT, Schwartz GJ, Rossetti L. Hypothalamic sensing of fatty acids. Nat Neurosci. 2005;8:579–584.
   PubMed Web of Science ®Google Scholar
• Franchi F, Lazzeri C, Barletta G, et al. Centrally mediated effects of bromocriptine on cardiac sympathovagal balance. Hypertension. 2001;38:123–129.
   PubMed Web of Science ®Google Scholar
• Luo S, Luo J, Cincotta AH. The anti-obesity effects of bromocriptine are associated with altered circadian neuroendocrine rhythms in the Syrian hamster. J Neurosci. 1997;23:143.
   Google Scholar
• Cincotta AH, MacEachern TA, Meier AH. Bromocriptine redirects metabolism and prevents seasonal onset of obese hyperinsulinemic state in Syrian hamsters. Am J Physiol. 1993;264:E285–E293.
   PubMed Web of Science ®Google Scholar
• Ezrokhi M, Luo S, Trubitsyna Y, et al. Appropriately timed daily bromocriptine administration reduces obesity, hypertension, insulin resistance, and pro-inflammatory humoral factors in spontaneously hypertensive rats (SHRS). Diabetes. 2008;57:A176.
   Web of Science ®Google Scholar
• Cincotta AH, Meier AH. Bromocriptine inhibits in vivo free fatty acid oxidation and hepatic glucose output in seasonally obese hamsters (Mesocricetus auratus). Metabolism. 1995;44:1349–1355.
   PubMed Web of Science ®Google Scholar
• Freeman JS. A physiologic and pharmacological basis for implementation of incretin hormones in the treatment of type 2 diabetes mellitus. Mayo Clin Proc. 2010;85:S5–S14.
   PubMedGoogle Scholar
• DeFronzo RA, Triplitt C, Qu Y, et al. Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin. Diabetes Care. 2010;33:951–957.
   PubMed Web of Science ®Google Scholar
• Ezrokhi M, Luo S, Trubitsyna Y, et al., Synergism of dopamine agonist plus GLP-1 analog therapy on improvement of glucose intolerance in syrian hamsters. Paper presented at: 71st Scientific Sessions of the American Diabetes Association; 2011 Jun 24–28; San Diego, CA.
   Google Scholar
• Roe E, Chamarthi B, Raskin P. Clinical study. Impact of bromocriptine-qr therapy on glycemic control and daily insulin requirement in type 2 diabetes mellitus subjects whose dysglycemia is poorly controlled on high-dose insulin: a pilot study. J Diabetes Res. 2015;2015:1–7.
   Web of Science ®Google Scholar
• Liang Y, Cincotta AH. Increased responsiveness to the hyperglycemic, hyperglucagonemic and hyperinsulinemic effects of circulating norepinephrine in ob/ob mice. Int J Obes Relat Metab Disord. 2001;25:698–704.
   PubMed Web of Science ®Google Scholar
• Paneni F, Costantino S, Cosentino F. Molecular mechanisms of vascular dysfunction and cardiovascular biomarkers in type 2 diabetes. Cardiovasc Diagn Ther. 2014;4:324–332.
   PubMedGoogle Scholar
• Ezrokhi MTY, Luo S, Cincotta AH. Timed dopamine agonist treatment ameliorates both vascular nitrosative/oxidative stress pathology and aortic stiffness in arteriosclerotic, hypertensive SHR rats. Diabetes. 2010;59:A67.
   Web of Science ®Google Scholar
• Zhang Y, Cincotta AH. Inhibitory effects of bromocriptine on vascular smooth muscle cell proliferation. Atherosclerosis. 1997;133:37–44.
   PubMed Web of Science ®Google Scholar
• Ezrokhi M, Cincotta AH, The anti-diabetes efficacy of bromocriptine-QR in type 2 diabetes mellitus (T2DM) subjects is enhanced among those with elevated blood pressure and plasma triglyceride levels. Paper presented at: 73rd Scientific Sessions of the American Diabetes Association; 2013 Jun 21–25; Chicago, IL.
   Google Scholar
• Erdmann E, Dormandy JA, Charbonnel B, et al. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol. 2007;49:1772–1780.
   PubMed Web of Science ®Google Scholar
• Cincotta AH, Meier AH, Haag B, et al. Bromocriptine (ERGOSET™) improves glycemic control in obese-NIDDM subjects. Diabetes. 1995;44:69A.
   Web of Science ®Google Scholar
• Scranton RE, Erzoki M, Farwell W, et al. Quick release bromocriptine (Cycloset™) a novel treatment for type 2 diabetes also demonstrates improvements in blood pressure. Can J Diabetes. 2009;33:235.
   Google Scholar
• Gaziano JM, Cincotta AH, O’Connor CM, et al. Randomized clinical trial of quick-release bromocriptine among patients with type 2 diabetes on overall safety and cardiovascular outcomes. Diabetes Care. 2010;33:1503–1508.
   PubMed Web of Science ®Google Scholar
• Florez H, Scranton R, Farwell WR, et al. Randomized clinical trial assessing the efficacy and safety of bromocriptine-QR when added to ongoing thiazolidinedione therapy in patients with type 2 diabetes mellitus. J Diabetes Metab. 2011;2(5):1–8.
   Google Scholar
• Gaziano JM, Cincotta AH, Vinik A, et al. Effect of bromocriptine-QR (a quick-release formulation of bromocriptine mesylate) on major adverse cardiovascular events in type 2 diabetes subjects. J Am Heart Assoc. 2012;1:e002279.
   PubMed Web of Science ®Google Scholar
• Vinik AI, Cincotta AH, Scranton RE, et al. Effect of bromocriptine-QR on glycemic control in subjects with uncontrolled hyperglycemia on one or two oral anti-diabetes agents. Endocr Pract. 2012;18:931–943.
   PubMed Web of Science ®Google Scholar
• Ghosh A, Sengupta N, Sahana P, et al. Efficacy and safety of add on therapy of bromocriptine with metformin in Indian patients with type 2 diabetes mellitus: a randomized open labeled phase IV clinical trial. Indian J Pharmacol. 2014;46:24–28.
   PubMed Web of Science ®Google Scholar
• Ramteke KB, Ramanand SJ, Ramanand JB, et al. Evaluation of the efficacy and safety of bromocriptine QR in type 2 diabetes. Indian J Endocrinol Metab. 2011;15:S33–S39.
   PubMedGoogle Scholar
• Pijl H, Ohashi S, Matsuda M, et al. Bromocriptine: a novel approach to the treatment of type 2 diabetes. Diabetes Care. 2000;23:1154–1161.
   PubMed Web of Science ®Google Scholar
• Ukena C, Mahfoud F, Linz D, et al. Potential role of renal sympathetic denervation for the treatment of cardiac arrhythmias. EuroIntervention. 2013;9 Suppl R:R110–R116.
   PubMed Web of Science ®Google Scholar
• Thorp AA, Schlaich MP. Relevance of Sympathetic nervous system activation in obesity and metabolic syndrome. J Diabetes Res. 2015;2015:341583.
   PubMed Web of Science ®Google Scholar
• Ameer OZ, Hildreth CM, Phillips JK. Sympathetic overactivity prevails over the vascular amplifier phenomena in a chronic kidney disease rat model of hypertension. Physiol Rep. 2014;2(11):1–11.
   Google Scholar
• Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology - clinical practice guidelines for developing a diabetes mellitus comprehensive care plan - 2015. Endocr Pract. 2015;21 Suppl 1:1–87.
   PubMed Web of Science ®Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140–149.
   PubMed Web of Science ®Google Scholar
• Garber AJ, Abrahamson MJ, Barzilay JI, et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm - 2016 executive summary. Endocr Pract. 2016;22:84–113.
   PubMed Web of Science ®Google Scholar
• Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346:393–403.
   PubMed Web of Science ®Google Scholar
• DeFronzo RA, Tripathy D, Schwenke DC, et al. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011;364:1104–1115.
   PubMed Web of Science ®Google Scholar
• Chiasson JL, Josse RG, Gomis R, et al. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002;359:2072–2077.
   PubMed Web of Science ®Google Scholar
• Cincotta AH, Meier AH. Bromocriptine (Ergoset) reduces body weight and improves glucose tolerance in obese subjects. Diabetes Care. 1996;19:667–670.
   PubMed Web of Science ®Google Scholar
• Garber AJ, Blonde L, Bloomgarden ZT, et al. The role of bromocriptine-QR in the management of type 2 diabetes expert panel recommendations. Endocr Pract. 2013;19:100–106.
   PubMed Web of Science ®Google Scholar
• Chamarthi B, Gaziano JM, Blonde L, et al. Timed bromocriptine-QR therapy reduces progression of cardiovascular disease and dysglycemia in subjects with well-controlled type 2 diabetes mellitus. J Diabetes Res. 2015;2015:157698.
   PubMed Web of Science ®Google Scholar