Cycloset (bromocriptine) / Veroscience, Bausch Health - LARVOL DELTA

Bromocriptine-QR Reduces Elevated Postprandial Cardiometabolic Risk Factors in Type 2 Diabetes Subjects (ADA 2024) - "Moreover, this BQR effect was accentuated in the HL - HT group (See Table). This BQR-induced reduction in all these CVD risk factors in HL and HL - HT T2D subjects may contribute to the therapy's observed impact to reduce CVD outcomes in the T2D population."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Bromocriptine-QR as an Adjunctive Therapy on Glycemic Control in Subjects with Uncontrolled Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis. (PubMed, J ASEAN Fed Endocr Soc) - "Administration of bromocriptine-QR at a dose range of 1.6 to 4.8 mg/day as an adjunctive therapy reduced HbA1c and FBG in patients with uncontrolled type 2 diabetes mellitus (T2DM). However, there were also statistically greater odds of the occurrence of adverse events such as nausea, vomiting, and headache compared to controls."

Clinical • Journal • Retrospective data • Review • Diabetes • Fatigue • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

Sleep duration and association with cardiometabolic health in adolescents and adults with type 1 diabetes: Results from the BCQR-T1D study. (PubMed, Diabetes Obes Metab) - "Objectively measured sleep <7 h per night was prevalent in adolescents and adults with T1D and associated with poorer cardiometabolic health markers. Small changes in sleep were seen following BCQR treatment in adolescents only. Sleep may be an important and novel target for improving cardiometabolic health in individuals with T1D."

Journal • Cardiovascular • Diabetes • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

Brain Dopamine-Clock Interactions Regulate Cardiometabolic Physiology: Mechanisms of the Observed Cardioprotective Effects of Circadian-Timed Bromocriptine-QR Therapy in Type 2 Diabetes Subjects. (PubMed, Int J Mol Sci) - "Clinically, across a variety of different study designs, circadian-timed bromocriptine-QR (quick release) (a unique formulation of micronized bromocriptine-a dopamine D2 receptor agonist) therapy of type 2 diabetes subjects improved hyperglycemia, hyperlipidemia, hypertension, immune sterile inflammation, and/or adverse cardiovascular event rate. The present review details the seminal circadian science investigations delineating important roles for CNS circadian peak dopaminergic activity in the regulation of peripheral fuel metabolism and cardiovascular biology and also summarizes the clinical study findings of bromocriptine-QR therapy on cardiometabolic outcomes in type 2 diabetes subjects."

Journal • Review • Cardiovascular • CNS Disorders • Depression • Diabetes • Dyslipidemia • Hypertension • Inflammation • Metabolic Disorders • Obesity • Psychiatry • Type 2 Diabetes Mellitus • DRD2

Evaluation of Efficacy of Bromocriptine as a Therapeutic Modality in the Treatment of Diabetes Mellitus: A Systematic Review. (PubMed, Cureus) - "In our study based on included studies, it was found that bromocriptine was superior as an add-on therapy to metformin compared to metformin alone, also it was found beneficial in people failing treatment with any one oral hypoglycemic agent. On the contrary, bromocriptine was found inferior to teneligliptin in treating DM. Still, more studies are required to make an accurate and reliable assessment of the efficacy of bromocriptine in treating DM."

Journal • Review • Diabetes • Metabolic Disorders

REBIRTH: Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (clinicaltrials.gov) - P4 | N=250 | Recruiting | Sponsor: Dennis M. McNamara, MD, MS | Trial completion date: Jan 2027 ➔ Dec 2028

Trial completion date • Cardiomyopathy • Cardiovascular • Congestive Heart Failure

Bromocriptine Improves Central Aortic Stiffness in Adolescents With Type 1 Diabetes: Arterial Health Results From the BCQR-T1D Study. (PubMed, Hypertension) - "BCQR improved blood pressure and central and peripheral aortic stiffness and pressure hemodynamics in adolescents with T1D over 4 weeks versus placebo. BCQR may improve aortic stiffness in youth with T1D, supporting future longer-term studies."

Journal • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Pediatrics • Type 1 Diabetes Mellitus

DECIST: Dapagliflozin Effect in Cognitive Impairment in Stroke Trial (clinicaltrials.gov) - P2/3 | N=270 | Recruiting | Sponsor: Jaime Daniel Mondragon

New P2/3 trial • Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Ischemic stroke • Metabolic Disorders

Bromocriptine-QR Therapy Reduces Sympathetic Tone and Ameliorates a Pro-Oxidative/Pro-Inflammatory Phenotype in Peripheral Blood Mononuclear Cells and Plasma of Type 2 Diabetes Subjects. (PubMed, Int J Mol Sci) - "Relative to baseline, bromocriptine-QR therapy also significantly reduced plasma levels of norepinephrine and normetanephrine by 33% and 22%, respectively, plasma pro-oxidative markers nitrotyrosine and TBARS by 13% and 10%, respectively, and pro-inflammatory factors IL-18, MCP1, IL-1β, prolactin, and CRP by 21%,13%, 12%, 42%, and 45%, respectively. These findings suggest a unique role for circadian-timed bromocriptine-QR sympatholytic dopamine agonist therapy in reducing systemic low-grade sterile inflammation to thereby reduce cardiovascular disease risk."

Journal • Cardiovascular • Diabetes • Immunology • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • ATF4 • ATF6 • BECN1 • CCR2 • CRP • GPX1 • GPX4 • HMOX1 • HSPA5 • ICAM1 • IL18 • IL1B • IL6 • MAPK8 • NLRP3 • NQO1 • SOD2 • TLR2 • TLR4 • TXNIP • VCAM1 • XBP1

Bromocriptine Quick-Release as Adjunct Therapy in Youth and Adults with Type 1 Diabetes: A Randomized, Placebo-Controlled Crossover Study. (PubMed, Diabetes Obes Metab) - "Greater hyperglycemia, insulin resistance, metabolic dysfunction and renal hyperfiltration in adolescents argues for increased attention during this high-risk age period. Though BCQR had little impact on glycemia or insulin sensitivity, initial vascular and renal responses suggest potential benefits of BCQR in youth and adults with type 1 diabetes requiring further study."

Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

REBIRTH: Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (clinicaltrials.gov) - P4 | N=250 | Recruiting | Sponsor: Dennis M. McNamara, MD, MS | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2022 ➔ Jul 2022

Clinical data • Enrollment open • Trial initiation date • Cardiomyopathy • Cardiovascular • Congestive Heart Failure

Bromocriptine Quick Release (BCQR) Improves Vascular Health in Youth with Type 1 Diabetes Even if Normal Weight (ADA 2022) - "BCQR improved BP, central and peripheral aortic stiffness and pressure hemodynamics in T1D adolescents over 4 weeks vs. placebo, even if normal weight, supporting future longer-term studies."

Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM (clinicaltrials.gov) - P3 | N=56 | Completed | Sponsor: University of North Carolina, Chapel Hill

New P3 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • DRD2

REBIRTH: Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (clinicaltrials.gov) - P4; N=250; Not yet recruiting; Sponsor: Dennis McNamara

Clinical • Clinical data • New P4 trial • Cardiomyopathy • Cardiovascular • Congestive Heart Failure

Time-of-Day-Dependent Effects of Bromocriptine to Ameliorate Vascular Pathology and Metabolic Syndrome in SHR Rats Held on High Fat Diet. (PubMed, Int J Mol Sci) - "These findings indicate that circadian-timed bromocriptine administration at the natural circadian peak of CNS dopaminergic activity (that is diminished in insulin resistant states), but not outside this daily time window when such CNS dopaminergic activity is naturally low, produces widespread improvements in biomarkers of vascular oxidative stress that are associated with the amelioration of metabolic syndrome and reductions in MBH neuropeptides and gene expressions known to facilitate metabolic syndrome. These results of such circadian-timed bromocriptine treatment upon vascular pathology provide potential mechanisms for the observed marked reductions in adverse cardiovascular events with circadian-timed bromocriptine-QR therapy (similarly timed to the onset of daily waking as in this study) of type 2 diabetes subjects and warrant further investigations into related mechanisms and the potential application of such intervention to prediabetes and metabolic syndrome..."

Journal • Preclinical • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • LEP • NOS3 • sGC HDA+

[VIRTUAL] Bromocriptine-QR (BQR) Ameliorates Immunocyte Pro-Oxidative Stress/Proinflammatory (POS/PI) and ER Stress Phenotype in T2DM Subjects (ADA 2021) - "BQR reduces postprandial dysglycemia, improves endothelial function, and markedly attenuates the POS/PI/ER stress condition in plasma and PBMN cells of T2DM subjects, providing potential mechanisms for BQR’s CV protective effect."

Clinical • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] Bromocriptine improves central aortic health in adolescents with type 1 diabetes (WSMRF 2021) - "However, BCQR decreased peripheral RHI. BCQR therapy might serve as a potential clinical intervention to attenuate accelerated aortic stiffness in youth with T1D supporting future longer-term studies."

Cardiovascular • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • MRI

The regulatory effect of bromocriptine on cardiac hypertrophy by prolactin and D2 receptor modulation. (PubMed, Clin Exp Hypertens) - "We concluded that bromocriptine has a protective effect on cardiac hypertrophy, and due to this effect, it may modulate the expression of Prlr and D2 r, which are involved in the development of cardiac hypertrophy."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] Bromocriptine Improves Central Aortic Stiffness in Adolescents With Type 1 Diabetes Mellitus: Arterial Health Results From the BCQR-T1D Study (AHA 2020) - "BCQR therapy improved central aortic stiffness and pressure hemodynamics in adolescents with T1D over 4 weeks. However, BCQR decreased peripheral RHI. BCQR therapy might serve as a potential clinical intervention to attenuate accelerated aortic stiffness in youth with T1D supporting future longer-term studies."

Cardiovascular • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • MRI

Late phase completed clinical trials investigating bromocriptine mesylate quick release as treatment of type 2 diabetes mellitus. (PubMed, Expert Opin Pharmacother) - "As a valuable additional benefit, bromocriptine is associated with significant cardiovascular risk reduction. Current recommendations include bromocriptine mesylate QR as part of dual or triple antihyperglycemic therapy especially in individuals with type 2 diabetes who are hesitant to add injectable treatment options and/or have cardiovascular disease."

Clinical • Journal • Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

[VIRTUAL] Dopamine acts through distinct mechanisms in liver, adipose tissue and skeletal muscle regulating glucose uptake and insulin receptor and AMPK phosphorylation (EASD 2020) - "In agreement with this role, bromocriptine (BR), a D2 receptor agonist, is an FDA approved drug for the treatment of type 2 diabetes... Our results suggest that different dopamine receptors are involved in glucose uptake and regulation of insulin receptor and AMPK phosphorylation in the liver, adipose tissue and skeletal muscle. Modulation of peripheral dopaminergic signalling in insulin-sensitive tissues could constitute a therapeutic target to treat metabolic disorders such as obesity, type 2 diabetes and metabolic syndrome."

Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • AMPK

The effect of dopamine agonists on metabolic variables in adults with type 2 diabetes. A systematic review with meta-analysis and trial sequential analysis of randomized clinical trials. (PubMed, Diabetes Obes Metab) - "Dopamine agonists reduces HbA1c as well as fasting plasma glucose and triglycerides in patients with T2DM without causing SAE. These data are based on moderate to low quality evidence thus our confidence in the effect estimates is limited."

Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

[VIRTUAL] Missed Pituitary Apoplexy in a HIV Patient (ENDO-I 2020) - "Meropenem and vancomycin were started for presumed meningitis...IV dexamethasone and levothyroxine were started post-operatively...Predisposing factors include hypertension, diabetes mellitus, pituitary dynamic testing, bromocriptine, estrogens or radiotherapy. Differential diagnoses of pituitary apoplexy include bacterial meningitis and subarachnoid hemorrhage with aneurysmal rupture. A nonpupil-sparing third nerve palsy suggests a mass lesion. Given his symptoms and xanthochromia, this patient likely presented with pituitary apoplexy that was overlooked on initial scans."

Clinical • Cardiovascular • Coronary Artery Disease • Diabetes • Endocrine Disorders • Gene Therapies • Hematological Disorders • Hypertension • Infectious Disease • Ischemic stroke • Metabolic Disorders • Ophthalmology • Renal Disease • Subarachnoid Hemorrhage • IGF1 • MRI

Rapid and dramatic glucose-lowering effect of bromocriptine in an inadequately controlled type 2 diabetes patient with prolactinoma. (PubMed, J Diabetes Investig) - "Because bromocriptine-QR (quick release) has been approved for the treatment of type 2 diabetes mellitus in the United States, a continuous glucose monitoring system, FreeStyle Libre Pro, was utilized to examine the effect of bromocriptine on glycemic control. After the initial administration of bromocriptine, glucose levels were rapidly and dramatically ameliorated, and the time in range (70-180 mg/dL) improved from 90 % between 1 week before and after the initial administration of bromocriptine."

Clinical • Journal • CNS Disorders • Diabetes • Gene Therapies • Metabolic Disorders • Movement Disorders • Oncology • Parkinson's Disease • Type 2 Diabetes Mellitus

[VIRTUAL] What Else Should Be Done in Patients with Uncontrolled Type 2 Diabetes and Severe Insulin Allergy? (ENDO-I 2020) - "The patient was actually diagnosed with T2DM in 2001, then started on metformin, glyburide initially...We started the patient on bromocriptine mesylate(cyclocet) with pioglitazone and the A1C improved in the next 3 months from 11.1%➔9.8%... Insulin allergy is a rare but severe condition that calls for immediate work-up. It can be managed well in close cooperation between the endocrinologist and the immunologist. Our patient developed IgE-mediated symptoms occurring immediately after insulin injection and confirmed by intradermal skin testing."

Clinical • Allergy • Diabetes • Immunology • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • IGF1