Vivian A Fonseca

Tulane University, New Orleans, Louisiana, United States

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Publications (215)1165.69 Total impact

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    ABSTRACT: Effective treatment algorithms are needed to guide diabetes care at hospital discharge in general medicine and surgery patients with type 2 diabetes.
    Diabetes care. 08/2014;
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    ABSTRACT: GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy. Harmony 6 was a randomized, open-label, active-controlled trial testing once-weekly albiglutide vs thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine.RESEARCH DESIGN AND METHODS: Patients taking basal insulin (with or without oral agents) with HbA1c 7-10.5% (53-91 mmol/mol) entered a glargine standardization period, followed by randomization to albiglutide, 30 mg weekly (n = 282), subsequently uptitrated to 50 mg, if necessary, or thrice-daily prandial lispro (n = 281) while continuing metformin and/or pioglitazone. Glargine was titrated to fasting plasma glucose of <5.6 mmol/L, and lispro was adjusted based on glucose monitoring. The primary end point was the difference in the HbA1c change from baseline at week 26.RESULTS: At week 26, HbA1c decreased from baseline by -0.82 ± SE 0.06% (9.0 mmol/mol) with albiglutide and -0.66 ± 0.06% (7.2 mmol/mol) with lispro; treatment difference, -0.16% (95% CI -0.32 to 0.00; 1.8 mmol/mol; P < 0.0001), meeting the noninferiority end point (margin, 0.4%). Weight decreased with albiglutide but increased with lispro (-0.73 ± 0.19 kg vs. +0.81 ± 0.19 kg). The mean glargine dose increased from 47 to 53 IU (albiglutide) and from 44 to 51 IU (lispro). Adverse events for albiglutide versus lispro included severe hypoglycemia (0 vs. 2 events), documented symptomatic hypoglycemia (15.8% vs. 29.9%), nausea (11.2% vs. 1.4%), vomiting (6.7% vs. 1.4%), and injection site reactions (9.5% vs. 5.3%).CONCLUSIONS: Weekly albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy, resulting in comparable HbA1c reduction with weight loss and lower hypoglycemia risk.
    Diabetes care. 06/2014;
  • Vivian A Fonseca, Michelle A Haggar
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    ABSTRACT: Insulin therapy is an effective method for reducing blood glucose levels in patients with type 2 diabetes mellitus (T2DM), and most patients with T2DM eventually require insulin replacement to attain and preserve satisfactory glycaemic control. All patients with T2DM should be considered as potential candidates for intensive insulin treatment; however, there are certain considerations regarding replacement therapy for different types of people and special populations, such as patients with multiple comorbidities, adolescents, pregnant women and the elderly. Lowering HbA1c levels in isolation without assessing the patient as a whole is becoming redundant. HbA1c targets should be individualized to the specific patient, and insulin treatment ought to be customized accordingly. There are several questions that need to be taken into account when considering adding insulin therapy to other oral antidiabetic agents, for example, for whom and when insulin therapy is indicated and which basal insulin should be utilized. Potential barriers exist related to patients, providers and health-care systems that can delay the start of insulin therapy, and every effort should be made to identify and address these obstacles.
    Nature Reviews Endocrinology 02/2014; · 11.03 Impact Factor
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    ABSTRACT: Aims To quantify the effect of liraglutide on systolic blood pressure (SBP) and pulse in patients with type 2 diabetes (T2D), and assess the influence of covariates on observed SBP reductions. Methods A patient-level pooled analysis of six phase 3, randomized trials was conducted. Results The analysis included 2792 randomized patients. In the intention-to-treat population (n = 2783), mean [± SE] SBP reductions from baseline with liraglutide 1.2 mg (2.7 [0.8] mmHg) and 1.8 mg (2.9 [0.7] mmHg) once daily were significantly greater than with placebo (0.5 [0.9] mmHg; P = 0.0029 and P = 0.0004, respectively) after 26 weeks, and were evident after 2 weeks. Liraglutide was also associated with significantly greater SBP reductions than glimepiride and, at a dose of 1.8 mg, insulin glargine and rosiglitazone. SBP reductions with liraglutide weakly correlated with weight loss (Pearson’s correlation coefficient: 0.08-0.12; P ≤ 0.0148). No dependence of these reductions on concomitant antihypertensive medications was detected (P = 0.1304). Liraglutide 1.2 and 1.8 mg were associated with mean increases in pulse of 3 beats per minute (bpm), versus a 1 bpm increase with placebo (P < 0.0001 for each dose versus placebo). Conclusions Liraglutide reduces SBP in patients with T2D, including those receiving concomitant antihypertensive medication.
    Journal of diabetes and its complications 01/2014; · 2.11 Impact Factor
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    ABSTRACT: Predisposition to genital infections and urinary tract infections (UTIs) in type 2 diabetes mellitus (T2DM) results from several factors such as glucosuria, adherence of bacteria to the uroepithelium and immune dysfunction. The tendency to develop these infections could be even higher in patients with T2DM treated with the emerging class of sodium-glucose cotransporter-2 (SGLT2) inhibitors. Studies have shown that pharmacologically-induced glucosuria with SGLT2 inhibitors raises the risk of developing genital infections and, to a relatively lesser extent, UTIs. However, a definitive dose relationship of the incidence of these infections with the SGLT2 doses is not evident in the existing data. Therefore, the precise role of glucosuria as a causative factor for these infections is yet to be fully elucidated.
    Diabetes research and clinical practice 01/2014; · 2.74 Impact Factor
  • Vivian A. Fonseca
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    ABSTRACT: Background Suboptimal blood glucose control among patients with type 2 diabetes continues to support the need for new pharmacologic approaches. Objective The purpose of this commentary was to highlight newly available and soon-to-be available agents that are promising tools for targeting specific pathophysiologic pathways in the management of diabetes. Methods Published evidence to support the application of novel incretin-based therapies, dipeptidyl peptidase (DPP)-4 inhibitors, sodium-glucose cotransporter (SGLT)-2 inhibitors, other oral agents and insulins for managing specific aspects of type 2 diabetes, as well as disadvantages associated with those novel medications, are discussed. Results Several new glucagon-like peptide (GLP)-1 receptor agonists with different time frames of action, although each has unique advantages and disadvantages, have been through clinical trials. Examples of these are lixisenatide and albiglutide. Currently available DPP-4 inhibitor agents, important for inhibiting the breakdown of endogenous GLP-1, have not been associated with weight gain or hypoglycemia. SGLT-2 inhibitors, which do not depend on insulin secretion or insulin action, may be advantageous in that they appear to be broadly efficacious at all stages of diabetes. New insulin analogues, such as degludec and U-500, improve glycemic control without contributing to hypoglycemia. Conclusions Advances in pharmacologic options offer the promise of improving glycemic control for longer periods, with limited glycemic fluctuations, hypoglycemia, and weight gain. However, the effectiveness of these agents ultimately depends on their availability to providers managing the health care of patients at high risk for poor diabetes outcomes and patients’ use of them as directed. Long-term effectiveness and safety trials are ongoing.
    Clinical Therapeutics 01/2014; · 2.23 Impact Factor
  • Vivian A Fonseca
    Journal of diabetes and its complications 10/2013; · 2.11 Impact Factor
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    Diabetes care 09/2013; 36(9):e159-60. · 7.74 Impact Factor
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    ABSTRACT: To evaluate the efficacy and safety of initial combination therapy of sitagliptin 100 mg/day coadministered with all marketed doses of pioglitazone in patients with type 2 diabetes. Patients with A1C ≥7.5% and ≤11.0% were randomized among 7 arms that received, once daily, 100 mg sitagliptin alone, 15, 30, or 45 mg pioglitazone alone, or 100 mg sitagliptin plus 15, 30, or 45 mg pioglitazone for 54 weeks. The primary endpoint was change from baseline in A1C at Week 24. Protocol-specified analyses compared combination therapies with monotherapies at respective dose-strengths and combination of sitagliptin plus pioglitazone 30 mg with pioglitazone 45 mg monotherapy. Post-hoc analyses compared sitagliptin plus pioglitazone 15 mg with pioglitazone monotherapy at the two higher doses. Initial combination therapy with sitagliptin and pioglitazone provided significantly greater reductions in A1C (0.4-0.7% differences) and other glycemic endpoints than either monotherapy at the same doses. Combining sitagliptin with low-dose pioglitazone generally produced greater glycemic improvements than higher doses of pioglitazone monotherapy (0.3-0.4% differences in A1C ). Combination therapy was generally well tolerated; AEs of hypoglycemia were reported with similar incidence (7.8-11.1%) in all treatment groups over the 54 weeks of study; edema was reported in 0.5% of patients in the sitagliptin monotherapy group and 2.7-5.3% among pioglitazone-treated groups. Significant weight gain was observed in all combination-treated groups compared with the sitagliptin monotherapy group. Initial combination therapy with sitagliptin and pioglitazone provided better glycemic control than either monotherapy and was generally well tolerated.
    Diabetes Obesity and Metabolism 08/2013; · 5.18 Impact Factor
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    ABSTRACT: To determine differences in inpatient glycemic control and response to two different glargine-based insulin regimens in general medicine and surgery patients with type 2 diabetes (T2D). This is a post-hoc analysis of a prospective, multicenter, randomized trial of 298 non-ICU medicine and surgery patients with T2D treated with Basal Bolus regimen with glargine once daily and glulisine before meals and with Basal Plus regimen with glargine once daily and supplemental doses of glulisine before meals for blood glucose (BG)>140mg/dl. Major study outcomes included differences in mean daily BG, frequency of treatment failures (defined as >2 consecutive BG>240mg/dl or a mean daily BG>240mg/dl), and hypoglycemia between the medicine and surgery cohorts. Patients treated with Basal Bolus or with Basal Plus experienced similar improvement in mean daily BG after 1st day of therapy (p=0.16), number of treatment failures (p=0.11) and hypoglycemic events (p=0.50). Compared to surgery patients (n=130), medicine patients (n=168) had higher admission BG (p=0.01) and HbA1c levels (p<0.01); however, they had similar response to either treatment regimen without differences in mean daily BG after 1st day of therapy (p=0.18), number of treatment failures (p=0.58), daily insulin requirements (p=0.36), or in the frequency of hypoglycemia (p=0.79). The Basal Plus regimen with glargine once daily and correction doses with glulisine before meals resulted in similar glycemic control to basal bolus regimen. We observed no differences in response to either basal insulin regimen between medicine and surgery patients with type 2 diabetes.
    Journal of diabetes and its complications 08/2013; · 2.11 Impact Factor
  • Vanita R Aroda, Vivian A Fonseca
    American journal of preventive medicine 08/2013; 45(2):246-7. · 4.24 Impact Factor
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    ABSTRACT: OBJECTIVE This study compared the clinical and economic benefits associated with dual-goal achievement, glycated hemoglobin (HbA1c) <7% (53 mmol/mol) and LDL cholesterol (LDL-C) <100 mg/dL, with achievement of only the LDL-C goal or only the HbA1c goal in veterans with type 2 diabetes mellitus (T2DM).RESEARCH DESIGN AND METHODS This retrospective cohort analysis evaluated electronic medical records (Veterans Integrated Service Network 16) in adult T2DM patients with two or more measurements of LDL-C and HbA1c between 1 January 2004 and 30 June 2010 (N = 75,646). Cox proportional hazards models were used to compare microvascular and cardiovascular outcomes by goal achievement status; generalized linear regression models were used to assess diabetes-related resource utilization (hospitalization days and number of outpatient visits) and medical service costs.RESULTSRelative to achievement of only the LDL-C goal, dual-goal achievement was associated with lower risk of microvascular complications (adjusted hazard ratio [aHR] 0.79), acute coronary syndrome (0.88), percutaneous coronary intervention (0.78), and coronary artery bypass graft (CABG) (0.74); it was also associated with fewer hospitalization days (adjusted incidence rate ratio [aIRR] 0.93) and outpatient visits (0.88), as well as lower diabetes-related annual medical costs (-$130.89). Compared with achievement of only the HbA1c goal, dual-goal achievement was associated with lower risk of the composite cardiovascular-related end point (aHR 0.87) and CABG (aHR 0.62), as well as fewer outpatient visits (aIRR 0.98).CONCLUSIONS Achieving both HbA1c and LDL-C goals in diabetes care is associated with additional clinical and economic benefits, as compared with the achievement of either goal alone.
    Diabetes care 06/2013; · 7.74 Impact Factor
  • L Shi, S Parasuraman, H Shao, V Fonseca
    Value in Health 05/2013; 16(3):A170. · 2.19 Impact Factor
  • Value in Health 05/2013; 16(3):A172. · 2.19 Impact Factor
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    ABSTRACT: OBJECTIVE Effective and easily implemented insulin regimens are needed to facilitate hospital glycemic control in general medical and surgical patients with type 2 diabetes (T2D).RESEARCH DESIGN AND METHODS This multicenter trial randomized 375 patients with T2D treated with diet, oral antidiabetic agents, or low-dose insulin (≤0.4 units/kg/day) to receive a basal bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI).RESULTSImprovement in mean daily blood glucose (BG) after the first day of therapy was similar between basal bolus and basal plus groups (P = 0.16), and both regimens resulted in a lower mean daily BG than did SSI (P = 0.04). In addition, treatment with basal bolus and basal plus regimens resulted in less treatment failure (defined as >2 consecutive BG >240 mg/dL or a mean daily BG >240 mg/dL) than did treatment with SSI (0 vs. 2 vs. 19%, respectively; P < 0.001). A BG <70 mg/dL occurred in 16% of patients in the basal bolus group, 13% in the basal plus group, and 3% in the SSI group (P = 0.02). There was no difference among the groups in the frequency of severe hypoglycemia (<40 mg/dL; P = 0.76).CONCLUSIONS The use of a basal plus regimen with glargine once daily plus corrective doses with glulisine insulin before meals resulted in glycemic control similar to a standard basal bolus regimen. The basal plus approach is an effective alternative to the use of a basal bolus regimen in general medical and surgical patients with T2D.
    Diabetes care 02/2013; · 7.74 Impact Factor
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    ABSTRACT: AIM: To evaluate the efficacy, safety, and tolerability of multiple doses of ipragliflozin. This novel selective inhibitor of sodium glucose co-transporter 2 is in clinical development for the treatment of patients with type 2 diabetes mellitus (T2DM). METHODS: In a 12-week, multicenter, double-blind, randomized, active- and placebo-controlled dose-finding study, patients were randomized to one of four ipragliflozin treatment groups (12.5, 50, 150, and 300mg once daily), placebo, or active control (metformin). The primary efficacy outcome was the mean change from baseline to Week 12 of glycosylated hemoglobin (HbA1c) compared with placebo. RESULTS: Ipragliflozin showed a dose-dependent decrease in HbA1c of -0.49% to -0.81% at Week 12 compared with placebo (P<0.001); a decrease of -0.72% was seen with metformin. Among the ipragliflozin groups there was also a dose-dependent reduction in body weight of up to 1.7kg. Proportions of patients experiencing treatment-emergent adverse events were similar across all groups: ipragliflozin (45.7-58.8%), placebo (62.3%), and metformin (59.4%). No clinically relevant effects were observed for other safety measures. CONCLUSIONS: After 12weeks of treatment, ipragliflozin dose-dependently decreased HbA1c, with ipragliflozin ≥50mg/day in patients with T2DM; an effect comparable to metformin. No safety or tolerability concerns were identified.
    Journal of diabetes and its complications 12/2012; · 2.11 Impact Factor
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    ABSTRACT: Elevated serum uric acid (SUA) levels (i.e. hyperuricaemia) have been associated with metabolic syndrome (MetS) and cardiovascular disease (CVD) morbidity and mortality. Elevated SUA levels predict the onset of type 2 diabetes (T2DM). SUA levels are increased during the early stages of impaired glucose metabolism. Furthermore, in diabetic patients, hyperuricaemia has been linked to both micro- and macrovascular complications. The present review considers: (1) SUA levels in patients with MetS, type 1 diabetes and T2DM; (2) the mechanisms that influence SUA levels in these patients; (3) the potential links between SUA and diabetic complications. The effect on SUA levels of drugs commonly prescribed for T2DM and the risk of uric acid nephrolithiasis in patients with MetS or DM are also briefly discussed.
    Current pharmaceutical design 12/2012; · 4.41 Impact Factor
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    ABSTRACT: PURPOSE: To determine whether a combination of L-methylfolate, methylcobalamin, and pyridoxal-5'-phosphate (LMF-MC-PLP [Metanx; Pamlab LLC, Covington, La]) improves sensory neuropathy. RESEARCH DESIGN AND METHODS: This multicenter, randomized, double-blind, placebo-controlled trial involved 214 patients with type 2 diabetes and neuropathy (baseline vibration perception threshold [VPT]: 25-45 volts), who were randomly assigned to 24 weeks of treatment with either L-methylfolate calcium 3 mg, methylcobalamin 2 mg, and pyridoxal-5'-phosphate 35 mg or placebo. The primary end point was effect on VPT. Secondary end points included Neuropathy Total Symptom Score (NTSS-6) and Short Form 36 (SF-36), as well as plasma levels of folate, vitamins B(6) and B(12), methylmalonic acid (MMA), and homocysteine. RESULTS: There was no significant effect on VPT. However, patients receiving LMF-MC-PLP consistently reported symptomatic relief, with clinically significant improvement in NTSS-6 scores at week 16 (P=.013 vs placebo) and week 24 (P=.033). Improvement in NTSS scores was related to baseline MMA and inversely related to baseline PLP and metformin use. Quality-of-life measures also improved. Homocysteine decreased by 2.7±3.0 μmol/L with LMF-MC-PLP versus an increase of 0.5±2.4 μmol/L with placebo (P=.0001). Adverse events were infrequent, with no single event occurring in ≥2% of subjects. CONCLUSIONS: LMF-MC-PLP appears to be a safe and effective therapy for alleviation of peripheral neuropathy symptoms, at least in the short term. Additional long-term studies should be conducted, as the trial duration may have been too short to show an effect on VPT. In addition, further research on the effects in patients with cobalamin deficiency would be useful.
    The American journal of medicine 12/2012; · 5.30 Impact Factor
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    ABSTRACT: AIMS: Ipragliflozin is a novel, selective inhibitor of sodium glucose co-transporter 2 (SGLT2 inhibitor) in clinical development for type 2 diabetes mellitus (T2DM) treatment. This study assessed the efficacy and safety of different doses of ipragliflozin. MATERIALS AND METHODS: In a 12-week, multicentre, double-blind, randomized, placebo-controlled, dose-finding study patients with inadequate glycaemic control on metformin monotherapy (≥1500 mg/day) were randomized to one of four ipragliflozin treatment groups (12.5, 50, 150, or 300mg once daily) or placebo. Primary efficacy outcome was mean change from baseline in haemoglobin A(1c) (HbA(1c) ) compared to placebo at Week 12. Adverse events (AEs), vital signs, and laboratory safety measurements were assessed. RESULTS: Ipragliflozin dose-dependently decreased HbA(1c) from baseline to Week 12 compared to placebo (-0.22%, -0.34%, -0.40%, -0.48% for ipragliflozin 12.5, 50, 150, and 300mg, respectively). Decreases in body weight and blood pressure were observed for all ipragliflozin groups. AEs occurred in 39.7-51.4% of the ipragliflozin groups and 39.4% of placebo patients. Urinary tract infections (1.4-6.9% vs. 6.1%), genital infections (0-4.3% vs. 1.5%), and hypoglycaemia (0-5.9% vs. 3.0%) were similar in the ipragliflozin and placebo groups, respectively, without dose-dependency. There were no clinically relevant effects on other safety measurements. CONCLUSIONS: Ipragliflozin treatment improved glycaemic control when added to metformin therapy and may be associated with weight loss and reductions in blood pressure compared to placebo. No safety or tolerability concerns were identified at any of the tested doses supporting the further development of ipragliflozin at ≥50 mg doses in T2DM patients.
    Diabetes Obesity and Metabolism 11/2012; · 5.18 Impact Factor
  • Nicholas A. Avitabile, Ajaz Banka, Vivian A. Fonseca
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    ABSTRACT: Glucose lowering should be approached by managing overall cardiovascular risk. Glycemic goals should be individualized based on duration of diabetes, preexisting cardiovascular disease, age, and life expectancy. Intensive glycemic control has consistently been shown to produce a substantial benefit for preventing long-term microvascular complications in both type 1 and type 2 diabetes mellitus. Although cardiovascular disease is the major cause of death in patients with diabetes, microvascular complications cause substantial morbidity and disability. Thus, it is apparent that additional strategies on multimodal treatment options are necessary to promote effective management and prevention of diabetic complications.
    Heart Failure Clinics 10/2012; 8(4):513–522.

Publication Stats

3k Citations
1,165.69 Total Impact Points

Institutions

  • 1999–2014
    • Tulane University
      • • Department of Medicine
      • • Section of Endocrinology and Metabolism
      • • Department of Pharmacology
      New Orleans, Louisiana, United States
    • Sriram Chandra Bhanj Medical College and Hospital
      Каттаке, Orissa, India
    • University of Arkansas for Medical Sciences
      • Department of Pharmacy Practice
      Little Rock, AR, United States
  • 2013
    • MedStar Health Research Institute
      Maryland, United States
    • Emory University
      • Division of Endocrinology
      Atlanta, GA, United States
  • 2012
    • Buffalo General Medical Center
      Buffalo, New York, United States
    • Southeast Louisiana Veterans Health Care System
      Alabama, United States
  • 2002–2012
    • Louisiana State University Health Sciences Center New Orleans
      • • Department of Medicine
      • • Section of Pediatric Endocrinology
      New Orleans, LA, United States
    • Central Arkansas Veterans Healthcare System
      Washington, Washington, D.C., United States
  • 2011
    • University College London
      • Division of Medicine
      London, ENG, United Kingdom
  • 2010
    • Lund University
      Lund, Skåne, Sweden
  • 2009
    • University of Lille Nord de France
      Lille, Nord-Pas-de-Calais, France
    • Joslin Diabetes Center
      Boston, Massachusetts, United States
  • 2008
    • Wildwood Programs
      Schenectady, New York, United States
    • University of Miami Miller School of Medicine
      Miami, Florida, United States
  • 1996–2007
    • University of Arkansas at Little Rock
      Little Rock, Arkansas, United States
  • 2006
    • Baylor College of Medicine
      Houston, Texas, United States
  • 2005
    • Novartis
      Bâle, Basel-City, Switzerland
    • University of Texas - Pan American
      • College of Health Sciences and Human Services
      Edinburg, TX, United States
    • University of California, San Francisco
      • Division of Cardiology
      San Francisco, CA, United States
  • 2004
    • University of Nebraska Medical Center
      Omaha, Nebraska, United States
  • 2001
    • U.S. Food and Drug Administration
      • Division of Epidemiology
      Washington, D. C., DC, United States