Research Spotlight

Posted March 15th 2019

Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin.

Priscilla A. Hollander M.D.

Priscilla A. Hollander M.D.

Hollander, P., J. Hill, J. Johnson, Z. W. Jiang, G. Golm, S. Huyck, S. G. Terra, J. P. Mancuso, S. S. Engel, B. Lauring and J. Liu (2019). “Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin.” Curr Med Res Opin Feb 14. [Epub ahead of print].

Full text of this article.

OBJECTIVE: To assess the safety and efficacy of ertugliflozin over 104 weeks in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. METHODS: In this double-blind, multicenter, randomized, Phase III study (VERTIS SU; NCT01999218), adults with T2DM and glycated hemoglobin (HbA1c) 7.0-9.0% on metformin >/=1500 mg/day received ertugliflozin 5 mg, 15 mg, or glimepiride. The primary efficacy time point was Week 52; double-blinded treatment continued until Week 104. RESULTS: Baseline characteristics of randomized, treated patients (n = 1315) were similar across groups (mean age 58.2 years, HbA1c 7.8%). 76.4% completed the study; 61.6% completed on study medication. Mean glimepiride dose at 104 weeks was 3.5 mg/day. At Week 104, least squares mean change from baseline in HbA1c (95% confidence intervals) were -0.3% (-0.4, -0.2), -0.4% (-0.5, -0.3) and -0.4% (-0.5, -0.3) for ertugliflozin 5 mg, 15 mg, and glimepiride, respectively. Ertugliflozin provided sustained reductions in body weight and systolic blood pressure (SBP) over 104 weeks. The incidence of adverse events (AEs) and serious AEs was similar across groups. The incidence of symptomatic hypoglycemia was 3.8%, 6.4% and 22.1% in the ertugliflozin 5 mg, 15 mg, and glimepiride groups, respectively. Genital mycotic infections were reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of women, respectively. The incidence of urinary tract infection and hypovolemia AEs was similar across groups. CONCLUSIONS: Ertugliflozin was well tolerated and provided clinically meaningful glycemic control and durable reductions in body weight and SBP over 104 weeks. Clinicaltrials.gov identifier NCT01999218.


Posted March 15th 2019

Clinico-radiologic features and management of hematological tumors in the breast: a case series.

John E. Pippen M.D.

John E. Pippen M.D.

Hoang, J. T., R. Yang, Z. A. Shah, J. J. Spigel and J. E. Pippen (2019). “Clinico-radiologic features and management of hematological tumors in the breast: a case series.” Breast Cancer 26(2): 244-248.

Full text of this article.

Hematological tumors arising in the breast are uncommon and require different treatment modalities dependent upon tumor type. Current treatment options include surgical excision, chemotherapy, and radiotherapy. Management of these breast malignancies are poorly outlined in the literature. The purpose of this case series is to report five cases consisting of extranodal marginal zone lymphoma, lymphoplasmacytic lymphoma, and extramedullary plasmacytoma occurring in the breast. The cases illustrate heterogeneous radiologic findings and varying management approaches to these tumors. The case series underscores the importance of having a wide differential at diagnosis and recognizes management of disease should be taken on an individual basis with consideration of prognosis and first-line treatment options.E


Posted March 15th 2019

Multimodality Imaging of Suspected Mechanical Prosthetic Valve Obstruction: Importance of the Patient and the Clinical Context.

Paul A. Grayburn M.D.

Paul A. Grayburn M.D.

Grayburn, P. A. (2019). “Multimodality Imaging of Suspected Mechanical Prosthetic Valve Obstruction: Importance of the Patient and the Clinical Context.” JACC Cardiovasc Imaging Feb 11. [Epub ahead of print].

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[Editorial; no abstract available.]


Posted March 15th 2019

The Challenge of Assessing Residual Mitral Regurgitation During MitraClip Procedures: Is 3D Vena Contracta Area the Answer?

Paul A. Grayburn M.D.

Paul A. Grayburn M.D.

Grayburn, P. A. (2019). “The Challenge of Assessing Residual Mitral Regurgitation During MitraClip Procedures: Is 3D Vena Contracta Area the Answer?” JACC Cardiovasc Interv Feb 22. [Epub ahead of print].

Full text of this article.

[Editorial; no abstract available.]


Posted March 15th 2019

Clinical evidence that treatment of metabolic acidosis slows the progression of chronic kidney disease.

Donald E. Wesson M.D.

Donald E. Wesson M.D.

Goraya, N. and D. E. Wesson (2019). “Clinical evidence that treatment of metabolic acidosis slows the progression of chronic kidney disease.” Curr Opin Nephrol Hypertens Mar 1. [Epub ahead of print].

Full text of this article.

PURPOSE OF REVIEW: We review the growing clinical evidence that metabolic acidosis mediates chronic kidney disease (CKD) progression and that treatment to increase the associated low serum bicarbonate (HCO3) in CKD is disease-modifying. RECENT FINDINGS: Seven prospective studies of patients with wide ranges of estimated glomerular filtration rates (eGFRs) and serum HCO3 examined the effect on CKD of increasing serum HCO3 using dietary acid reduction with either oral alkali (sodium bicarbonate or sodium citrate), a vegetarian diet very low in acid-producing protein (0.3 g/kg/day) supplemented with ketoanalogues or added base-producing fruits and vegetables. Clinical outcomes included slower kidney function decline (using eGFR measurements) and fewer patients progressing to end-stage kidney disease. Post hoc analyses demonstrated that: treatment of metabolic acidosis for 2 years decreased the number of patients with at least a 40% eGFR decline, a validated surrogate for progression to end-stage kidney disease and across four studies, treatment to increase serum HCO3 by 4-6.8 mEq/l in acidotic patients with CKD was associated with a approximately 4 ml/min/1.73 m reduction in the rate of eGFR decline over 6-24 months compared with controls. SUMMARY: Metabolic acidosis appears to enhance CKD progression and its treatment should be studied further as a potential disease-modifying intervention.