Research Spotlight

Kazory, A., P. A. McCullough, J. Rangaswami and C. Ronco (2018). “Cardionephrology: Proposal for a Futuristic Educational Approach to a Contemporary Need.” Cardiorenal Med 8(4): 296-301.

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The field of cardiorenal medicine is vast, rapidly expanding, and complex. Conventional nephrology training programs provide the fellows with the necessary core knowledge to provide general care for patients with renal and cardiovascular diseases. However, there is a need for focused training of interested physicians to master the specialized aspects of these exceedingly common clinical scenarios and optimize the care of such patients. A cardionephrology-focused training can add value to the nephrology subspecialty and potentially increase its attractiveness for a significant subset of trainees. Herein, we provide a proposal for the framework and content of such an educational activity. Creation of an international multidisciplinary workgroup to formulate a comprehensive curriculum for a dedicated cardionephrology track would be the first step. A variety of practical aspects such as implementation methods, the identification of the required skills, and the development of educational assessment tools are discussed. While this proposal primarily focuses on the integration of the curriculum into the training of nephrology fellows, it would also be appropriate (albeit in a modified and customized format) for a wider range of trainees, including cardiology fellows.

Home, P. D., R. L. H. Lam, W. L. Carofano, G. T. Golm, R. Eldor, M. F. Crutchlow, M. C. Marcos, J. Rosenstock, P. A. Hollander and B. Gallwitz (2018). “Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial.” Diabetes Obes Metab 20(9): 2220-2228.

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AIM: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla; 100 U/mL) with originator insulin glargine, Lantus (Sa-Gla), in people with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: This phase 3, randomized, active-controlled, open-label, 52-week study (ClinicalTrials.gov NCT02059161) enrolled 508 people with T1DM (HbA1c
less than or equal to 11.0%; 97 mmol/mol) taking basal and prandial insulin. Participants were randomized 1:1 to once-daily Mk-Gla (n = 245) or Sa-Gla (n = 263). Dose titration of basal insulin was by a pre-breakfast plasma glucose dosing algorithm. The primary efficacy objective was assessment of the non-inferiority of HbA1c change from baseline (margin of 0.40% [4.4 mmol/mol]) for Mk-Gla compared with Sa-Gla over 24 weeks. The primary safety objective was assessment of anti-insulin antibody development over 24 weeks. RESULTS: The least squares (LS) mean HbA1c change from baseline at week 24 was -0.62 (95% CI -0.79, -0.45)% (-6.8 [-8.7, -4.9] mmol/mol) and -0.66 (-0.82, -0.50)% (-7.2 [-9.0, -5.4] mmol/mol) for Mk-Gla and Sa-Gla. The LS mean HbA1c difference was 0.04 (-0.11, 0.19)% (0.4 [-1.2, 2.0] mmol/mol) for Mk-Gla minus Sa-Gla, meeting the primary and secondary objective criteria for non-inferiority and equivalence. Week 24 mean insulin glargine dose for Mk-Gla and Sa-Gla was 0.46 and 0.48 U/kg, respectively. Similarity of HbA1c response and basal insulin dose trajectory persisted over the 52 weeks. Safety and tolerability, including anti-insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins over the 52-week study duration. CONCLUSIONS: Mk-Gla and Sa-Gla exhibited similar efficacy and safety over 52 weeks in people with T1DM. ClinicalTrials.gov: NCT02059161.

Hollander, P. A., W. L. Carofano, R. L. H. Lam, G. T. Golm, R. Eldor, M. F. Crutchlow, M. C. Marcos, M. S. Rendell, P. D. Home, B. Gallwitz and J. Rosenstock (2018). “Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial.” Diabetes Obes Metab 20(9): 2229-2237.

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AIM: To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial (ClinicalTrials.gov number NCT02059187) enrolled 531 participants with T2DM (HbA1c /=10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n = 263) or Sa-Gla (n = 263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm. The primary efficacy objective was to demonstrate the non-inferiority of change from baseline in HbA1c (margin of 0.40% [4.4 mmol/mol]) with Mk-Gla versus Sa-Gla after 24 weeks. The primary safety objective was anti-insulin antibody development after 24 weeks. RESULTS: For Mk-Gla and Sa-Gla, the least squares (LS) mean HbA1c change from baseline (95% CI) was -1.28 (-1.41, -1.15)% (-14.0 [-15.4, -12.6] mmol/mol) and -1.30 (-1.43, -1.18)% (-14.2 [-15.6, -12.8] mmol/mol). The LS mean HbA1c difference (Mk-Gla minus Sa-Gla) was 0.03 (-0.12, 0.18)% (0.3 [-1.4, 1.9] mmol/mol), meeting non-inferiority and equivalence (secondary objective) criteria. Insulin doses, FPG, and seven-point plasma glucose profiles were similar between groups. Safety and tolerability, including anti-insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins. The efficacy and safety of Mk-Gla and Sa-Gla were similar both in participants who were insulin-treated or insulin-naive at baseline. CONCLUSIONS: Mk-Gla and Sa-Gla demonstrated similar efficacy and safety over 24 weeks of treatment in people with T2DM.

Hart, T., S. Driver, A. Sander, M. Pappadis, K. Dams-O’Connor, C. Bocage, E. Hinkens, M. N. Dahdah and X. Cai (2018). “Traumatic brain injury education for adult patients and families: a scoping review.” Brain Inj. Aug 7: 1-12. [Epub ahead of print].

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Traumatic brain injury (TBI) is increasingly viewed as a chronic condition, bringing long-term needs for patient and caregiver knowledge pertaining to symptom and problem management over time. In light of these needs, we performed a scoping review of the literature on brain injury education provided to adult patients and/ or family members affected by TBI. Objectives were to describe the types of educational interventions that have been developed; to review the effects of these interventions; and to determine gaps that might be filled by future research efforts. Of 88 articles meeting search criteria and subjected to data extraction, 34 concerned education about mild TBI and 54, moderate to severe TBI. Most mild TBI articles focused on education in the Emergency Room, while most moderate/ severe TBI education was directed toward family members/ caregivers and was frequently combined with other treatment components, making the effects of education difficult to discern. Only 1 article incorporated elements of self-management training (SMT), a model proved effective in other chronic health conditions. We recommend further exploration of SMT principles in long-term TBI care, as well as more precise definition of treatment components in all patient and family interventions, so that the specific effects of education and other treatment elements may be more readily evaluated.

Hamilton, R., S. Kirshblum, S. Sikka, L. Callender, M. Bennett and P. Prajapati (2018). “Sacral examination in spinal cord injury: Is it really needed?” J Spinal Cord Med 41(5): 556-561.

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OBJECTIVE: To determine if a self-report measure of S4-5 motor and sensory function in patients with chronic SCI accurately predicts sacral examination results. DESIGN: Prospective, single-blinded self-report survey compared with sacral exam. SETTING: Outpatient SCI clinic. PARTICIPANTS: 116 patients aged 18+ with chronic SCI > 6 months who have undergone sacral exam. INTERVENTIONS: The survey included demographic/clinical and sacral function information such as light tough (LT), pinprick sensation (PP), deep anal pressure (DAP) and voluntary anal contraction (VAC). Survey results and sacral exam were compared and stratified by the patient’s American Spinal Cord Injury Association Impairment Scale (AIS) category. OUTCOME MEASURES: Sacral self-report survey, AIS examination. RESULTS: Mean age was 41.3 +/- 14.4 years with majority male (69%) and Caucasian (71.6%). Overall, Positive Predictive Value (PPV) ranged between 48% (VAC) to 73% (DAP) and Negative Predictive Value (NPV) between 92% (VAC) to 100% (LT). AIS-A had NPV of 100% across all categories, and AIS-D had PPV of 100% across all categories. CONCLUSION: Patient report of sacral sparing can predict negative sensation in patients with AIS-A and predict positive sensation in persons with AIS-D. Overall, the self-report of sacral sparing of motor and sensory function is not predictive enough to rely on for accurate classification.