13 results on '"Kanevsky, Estella"'
Search Results
2. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial
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Bergmark, Brian A., Bhatt, Deepak L., McGuire, Darren K., Cahn, Avivit, Mosenzon, Ofri, Steg, Ph. Gabriel, Im, KyungAh, Kanevsky, Estella, Gurmu, Yared, Raz, Itamar, Braunwald, Eugene, and Scirica, Benjamin M.
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- 2019
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3. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)
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Bonaca, Marc P., Nault, Patrice, Giugliano, Robert P., Keech, Anthony C., Pineda, Armando Lira, Kanevsky, Estella, Kuder, Julia, Murphy, Sabina A., Jukema, J. Wouter, Lewis, Basil S., Tokgozoglu, Lale, Somaratne, Ransi, Sever, Peter S., Pedersen, Terje R., and Sabatine, Marc S.
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- 2018
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4. Abstract 20183: Atherothrombotic Risk Stratification and Magnitude of Benefit of Evolocumab in FOURIER
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Bohula, Erin A, Morrow, David A, Pedersen, Terje R, Kanevsky, Estella, Murphy, Sabina A, Giugliano, Robert P, Sever, Peter S, Keech, Anthony C, and Sabatine, Marc S
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- 2017
5. Long-term safety and efficacy of breast biopsy markers in clinical practice.
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Smith, Sharon, Taylor, Clayton R., Kanevsky, Estella, Povoski, Stephen P., and Hawley, Jeffrey R.
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BREAST biopsy ,DRUG efficacy ,BIOMARKERS ,MEDICAL personnel ,MEDICATION safety ,MEDICAL records - Abstract
Objective: Percutaneous breast and axillary core biopsy followed by marker placement are integral parts of a breast imager's practice benefiting both patients and clinicians. Marker placement is the standard to facilitate future care. The purpose of this study is to characterize the safety and performance of MammoMARK, CorMARK, and HydroMARK biopsy markers by evaluating device-related adverse events, device deficiencies, and long-term safety. Methods: A retrospective review of three radiology practices identified patients who underwent image-guided breast or axillary biopsies followed by marker placement between 1 January 2012 and 1 January 2017. Medical records were reviewed with adverse events related to marker placement and use recorded. Results: 768 markers were placed with three (0.4%) events recorded. Two device deficiencies and one non-serious adverse event occurred in three patients. Device deficiency events involved user errors deploying the markers, one to inability to locate the marker on post-biopsy imaging, and the second to misplacement relative to biopsy target. One non-serious adverse event involved inability to locate/retain the marker in a surgically resected specimen. No serious adverse events were reported. Conclusion: Placement of breast biopsy markers is safe with minimal associated risks. Issues related to device malfunction, durability, reliability, safety, or performance were not reported. [ABSTRACT FROM AUTHOR]
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- 2021
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6. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk.
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O'Donoghue, Michelle L., Fazio, Sergio, Giugliano, Robert P., Stroes, Erik S.G., Kanevsky, Estella, Gouni-Berthold, Ioanna, Im, KyungAh, Lira Pineda, Armando, Wasserman, Scott M., Češka, Richard, Ezhov, Marat V., Jukema, J. Wouter, Jensen, Henrik K., Tokgözoğlu, S. Lale, Mach, François, Huber, Kurt, Sever, Peter S., Keech, Anthony C., Pedersen, Terje R., and Sabatine, Marc S.
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- 2019
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7. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial.
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Scirica, Benjamin M., Mosenzon, Ofri, Bhatt, Deepak L., Udell, Jacob A., Steg, Gabriel, McGuire, Darren K., KyungAh Im, Kanevsky, Estella, Stahre, Christina, Sjöstrand, Mikaela, Raz, Itamar, and Braunwald, Eugene
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- 2018
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8. Hypoglycaemia manifestations and recurrent events: Lessons from the SAVOR-TIMI 53 outcome study.
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Cahn, Avivit, Mosenzon, Ofri, Bhatt, Deepak L., Leibowitz, Gil, Yanuv, Ilan, Rozenberg, Aliza, Iqbal, Nayyar, Hirshberg, Boaz, Stahre, Christina, Im, KyungAh, Kanevsky, Estella, and Raz, Itamar
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HYPOGLYCEMIA ,TYPE 2 diabetes complications ,DISEASE relapse ,GLYCEMIC control ,PLACEBOS ,HEALTH outcome assessment ,DISEASE risk factors - Abstract
Hypoglycaemia is a well-known risk associated with the use of sulphonylureas and insulin, often limiting achievement of glycaemic goals. Recognizing the precipitants and recurrence patterns of hypoglycaemic events, particularly major events, is therefore clinically important. The SAVOR-TIMI-53 trial was a cardiovascular outcome study of 16 492 patients allocated to saxagliptin vs placebo added to conventional care for a median of 2.1 years. Hypoglycaemic events were a prespecified outcome in the study and were defined as a symptomatic episode that recovered with carbohydrates or any recorded blood glucose <3.0 mmol/l (<54 mg/ dL). A major event was defined as one that required third-party assistance. Analysis of the features of the first hypoglycaemic event for each patient showed that a precipitant for the event was recognized by fewer than half of the patients, with the precipitant most often being a missed meal. In 40% of patients reporting major hypoglycaemic events, no precipitating factor was recognized, and in >60%, no previous hypoglycaemic event was reported during the timespan of the study, underscoring the lack of predictability of such an event. [ABSTRACT FROM AUTHOR]
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- 2017
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9. CLINICAL FACTORS ASSOCIATED WITH SUDDEN CARDIAC DEATH IN TYPE 2 DIABETES: INSIGHTS FROM THE SAVOR-TIMI 53 TRIAL
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Cavallari, Ilaria, Patel, Ravi, Bhatt, Deepak, Steg, Philippe, Leiter, Lawrence, McGuire, Darren, Mosenzon, Ofri, Kanevsky, Estella, Im, Kyungah, Raz, Itamar, Braunwald, Eugene, and Scirica, Benjamin
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- 2016
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10. Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial.
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Cahn, Avivit, Raz, Itamar, Mosenzon, Ofri, Leibowitz, Gil, Yanuv, Ilan, Rozenberg, Aliza, Iqbal, Nayyar, Hirshberg, Boaz, Sjostrand, Mikaela, Stahre, Christina, KyungAh Im, Kanevsky, Estella, Scirica, Benjamin M., Bhatt, Deepak L., Braunwald, Eugene, and Im, KyungAh
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HYPOGLYCEMIA ,BLOOD sugar ,ENDOCRINE diseases ,PLACEBOS ,TYPE 2 diabetes ,TYPE 2 diabetes complications ,COMPARATIVE studies ,GLYCOSYLATED hemoglobin ,HYDROCARBONS ,HYPOGLYCEMIC agents ,HYPOGLYCEMIC sulfonylureas ,INSULIN ,INSULIN derivatives ,LONGITUDINAL method ,RESEARCH methodology ,MEDICAL cooperation ,MULTIVARIATE analysis ,OLIGOPEPTIDES ,KIDNEY failure ,RESEARCH ,STATISTICAL sampling ,EVALUATION research ,BODY mass index ,RANDOMIZED controlled trials ,SULFONYLUREAS ,PROPORTIONAL hazards models ,PREVENTION - Abstract
Objective: To analyze the impact of adding saxagliptin versus placebo on the risk for hypoglycemia and to identify predictors of any and major hypoglycemia in patients with type 2 diabetes included in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) study.Research Design and Methods: Patients with type 2 diabetes (n = 16,492) were randomized to saxagliptin or placebo and followed for a median of 2.1 years. Associations between any hypoglycemia (symptomatic or glucose measurement <54 mg/dL) or major hypoglycemia (requiring extended assistance) and patient characteristics overall and by treatment allocation were studied.Results: At least one hypoglycemic event was reported in 16.6% of patients, and 1.9% reported at least one major event. Patients allocated to saxagliptin versus placebo experienced higher rates of any (hazard ratio [HR] 1.16 [95% CI 1.08, 1.25]; P < 0.001) or major (HR 1.26 [1.01, 1.58]; P = 0.038) hypoglycemia. Hypoglycemia rates (any or major) were increased with saxagliptin in patients taking sulfonylureas (SURs) but not in those taking insulin. Rates were increased with saxagliptin in those with baseline HbA1c ≤7.0% and not in those with baseline HbA1c >7.0%. Multivariate analysis of the overall population revealed that independent predictors of any hypoglycemia were as follows: allocation to saxagliptin, long duration of diabetes, increased updated HbA1c, macroalbuminuria, moderate renal failure, SUR use, and insulin use. Predictors of major hypoglycemia were allocation to saxagliptin, advanced age, black race, reduced BMI, long duration of diabetes, declining renal function, microalbuminuria, and use of short-acting insulin. Among SURs, glibenclamide was associated with increased risk of major but not any hypoglycemia.Conclusions: The identification of patients at risk for hypoglycemia can guide physicians to better tailor antidiabetic therapy. [ABSTRACT FROM AUTHOR]- Published
- 2016
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11. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial.
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Bohula, Erin A., Scirica, Benjamin M., Inzucchi, Silvio E., McGuire, Darren K., Keech, Anthony C., Smith, Steven R., Kanevsky, Estella, Murphy, Sabina A., Leiterf, Lawrence A., Dwyer, Jamie P., Corbalan, Ramon, Hamm, Christian, Kaplan, Lee, Nicolau, Jose Carlos, Ophuis, Ton Oude, Ray, Kausik K., Ruda, Mikhail, Spinar, Jindrich, Patel, Tushar, and Wenfeng Miao
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DIABETES , *CARBOHYDRATE intolerance , *ENDOCRINE diseases , *RANDOMIZED controlled trials , *OBESITY , *SEROTONIN agonists , *TRYPTAMINE , *ATHEROSCLEROSIS complications , *TYPE 2 diabetes prevention , *HYPOGLYCEMIC agents , *HETEROCYCLIC compounds , *APPETITE depressants , *TYPE 2 diabetes complications , *OBESITY complications , *ATHEROSCLEROSIS , *BODY weight , *COMPARATIVE studies , *RESEARCH methodology , *MEDICAL cooperation , *TYPE 2 diabetes , *PREDIABETIC state , *RESEARCH , *STATISTICAL sampling , *WEIGHT loss , *EVALUATION research , *TREATMENT effectiveness , *DISEASE remission , *BLIND experiment , *DISEASE complications , *PREVENTION , *THERAPEUTICS - Abstract
Background: There is a direct relationship between bodyweight and risk of diabetes. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. We aimed to evaluate the long-term effects of lorcaserin on diabetes prevention and remission.Methods: In this randomised, double-blind, placebo-controlled trial done in eight countries, we recruited overweight or obese patients (body-mass index ≥27 kg/m2) with or at high risk for atherosclerotic vascular disease. Eligible patients were aged 40 years or older; patients at high risk for atherosclerotic vascular disease had to be aged 50 years or older with diabetes and at least one other risk factor. Patients were randomly assigned to receive either lorcaserin (10 mg twice daily) or matching placebo. Additionally, all patients had access to a standardised weight management programme based on lifestyle modification. The prespecified primary metabolic efficacy endpoint of time to incident diabetes was assessed in patients with prediabetes at baseline. The prespecified secondary outcomes for efficacy were incident diabetes in all patients without diabetes, achievement of normoglycaemia in patients with prediabetes, and change in glycated haemoglobin (HbA1c) in patients with diabetes. Hypoglycaemia was a prespecified safety outcome. Analysis was by intention to treat, using Cox proportional hazard models for time-to-event analyses. This trial is registered with ClinicalTrials.gov, number NCT02019264.Findings: Between Feb 7, 2014, and Nov 20, 2015, 12 000 patients were randomly assigned to lorcaserin or placebo (6000 patients in each group) and followed up for a median of 3·3 years (IQR 3·0-3·5). At baseline, 6816 patients (56·8%) had diabetes, 3991 (33·3%) prediabetes, and 1193 (9·9%) normoglycaemia. At 1 year, patients treated with lorcaserin had a net weight loss beyond placebo of 2·6 kg (95% CI 2·3-2·9) for those with diabetes, 2·8 kg (2·5-3·2) for those with prediabetes, and 3·3 kg (2·6-4·0) for those with normoglycaemia (p<0·0001 for all analyses). Lorcaserin reduced the risk of incident diabetes by 19% in patients with prediabetes (172 [8·5%] of 2015 vs 204 [10·3%] of 1976; hazard ratio 0·81, 95% CI 0·66-0·99; p=0·038) and by 23% in patients without diabetes (174 [6·7%] of 2615 vs 215 [8·4%] of 2569; 0·77, 0·63-0·94; p=0·012). Lorcaserin resulted in a non-significant increase in the rate of achievement of normoglycaemia in patients with prediabetes (185 [9·2%] vs 151 [7·6%]; 1·20, 0·97-1·49; p=0·093). In patients with diabetes, lorcaserin resulted in a reduction of 0·33% (95% CI 0·29-0·38; p<0·0001) in HbA1c compared with placebo at 1 year from a mean baseline of 53 mmol/mol (7·0%). In patients with diabetes at baseline, severe hypoglycaemia with serious complications was rare, but more common with lorcaserin (12 [0·4%] vs four [0·1%] events; p=0·054).Interpretation: Lorcaserin decreases risk for incident diabetes, induces remission of hyperglycaemia, and reduces the risk of microvascular complications in obese and overweight patients, supporting the role of lorcaserin as an adjunct to lifestyle modification for chronic management of weight and metabolic health.Funding: Eisai. [ABSTRACT FROM AUTHOR]- Published
- 2018
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12. Cognitive Function in a Randomized Trial of Evolocumab.
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Giugliano, Robert P., Mach, François, Zavitz, Kenton, Kurtz, Christopher, Kyungah Im, Kanevsky, Estella, Schneider, Jingjing, Huei Wang, Keech, Anthony, Pedersen, Terje R., Sabatine, Marc S., Sever, Peter S., Robinson, Jennifer G., Honarpour, Narimon, Wasserman, Scott M., Ott, Brian R., Im, Kyungah, Wang, Huei, and EBBINGHAUS Investigators
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COGNITIVE ability , *RANDOMIZED controlled trials , *LOW density lipoproteins , *STATINS (Cardiovascular agents) , *CLINICAL trials , *THERAPEUTIC use of monoclonal antibodies , *ANTILIPEMIC agents , *ATHEROSCLEROSIS , *COMBINATION drug therapy , *COGNITION , *COMPARATIVE studies , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *MEMORY , *MONOCLONAL antibodies , *PSYCHOLOGICAL tests , *RESEARCH , *SELF-evaluation , *EVALUATION research , *BLIND experiment , *PSYCHOLOGY - Abstract
Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (P<0.001 for noninferiority; P=0.85 for superiority). There were no significant between-group differences in the secondary end points of scores for working memory (change in raw score, -0.52 in the evolocumab group and -0.93 in the placebo group), episodic memory (change in raw score, -1.53 and -1.53, respectively), or psychomotor speed (change in raw score, 5.2 msec and 0.9 msec, respectively). In an exploratory analysis, there were no associations between LDL cholesterol levels and cognitive changes. Conclusions In a randomized trial involving patients who received either evolocumab or placebo in addition to statin therapy, no significant between-group difference in cognitive function was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .). [ABSTRACT FROM AUTHOR]
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- 2017
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13. Regional implementation of a pediatric cardiology chest pain guideline using SCAMPs methodology.
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Angoff GH, Kane DA, Giddins N, Paris YM, Moran AM, Tantengco V, Rotondo KM, Arnold L, Toro-Salazar OH, Gauthier NS, Kanevsky E, Renaud A, Geggel RL, Brown DW, and Fulton DR
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- Adolescent, Ambulatory Care methods, Chest Pain physiopathology, Chest Pain therapy, Child, Disease Management, Echocardiography methods, Electrocardiography methods, Female, Follow-Up Studies, Guideline Adherence, Heart Diseases physiopathology, Heart Diseases therapy, Humans, Male, Radiography, Thoracic standards, Young Adult, Chest Pain diagnosis, Echocardiography standards, Electrocardiography standards, Heart Diseases diagnosis, Pediatrics methods, Practice Guidelines as Topic standards
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Background and Objectives: Chest pain is a complaint for which children are frequently evaluated. Cardiac causes are rarely found despite expenditure of considerable time and resources. We describe validation throughout New England of a clinical guideline for cost-effective evaluation of pediatric patients first seen by a cardiologist for chest pain using a unique methodology termed the Standardized Clinical Assessment and Management Plans (SCAMPs)., Methods: A total of 1016 ambulatory patients, ages 7 to 21 years initially seen for chest pain at Boston Children's Hospital (BCH) or the New England Congenital Cardiology Association (NECCA) practices, were evaluated by using a SCAMPs chest pain guideline. Findings were analyzed for diagnostic elements, patterns of care, and compliance with the guideline. Results from the NECCA practices were compared with those of Boston Children's Hospital, a regional core academic center., Results: Two patients had chest pain due to a cardiac etiology, 1 with pericarditis and 1 with an anomalous coronary artery origin. Testing performed outside of guideline recommendations demonstrated only incidental findings. Patients returning for persistent symptoms did not have cardiac disease. The pattern of care for the NECCA practices and BCH differed minimally., Conclusions: By using SCAMPs methodology, we have demonstrated that chest pain in children is rarely caused by heart disease and can be evaluated in the ambulatory setting efficiently and effectively using minimal resources. The methodology can be implemented regionally across a wide range of clinical practice settings and its approach can overcome a number of barriers that often limit clinical practice guideline implementation.
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- 2013
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