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  • 1
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    Thrombin-Receptor Antagonist Vorapaxar in Acute Coronary Syndromes
    Massachusetts Medical Society ; 2012
    In:  New England Journal of Medicine Vol. 366, No. 1 ( 2012-01-05), p. 20-33
    Details
    In: New England Journal of Medicine, Massachusetts Medical Society, Vol. 366, No. 1 ( 2012-01-05), p. 20-33
    Type of Medium: Online Resource
    ISSN: 0028-4793 , 1533-4406
    URL: Article
    DOI: 10.1056/NEJMoa1109719
    RVK:
    XA 10000
    Language: English
    Publisher: Massachusetts Medical Society
    Publication Date: 2012
    detail.hit.zdb_id: 1468837-2
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  • 2
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    Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events : Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Hypertension Vol. 70, No. 5 ( 2017-11), p. 907-914
    Details
    In: Hypertension, Ovid Technologies (Wolters Kluwer Health), Vol. 70, No. 5 ( 2017-11), p. 907-914
    Abstract: Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) randomized trial of sitagliptin versus placebo. The association between baseline SBP and recurrent cardiovascular disease was evaluated using multivariable Cox proportional hazards modeling with restricted cubic splines, adjusting for clinical characteristics. Kaplan–Meier curves by baseline SBP were created to assess time to cardiovascular disease and 2 potential hypotension-related adverse events: worsening kidney function and fractures. The association between time-updated SBP and outcomes was examined using multivariable Cox proportional hazards models. Overall, 42.2% of adults with diabetes mellitus, cardiovascular disease, and hypertension had an SBP ≥140 mm Hg. The association between SBP and cardiovascular disease risk was U shaped, with a nadir ≈130 mm Hg. When the analysis was restricted to those with baseline SBP of 110 to 150 mm Hg, the adjusted association between SBP and cardiovascular disease risk was flat (hazard ratio per 10-mm Hg increase, 0.96; 95% confidence interval, 0.91–1.02). There was no association between SBP and risk of fracture. Above 150 mm Hg, higher SBP was associated with increasing risk of worsening kidney function (hazard ratio per 10-mm Hg increase, 1.10; 95% confidence interval, 1.02–1.18). Many patients with diabetes mellitus have uncontrolled hypertension. The U-shaped association between SBP and cardiovascular disease events was largely driven by those with very high or low SBP, with no difference in cardiovascular disease risk between 110 and 150 mm Hg. Lower SBP was not associated with higher risks of fractures or worsening kidney function.
    Type of Medium: Online Resource
    ISSN: 0194-911X , 1524-4563
    URL: Article
    DOI: 10.1161/HYPERTENSIONAHA.117.09482
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 2094210-2
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  • 3
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    Abstract 16708: Increasing Age and the Benefit From Higher-intensity Lipid Lowering With Ezetimibe/Simvastatin vs. Simvastatin Alone: Results From the IMPROVE-IT Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2015
    In:  Circulation Vol. 132, No. suppl_3 ( 2015-11-10)
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 132, No. suppl_3 ( 2015-11-10)
    Abstract: Introduction: While lipid lowering reduces cardiovascular (CV) events, evidence supporting high-intensity lipid lowering among elderly pts is more limited, and recent guidelines recommend moderate rather than high-intensity therapy for pts 〉 75 yrs. We explored age subgroups within the IMPROVE-IT trial to evaluate whether age modified the benefit of adding ezetimibe (EZ) to statin therapy. Methods and Results: The IMPROVE-IT trial demonstrated the combination of EZ and simvastatin (EZ/S) significantly reduced major CV events vs. simvastatin (S) alone in pts with acute coronary syndrome (ACS) and LDL-C between 50 and 125 mg/dL. The primary composite endpoint was CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, and coronary revascularization 〉 30 days. Outcomes according to age were compared in pre-specified subgroups using Kaplan-Meier (KM) analysis and Cox proportional hazards models using age as a continuous variable. Of the 18,144 pts enrolled, 7971 (44%) were 65 yrs or older and 2798 (15%) were 75 yrs or older at randomization. As age increased, event rate increased with KM rates at 7 yrs in the S arm of 30.8% for pts 〈 65 yrs, 39.9% for pts ≥65 yrs, and 47.6% for pts ≥75 yrs. Treatment with EZ/S compared with S resulted in lower event rates in all age groups with an absolute reduction for pts 〈 65 yrs of 0.85% (HR 0.98 CI 0.90-1.05), for pts ≥65 yrs of 3.6% (HR 0.89 CI 0.82-0.96), and for pts ≥75 yrs of 8.7% (HR 0.80 CI 0.70-0.90), with interaction P values of 0.09 and 0.005, respectively. Using age as a continuous variable found event rates for EZ/S vs. S were always lower, but the test for interaction between age and treatment effect for the primary endpoint was non-significant (P=0.15). The rate of gallbladder, liver, and muscle-related adverse events was not increased with EZ/S vs. S among older pts or younger pts. Conclusions: In the IMPROVE-IT trial, pts 65 yrs or older and especially pts 75 yrs or older after ACS derived substantial benefit from higher-intensity lipid lowering therapy with EZ/S compared with S alone, with no increase in safety issues among older age subgroups. These results may have implications for guideline recommendations regarding more intensive lipid lowering in the elderly.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/circ.132.suppl_3.16708
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1466401-X
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  • 4
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    Abstract 148: Efficacy and Safety of Rivaroxaban Compared with Warfarin Among Elderly Patients with Nonvalvular Atrial Fibrillation in the ROCKET-AF Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. suppl_1 ( 2012-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Background: Nonvalvular atrial fibrillation (AF) affects 5-10% of people over 75 years of age, in whom the risk of thromboembolism is higher than in younger individuals. Although warfarin protects against ischemic stroke, many patients cannot sustain treatment because of bleeding, drug interactions and coagulation monitoring. The oral Factor Xa inhibitor, rivaroxaban, displayed noninferior efficacy and safety as an alternative anticoagulant in the ROCKET-AF trial (median age 73 years). This analysis compares these treatments in patients 〉 75 years. Methods: The ROCKET-AF trial (n=14,264) included 6,229 patients 〉 75 years of age with AF and at least 1 additional stroke risk factor randomized to adjusted-dose warfarin (target INR 2.0-3.0) or fixed-dose rivaroxaban (20 mg daily; 15 mg daily if baseline creatinine clearance 〈 50 ml/min), double-blind. The primary endpoint was all strokes (ischemic or hemorrhagic) and systemic embolism analyzed during the on-treatment period and according to intention-to-treat (ITT). Results: Compared to younger patients, those ≥75 years at baseline had a mean CHADS 2 score of 3.7 vs. 3.3, 46 vs. 35% were female, and 42 vs. 65% had prior stroke/TIA. During 9,247 patient-years exposure, 429 stroke or systemic embolic events occurred among patients 〉 75 years old. Long-term tolerability was similar between treatments; 59.4% of patients on warfarin (W) and 59.3% on rivaroxaban (R) completed the trial taking assigned treatment, compared with 69.9 and 68.7% in younger patients. The mean INR in the warfarin group (2.44, SD=0.86) was within target range for 56.9% (SD=21.6) of follow-up, compared to 53.9% (SD=20.9) in younger patients. The table compares annualized event rates for patients 〈 75 and 〉 75 years of age at entry. The on-treatment thromboembolism rates of 1.78 vs. 2.65%/year with rivaroxaban and warfarin, respectively (HR 0.67; 95% CI 0.51-0.89) were not much higher than in younger patients. Older patients had higher rates of (mostly non-major) clinically relevant bleeding (interaction p =0.009), but rates with warfarin and rivaroxaban were comparable. Conclusions: In elderly, high-risk patients with AF, once-daily oral rivaroxaban without coagulation monitoring or dose adjustment performed favorably compared to adjusted-dose warfarin as it did in the overall ROCKET-AF population. 1
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.43.suppl_1.A148
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 1467823-8
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  • 5
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    Abstract 152: Predictors of Intracranial Hemorrhage Among Anticoagulated Patients with Atrial Fibrillation: Insights from the Rivaroxaban Once-daily oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. suppl_1 ( 2012-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Background: For patients with atrial fibrillation (AF) at moderate to high risk of stroke, oral anticoagulation reduces the risk of ischemic stroke but may increase hemorrhagic stroke and offset the intended benefits in certain individuals. Identifying individuals with AF at high risk of stroke who are likely to have an intracranial hemorrhage (ICH) if treated with anticoagulants remains a challenge. Methods: We investigated factors associated with ICH in 14,264 patients with nonvalvular AF randomized to rivaroxaban or dose-adjusted warfarin in ROCKET AF. The endpoint of interest was ICH in the entire intention-to-treat population. Cox proportional hazards modeling was used to identify factors associated with ICH. Results: Over a median follow-up of 1.94 years, 136 patients experienced ICH events (intracerebral hemorrhage [n=98], subarachnoid hemorrhage [n=5] , subdural hemorrhage [n=32], extradural hemorrhage [n=1] ). The average annual rate of ICH was 0.55 per 100 patient-years. The significant independent predictors of increased risk for ICH were increased age, history of prior stroke or TIA, black or Asian race, decreasing serum albumin, and decreased platelet count below 210 x 10 9 /l (Table, C-index=0.677). Creatinine clearance was not associated with the occurrence of ICH after accounting for other variables in the model (P=0.3181). Aspirin and thienopyridine use at baseline were associated with an increased risk of ICH whereas randomization to rivaroxaban (versus warfarin) was protective. Conclusions: Among patients with AF at moderate to high risk of stroke who were treated with anticoagulation, the average annual rate of ICH was 0.55 per 100 patient-years. Risk of ICH was increased among those who were non-white, older, had prior stroke or TIA, had low platelet counts, low serum albumin, and were taking antiplatelet therapy. Rivaroxaban was associated with a significantly lower risk of ICH compared with warfarin. The external validity of these findings requires testing in other AF populations.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.43.suppl_1.A152
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
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  • 6
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    Abstract 31: The Development and Validation of a Biochemical Biomarker Panel to Detect Acute Stroke: A Preliminary Study
    Ovid Technologies (Wolters Kluwer Health) ; 2013
    In:  Stroke Vol. 44, No. suppl_1 ( 2013-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: A Biochemical Biomarker Panel Detects Acute Ischemic Stroke and Intracerebral Hemorrhage INTRODUCTION: The accurate diagnosis of acute ischemic stroke(IS), intracranial hemorrhage(ICH), and stroke mimics is essential for administering appropriate time-sensitive therapies which are currently underutilized due to diagnostic uncertainty. HYPOTHESIS: We hypothesize that a panel of biomarkers which singly predict inflammation, neuronal injury, and glial activation together may be diagnostic of acute cerebral ischemia with clinically relevant discriminative capacity. METHODS: Serum samples were collected from 167 patients presenting with acute neurologic deficits within 24 hours of symptom onset. Patients were classified as IS if symptoms fit a vascular distribution, if they had either a radiographically apparent lesion, and/or symptoms persisting more than 24 hours. Presentation CT determined ICH. Mimics were those with confirmed non-vascular etiologies of neurologic deficits. Of the 262 biomarkers measured, those significant in univariate analyses underwent stepwise selection from which a 5-biomarker multivariate logistic model was built and internally validated by bootstrapping. Its capacity to discriminate IS versus mimic, IS versus ICH, and IS plus ICH versus mimic was evaluated by area under the receiver operating characteristic, equivalent to concordance index (c-index) in logistic regression analysis. RESULTS: The 5-biomarker model consisted of eotaxin, epidermal growth factor receptor(EGFR), S100A12, metalloproteinase inhibitor-4(MPI-4), and prolactin. When discriminating between IS and mimics, eotaxin (c=0.812), EGFR(c=0.690), S100A12 (c=0.605), MPI-4 (c=0.588), and prolactin (c=0.645) together yielded a c-index of 0.918. With age, race, and gender, the sensitivity, specificity, and negative predictive value of the model were 90.3%, 85.2%, and 92.0%, respectively. This model also predicted IS plus ICH versus mimic (c= 0.927), and IS versus ICH (c = 0.896). CONCLUSIONS: The biomarkers identified in this study are essentially novel and show promise in acutely distinguishing IS, ICH, and mimics. Such a biomarker panel may assist in the early evaluation and management of patients with stroke-like symptoms.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.44.suppl_1.A31
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
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  • 7
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    Benefit of Ezetimibe Added to Simvastatin in Reduced Kidney Function
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Journal of the American Society of Nephrology Vol. 28, No. 10 ( 2017-10), p. 3034-3043
    Details
    In: Journal of the American Society of Nephrology, Ovid Technologies (Wolters Kluwer Health), Vol. 28, No. 10 ( 2017-10), p. 3034-3043
    Abstract: Efficacy of statin-based therapies in reducing cardiovascular mortality in individuals with CKD seems to diminish as eGFR declines. The strongest evidence supporting the cardiovascular benefit of statins in individuals with CKD was shown with ezetimibe plus simvastatin versus placebo. However, whether combination therapy or statin alone resulted in cardiovascular benefit is uncertain. Therefore, we estimated GFR in 18,015 individuals from the IMPROVE-IT (ezetimibe plus simvastatin versus simvastatin alone in individuals with cardiovascular disease and creatinine clearance 〉 30 ml/min) and examined post hoc the relationship of eGFR with end points across treatment arms. For the primary end point of cardiovascular death, major coronary event, or nonfatal stroke, the relative risk reduction of combination therapy compared with monotherapy differed by eGFR ( P =0.04). The difference in treatment effect was observed at eGFR≤75 ml/min per 1.73 m 2 and most apparent at levels ≤60 ml/min per 1.73 m 2 . Compared with individuals receiving monotherapy, individuals receiving combination therapy with a baseline eGFR of 60 ml/min per 1.73 m 2 experienced a 12% risk reduction (hazard ratio [HR], 0.88; 95% confidence interval [95% CI] , 0.82 to 0.95); those with a baseline eGFR of 45 ml/min per 1.73 m 2 had a 13% risk reduction (HR, 0.87; 95% CI, 0.78 to 0.98). In stabilized individuals within 10 days of acute coronary syndrome, combination therapy seemed to be more effective than monotherapy in individuals with moderately reduced eGFR (30–60 ml/min per 1.73 m 2 ). Further studies examining potential benefits of combination lipid-lowering therapy in individuals with CKD are needed.
    Type of Medium: Online Resource
    ISSN: 1046-6673 , 1533-3450
    URL: Article
    DOI: 10.1681/ASN.2016090957
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
    detail.hit.zdb_id: 2029124-3
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  • 8
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    Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis
    Elsevier BV ; 2018
    In:  The Lancet Diabetes & Endocrinology Vol. 6, No. 2 ( 2018-02), p. 105-113
    Details
    In: The Lancet Diabetes & Endocrinology, Elsevier BV, Vol. 6, No. 2 ( 2018-02), p. 105-113
    Type of Medium: Online Resource
    ISSN: 2213-8587
    URL: Article
    DOI: 10.1016/S2213-8587(17)30412-6
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2018
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  • 9
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    Confirming the Bidirectional Nature of the Association Between Severe Hypoglycemic and Cardiovascular Events in Type 2 Diabetes: Insights From EXSCEL
    American Diabetes Association ; 2020
    In:  Diabetes Care Vol. 43, No. 3 ( 2020-03-01), p. 643-652
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 3 ( 2020-03-01), p. 643-652
    Abstract: We sought to confirm a bidirectional association between severe hypoglycemic events (SHEs) and cardiovascular (CV) event risk and to characterize individuals at dual risk. RESEARCH DESIGN AND METHODS In a post hoc analysis of 14,752 Exenatide Study of Cardiovascular Event Lowering (EXSCEL) participants, we examined time-dependent associations between SHEs and subsequent major adverse cardiac events (CV death, nonfatal myocardial infarction [MI] or stroke), fatal/nonfatal MI, fatal/nonfatal stroke, hospitalization for acute coronary syndrome (hACS), hospitalization for heart failure (hHF), and all-cause mortality (ACM), as well as time-dependent associations between nonfatal CV events and subsequent SHEs. RESULTS SHEs were uncommon and not associated with once-weekly exenatide therapy (hazard ratio 1.13 [95% CI 0.94–1.36], P = 0.179). In fully adjusted models, SHEs were associated with an increased risk of subsequent ACM (1.83 [1.38–2.42] , P & lt; 0.001), CV death (1.60 [1.11–2.30], P = 0.012), and hHF (2.09 [1.37–3.17] , P = 0.001), while nonfatal MI (2.02 [1.35–3.01], P = 0.001), nonfatal stroke (2.30 [1.25–4.23] , P = 0.007), hACS (2.00 [1.39–2.90], P & lt; 0.001), and hHF (3.24 [1.98–5.30], P & lt; 0.001) were all associated with a subsequent increased risk of SHEs. The elevated bidirectional time-dependent hazards linking SHEs and a composite of all CV events were approximately constant over time, with those individuals at dual risk showing higher comorbidity scores compared with those without. CONCLUSIONS These findings, showing greater risk of SHEs after CV events as well as greater risk of CV events after SHEs, validate a bidirectional relationship between CV events and SHEs in patients with high comorbidity scores.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-1079
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
    detail.hit.zdb_id: 1490520-6
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  • 10
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    Pancreatic Safety of Sitagliptin in the TECOS Study
    American Diabetes Association ; 2017
    In:  Diabetes Care Vol. 40, No. 2 ( 2017-02-01), p. 164-170
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 40, No. 2 ( 2017-02-01), p. 164-170
    Abstract: We evaluated the incidence of acute pancreatitis and pancreatic cancer in patients with type 2 diabetes and cardiovascular disease who were treated with sitagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i). RESEARCH DESIGN AND METHODS In the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study, a cardiovascular safety study of sitagliptin, all suspected cases of acute pancreatitis and pancreatic cancer were collected prospectively for 14,671 participants during a median follow-up time of 3 years, and were adjudicated blindly. RESULTS Baseline differences were minimal between participants confirmed to have no pancreatic events, acute pancreatitis, or pancreatic cancer. Among those participants randomized to receive sitagliptin, 23 (0.3%) (vs. 12 randomized to receive placebo [0.2%]) had pancreatitis (hazard ratio 1.93 [95% CI 0.96–3.88] , P = 0.065; 0.107 vs. 0.056/100 patient-years), with 25 versus 17 events, respectively. Severe pancreatitis (two fatal) occurred in four individuals allocated to receive sitagliptin. Cases of pancreatic cancer were numerically fewer with sitagliptin (9 [0.1%]) versus placebo (14 [0.2%] ) (hazard ratio 0.66 [95% CI 0.28–1.51], P = 0.32; 0.042 vs. 0.066 events/100 patient-years). Meta-analysis with two other DPP-4i cardiovascular outcome studies showed an increased risk for acute pancreatitis (risk ratio 1.78 [95% CI 1.13–2.81] , P = 0.01) and no significant effect for pancreatic cancer (risk ratio 0.54 [95% CI 0.28–1.04], P = 0.07). CONCLUSIONS Pancreatitis and pancreatic cancer were uncommon events with rates that were not statistically significantly different between the sitagliptin and placebo groups, although numerically more sitagliptin participants developed pancreatitis and fewer developed pancreatic cancer. Meta-analysis suggests a small absolute increased risk for pancreatitis with DPP-4i therapy.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc15-2780
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2017
    detail.hit.zdb_id: 1490520-6
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