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Background pharmacological therapy in the ANTHEM-HF: comparison to contemporary trials of novel heart failure therapies.
Premchand, RK, Sharma, K, Mittal, S, Monteiro, R, Libbus, I, Ardell, JL, Gregory, DD, KenKnight, BH, Amurthur, B, DiCarlo, LA, et al
ESC heart failure. 2019;(5):1052-1056
Abstract
AIMS: Clinical trials of new heart failure (HF) therapies administer guideline-directed medical therapy (GDMT) as background pharmacologic treatment (BPT). In the ANTHEM-HF Pilot Study, addition of autonomic regulation therapy to GDMT significantly improved left ventricular function, New York Heart Association (NYHA) class, 6 min walk distance, and quality of life in patients with HF with reduced ejection fraction (HFrEF). A post hoc analysis was performed to compare BPT in ANTHEM-HF with two other trials of novel HF therapies: the PARADIGM-HF study of sacubitril-valsartan and the SHIFT study of ivadrabine. All three studies evaluated patients with HFrEF, and the recommendations for use of GDMT were similar. A left ventricular ejection fraction ≤40% was required for entry into ANTHEM-HF and PARADIGM-HF and ≤35% for SHIFT. NYHA 2 or 3 symptoms were required for entry into ANTHEM-HF, and patients with predominantly NYHA 2 or 3 symptoms were enrolled in PARADIGM-HF and SHIFT. METHODS AND RESULTS Data on BPT were obtained from peer-reviewed publications and the public domain. Pearson's χ2 test was used to evaluate differences in proportions, and Student's unpaired t-test was used to evaluate differences in mean values. The minimum period of stable GDMT required before randomization was longer in ANTHEM-HF: 3 months vs. 1 month in PARADIGM-HF and SHIFT, respectively. When compared with PARADIGM-HF and SHIFT, more patients in ANTHEM-HF received beta-blockers (100% vs. 93% and 89%, P < 0.04 and P < 0.007) and mineralocorticoid receptor antagonists (75% vs. 55% and 61%, P < 0.002 and P < 0.03). More patients in PARADIGM-HF received an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker than in ANTHEM-HF or SHIFT (100% vs. 85%, P < 0.0001, and 100% vs. 91%, P < 0.001), which was related to PARADIGM's design. When beta-blocker doses in ANTHEM-HF and SHIFT were compared, significantly fewer patients in ANTHEM-HF received doses ≥100% of target (10% vs. 23%, P < 0.02), and fewer patients tended to receive doses ≥50% of target (17% vs. 26%, P = 0.11). When ANTHEM-HF and PARADIGM-HF were compared, more patients in ANTHEM-HF tended to receive doses ≥100% of target (10% vs. 7%, P = 0.36), and fewer patients tended to receive doses ≥50% of target (17% vs. 20%, P = 0.56). CONCLUSIONS Background treatment with GDMT in ANTHEM-HF compared favourably with that in two other contemporary trials of new HF therapies. The minimum period of stable GDMT required before randomization was longer, and GDMT remained unchanged for the study's duration. These findings serve to further support the potential role of autonomic regulation therapy as an adjunct to GDMT for patients with HFrEF.
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Impact of the 2017 American Academy of Pediatrics Guideline on Hypertension Prevalence Compared With the Fourth Report in an International Cohort.
Yang, L, Kelishadi, R, Hong, YM, Khadilkar, A, Nawarycz, T, Krzywińska-Wiewiorowska, M, Aounallah-Skhiri, H, Motlagh, ME, Kim, HS, Khadilkar, V, et al
Hypertension (Dallas, Tex. : 1979). 2019;(6):1343-1348
Abstract
In 2017, the American Academy of Pediatrics (AAP) updated the clinical practice guideline for high blood pressure (BP) in the pediatric population. In this study, we compared the difference in prevalence of elevated and hypertensive BP values defined by the 2017 AAP guideline and the 2004 Fourth Report and estimated the cardiovascular risk associated with the reclassification of BP status defined by the AAP guideline. A total of 47 200 children and adolescents aged 6 to 17 years from 6 countries (China, India, Iran, Korea, Poland, and Tunisia) were included in this study. Elevated BP and hypertension were defined according to 2 guidelines. In addition, 1606 children from China, Iran, and Korea who were reclassified upward by the AAP guideline compared with the Fourth Report and for whom laboratory data were available were 1:1 matched with children from the same countries who were normotensive by both guidelines. Compared with the Fourth Report, the prevalence of elevated BP defined by the AAP guideline was lower (14.9% versus 8.6%), whereas the prevalence of stages 1 and 2 hypertension was higher (stage 1, 6.6% versus 14.5%; stage 2, 0.4% versus 1.7%). Additionally, comparison of laboratory data in the case-control study showed that children who were reclassified upward were more likely to have adverse lipid profiles and high fasting blood glucose compared with normotensive children. In conclusion, the prevalence of elevated BP and hypertension varied significantly between both guidelines. Applying the new AAP guideline could identify more children with hypertension who are at increased cardiovascular risk.
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ACC/AHA Versus ESC/ESH on Hypertension Guidelines: JACC Guideline Comparison.
Bakris, G, Ali, W, Parati, G
Journal of the American College of Cardiology. 2019;(23):3018-3026
Abstract
This study compares the recommendations of the most recent American College of Cardiology (ACC)/American Heart Association (AHA) and European Society of Cardiology (ESC)/European Society of Hypertension (ESH) blood pressure guidelines. Both guidelines represent updates of previous guidelines and reinforce previous concepts of prevention regarding elevated blood pressure. Specifically, a low-sodium diet, exercise, body weight reduction, low to moderate alcohol intake, and adequate potassium intake are emphasized. Overall, both guidelines agree on the proper method of blood pressure measurement, the use of home blood pressure and ambulatory monitoring, and restricted use of beta-blockers as first-line therapy. The major disagreements are with the level of blood pressure defining hypertension, flexibility in identifying blood pressure targets for treatment, and the use of initial combination therapy. Although initial single-pill combination therapy is strongly recommended in both guidelines, the ESC/ESH guideline recommends it as initial therapy in patients at ≥140/90 mm Hg. The ACC/AHA guideline recommends its use in patients >20/10 mm Hg above blood pressure goal. Thus, the only real disagreement is that the ACC/AHA guidelines maintain that all people with blood pressure >130/80 mm Hg have hypertension, and blood pressure should be lowered to <130/80 mm Hg in all. In contrast, the ESC/ESH guidelines state that hypertension is defined as >140/90 mm Hg, with the goal being a level <140/90 mm Hg for all targeting to <130/80 mm Hg only in those at high cardiovascular risk, but always considering individual tolerability of the proposed goal.
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ACC/AHA Versus ESC Guidelines for Diagnosis and Management of Peripheral Artery Disease: JACC Guideline Comparison.
Kithcart, AP, Beckman, JA
Journal of the American College of Cardiology. 2018;(22):2789-2801
Abstract
Peripheral artery disease is a common yet underdiagnosed cause of morbidity worldwide. Significant recent advances in management have resulted in new guideline creation for the diagnosis and management of peripheral artery disease in the United States and Europe. Here, we analyze each set of guidelines with special attention to those areas where the 2 groups disagree. Both groups emphasize the importance of risk factor reduction, including smoking cessation, lipid lowering, blood pressure management, and glucose control. The U.S. guidelines place additional attention on lifestyle factors, including regular physical activity and supervised exercise. The European guidelines offer a number of recommendations for revascularization in patients with limb-threatening ischemia. Both agree that more evidence is needed to understand which patients are at highest risk for tissue loss. A consistent charge to each committee fostering a similar approach to available data and more randomized studies would align recommendations across both organizations.
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A Comparative Analysis of Current Lipid Treatment Guidelines: Nothing Stands Still.
Tibrewala, A, Jivan, A, Oetgen, WJ, Stone, NJ
Journal of the American College of Cardiology. 2018;(7):794-799
Abstract
Lipid treatment guidelines have continued to evolve as new evidence emerges. We sought to review similarities and differences of 5 lipid treatment guidelines from the American College of Cardiology/American Heart Association, Canadian Cardiovascular Society, European Society for Cardiology/European Atherosclerosis Society, U.S. Preventive Services Task Force, and U.S. Veterans Affairs/Department of Defense. All guidelines utilize rigorous evidentiary review, highlight statin therapy for primary and secondary prevention of atherosclerotic cardiovascular disease, and emphasize a clinician-patient risk discussion. However, there are differences in statin intensities, use of risk estimators, treatment of specific patient subgroups, and consideration of safety concerns. Clinicians should understand these similarities and differences in current and future guideline recommendations when considering if and how to treat their patients with statin therapy.
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Identifying and integrating consumer perspectives in clinical practice guidelines on autosomal-dominant polycystic kidney disease.
Tong, A, Tunnicliffe, DJ, Lopez-Vargas, P, Mallett, A, Patel, C, Savige, J, Campbell, K, Patel, M, Tchan, MC, Alexander, SI, et al
Nephrology (Carlton, Vic.). 2016;(2):122-32
Abstract
AIM: This study aimed to identify consumer perspectives on topics and outcomes to integrate in the Kidney Health Australia Caring for Australasians with Renal Impairment (KHA-CARI) clinical practice guidelines on autosomal-dominant polycystic kidney disease (ADPKD). METHODS A workshop involving three concurrent focus groups with 18 consumers (patients with ADPKD (n = 15), caregivers (n = 3)) was convened. Guideline topics, interventions and outcomes were identified, and integrated into guideline development. Thematic analysis was used to analyse the reasons for their choices. RESULTS Twenty-two priority topics were identified, with most focussed on non-pharmacological management (diet, fluid intake, physical activity, complementary medicine), pain management and psychosocial care (mental health, counselling, cognitive and behavioural training, education, support groups). They also identified 26 outcomes including quality of life (QoL), progression of kidney disease, kidney function, cyst growth and nephrotoxity. Almost all topics and outcomes suggested were identified by health professionals with the exception of five topics/outcomes. Six themes reflected reasons for their choices: clarifying ambiguities, resolving debilitating pain, concern for family, preparedness for the future, taking control and significance of impact. CONCLUSION Although there was considerable concordance between the priority topics and outcomes of health professionals and consumers for guidelines of ADPKD, there was also important discordance with consumers focused on fewer issues, but particularly on lifestyle, psychosocial support, pain, and QoL and renal outcomes. Active consumer engagement in guidelines development can help to ensure the inclusion of patient-centred recommendations, which may lead to better management of disease progression, symptoms, complications, and psychosocial impact.
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Recent Update to the US Cholesterol Treatment Guidelines: A Comparison With International Guidelines.
Nayor, M, Vasan, RS
Circulation. 2016;(18):1795-806
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Abstract
The 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol guideline advocated several changes from the previous Adult Treatment Panel III guidelines. Assuming full implementation, the 2013 ACC/AHA guideline would identify ≈13 million Americans as newly eligible for consideration of statin therapy. Three features of the 2013 ACC/AHA guideline primarily responsible for these differences are the specific risk assessment tool endorsed, the risk threshold considered sufficient to warrant primary prevention statin therapy, and the decision not to include cholesterol treatment targets. There is no consensus among international guidelines on the optimal approach to these 3 components. The 2013 ACC/AHA guideline recommends assessing absolute risk with the Pooled Cohort equations, which were developed to improve on previous risk assessment models by including stroke as an outcome and by broadening racial and geographic diversity. Each of the leading international guidelines recommends a different equation for absolute risk assessment. The 2013 ACC/AHA guideline advises consideration of statin therapy for an estimated 10-year risk of atherosclerotic vascular disease of ≥7.5%, which is lower than the thresholds recommended by other leading international guidelines. Lastly, the 2013 ACC/AHA guideline does not endorse a treat-to-target strategy but instead specifies the appropriate intensity of statin for each risk category. This approach is shared by the National Institute for Health and Care Excellence guidelines but differs from other international guidelines. In this review, we summarize the 2013 ACC/AHA cholesterol guideline recommendations and compare them with recommendations from Adult Treatment Panel III and other leading international guidelines.
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Implementing a pediatric obesity care guideline in a freestanding children's hospital to improve child safety and hospital preparedness.
Porter, RM, Thrasher, J, Krebs, NF
Journal of pediatric nursing. 2012;(6):707-14
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Abstract
Medical and surgical care of children with severe obesity is complicated and requires recognition of the problem, appropriate equipment, and safe management. There is little literature describing patient, provider, and institutional needs for the severely obese pediatric patient. Nonetheless, the limited data suggest 3 broad categories of needs unique to this population: (a) airway management, (b) drug dosing and pharmacology, and (c) equipment and infrastructure. We describe an opportunity at the Children's Hospital Colorado to better prepare and optimize care for this patient population by creation of a Pediatric Obesity Care Guideline that focused on key areas of quality and safety.
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Pharmacokinetics of isoniazid, rifampin, and pyrazinamide in children younger than two years of age with tuberculosis: evidence for implementation of revised World Health Organization recommendations.
Thee, S, Seddon, JA, Donald, PR, Seifart, HI, Werely, CJ, Hesseling, AC, Rosenkranz, B, Roll, S, Magdorf, K, Schaaf, HS
Antimicrobial agents and chemotherapy. 2011;(12):5560-7
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Abstract
The World Health Organization (WHO) recently issued revised first-line antituberculosis (anti-TB) drug dosage recommendations for children. No pharmacokinetic studies for these revised dosages are available for children <2 years. The aim of the study was to document the pharmacokinetics of the first-line anti-TB agents in children <2 years of age comparing previous and revised WHO dosages of isoniazid (INH; 5 versus 10 mg/kg/day), rifampin (RMP; 10 versus 15 mg/kg/day), and pyrazinamide (PZA; 25 versus 35 mg/kg/day) and to investigate the effects of clinical covariates, including HIV coinfection, nutritional status, age, gender, and type of tuberculosis (TB), and the effect of NAT2 acetylator status. Serum INH, PZA, and RMP levels were prospectively assessed in 20 children <2 years of age treated for TB following the previous and the revised WHO dosage recommendations. Samples were taken prior to dosing and at 0.5, 1.5, 3, and 5 h following dosing. The maximum drug concentration in serum (C(max)), the time to C(max) (t(max)), and the area under the concentration-time curve (AUC) were calculated. Eleven children had pulmonary and 9 had extrapulmonary TB. Five were HIV infected. The mean C(max) (μg/ml) following the administration of previous/revised dosages were as follows: INH, 3.19/8.11; RMP, 6.36/11.69; PZA, 29.94/47.11. The mean AUC (μg·h/ml) were as follows: INH, 8.09/20.36; RMP, 17.78/36.95; PZA, 118.0/175.2. The mean C(max) and AUC differed significantly between doses. There was no difference in the t(max) values achieved. Children less than 2 years of age achieve target concentrations of first-line anti-TB agents using revised WHO dosage recommendations. Our data provided supportive evidence for the implementation of the revised WHO guidelines for first-line anti-TB therapy in young children.
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Changing physician practice behavior to measure and improve clinical outcomes.
Schuster, RJ, Terwoord, NA, Tasosa, J
American journal of medical quality : the official journal of the American College of Medical Quality. 2006;(6):394-400
Abstract
Physician practice behavior often produces poor clinical outcomes in the management of cardiovascular disease risk factors in spite of effective treatments and guidelines. The behavior of 165 physicians in 2 settings (suburban and urban) was studied. After collecting baseline clinical data, including systolic blood pressure and low-density lipoprotein cholesterol, a series of interventions was conducted, including academic detailing. Low-density lipoprotein cholesterol decreased 10.4% in suburban patients with cardiovascular disease in the intervention group (P = .001) and 10.5% in the enhanced intervention group (P = .001). Systolic blood pressure decreased 1.11% (P = .357) in the intervention group and 5.13% in the enhanced intervention group (P < .001). In urban hypertensive patients, systolic blood pressure decreased 5.03% (P = .001) and low-density lipoprotein cholesterol decreased 7.01% (P < .001). Combining urban and suburban data, low-density lipoprotein cholesterol decreased 9.32% (P < .001) and systolic blood pressure decreased 4.00% (P < .001). Providing physicians with their clinical outcomes, reviewing national guidelines, and setting expectations, associated with modest practice systems innovations, can produce significant measurable clinical improvements.