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Cardiac Safety of the Trastuzumab Biosimilar ABP 980 in Women with HER2-Positive Early Breast Cancer in the Randomized, Double-Blind, Active-Controlled LILAC Study.
Kolberg, HC, Colleoni, M, Demetriou, GS, Santi, P, Tesch, H, Fujiwara, Y, Tomasevic, Z, Hanes, V
Drug safety. 2020;(3):233-242
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Abstract
INTRODUCTION Although the human epidermal growth factor receptor 2 (HER2) blocker trastuzumab is generally well tolerated, cardiotoxicity can be an important therapeutic limitation. OBJECTIVE In this prespecified analysis, we compared the cardiac safety of the trastuzumab biosimilar ABP 980 (KANJINTI™) and the trastuzumab reference product (RP; Herceptin®) in the phase III LILAC study (ClinicalTrials.gov identifier NCT01901146). METHODS In the neoadjuvant phase of LILAC, after run-in chemotherapy, 725 patients were randomized 1:1 to ABP 980 (n = 364) or trastuzumab RP (n = 361) plus paclitaxel (every 3 weeks [Q3W] or every week [QW]) for four cycles. After surgery, patients continued treatment Q3W for up to 1 year; ABP 980-treated patients continued ABP 980 (ABP 980/ABP 980; n = 364), and trastuzumab RP-treated patients either continued on the RP (trastuzumab RP/trastuzumab RP; n = 190) or switched to ABP 980 (trastuzumab RP/ABP 980; n = 171). Cardiac safety was monitored by computerized 12-lead electrocardiogram, and left ventricular ejection fraction (LVEF) was assessed by two-dimensional (2D) echocardiogram. LVEF decline was defined as LVEF value decrease from study baseline by ≥ 10 percentage points and to < 50%. RESULTS Over the entire study, 22 (3.1%) patients had protocol-defined LVEF decline; no meaningful between-group differences were observed (ABP 980/ABP 980: 2.8%; trastuzumab RP/trastuzumab RP: 3.3%; trastuzumab RP/ABP 980: 3.5%). The incidence of cardiac adverse events was low and comparable in the treatment groups. One grade 3 cardiac failure event reported in the trastuzumab RP/ABP 980 arm, and another in the trastuzumab RP/trastuzumab RP arm, were coincident with LVEF decline. One patient discontinued the investigational product during the adjuvant phase because of cardiac failure. CONCLUSION These prespecified analyses confirm the tolerability of ABP 980 and demonstrate clinical similarity of ABP 980 and trastuzumab RP with respect to cardiac safety. No new cardiac safety signals were observed whether patients were receiving ABP 980 or switched from the RP to ABP 980.
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Effects of a High-Protein Diet Including Whole Eggs on Muscle Composition and Indices of Cardiometabolic Health and Systemic Inflammation in Older Adults with Overweight or Obesity: A Randomized Controlled Trial.
Wright, CS, Zhou, J, Sayer, RD, Kim, JE, Campbell, WW
Nutrients. 2018;(7)
Abstract
Age-related increases in intermuscular adipose tissue (IMAT) impair muscle quality, decrease functional capacity, and promote several cardiometabolic and inflammatory disorders. Whether these age-related alterations in muscle composition improve by consuming a high-protein (HP) diet with whole eggs are unclear. This parallel-design, randomized-controlled trial assessed the effects of a 12-week eucaloric HP diet with three whole eggs per day (1.4 g protein kg-1 day-1) versus a normal-protein diet void of eggs (NP, 0.8 g protein kg-1 day-1) on muscle composition (IMAT), cardiometabolic health, and systemic inflammation in older adults with overweight or obesity (12 men and 10 women; age 70 ± 5 years, BMI 31.3 ± 3.2 kg/m², mean ± SD). No changes in muscle composition were observed over time, independent of protein intake. Total body weight was reduced in both groups (-3.3 ± 1.2%) and lean mass was preserved only with the HP diet. LDL concentration and hip circumference decreased only with the NP diet, while MCP-1 and HsCRP concentrations increased over time in both groups. A HP diet with whole eggs promotes lean mass retention with modest weight loss, but does not positively influence muscle composition, cardiometabolic health or systemic inflammation, compared to a NP diet void of eggs.
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Effects of calcium channel blocker-based combinations on intra-individual blood pressure variability: post hoc analysis of the COPE trial.
Umemoto, S, Ogihara, T, Matsuzaki, M, Rakugi, H, Ohashi, Y, Saruta, T, ,
Hypertension research : official journal of the Japanese Society of Hypertension. 2016;(1):46-53
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Abstract
Visit-to-visit blood pressure (BP) variability is an important predictor of stroke. However, which antihypertensive drug combination is better at reducing visit-to-visit BP variability and therefore at reducing stroke incidence remains uncertain. We have previously reported that the dihydropyridine calcium channel blocker benidipine combined with a β-blocker appeared to be less beneficial in reducing the risk of stroke than a combination of benidipine and thiazide. Here, we further compare the visit-to-visit BP variability among three benidipine-based regimens, namely angiotensin receptor blocker (ARB), β-blocker and thiazide combinations. The present post hoc analysis included 2983 patients without cardiovascular events or death during the first 18 months after randomization. We compared the BP variability (defined as the s.d. and the coefficient of variation (CV)), maximum systolic BP (SBP) and diastolic BP (DBP) of the clinic mean on-treatment BPs obtained at 6-month intervals, starting 6 months after the treatment initiation, among the 3 treatments (ARB, n=1026; β-blocker, n=966; thiazide, n=991). During the first 6-36 months after randomization, both the s.d. and CV-BPs were lower in the benidipine-thiazide group than in the benidipine-β-blocker group (s.d.-SBP, P=0.019; s.d.-DBP, P=0.030; CV-SBP, P=0.012; CV-DBP, P=0.022). The s.d. and CV in the ARB group did not reach statistical significance compared with the other two groups. The maximum BPs did not differ among the three treatments. These findings suggest that the benidipine-thiazide combination may reduce visit-to-visit BP variability more than the benidipine-β-blocker combination.
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Long-term outcomes from Healthy Eating and Exercise Lifestyle Program for overweight people with heart disease and diabetes.
Alharbi, M, Gallagher, R, Kirkness, A, Sibbritt, D, Tofler, G
European journal of cardiovascular nursing. 2016;(1):91-9
Abstract
BACKGROUND The benefits of exercise and weight reduction for overweight or obese people with coronary heart disease and/or diabetes mellitus are well recognised. The Healthy Eating and Exercise Lifestyle Program demonstrated these outcomes at 4 months, but longer-term outcomes are not yet reported. AIM: To determine whether positive weight, body mass index, waist and exercise duration outcomes were sustained in the long term (12 months) and to identify the independent predictors of these outcomes at 4 and 12 months. METHODS Longitudinal design, combining data of all Healthy Eating and Exercise Lifestyle Program participants (intervention and wait-list control, n = 134). Participants had a body mass index between 27 and 39 kg/m(2) and had completed cardiac rehabilitation and/or diabetes education programmes. Healthy Eating and Exercise Lifestyle Program intervention included an active phase of two 1-hour group-based supervised structured exercise sessions every week for 4 months and four 90-minute group information and support sessions. The maintenance phase included one 90-minute group-based booster information session and three 15-minute goal-focused telephone follow-up calls over 8 months. RESULTS Participants had statistically significant reductions from baseline in weight, body mass index and waist circumference and improvements in exercise duration and capacity at 4 and 12 months. Time, self-efficacy, depressive symptoms and male gender were independent predictors for body mass index, waist and/or exercise duration (p < 0.05). CONCLUSION The Healthy Eating and Exercise Lifestyle Program was an effective programme to achieve and sustain weight loss and increase exercise participation over 1 year.
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Effect of exercise-based cardiac rehabilitation on arterial stiffness and inflammatory and endothelial dysfunction biomarkers: a randomized controlled trial of myocardial infarction patients.
Oliveira, NL, Ribeiro, F, Silva, G, Alves, AJ, Silva, N, Guimarães, JT, Teixeira, M, Oliveira, J
Atherosclerosis. 2015;(1):150-7
Abstract
BACKGROUND Arterial stiffness have shown an independent predictive value for cardiovascular and all-cause mortality. OBJECTIVE This study sought to evaluate the effects of an 8-week exercise-based cardiac rehabilitation program (ECR) on arterial stiffness, and on inflammatory and endothelial dysfunction biomarkers. Additionally, it was assessed two potential confounding variables, daily physical activity and dietary intake. METHODS In this parallel-group trial, 96 patients (56 ± 10 years) were randomized to either the exercise group (EG) or control group (CG) 4 weeks after suffering acute myocardial infarction (MI). ECR consisted of 8 weeks of aerobic exercise at 70-85% of maximal heart rate during 3 sessions weekly, plus usual care. CG participants received only usual care. Baseline and final assessments included arterial stiffness through carotid-femoral pulse wave velocity (cf-PWV), inflammatory and endothelial dysfunction biomarkers, daily physical activity, and dietary intake. (ClinicalTrials.gov: NCT01432639). RESULTS After 8 weeks, no significant changes were found between groups in cf-PWV, inflammatory and endothelial dysfunction biomarkers, daily physical activity, or dietary intake. Excluding those patients (n = 7) who did not attend, at least 80% of the exercise sessions provided similar results, excepting a significant reduction in cf-PWV in the EG compared to the CG. CONCLUSIONS A short-term ECR does not seem to reduce arterial stiffness and inflammatory and endothelial dysfunction biomarkers of post-MI patients under optimized medication. Nevertheless, the decrease of cf-PWV observed in the EG, when considering only those patients who attended at least 80% of exercise sessions, warrants further investigation.
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An Interactive Computer Session to Initiate Physical Activity in Sedentary Cardiac Patients: Randomized Controlled Trial.
Almeida, FA, Smith-Ray, RL, Dzewaltowski, DA, Glasgow, RE, Lee, RE, Thomas, DS, Xu, S, Estabrooks, PA
Journal of medical Internet research. 2015;(8):e206
Abstract
BACKGROUND Physical activity (PA) improves many facets of health. Despite this, the majority of American adults are insufficiently active. Adults who visit a physician complaining of chest pain and related cardiovascular symptoms are often referred for further testing. However, when this testing does not reveal an underlying disease or pathology, patients typically receive no additional standard care services. A PA intervention delivered within the clinic setting may be an effective strategy for improving the health of this population at a time when they may be motivated to take preventive action. OBJECTIVE Our aim was to determine the effectiveness of a tailored, computer-based, interactive personal action planning session to initiate PA among a group of sedentary cardiac patients following exercise treadmill testing (ETT). METHODS This study was part of a larger 2x2 randomized controlled trial to determine the impact of environmental and social-cognitive intervention approaches on the initiation and maintenance of weekly PA for patients post ETT. Participants who were referred to an ETT center but had a negative-test (ie, stress tests results indicated no apparent cardiac issues) were randomized to one of four treatment arms: (1) increased environmental accessibility to PA resources via the provision of a free voucher to a fitness facility in close proximity to their home or workplace (ENV), (2) a tailored social cognitive intervention (SC) using a "5 As"-based (ask, advise, assess, assist, and arrange) personal action planning tool, (3) combined intervention of both ENV and SC approaches (COMBO), or (4) a matched contact nutrition control (CON). Each intervention was delivered using a computer-based interactive session. A general linear model for repeated measures was conducted with change in PA behavior from baseline to 1-month post interactive computer session as the primary outcome. RESULTS Sedentary participants (n=452; 34.7% participation rate) without a gym membership (mean age 58.57 years; 59% female, 78% white, 12% black, 11% Hispanic) completed a baseline assessment and an interactive computer session. PA increased across the study sample (F1,441=30.03, P<.001). However, a time by condition interaction (F3,441=8.33, P<.001) followed by post hoc analyses indicated that SC participants exhibited a significant increase in weekly PA participation (mean 45.1, SD 10.2) compared to CON (mean -2.5, SD 10.8, P=.004) and ENV (mean 8.3, SD 8.1, P<.05). Additionally, COMBO participants exhibited a significant increase in weekly PA participation (mean 53.4, SD 8.9) compared to CON (P<.001) and ENV (P=.003) participants. There were no significant differences between ENV and CON or between SC and COMBO. CONCLUSIONS A brief, computer-based, interactive personal action planning session may be an effective tool to initiate PA within a health care setting, in particular as part of the ETT system. TRIAL REGISTRATION Clinicaltrials.gov NCT00432133, http://clinicaltrials.gov/ct2/show/NCT00432133 (Archived by WebCite at http://www.webcitation.org/6aa8X3mw1).
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Low energy intakes are associated with adverse outcomes in infants after open heart surgery.
Larsen, BM, Goonewardene, LA, Field, CJ, Joffe, AR, Van Aerde, JE, Olstad, DL, Clandinin, MT
JPEN. Journal of parenteral and enteral nutrition. 2013;(2):254-60
Abstract
BACKGROUND Infants with congenital heart lesions who undergo open heart surgery may experience physiologic and metabolic stress in the postoperative period, leading to altered metabolism and hypercatabolism. The purpose of this study was to determine the relationship between energy intake and hospital outcomes during the first 10 days following neonatal open heart surgery. MATERIALS AND METHODS A post hoc analysis of all patients in a prospective randomized controlled trial was performed. Nutrition intake and hospital outcomes were assessed in 32 infants (40 ± 2.2 weeks, 3.4 ± 0.5 kg) in the neonatal and pediatric intensive care units. Infants received parenteral nutrition (PN) for 1-4 days before and 10 days after open heart surgery. Infants were separated into those who received a cumulative energy intake of <689 kcal (average 63 kcal/kg/d) and those who received an intake ≥689 kcal during postoperative days 0-10. RESULTS Lower energy intake was associated with a significantly increased duration of artificial ventilation (5 ± 1.2 days), time to chest closure (1.4 ± 0.5 days), time in intensive care (5 ± 1.8 days), and stay in the hospital (25 ± 6.4 days). Lower energy intake was also associated with a significant increase in the length of time infants required PN (8 ± 2.9 days) and longer time to achieve full enteral intake of 100 mL/kg/d (7 ± 2.2 days) and before enteral feeds could be initiated (5 ± 1.5 days). CONCLUSIONS Providing <63 kcal/kg/d to infants after open heart surgery was associated with adverse pediatric intensive care outcomes.
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Effects of extra virgin olive oil phenolic compounds and the Mediterranean diet on cardiovascular health.
Ross, SM
Holistic nursing practice. 2013;(5):303-7
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Pharmacist intervention in cardiac rehabilitation: a randomized controlled trial.
Alsabbagh, MW, Lemstra, M, Eurich, D, Wilson, TW, Robertson, P, Blackburn, DF
Journal of cardiopulmonary rehabilitation and prevention. 2012;(6):394-9
Abstract
PURPOSE We aimed to determine to what extent a telephone-based pharmacist intervention would (a) be utilized by individuals not attending a traditional cardiac rehabilitation (CR) program and (b) facilitate adherence to cardiovascular medications. METHODS We conducted a randomized, controlled open-label trial among patients eligible for CR in Saskatoon, Canada. Patients were invited to participate in telephone-based CR, regardless of participation in the formal program. Subjects in the intervention group were assessed by the CR pharmacist and received education and counseling on medication adherence. The primary endpoint was adherence to cardiovascular medication assessed by electronic filling records over a minimum of 6 months. Mean adherence was expected to reach 70% during the followup period. RESULTS Patient recruitment was halted early because of low enrollment. Of the 95 patients randomized, 90% had also registered in the traditional CR program. During the followup period, 129 telephone interactions were performed (median, 2 calls), with every subject taking part in at least 1 interaction. Over the study period, the mean adherence to all recently initiated cardiovascular medications combined was 88.8% in the intervention group and 89.9% in the usual care group (P = .73). CONCLUSIONS Participation in traditional CR programs does not appear to be influenced by the availability of telephone-based education and support. Furthermore, the high rate of adherence among the control group may suggest that CR programs are attracting "healthy adherers" who volunteer for such programs, while missing those with the greatest need for health care system resources.
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A randomized controlled trial of stage-matched intervention for smoking cessation in cardiac out-patients.
Chan, SS, Leung, DY, Wong, DC, Lau, CP, Wong, VT, Lam, TH
Addiction (Abingdon, England). 2012;(4):829-37
Abstract
AIM: To examine the effectiveness of a stage-matched smoking cessation counselling intervention for smokers who had cardiac diseases. METHODS A total of 1860 Chinese cardiac patients who smoked at least one cigarette in the past 7 days and aged 18 years or above recruited from cardiac out-patient clinics in Hong Kong hospitals were allocated randomly to an intervention group or control group. The intervention group (n = 938) received counselling matched with their stage of readiness to quit by trained counsellors at baseline, 1 week and 1 month. The control group (n = 922) received brief counselling on healthy diet at baseline. The primary outcomes were self-reported 7-day and 30-day point prevalence (PP) of tobacco abstinence at 12 months after baseline. The secondary outcome measures included biochemically validated abstinence at 12-month follow-up, self-reported 7-day and 30-day PP abstinence and reduction of cigarette consumption by 50% at 3 and 6 months. RESULTS By intention-to-treat analysis, the intervention and control groups showed no significant difference in self-reported 7-day PP abstinence (intervention: 26.5% versus control: 25.5%; P = 0.60) and 30-day PP (intervention: 25.4% versus control: 24.2%; P = 0.55), biochemically validated abstinence (intervention: 6.6% versus control: 4.9%; P = 0.14) and overall quit attempts of least 24 hours (intervention: 40.3% versus control: 34.3%; P = 0.007) at the 12-month follow-up, adjusted for the baseline stage of readiness to quit smoking. CONCLUSIONS An intervention, based on the Stages of Change model, to promote smoking cessation in cardiac patients in China failed to find any long-term benefit.