Jocelyne Benatar

Effects of High and Low Fat Dairy Food on Cardio-Metabolic Risk Factors: A Meta-Analysis of Randomized Studies

Importance Clear guidelines on the health effects of dairy food are important given the high prevalence of obesity, cardiovascular disease and diabetes, and increasing global consumption of dairy food. Objective To evaluate the effects of increased dairy food on cardio metabolic risk factors. Data Sources Searches were performed until April 2013 using MEDLINE, Science Direct, Google,Embase, the Cochrane Central Register of Controlled Trials, reference lists of articles, and proceedings of major meetings. Study Selection Randomized controlled studies with healthy adults randomized to increased dairy food for more than one month without additional interventions. Data Extraction and Synthesis A standard list was used to extract descriptive, methodological and key variables from all eligible studies. If data was not included in the published report corresponding authors were contacted. Results 20 studies with 1677 participants with a median duration of dietary change of 26 (IQR 10-39) weeks and mean increase in dairy food intake of 3.6 (SD 0.92) serves/day were included. There was an increase in weight with low (+0.82, 0.35 to 1.28 kg, p<0.001) and whole fat dairy food (+0.41, 0.04 to 0.79kg, p=0.03), but no significant change in waist circumference (-0.07 , -1.24 to 1.10 cm) ; HOMA –IR (-0.94 , -1.93 to 0.04 units); fasting glucose (+1.32 , 0.19 to 2.45 mg/dl) ; LDL-c (1.85 ,-2.89 to 6.60 mg/dl); HDL-c (-0.19 , -2.10 to 1.71 mg/dl); systolic BP (-0.4, -1.6 to 0.8 mmHg); diastolic BP (-0.4 , -1.7 to 0.8 mmHg) or CRP (-1.07 , -2.54 to 0.39 mg/L). Changes in other cardio-metabolic risk factors were similar for low and whole fat dairy interventions. Limitations Most clinical trials were small and of modest quality. . Conclusion Increasing whole fat and low fat dairy food consumption increases weight but has minor effects on other cardio-metabolic risk factors. Trial Registration ACTRN Australian New Zealand Clinical Trials Registry ACTRN12613000401752, http://www.anzctr.org.au Ethics Approval Number NTX/10/11/115

aVR ST elevation: an important but neglected sign in ST elevation acute myocardial infarction.

AIM This study evaluated the prognostic implications of aVR ST elevation during ST elevation acute myocardial infarction (AMI). METHODS AND RESULTS The Hirulog and Early Reperfusion/Occlusion-2 study randomized 17 073 patients with acute ST elevation AMI within 6 h of symptom onset to receive either bivalirudin or heparin, in addition to streptokinase and aspirin. The treatments had no effect on the primary endpoint of 30-day mortality. Electrocardiographic recordings were performed at randomization and at 60 min after commencing streptokinase. aVR ST elevation > or =1 mm was associated with higher 30-day mortality in 15 315 patients with normal intraventricular conduction regardless of AMI location (14.7% vs. 11.2% for anterior AMI, P = 0.0045 and 16.0% vs. 6.4% for inferior AMI, P < 0.0001). After adjusting for summed ST elevation and ST depression in other leads, associations with higher mortality were found with aVR ST elevation of > or =1.5 mm for anterior [odds ratio 1.69 (95% CI 1.16 to 2.45)] and of > or =1 mm for inferior AMI [odds ratio 2.41 (95% CI 1.76 to 3.30)]. There was a significant interaction between aVR ST elevation and infarct location. Thirty-day mortality was similar with anterior and inferior AMI when aVR ST elevation was present (11.5% vs. 13.2%, respectively, P = 0.51 with 1 mm and 23.5% vs. 22.5% respectively, P = 0.84 with > or = 1.5 mm ST elevation). After fibrinolytic therapy, resolution of ST elevation in aVR to <1 mm was associated with lower mortality, while new ST elevation > or =1 mm was associated with higher mortality. CONCLUSION aVR ST elevation is an important adverse prognostic sign in AMI.

Prognostic Value of Lead V1 ST Elevation During Acute Inferior Myocardial Infarction

Background— Lead V1 directly faces the right ventricle and may exhibit ST elevation during an acute inferior myocardial infarction when the right ventricle is also involved. Leads V1 and V3 indirectly face the posterolateral left ventricle, and ST depression (“mirror-image” ST elevation) in V1 through V3 may reflect concomitant posterolateral infarction. The prognostic significance of V1 ST elevation during an acute inferior myocardial infarction may therefore be dependent on V3 ST changes. Methods and Results— In 7967 patients with acute inferior myocardial infarction in the Hirulog and Early Reperfusion or Occlusion-2 (HERO-2) trial, V1 ST levels were analyzed with adjustment for lead V3 ST level for predicting 30-day mortality. V1 ST elevation at baseline, analyzed as a continuous variable, was associated with higher mortality. Unadjusted, each 0.5-mm-step increase in ST level above the isoelectric level was associated with ≈25% increase in 30-day mortality; this was true whether V3 ST depression was present or not. The odds ratio for mortality was 1.21 (95% confidence interval, 1.07 to 1.37) after adjustment for inferolateral ST elevation and clinical factors and 1.24 (95% confidence interval, 1.09 to 1.40) if also adjusted for V3 ST level. In contrast, lead V1 ST depression was not associated with mortality after adjustment for V3 ST level. V1 ST elevation ≥1 mm, analyzed dichotomously in all patients, was associated with higher mortality. The odds ratio was 1.28 (95% confidence interval, 1.01 to 1.61) unadjusted, 1.51 (95% confidence interval, 1.19 to 1.92) adjusted for V3 ST level, and 1.35 (95% confidence interval, 1.04 to 1.76) adjusted for ECG and clinical factors. Persistence of V1 ST elevation ≥1 mm 60 minutes after fibrinolysis was associated with higher mortality (10.8% versus 5.5%, P=0.001). Conclusion— V1 ST elevation identifies patients with acute inferior myocardial infarction who are at higher risk.

Dietary patterns and the risk of major adverse cardiovascular events in a global study of high-risk patients with stable coronary heart disease

Abstract Objectives To determine whether dietary pattern assessed by a simple self-administered food frequency questionnaire is associated with major adverse cardiovascular events (MACE) in high-risk patients with stable coronary artery disease. Background A Mediterranean dietary pattern has been associated with lower cardiovascular (CV) mortality. It is less certain whether foods common in western diets are associated with CV risk. Methods At baseline, 15 482 (97.8%) patients (mean age 67 ± 9 years) with stable coronary heart disease from 39 countries who participated in the Stabilisation of atherosclerotic plaque by initiation of darapladib therapy (STABILITY) trial completed a life style questionnaire which included questions on common foods. A Mediterranean diet score (MDS) was calculated for increasing consumption of whole grains, fruits, vegetables, legumes, fish, and alcohol, and for less meat, and a ‘Western diet score’ (WDS) for increasing consumption of refined grains, sweets and deserts, sugared drinks, and deep fried foods. A multi-variable Cox proportional hazards models assessed associations between MDS or WDS and MACE, defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. Results After a median follow-up of 3.7 years MACE occurred in 7.3% of 2885 subjects with an MDS ≥15, 10.5% of 4018 subjects with an MDS of 13–14, and 10.8% of 8579 subjects with an MDS ≤12. A one unit increase in MDS >12 was associated with lower MACE after adjusting for all covariates (+1 category HR 0.95, 95% CI 0.91, 0.98, P = 0.002). There was no association between WDS (adjusted model +1 category HR 0.99, 95% CI 0.97, 1.01) and MACE. Conclusion Greater consumption of healthy foods may be more important for secondary prevention of coronary artery disease than avoidance of less healthy foods typical of Western diets.

A randomized trial evaluating the effects of change in dairy food consumption on cardio-metabolic risk factors

Background It is currently not known whether dairy food influences the risk of cardiovascular disease or diabetes. This study evaluates effects of changing dairy intake on cardio-metabolic risk factors. Methods 180 healthy volunteers were randomised to increase, reduce or not change their dairy intake for 1 month in response to dietary advice. Body weight, waist circumference, blood pressure, fasting plasma lipids, insulin resistance and C-reactive protein (CRP) were measured at baseline and after 1 month and compared by dietary group. Results 176 (98%) subjects completed the study. Average change in self-reported dairy fat intake for increased dairy food was +0.9 SD 1.1 g/day (+71%), no change was −2.1 SD 0.4 g/day (−15%) and decreased dairy food was −10.8 SD 1.2 g/day (−77%) respectively. There was no statistically significant change in LDL or HDL cholesterol, triglycerides, systolic or diastolic blood pressure, C-reactive protein, glucose or insulin with 95% CI standard mean differences <0.2 for all and CRP <0.3. There was a small increase in weight (+0.4 kg, SD 3.1) in those asked to increase dairy food. Conclusions In healthy volunteers, dietary advice to change dairy intake for 1 month did not have a clinically significant effect on cardio-metabolic risk factors. These observations suggest that dairy food can be included as part of a normal healthy diet without increasing cardio-metabolic risk. Trial registration number: ACTRN12612000574842

The remote exercise monitoring trial for exercise-based cardiac rehabilitation (REMOTE-CR): a randomised controlled trial protocol

BackgroundExercise is an essential component of contemporary cardiac rehabilitation programs for the secondary prevention of coronary heart disease. Despite the benefits associated with regular exercise, adherence with supervised exercise-based cardiac rehabilitation remains low. Increasingly powerful mobile technologies, such as smartphones and wireless physiological sensors, may extend the capability of exercise-based cardiac rehabilitation by enabling real-time exercise monitoring for those with coronary heart disease. This study compares the effectiveness of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (REMOTE) to standard supervised exercise-based cardiac rehabilitation in New Zealand adults with a diagnosis of coronary heart disease.Methods/DesignA two-arm, parallel, non-inferiority, randomised controlled trial will be conducted at two sites in New Zealand. One hundred and sixty two participants will be randomised at a 1:1 ratio to receive a 12-week program of technology-assisted, home-based, remote monitored exercise-based cardiac rehabilitation (intervention), or an 8-12 program of standard supervised exercise-based cardiac rehabilitation (control).The primary outcome is post-treatment maximal oxygen uptake (V̇O2max). Secondary outcomes include cardiovascular risk factors (blood lipid and glucose concentrations, blood pressure, anthropometry), self-efficacy, intentions and motivation to be active, objectively measured physical activity, self-reported leisure time exercise and health-related quality of life. Cost information will also be collected to compare the two modes of delivery. All outcomes are assessed at baseline, post-treatment, and 6 months, except for V̇O2max, blood lipid and glucose concentrations, which are assessed at baseline and post-treatment only.DiscussionThis novel study will compare the effectiveness of technology-supported exercise-based cardiac rehabilitation to a traditional supervised approach. If the REMOTE program proves to be as effective as traditional cardiac rehabilitation, it has potential to augment current practice by increasing access for those who cannot utilise existing services.Trial registrationAustralian New Zealand Clinical Trials RegistryStudy ID number: ACTRN12614000843651. Registered 7 August 2014

Living longer by sitting less and moving more.

Purpose of review Regular exercise, physical fitness and sedentary behaviours are each known to be associated with cardiovascular and total mortality. This review evaluates recent research on these associations and its implications for guidelines on physical activity. Recent findings In several large cohort studies, modest levels of exercise, much less than recommended in current guidelines, were associated with lower mortality. Avoiding prolonged sitting has also been associated with lower mortality risk. Most research suggests graded decreases in long-term mortality with an increase in usual physical activity and fitness. However, at very high exercise levels, these benefits may be attenuated, particularly in patients with known coronary heart disease. Summary In sedentary persons, a modest increase in physical activity and avoiding prolonged sitting are likely to have important health benefits. Further research is needed to determine the most effective strategies for increasing physical activity.

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial

Objective Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). Conclusions A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

New ST-depression: an under-recognized high-risk category of ‘complete’ ST-resolution after reperfusion therapy

Aim: It is not known if there is an association between resolution of ST-elevation to ST-depression following fibrinolysis and 30-day mortality. Methods: In an ECG substudy of HERO-2, which compared bivalirudin to unfractionated heparin following streptokinase in 12,556 patients with ST-elevation myocardial infarction ECGs were recorded at baseline and at 60 minutes after commencing fibrinolysis. The main outcome measure was 30-day mortality. Results: Using summed ST-segment elevation and five categories of changes in the infarct leads, further ST-elevation, 0–30% ST-resolution, >30–70% (partial) ST-resolution, >70% (complete) ST-resolution, and new ST-depression occurred in 21.7, 24.9, 36.8, 14.8, and 1.8% of patients, with 30-day mortality of 12.3, 11.7, 8.0, 4.2, and 8.1%, respectively. For the comparison of new ST-depression with complete ST-resolution and no ST-depression, p<0.01 with 24-hour mortality 4.5 vs. 1.3%, respectively (p=0.0003). Patients with new ST-depression had similar peak cardiac enzyme elevations as patients with complete ST-resolution without ST-depression. On multivariate analysis including summed ST-elevation at baseline, age, sex, and infarct location, new ST-depression was a significant predictor of 30-day mortality (OR 1.82, 95% CI 1.42–4.29). Conclusions: In patients with complete ST-resolution following fibrinolysis, new ST-depression at 60 minutes developed in 10.8% of patients. These patients had higher mortality than patients with complete ST-resolution without ST-depression and represent a high-risk group which could benefit from rapid triage to early angiography and revascularization as appropriate.

Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial

Objective Compare the effects and costs of remotely monitored exercise-based cardiac telerehabilitation (REMOTE-CR) with centre-based programmes (CBexCR) in adults with coronary heart disease (CHD). Methods Participants were randomised to receive 12 weeks of telerehabilitation or centre-based rehabilitation. REMOTE-CR provided individualised exercise prescription, real-time exercise monitoring/coaching and theory-based behavioural strategies via a bespoke telerehabilitation platform; CBexCR provided individualised exercise prescription and coaching via established rehabilitation clinics. Outcomes assessed at baseline, 12 and/or 24 weeks included maximal oxygen uptake (V̇O2max, primary) modifiable cardiovascular risk factors, exercise adherence, motivation, health-related quality of life and programme delivery, hospital service utilisation and medication costs. The primary hypothesis was a non-inferior between-group difference in V̇O2max at 12 weeks (inferiority margin=−1.25 mL/kg/min); inferiority margins were not set for secondary outcomes. Results 162 participants (mean 61±12.7 years, 86% men) were randomised. V̇O2 max was comparable in both groups at 12 weeks and REMOTE-CR was non-inferior to CBexCR (REMOTE-CR-CBexCR adjusted mean difference (AMD)=0.51 (95% CI −0.97 to 1.98) mL/kg/min, p=0.48). REMOTE-CR participants were less sedentary at 24 weeks (AMD=−61.5 (95% CI −117.8 to −5.3) min/day, p=0.03), while CBexCR participants had smaller waist (AMD=1.71 (95% CI 0.09 to 3.34) cm, p=0.04) and hip circumferences (AMD=1.16 (95% CI 0.06 to 2.27) cm, p=0.04) at 12 weeks. No other between-group differences were detected. Per capita programme delivery (NZD1130/GBP573 vs NZD3466/GBP1758) and medication costs (NZD331/GBP168 vs NZD605/GBP307, p=0.02) were lower for REMOTE-CR. Hospital service utilisation costs were not statistically significantly different (NZD3459/GBP1754 vs NZD5464/GBP2771, p=0.20). Conclusion REMOTE-CR is an effective, cost-efficient alternative delivery model that could—as a complement to existing services—improve overall utilisation rates by increasing reach and satisfying unique participant preferences.