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Diabetes Care.

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Reprinted with permission of the American Diabetes Association. Drug-specific and patient factors to consider when selecting antihyperglycemic treatment in adults with type 2 diabetes. Reprinted with permission from the American Diabetes Association. Management of hyperglycemia in type 2 diabetes, a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP.

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Unauthorized use of the In the Clinic slide sets will constitute copyright infringement. Bangladesh Institute of Family Medicine and Research. This is an excellent review of ADA guideline. I like to add here that once statin is started, it should be continued lifelong. Statin discontinuation may lead to higher cardiovascular event risks [1]. My practice shows that after 3 months of discontinuation of statin for any reason, in maximum cases, LDL-C jumps much higher compared to baseline e.

Other non-statins; cholesterol absorption inhibitor or PCSK9 inhibitors may be used if statin is not tolerated but in the real world statin intolerant population is not so more that is traditionally though. References: 1. Curr Pharm Des ; The recommendations of the American Diabetes Association for cardiovascular disease and risk management proposes the use of aspirin in a situation described as the primary prevention of cardiovascular disease level of recommendation C.

This is a confusion between primary and secondary prevention as defined by the World Health Organization WHO [1] : this is a frequent misclassification of prevention types observed in medical literature. According to the WHO definitions, the use of chemoprohylactic agents in the presence of risk factors is virtually in fact a secondary prevention-type intervention, and the use of a clinically apparent cardiovascular disease a tertiary prevention.

These recommendations are based on relatively ancient studies, and the cited meta-analysis concludes that the net benefit of this prevention is still doubtful. More recent publications have either not detected any benefit or the authors have declared themselves unable to conclude, due to the possibility of selective reporting bia s[2,3].

Biochemical models also have suggested that these patients might have reduced sensitivity to the effect of cyclooxygenase-1 inhibitor, due to persistent thromboxane-induced activation[4]. Introducing a limitation to indications to diabetic patients over 50 years with at least one additional cardiovascular risk factor is unlikely to modify the result, since a large majority of type 2 diabetic patients respond to this definition[5]. Furthermore, if the considered risk factor is a reversible one such as smoking, the use of a prescription drug as an alternative to smoking cessation is likely to be counterproductive.

In conclusion, we propose to limit the use of aspirin to diabetic patients in tertiary prevention, ie with clinically apparent cardiovascular complications. Gordon RS Jr. Gordon R et al. An operational classification of disease prevention. Public Health Rep. Aspirin for primary prevention of cardiovascular disease in patients with diabetes: A meta-analysis. Diabetes Res Clin Pract. Kunutsor S. Seidu K. Khuntiet al. Thromb Haemost. Prevalence of hypertension and obesity in patients with type 2 diabetes mellitus in observational studies: a systematic literature review.

Diabetes Metab Syndr Obes. TO THE EDITOR: Chamberlain and colleagues May 1 issue in their Review of the American Diabetes Association Standards of Medical Care in Diabetes, maintained that the increased risk of diabetes mellitus associated with statins HMG-CoA reductase inhibitors use is small; therefore, the cardiovascular event rate reduction with statin use offsets the risk of diabetes, even in patients at high risk of developing diabetes with the use of statins.

The data from morbidity and mortality outcomes relating to diabetes mellitus complications shows benefits of diabetic treatments can be offset by increasing numbers of people diagnosed with diabetes, because although hyperglycemia can be controlled, other diabetes complications frequently cannot be treated which results in an increase in mortality and morbidity and disease burden on individual patients and a financial burden on patients and health care industry alike. Fortunately, statin-induced diabetes may not be permanent. In some cases it can be reversed if use of the causative medication is discontinued, the does is decreased, or the patient is switch to a different statin, such pravastatin which is the least diabetogenic statin and if intolerance is associated with all statins, even at the lowest dose, non-statin drugs and certain healthy diet plans, exercise or alternative therapies may be advisable.

Ann Intern Med. Preventive Services Task Force [Internet]. Diabetes Secondary to Treatment with Statins. Curr Diab. Drugs and hyperglycemia: A practical guide. Am J Cardiovasc Drugs. The imperative to prevent diabetes complications: a broadening spectrum and an increasing burden despite improved outcomes. Med J Aust. Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet.

N Engl J Med. I peruse with interest the guidelines. However, despite the tenacity, clarity, and thoroughness of the authors, I offer a few comments to understand the guidelines in perspective and better implementation. Though not emphasized adequately, masked hypertension is not uncommon in diabetics, and particularly after year of age, it must be ruled out preferably with hour ambulatory BP monitoring rather than home BP measurements, as they are proven to be less reliable than ambulatory BP monitoring.

The isolated nocturnal hypertension and lack of nocturnal dip are another valuable features worth exploring, as Hypertension is much bigger killer than glycemia. The use of new agents to control glycemia with added cardiovascular benefits: empagliflozin is mentioned first by name, while other drugs like empagliflozin is equally good. Now its proven to be a class effect. A completely ignored issue: Subclinical magnesium deficiency is very common in diabetics, particularly with concomitant hypertension as the soil is largely depleted of magnesium , serum magnesium is a poor marker of magnesium deficiency, the use of magnesium in patients with concomitant hypertension must be encouraged.

Rosanoff A, Plesset MR.

Guideline Development and Evidence Grading

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Clinical Guidelines 1 May Chamberlain, MD. This article was published at Annals. Abstract Description: The American Diabetes Association ADA annually updates its Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes. Recommendations: This synopsis focuses on guidance relating to cardiovascular disease and risk management in nonpregnant adults with diabetes.

Atherosclerotic cardiovascular disease ASCVD , defined as coronary heart disease, cerebrovascular disease, or peripheral artery disease, is the leading cause of morbidity and mortality in persons with diabetes and is the largest contributor to the direct and indirect costs of diabetes.

The American Diabetes Association ADA Standards of Medical Care recommend that cardiovascular risk factors be assessed at least annually in all patients with diabetes. This synopsis focuses on the ADA guidance relating to cardiovascular disease and risk management in nonpregnant adults with diabetes. To develop the standards, the ADA Professional Practice Committee, which comprises physicians, adult and pediatric endocrinologists, diabetes educators, registered dietitians, epidemiologists, and public health experts, searched MEDLINE through November and reviewed studies particularly high-quality trials that included persons with diabetes for potential incorporation into recommendations.

The committee also solicited feedback from the larger clinical community. The recommendations were rated as A, B, C, or E. Those with an A rating are based on large, well-designed, multicenter clinical trials or high-quality meta-analyses. Recommendations with lower-quality evidence may be equally important and are based on well-conducted cohort studies B rating or uncontrolled studies C rating. Those with an E rating are consensus recommendations for cases where there is no evidence from clinical trials, clinical trials may be impractical, or there is conflicting evidence.

The ADA funds development of the standards from its general revenues, with no industry support or involvement. Blood pressure should be measured at every routine clinical visit. Grade B recommendation.

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All hypertensive patients with diabetes should monitor their blood pressure at home. Hypertension coexistent with diabetes is a common risk factor for complications, such as coronary artery disease, cerebrovascular disease, peripheral vascular disease, and diabetic kidney disease. Appropriate treatment of hypertension reduces risk for such complications 1—3.

Blood pressure should be measured by a trained person following the guidelines for the general population after 5 minutes of rest and while the patient is seated, with feet on the floor and the arm supported at heart level. An average of at least 2 readings obtained on at least 2 occasions should be used to estimate blood pressure 4.

White coat hypertension can be confirmed with home self-monitoring or hour ambulatory monitoring 5. Postural changes in blood pressure and pulse may be evidence of autonomic neuropathy and therefore require adjustment of blood pressure targets. Grade A recommendation. Grade C recommendation. Guidelines from other organizations 4 and large randomized trials 6—10 clearly establish that treating patients with baseline systolic blood pressure of mm Hg or greater to targets below this level is beneficial.

More intensive targets may offer additional benefits for some patients but may also incur additional costs. Patients and clinicians should engage in a shared decision-making process to determine individual blood pressure targets 5. Factors that may influence targets include risks of treatment such as hypotension or drug adverse effects ; life expectancy; comorbidities, including vascular and renal complications; patient attitude and expected treatment efforts; and resources and support system.

In older adults, individualized blood pressure goals should minimize other risks, such as falls 11 , Lifestyle intervention should be initiated along with pharmacologic therapy when hypertension is diagnosed Treatment for hypertension should include drug classes demonstrated to reduce cardiovascular events in patients with diabetes angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers, thiazide-like diuretics, or dihydropyridine calcium channel blockers.

Multiple-drug therapy is generally required to achieve blood pressure targets. However, combinations of ACE inhibitors and angiotensin receptor blockers and combinations of ACE inhibitors or angiotensin receptor blockers with direct renin inhibitors should not be used. If one class is not tolerated, the other should be substituted grade B recommendation.

Patients with hypertension who are not meeting blood pressure targets on three classes of antihypertensive medications including a diuretic should be considered for mineralocorticoid receptor antagonist therapy. Initial treatment for patients with diabetes depends on the severity of hypertension Figure 1. Several considerations might affect selection of the class of antihypertensive medication. Figure 1. Patients should replace saturated fats with unsaturated fats rather than refined carbohydrates Randomized trials do not support use of n -3 fatty acid supplements for primary or secondary prevention of ASCVD 19— Randomized trials show that a Mediterranean-style diet rich in polyunsaturated and monounsaturated fats can improve glycemic control and lipid levels 18 , 24— In adults not taking statins or other lipid-lowering therapy, it is reasonable to obtain a lipid profile at the time of diabetes diagnosis, at an initial medical evaluation, and every 5 years thereafter if under the age of 40 years, or more frequently if indicated.

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  4. Grade E recommendation. Obtain a lipid profile at initiation of statins or other lipid-lowering therapy, 4—12 weeks after initiation or a change in dose, and annually thereafter as it may help to monitor the response to therapy and inform adherence. For patients of all ages with diabetes and ASCVD, high-intensity statin therapy should be added to lifestyle therapy.

    In clinical practice, providers may need to adjust the intensity of statin therapy based on individual patient response to medication e. For patients who do not tolerate the intended intensity of statin, the maximally tolerated statin dose should be used. Ezetimibe may be preferred due to lower cost.

    Patients with type 2 diabetes have increased prevalence of lipid abnormalities, contributing to their high risk for ASCVD. Given that clinical trials show beneficial effects of statin therapy on ASCVD outcomes in patients with and without coronary heart disease 31 , 32 , statins are the drug of choice for LDL cholesterol lowering and cardioprotection.

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    Low-dose statin therapy is generally not recommended in patients with diabetes but is sometimes the only dose that a patient can tolerate. For primary prevention in patients aged 40 to 75 years without clinical ASCVD, moderate-dose statin therapy is recommended 33—35 , although high-intensity therapy may be considered for certain patients with additional ASCVD risk factors. Few persons older than 75 years were enrolled in trials of statins; however, the absolute benefits of treatment for them may exceed the benefits for younger persons because increasing age generally confers higher risk for ASCVD Moderate-intensity statin therapy is recommended in patients with diabetes who are older than 75 years, with downward titration of the dose if needed on the basis of risk—benefit profile assessments.

    Little evidence from clinical trials exists for patients with type 2 diabetes who are younger than 40 years and for those with type 1 diabetes of any age. Patients younger than 40 years have lower risk for cardiovascular events over a year horizon; however, their lifetime risk for ASCVD and myocardial infarction, stroke, or cardiovascular death is high. For patients younger than 40 years with type 2 diabetes and other ASCVD risk factors and for patients with type 1 diabetes and other ASCVD risk factors, we recommend that the patient and the health care provider discuss relative benefits and risks and consider use of moderate-intensity statin therapy.

    For secondary prevention in patients with ASCVD, high-intensity statin therapy is recommended 32 , 36 , Recent randomized trials investigating the benefits of adding nonstatin agents ezetimibe [ 38 ] and PCSK9 inhibitors [ 39 ] to statin therapy showed reduced risk for ASCVD events with the added therapy that seemed to be related to the degree of further LDL cholesterol lowering.

    Ezetimibe is indicated to reduce LDL cholesterol levels in patients with hyperlipidemia, and the PCSK9 inhibitors evolocumab and alirocumab have been approved as adjunctive therapy for patients with ASCVD or familial hypercholesterolemia who are receiving maximum tolerated statin therapy but require additional lowering of LDL cholesterol levels 40 , Hypertriglyceridemia should be addressed with dietary and lifestyle changes, including abstinence from alcohol Combination therapy with a statin and a fibrate is associated with increased risk for abnormal aminotransferase levels, myositis, and rhabdomyolysis.

    In the ACCORD Action to Control Cardiovascular Risk in Diabetes trial, the combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke compared with simvastatin alone Combination therapy with a statin and extended-release niacin was evaluated in a trial that was halted early due to lack of efficacy on the primary composite outcome cardiac death, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome [ACS], or symptom-driven coronary or cerebral revascularization and a possible increase in ischemic stroke in patients receiving combination therapy Several studies have shown that statin use is associated with a modestly increased risk for incident diabetes; the increased risk may be limited to persons with diabetes risk factors 45— In one study, the absolute risk increase was small 1.

    Lancet ; There is now a large body of evidence on the causal relationship between a moderate reduction in population salt intake and the substantial and cost-effective reduction in avoidable cardiovascular events through blood pressure lowering. This extensive evidence has informed consistent national and global public health policies 1 - 5. Yet this concept is still apparently the object of chronic criticism by a few respondents, mostly selecting confounded study results, underpowered statistical analyses or problematic subgroup analyses.

    Thus O'Donnell and coll. These arguments are not new and have been discussed at length and demolished in past years Again, no new data is provided here apart from a dubious re-analysis of one meta-analysis by 'continents', which itself is open to a high risk of bias from post-hoc reiterations.

    Several opinions are then used to try and bolster their shaky argument. For instance, asserting that there is "underestimation of sodium intake in populations with increased sodium excreted in sweat" lacks a referenced proof. Likewise, it is incorrect to assume that "estimated urinary sodium excretion from early fasting morning urine [ The studies by Kawasaki et al. Others include systematic error in the assessment of sodium intake, inappropriate methods to assess agreement with 24h urines, residual confounding, the likelihood of reverse causality and, crucially, the selection of high risk and sick older patients on multiple drug therapy.

    The remaining three studies supporting their contention include a secondary analysis of only 84 events 16 and two diabetic cohorts 17,18 with a high baseline incidence of macrovascular disease and a very high mortality rate, making reverse causality distinctly possible once again. These important limitations seriously undermine any generalisability of their findings 5. According to O'Donnell and coll.

    Africa, South America, India and Russia, represent another reason to defer policy action. This confuses absence of evidence with evidence of absent effects. Accepting similarly muddled reasoning in earlier decades would have prevented the development of valuable policies on tobacco control, smoke free legislation, clean water and seatbelts. Furthermore, the huge trial proposed by O'Donnell and coll. These obstacles include the huge size of the study populations required to demonstrate significant effects on hard outcomes, methodological difficulties in assessing long term compliance to dietary salt reduction, the need for a very long observation period, substantial ethical problems, and the difficulty in ensuring financial support A prolonged wait for this 'mother of all trials' would be unreasonable and irresponsible, potentially delaying a major global public health benefit.

    In conclusion, successfully implementing population-based salt reduction strategies, as recommended by the WHO 1 and many other agencies, could save tens of thousands of lives every year. Further obstruction would thus be irresponsible and harmful. World Health Organization.

    Guideline: Sodium intake for adults and children. BMJ ; f Effect of longer term modest salt reduction on blood pressure: Cochrane systematic review and meta-analysis of randomized trials. Salt in health and disease. A delicate balance. NEJM ; Circulation ; Eur Heart J ; Unnecessary controversy regarding dietary sodium. A lot about a little. Can J Cardiol ; New evidence relating to the health impact of reducing salt intake. Nutr Metab Cardiovasc Dis ; 21 9 : Does reducing salt intake increase cardiovascular mortality?

    Kidney Int ; Strazzullo P. Benefit assessment of dietary salt reduction: while the doctors study, should more people die? J Hypertens ; A simple method for estimating 24 h urinary sodium and potassium excretion from second morning voiding urine specimen in adults. Clin Exp Pharmacol Physiol ; 20 1 : A simple method to estimate populational h urinary sodium and potassium excretion using a casual urine specimen.

    J Hum Hypertens ; 16 2 Systematic review of studies comparing h vs spot urine collections for estimating population salt intake. Rev Panam Salud Publica ; 32 4 : Comparisons of spot vs h urine samples for estimating salt intake. J Hum Hypertens ; Diabetes Care.

    Food and Diet

    Dietary salt intake and mortality in patients with type 2 diabetes. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign In. Advanced Search. Article Navigation. Close mobile search navigation Article Navigation.

    Volume Article Contents. Variations in methods of measuring sodium intake. Variations in population characteristics. Variations in outcome measures. What is the safe lower threshold for sodium intake? Study design and level of evidence. Other observations contributing to uncertainty. Conclusions and future directions. Oxford Academic. Google Scholar.

    Article history. Revision Received:. Cite Citation. Permissions Icon Permissions. Abstract Effective population-based interventions are required to reduce the global burden of cardiovascular disease CVD. Salt , Sodium , Cardiovascular , Prevention , Population health. View large Download slide. Search ADS. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association.

    Urinary sodium excretion and cardiovascular mortality in Finland: a prospective study. Dietary sodium intake and subsequent risk of cardiovascular disease in overweight adults. Efficacy of nonpharmacologic interventions in adults with high-normal blood pressure: results from phase 1 of the Trials of Hypertension Prevention. Sodium reduction and weight loss in the treatment of hypertension in older persons: a randomized controlled trial of nonpharmacologic interventions in the elderly TONE.

    Effect of modest salt reduction on blood pressure: a meta-analysis of randomized trials. Implications for public health. Medium term effects of different dosage of diuretic, sodium, and fluid administration on neurohormonal and clinical outcome in patients with recently compensated heart failure. Comparison of the prediction by 27 different factors of coronary heart disease and death in men and women of the Scottish Heart Health Study: cohort study. Low urinary sodium is associated with greater risk of myocardial infarction among treated hypertensive men.

    Sodium and potassium intake and risk of cardiovascular events and all-cause mortality: the Rotterdam Study. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention TOHP. Statistical issues in analyzing h dietary recall and h urine collection data for sodium and potassium intakes.

    Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. Dietary sodium intake and cardiovascular mortality: controversy resolved? Consumption of sodium and salted foods in relation to cancer and cardiovascular disease: the Japan Public Health Center-based Prospective Study. Reduced dietary salt for the prevention of cardiovascular disease: a meta-analysis of randomized controlled trials Cochrane review. Low sodium versus normal sodium diets in systolic heart failure: systematic review and meta-analysis.

    Salt reduction lowers cardiovascular risk: meta-analysis of outcome trials. A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Dietary patterns and cardiovascular disease mortality in Japan: a prospective cohort study. Dietary potassium and stroke-associated mortality. A year prospective population study. Effect of potassium-enriched salt on cardiovascular mortality and medical expenses of elderly men.

    Urinary sodium and cardiovascular disease risk: informing guidelines for sodium consumption. Urinary potassium is a clinically useful test to detect a poor quality diet. Cardiovascular and humoral responses to extremes of sodium intake in normal black and white men. Observations and influences on sodium sensitivity of blood pressure in humans. By how much does dietary salt reduction lower blood pressure? II—Analysis of observational data within populations.

    Intersalt: an international study of electrolyte excretion and blood pressure. Results for 24 h urinary sodium and potassium excretion. Intersalt Cooperative Research Group. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. Blood pressure and electrolyte excretion in the Yanomamo Indians, an isolated population.

    Trends in h urinary sodium excretion in the United States, — a systematic review. Published on behalf of the European Society of Cardiology. All rights reserved. For permissions please email: journals. Issue Section:. Download all figures. Comments 2. Conflict of Interest: A. Salt intake and cardiovascular disease: compelling evidence so hard to accept. BMJ ; f 3. BMJ ; f 4. NEJM ; 5. Circulation ; 6. Eur Heart J ; 7. Can J Cardiol ; 8. Nutr Metab Cardiovasc Dis ; 21 9 : 9.

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    Your comment will be reviewed and published at the journal's discretion. Please check for further notifications by email. View Metrics. Email alerts New issue alert. Advance article alerts. Article activity alert. Receive exclusive offers and updates from Oxford Academic. More on this topic Salt intake and Cardiovascular Disease. The technical report on sodium intake and cardiovascular disease in low- and middle-income countries by the joint working group of the World Heart Federation, the European Society of Hypertension and the European Public Health Association.

    Nutrition in cardiovascular disease: salt in hypertension and heart failure.