Statins_Versus_Portfolio_Diet

Slide 2 – Aim To carry out a literature review comparing the effect of diet and statins as interventions when lowering cholesterol. Objectives To develop an understanding of:- Cholesterol Statin Therapy Portfolio diet To conclude which is more effective in lowering cholesterol. Slide 3 – Introduction High blood cholesterol is one of the major risk factors of heart disease. Risk factors increase the chances of getting a disease. In fact, the higher the blood cholesterol level the greater the risk of having a heart attack or stroke. Whilst on various placements, I have observed a high proportion of patients on statin medication. I have researched the alternatives available to patients who require hypercholesterolemia interventions. Slide 4 Cholesterol Cholesterol is a substance found in all human and animal cells and is the basic component of the cell wall.  Cholesterol is carried in the blood by proteins, when the two combine they are called lipoproteins. There are harmful and protective lipoproteins known as LDL (bad cholesterol) and HDL (good cholesterol). Low-density lipoprotein (LDL): LDL carries cholesterol from the liver to the cells. Too much cholesterol for the cells to use, can build up in the artery walls, eventually, these deposits make it difficult for enough blood to flow through the arteries. The heart may not get as much oxygen-rich blood as it needs, which increases the risk of a heart attack and decreased blood flow to the brain can cause a stroke. High-density lipoprotein (HDL): HDL carries cholesterol away from the cells and back to the liver, where it is broken down or passed out of the body as a waste product, higher levels are better. The amount of cholesterol in the blood (both LDL and HDL) can be measured with a blood test. The recommended cholesterol levels in the blood vary between healthy adults and those at higher risk (NHS Choices 2011).  Slide 5 Contributing factors People with hypertension and diabetes often have high cholesterol. Some medical conditions can also cause raised levels of cholesterol. These include: Kidney disease, liver disease and under active thyroid gland.  But the main causes of high cholesterol are:- An unhealthy diet. Some foods contain cholesterol (known as dietary cholesterol). However, this has little effect on blood cholesterol and it is the amount of saturated fat in a diet which is more important. Lack of exercise. This can increase the level of "bad cholesterol“ low-density lipoprotein.  Obesity. If overweight, it is likely that higher levels of LDL cholesterol and triglycerides, and a lower level of high-density lipoprotein are found. Drinking alcohol. Regularly drinking a lot of alcohol can increase the cholesterol and triglyceride levels. Slide 6 – Cont…. Smoking. A chemical found in cigarettes called acrolein inhibits "good cholesterol" (HDL) from transporting the "bad cholesterol" (LDL) to the liver, for disposal A family history -for example if a close relative, such as a parent, brother or sister, has familial hypercholesterolemia. It is not caused by an unhealthy lifestyle, but by genetics. About one in 500 people inherit the condition from a parent. Ethnic group. People who are of Indian, Pakistani, Bangladeshi or Sri Lankan descent have an increased risk of high blood cholesterol. Age. The older you are, the greater the likelihood of the arteries narrowing (atherosclerosis). If there are any fixed risk factors (or a number of) it's more important to look at lifestyle and any underlying conditions. Slide 7 – This table shows the total cholesterol levels for both men an women in England and Scotland in 2008. These are the best available localized statistics available to me. The proportion of people with total cholesterol levels of 5mmol/l and over ranged between 54% and 64% for different regions of England for men and between 56% and 68% for women. South Central has the highest prevalence for men at 64%. East Midlands has the highest prevalence for women at 68%. London has the lowest prevalence of raised cholesterol for men at 52%. North East has the lowest for women at 56%. The World Health Organization estimates that almost 20% of all strokes and over 50% of all heart attacks can be linked to high cholesterol. Slide 8 –Recommendations by NICE (2008) are to lower cholesterol levels to less than 4mmol/l for patients with pre-existing conditions leading to higher risk of CVD. A HDL to be greater than 1mmol/l for those with pre existing conditions as we already know HDL helps to reduce the LDL. The audit level is set at 5mmol/l as it is recognised that a high proportion of patients will not achieve a level of less than 4mmol/l. UK guidelines are that medication should be started when an individual's risk of coronary disease is greater than 30 per cent over 10 years. Slide 9 –Statin medicines replace a reductase (HMG-CoA) that’s in the liver, it slows down the cholesterol production process. Additional enzymes in the liver cell sense that cholesterol production has decreased and respond by creating a protein that leads to an increase in the production of LDL receptors. These receptors relocate to the liver cell membranes and bind to passing LDL and VLDL (very low density lipoprotein). The LDL and VLDL then enter the liver and are digested. Several types of statins exist although in the United Kingdom only five are licensed which are atorvastatin, fluvastatin, pravastatin, rosuvastatin, and simvastatin The statin induces the expression of LDL receptors in the liver, which in turn increases the catabolism of plasma LDL and lowers the plasma concentration of cholesterol, which is an important determinant of atherosclerosis.) Others not used in the U.K are cerivastatin, lovastatin, mevastatin, pitavastatin. Slide 10 –Statin therapy is recommended for adults with clinical evidence of CVD, as part of the management strategy for the primary prevention for adults who have a 30% or greater 10-year risk of developing CVD. Treatment with the statin usually continues even after the target cholesterol level is reached in order to sustain good LDL levels. Most manufacturers of statins recommend that they are taken at night because physiological studies show that most cholesterol is synthesised when dietary intake is low. Morning V’s Evening - Studies (Wallace et al and Lund et al) support the recommendation that simvastatin should be taken in the evening to maximise lipid-lowering effects. It is not clear whether time of dosing influences other effects of statins, such as endothelial function and plaque stability, but the first study suggests that it does not influence effects on the immune system mediated by C-reactive protein. The size of the change is probably of clinical relevance, but only if evening dosing is reliable. There is an inverse relationship between patient compliance and both number of drugs and number of doses per day, and there can be further loss in compliance when medication regimens are changed. What is really important is that the patient takes the drug reliably, and if that is easier with morning dosing, the extra10 to 13% reduction in LDL-cholesterol potentially achieved with evening dosing is probably worth foregoing. An evening dose is more easily forgotten. Finally, these studies have looked at simvastatin, and may not apply to other statins. One trial using Atorvastatin found no differences with morning and evening dosing, which may be explained by its longer half life. Cost effectiveness depends on patient compliance when taking the medication, and if patients develop co morbidities then the cost effectiveness comes into question. Dr Keane Lee of Stanford University says that if the connection between diabetes and statins are true then they will not be as safe or cost effective as the thinking is now. Slide 11- Issues with Statin therapies and untreated hypercholesteremia Although most people who take statins have minor or no side-effects, some suffer from headache, pins and needles, abdominal pain, bloating, diarrhoea, nausea, and a rash. Rarely, patients get a severe form of muscle inflammation. If high LDL levels are left untreated, plaques can form anywhere. If they form in the carotid artery in the neck, it's carotid artery disease. When they form in the coronary arteries it's called coronary artery disease. Like any organ, the heart needs a good supply of blood to work. If it doesn't get that blood, angina could develop, There are other high cholesterol risks. If plaques break open, they can form a clot. If a clot lodges in an artery and completely cuts off the blood supply, the cells don't get the nutrients and oxygen they need and die. If a clot gets to the brain and blocks blood flow, it can cause a stroke. If a clot lodges in the coronary arteries, it can cause a heart attack. One problem is that high cholesterol doesn't cause symptoms that make people pay attention. "People naturally respond more to medical conditions that cause symptoms, and as rising cholesterol levels are not something to be felt, People won't go to the GP about it. Slide 12 – Diets recommended to patients with high LDL are traditionally low in saturated fat, however an alternative diet known as a portfolio diet is also available and it includes cholesterol lowering heart healthy foods such as plant sterols (margarine) and whole almonds which contain monounsaturated fats that help to reduce cholesterol absorption. Other foods included in a portfolio diet are:- Viscous fibers, which increase bile acid loss. Soy protein reduces hepatic cholesterol synthesis –increases the hepatic LDL receptor uptake of cholesterol. Fish Oils – Eating fatty fish can be heart-healthy because of its high levels of omega-3 fatty acids, which can reduce blood pressure and risk of developing blood clots. Red Yeast Rice –is the product of yeast grown on rice. It contains several compounds collectively known as monacolins, these are known to inhibit cholesterol synthesis. One of these, the monacolin K, is a potent inhibitor of the (HMG-CoA) reductase, and is also known as lovastatin. Cholesterol lowering foods are better when used in combination as they each lower cholesterol in different ways. Slide 13 – research question Slide 14 - Included Western cultures namely English speaking :- for ease of reading and due to England and America having similar lifestyles. All articles are based on quantative data as all information could be measured and recorded. Academic for more reliability. EXCLUDED Information may be too old – guide lines may have changed. Foreign Language – Not able to read and time pressures may have inhibited good interpretation of the research. Qualitative does not suit the research question. Slide 15 A slide representing quantative and qualitative date to help you understand why I have included quantative and excluded qualitative research methods. Quantitative Characteristics of quantative data studies are:- Relying on numbers to quantify errors. Studying objective characteristics and responses that can be measured. Compares groups of subjects. Applies interventions to samples to generalize to populations. To determine the effects of an intervention through a high level of control. Qualitative Characteristics of qualitative data include:- Data is not predetermined but derives directly from the data. Research is context bound so researchers must be context sensitive. Researchers immerse themselves in the world of the natural setting of those whose behaviour and thoughts they wish to observe. Researchers concentrate on the views of the people involved in the research and their perceptions, meanings and interpretations. Slide 16 I found searching for specific evidence quite difficult as there isn’t an awful lot of research into my specific question; I had to ask a series of questions to narrow down the data to enable the choice of key literature I have chosen. Slide 17 – I used the Critical Appraisal Skills Programme tool for randomised trials. It consists of 11 questions to enable the consideration of applicability, reliability and validity of published research. It helped me appraise the literature in a logical order to help me make sense of the research evidence, and enabling me to put knowledge into practice. Slide 18 The similarities running through each research article are – that they all compare diet and statin medication however Jenkins et al (2006) uses the statin results from his 2005 research to compare with the long term effects of a portfolio diet rather than repeating this part of the study. The trials are all randomized. All participants had hypercholesterolemia. All groups were split into male and female groups and then randomized. All the female participants were post menopausal. Inconsistencies in the articles - Becker et al specifically included red yeast rice and fish oils into the portfolio diet however both trials by Jenkins et al consisted of viscous fibers', plant sterols, soy protein and almonds. All over different time periods Jenkins et al (2005) was over 1 month, Becker et al (2008) was over 3 months and Jenkins et al was over a 12 month period. However I choose this particular article to enhance the understanding of the effects of a portfolio diet over a longer period of time. Jenkins et al (2006) consisted of cohort studies, 29 of the participants were from the 1 month study also carried out by Jenkins et al (2005), and the remaining 37 were recruited specifically for the 1 year trial. Jenkins et al (2005) is a double blinded study – however dieticians were not blinded as they were responsible for packaging the participant’s food and checking their diet records. A crossover clinical trial is a repeated measures design in which each patient is randomly assigned to a sequence of treatments, including at least two treatments (of which one "treatment" may be a standard treatment or a placebo). A double-blind experiment, neither the participants nor the researchers know who belongs to the control group and the experimental group. Only after all the data have been recorded (and in some cases, analysed) do the researchers learn which participants are which. Performing an experiment in double-blind fashion is a way to lessen the influence of the prejudices and unintentional physical cues on the results. Random Assignment of the subject to the experimental or control group is a critical part of double-blind research design. The key that identifies the subjects and which group they belonged to is kept by a third party and not given to the researchers until the study is over. A Cohort Study is a group of people who share a common characteristic or experience within a defined period. Slide 19 Jenkins et al (2005) after four weeks, results showed that statin medication reduced lipid levels more than diet even though 9 participants showed a better response to the portfolio diet than the statin therapy. Jenkins also reported no significant differences between the sexes, however Becker et al (2008) does not mention any results between sexes on the other hand it does state that there were no differences between the baseline groups other than border line significance of weight loss when following the portfolio diet. Jenkins et al (2006) says that a combination of cholesterol lowering foods, such as soy protein, almonds, plant sterols, oats and barley can reduce LDL as effectively as statin medication. The patients who fully adhered to the portfolio diet, reduced cholesterol levels by at least 20% after 1 year which is approaching the levels of a first line statin. However this was a third of the participants so on a mean, the statistical results show statins as being more effective. Becker et al (2008) also compared the lipid lowering effects of a 12 week regime with a statin and showed similar results, that an alternative diet reduced LDLs as much as statin therapy. Slide 20 – Larger trials with longer follow up to establish cardio vascular effects. To educate the general public on dietary portfolios which include cholesterol lowering foods with a low fat diet. To incorporate into practice a portfolio diet as part of health promotion information and advice on lifestyle changes. Portfolio diet to be introduced as a primary intervention in mild hypercholesterolemia to patients unwilling or unable to take statin therapy. Plant sterols in the form of margarines etc are advertised on the television but this is for marketing purposes for a private based company for profit more than prevention, other cholesterol lowering beneficial foods are not mentioned. Although there is a lot of advice on the internet, many people still do not have access to the information using computers and these people due to socioeconomic circumstances are probably at the highest risk of developing hypercholesterolemia, more information needs to be provided in the form of leaflets and notice board messages in easily assessable areas such as surgeries, hospitals, public leisure facilities.... Slide 21- James Prochaska and Carlo Diclemente (1992) developed a model of change. The authors contend that it is quite normal for people to require several trips through the five stages to make lasting change. So in this sense relapse is viewed as a normal part of the change process, as opposed to a complete failure. PRECONTEMPLATION STAGE - enter the stages of change from a state of precontemplation, during which the idea of change is not seriously considered. CONTEMPLATIVE STAGE - contemplate the need for change; but take no active steps (Miller and Rollnick 1991). DETERMINATION STAGE - determine to take action. E.g. a lifestyle change. ACTION STAGE Then action is initiated. E.g. have oats instead of toast and butter for breakfast. MAINTENANCE STAGE Finally the action is maintained for several weeks. But most having maintained the change, whether in diet, smoking habit, exercise or whatever, will sooner or later fail and revert to the first or second stage. The verdict that is most helpful is TO FAIL IS NORMAL!!! And do not engage in self recrimination but instead DISCOVER WHY WE FAILED. Slide 22 - The time line for my recommendations of change is that initially GP’s and Health Trainers would introduce the idea of portfolio diets to patients where appropriate, they would be giving out information and advice on incorporating a portfolio diet into lifestyle changes. Trial patients who are diagnosed with mild hypercholestrolemia who are unable or unwilling to take statin medication. These patients would then be reviewed at 6mthly intervals to see if LDL levels have reduced and if they are coping with compliance to the portfolio diet and other lifestyle changes. At 12 months if levels have not reduced the patient would need to look at using a statin medication to reduce risk of developing CVD. Slide 23 - conclusion to the literature review carried out, it becomes apparent that in primary prevention and control of hyperlipademia a portfolio diet could be an effective and essential intervention to certain groups of patients. Lifestyle and dietary changes can reduce cholesterol to within similar proportions as a standard lipid reducing therapy when hypercholesterolemia is mild to moderate. However, the patient must be willing to commit to a lifestyle change that may be a complete one. I think this option is relevant for those who are prepared to make the change to diet and lifestyle, and maybe particularly useful to those who are already following a low fat diet and are low risk for CV events but still have higher concentrations of cholesterol levels. For those unwilling or unable to take medication. It could also help those who are already on a statin medication to reduce the need for higher doses. Slide 24 & 25 – REFERENCES Slide 26 – any questions References Aveyard H. (2010) Doing a Literature Review in Health and Social Care: A Practical Guide (2nd Edition) Berkshire, Open University. 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