Member Groups Requesting Changes: Lakeview Clinic, Ltd. Winona Health Physician Clinics Allina Medical Clinic Marshfield Clinic CentraCare Health System Member Groups that Reviewed the Guideline, No Changes Requested: Mankato Clinic, Ltd.
Member Groups that Responded but the Guideline Does Not Pertain to Practice: None Sponsoring Health Plans Requesting Changes: None Sponsoring Health Plans that Reviewed the Guideline, No Changes Requested: Medica
GENERAL COMMENT 1) Impressive guideline! A very good resource. (Lakeview Clinic, Ltd.) Thank you for your comment. 2) “This guideline is used in the following way in our organization: “Resource” (Winona Health Physician Clinics) Thank you for your comment. 3) All primary physicians reviewed this guideline and found no reason to change or amend it. (Multicare) Thank you for your comment based on new evidence and updated information the guideline has been updated. MEDICAL CONTENT: 4) Algorithm Box #2 - Recommend adding the link to the Framington Risk Assessment tool calculator either next to box #2 or inside the box as an option for calculating the 10 year risk. The website is a quicker way to calculate rather than using the tables in Appendix A. (Marshfield Clinic) Thank you for your comment. The work group is recommending a risk calculator based on Framingham. A link to an online calculator is now in the guideline. 5) Algorithm Box #3-6 – (Therapeutic Lifestyle Changes (TLC) page 10) Lipid Profile results have been found to be better in people on a Mediterranean or low-carbohydrate diets versus a low fat diet. (Lakeview Clinic, Ltd.) Thank you for your comment. TLC is not a low fat diet; it is low in saturated and transfats. It has adequate amounts of unsaturated fats. It has been shown to reduce LDL from 20-30%. Data is lacking to recommend any one diet versus another. 6) Algorithm Box #5 – Suggest updating box 5 for moderately high risk patients with the updated recommendations that ATP III released in 2004. Update: Moderately high-risk – Therapeutic option to set treatment goal at an LDL less than 100mg/dl and to use drug treatment if LDL is 100-129 mg/dl. Reference: See attached update from NHLBI (Marshfield Clinic) Thank you for your suggestion. The work group discussed this and will change the goal to < than 100mg/dl and add in the algorithm box, "(optional if LDL is 100-129)" to drug therapy. 7) Box #6 - This box is confusing and does not have the same format as the other boxes in the risk categories. Recommend updating according to new updates for ATP III. Update: High-risk – Therapeutic option to set LDL goal less than 70 for those patients who are considered very high risk e.g. those that have had a recent heart attack, CVD with either diabetes, or poorly controlled risk factors. Consideration of drug treatment for LDL levels greater than 100 mg/dl and optional drug treatment of LDL less than 100 mg/dl. Reference: See attached update from NHLBI (Marshfield Clinic) Thank you. We have reformatted box #6. Statin therapy for these patients is not an option. 8) Algorithm Box #8 - There is plenty of evidence included about the value of fish oil (and aspirin). It seems to me enough evidence to include them on the flow sheet. I have not yet encouraged all my patients in this group to take fish oil, though many do. But if it is as effective as the studies suggest, more use could be encouraged by highlighting its use in the flow diagram. It appears that the evidence for it may rival the lifestyle changes and statins, which are emphasized. (Allina Medical Clinic) Thank you for your comment. The work group discussed it and with regard to lipids, the data is not conclusive at this time to recommend it. However, Appendix B "Omega-3 Fatty Acids" does discuss fish oil supplements may reduce high LDL levels. 9) Algorithm Box #11-14 - Recommend adding a box somewhere between boxes 11 and 14 mentioning evaluation of non-HDL cholesterol. The discussion in annotation 11 focuses on non-HDL cholesterol as a secondary target, but is not included in the algorithm box. JACC Vol. 51 April 15, 2008:1512-24. NCEP ATP III (Marshfield Clinic) Thank you for your comment. While non-HDL can be an indicator of risk, lowering LDL has been proven to prevent cardiovascular events. Non-HDL cholesterol is addressed in annotation 14. 10) Annotation Page 7, #1 - Last paragraph annotation #1 mentions risk equivalents, recommend adding the word ‘symptomatic’ to carotid occlusive vascular disease. Please see Section II 46-48 of the ATP III guideline. (Marshfield Clinic) Thank you for your comment. All patients with carotid occlusive disease with or without symptoms are considered to be at high risk. The ATP III guideline includes those with and without symptoms. 11) Annotation Page 7, #1 - Suggest adding information about therapeutic lifestyle changes (TLC) diet. The AHA no longer uses the terms step I and step II diets in reference to heart healthy diets. The new recommendation for people not at LDL goal and high risk is for the therapeutic lifestyle changes diet which targets those individuals whose LDL cholesterol is above the goal level for their category of risk for heart disease. It also is recommended for the high risk patients that are at their target LDL goal. Information about TLC diets can be found at the web link in the attached word document, and the NCEP report. (Marshfield Clinic) Thank you for your comments. We will eliminate references to the AHA Step 1 and Step 2 diets. 12) Annotation Page 7, #2 - First dot point states that NCEP ATP III places women who have premature menopause that are not on hormone replacement therapy are at risk for CHD. This information is not in that document. There is information about HRT in postmenopausal women. Is there information in ATP III regarding women who have premature menopause and the benefit of HRT? (Marshfield Clinic) Observational studies have consistently suggested that postmenopausal estrogen users are at lower risk of CHD than non-users. However, these studies are confounded by a number of powerful biases that may account for a large overestimation of potential benefit. NCEP ATP III Section VII-2. (Marshfield Clinic) Hormone replacement therapy in postmenopausal women does not reduce risk for major CHD events or coronary deaths in secondary prevention (A2). Moreover, hormone replacement therapy carries an increased risk for thromboembolism and gallbladder disease. NCEP ATP III Section VI-17. (Marshfield Clinic) Thank you for your comment. You are correct that the ATP III study does NOT include any information about increased risk of CHD in premature menopause. A single meta-analysis, Atsma, et al, which was based on observational data suggests there may be some increased risk for premature menopause, but the evidence supporting this is poor. There are 3 meta-analyses including a recent Cochrane review of the long term use of estrogen replacement therapy (ERT) in pre and post menopausal women that does NOT support ERT for either primary or secondary prevention of CHD. The risks of its long term use are as you have identified. The annotation will be edited. 13) Annotation Page 7, #2 - Sixth dot point: Suggest changing the words non-traditional to non-lipid risk factors and include the other risk factors that are discussed in the ATP III document. NCEP ATP III, sections II-23 and II-24 which include discussions on thrombogenic/hemostatic factors and impaired fasting glucose. (Marshfield Clinic) Thank you for your comment. The work group considers non traditional to include both lipid and non- lipid risk factors and have changed that bullet point. 14) Annotation #3-6 – Lifestyle Modification/Drug Therapy/Adjunctive Measures Consider including pain relief recommendations, re. avoidance of NSAIDS Reference – http://www.americanheart.org/presenter.jhtml?identify=3045689 (HealthPartners) Thank you for your comment. This is not within the scope of this guideline. Please refer to the ICSI Stable Coronary Artery http://www.icsi.org/guidelines_and_more/gl_os_prot/cardiovascular/coronary_artery_disease/coronary_artery_disease__stable__3.html 15) Annotation #3-6 – Lifestyle Modification/Drug Therapy/Adjunctive Measures: Fish Oil. Consider defining “the equivalent amount in alpha-linolenic acid (ALA) from vegetable source” as 7.2-10g/1 g EPA Reference – Indu M, Ghafoorunissa. n-3 fatty acids in Indian diets: comparison of the effects of precursor (alpha-linolenic acid) vs product (long-chain n-3 1992; 12:569-82. (HealthPartners) Thank you for your comment. This came from the American Dietetic Association and the information is not accurate - See Omega-3 section in the ICSI Stable CAD guideline and Appendix A: Omega-3 Fatty Acids in the revised Lipid Management guideline. 16) Annotation #3-6 – Lifestyle Modification/Drug Therapy/adjunctive Measures: Diet. Consider adding a recommendation for tree nuts to the diet section, for LDL-C reduction of 3-19%. Reference – Griela AE, Kris-Etherton PM. Tree nuts and the lipid profile: a review of clinical studies. Br Med 2006;96 (Supple 2):S68-78. (HealthPartners) Thank you for this reference. We agree that tree nuts may have a favorable effect on lipid profile. The caution lies in portion control. 17) Annotation Page 8, #3-6 - First paragraph, Suggest adding plant stanols/sterols after ‘nutritional supplements containing sitostanol ester’ (Marshfield Clinic) Thank you for your suggestion. We have added this to the annotation. 18) Annotation Page 10, #3-6 - TLC Discussion - Under diet discussion, first sentence: Please add a space between ATP III. (Marshfield Clinic) Thank you. This change has been made. 19) Annotation Page 10, #3-6 - TLC Discussion - Although ATP III recommends TLC for those who have not met their LDL goal for their category, ATP III also recommends the TLC diet for those individuals with CHD and CHD risk equivalent who are at a baseline LDL of less than 100 mg/dl to help maintain low LDL. Recommend adding this information to the discussion. Please see NCEP ATP III Section IV-3 and IV-4. (Marshfield Clinic) Thank you. We have added this information to the annotation. 20) Annotation Page 10, #3-6 - Under TLC discussion, The first sentence states, This algorithm assumes that... Should the word algorithm read annotation? (Marshfield Clinic) Thank you. The work group removed the sentence since the placement of TLC was changed. 21) Annotation Page 12, #3-6 - Fish oil (EPA-DHA) and Homocysteinemia and Vascular disease discussion: In the first paragraph, the discussion clearly states that evidence demonstrates homosysteine therapy has no benefit for patients at risk for CAD. However, the last statement in the paragraph seems to lean towards supporting its use. (Marshfield Clinic) Thank you for your comment. The sentence has been removed. 22) Annotation #8 – Initiate Statin Therapy and Establish LDL Goals. Consider recommending avoidance of pomegranate and grapefruit juice if taking a statin (HealthPartners) Thank you for your comment. This is addressed in Appendix C - it is only related to specific statins. We are not aware of any data on pomegranate juice. 23) Annotation #8 – Is there really evidence for checking the TSH on everyone? And for stopping statins during a short course of macrolide and ketolide use? I don’t think that is widespread practice. (Allina Medical Clinic) The work group discussed this and because hypothroidism is a relatively common medical condition and a contributor to dyslipidema, a baseline measurement should be included. Also, this is the manufacturers and FDA's recommendation. 24) Annotation Page 16, #8 - Under Patients Unable to Use Statin therapy, we recommend not using the term fibric acids, instead, use the term fibric acid derivatives or fibrates. Recommend doing throughout the guideline. (Marshfield Clinic) Thank you for your comments. We have made the changes in the guideline. 25) Annotation Page 16, #8 - Recommend including Lovaza® as an option for patients that are unable to use statin therapy. (Marshfield Clinic) There is not sufficient evidence at this point to include in the recommendations. Thank you. 26) Annotation #12 – Question your recommendation to do transaminase testing. (Lakeview Clinic, Ltd.) Thank you. This is recommended in the manufacturers package insert. 27) Appendix A - Feel that a more accurate way to look at risk is by using the Reynolds Risk Score that has been verified by JAMA. (Winona Health Physician Clinics) Thank you for your suggestion. The work group feels that the Reynolds Risk Score is not as good as the Framingham Score in predicting 5-10 year risk. Framingham is widely used and easily accessible on the internet. However, the Reynolds Risk Score is still a good tool. 28) Appendix A - Finally, I know the task force did not create the risk analysis tool, but it seems odd that the guidelines focus on LDL reduction as the mainstay of risk management, and the LDL level is not a factor in analyzing the patient’s risk. It would be interesting to see a discussion of that paradox. If the LDL is the most important factor to treat, why isn’t it key in determining the patient’s risk status? (Allina Medical Clinic) Thank you for your comment. We are aware that this seems contradictory and we are not saying that LDL is the most important factor to treat. In some risk analysis tools, the LDL level is entered as a component in accessing risk. 29) Appendix A - A general suggestion: although Appendix A – Lipid Mgmt in Adults –Risk Calculator includes gender and age differences, I think it is worth considering adding a separate section on “Women & Lipid Mgmt” in the guideline somewhere. This could also apply for other guidelines where there are gender differences or even race/ethnicity differences. Thank you for your comments. Gender is included in the Framingham equation and the tool for risk stratification used by the National Heart Lung and Blood Institute. Female gender does confer decreased risk when compared to a man of equivalent age. We are not aware of enough other differences in this setting to warrant an entire section. There are no gender associated differences in targets for the treatment of dyslipidemia. 30) Consider addressing: low molecular size LDL
31) Appendix C - I would welcome more discussion of myalgia management, including the value of vitamin D correction, coenzyme Q addition. (Allina Medical Clinic) Myaligias are common in patients with statins; however, the cause and effect relationship is unclear. We recommend trying other statins or lowering the dose. Consider a 10-14 day vacation from statins and see if the myalgia symptoms abate as a diagnostic maneuver. The evidence is inconclusive at this time for treating myalgia wtih Vitamin D and coenzymeQ. We will add this to the guideline. 32) Appendix C - Consider including pain relief recommendations for those at risk for CAD (see below) (HealthPartners) Thank you for your comments. This is not within the scope of this guideline. If you are referring to myalgia please see comments above. 33) Annotation Page 26, Appendix D - Suggest including information from the ACC statement on the ENHANCE trial on page 26. Web link to the statement http://www.acc.org/enhance.htm (Marshfield Clinic) Thank you for your comment. See annotation (#8) 34) Annotation Page 27, Appendix D - Fifth paragraph, there is a reference to rosuvastatin 80 mg. Is this from a study? If so, recommend stating in discussion. Also recommend spelling out the abbreviations AUC and C max/C min. (Marshfield Clinic) This was based on a study. (Schneck, 2004) However, we have revised the statement in the guideline and have removed the reference. We will use abbreviations only after the first reference of the item so they are defined. 35) Annotation Page 27, Appendix D - Seventh paragraph, consider adding atorvastatin to the last sentence as one that does not have dose restrictions when combined with gemfibrozil. See table in guideline on page 33. (Marshfield Clinic) Thank you for your comment. This has been revised in appendix C. 36) Annotation Page 35, Appendix D - Under Fibrates efficacy, first bullet point ‘HDL cholesterol increases 10-20%’ is stated twice in the paragraph. (Marshfield Clinic) Thank you. The redundant statement has been removed. 37) Annotation Page 35, Appendix D - Under Fibrates dosing, consider adding information on the variety of strengths available. See attached information from Micromedex on dosing information. Attachment, Micromedex dosing for fibrates. (Marshfield Clinic) Thank you for your comments. This section has been revised. Due to frequent changes of the strengths available we are not including all dosing strengths available. 38) Annotation Page 35, Appendix D - There is a new fibrate approved (fenofibric acid) recommend including in the discussion under fibrates. Please see PDF attachment from FDA (Marshfield Clinic)
39) Annotation Page 37, Appendix D - Niacin dosing second bullet point, recommend including NSAIDs for reducing flushing. (Marshfield Clinic) Thank you for your comments. We have revised this section to include aspirin only. We are not aware of any evidence of NSAIDS over aspirin. 40) Annotation Page 37, Appendix D - Niacin statin combinations: simvastatin/niacin combination is now available (Simcor). (Marshfield Clinic) Thank you. This will be added to Appendix C. 41) Annotation Page 39, Appendix D - Omega-3 fatty acids: recommend changing Omacor® to Lovaza® throughout section and leaving brand name so there is no confusion with OTC supplements. (Marshfield Clinic) Thank you for your comment. We are recommending a daily dose of fish oil containing up to 4 grams of DHA and EPA. We are removing the brand names from the guideline. Appendix C has been updated to be consistent with the SCAD guideline. 42) Annotation Page 39, Appendix D - Under Efficacy for Lovaza®, (formerly Omacor®) 6th dot point states that LDL was decreased by 31%. Micromedex sites a 31% increase in LDL. Recommend correcting. See attachment from Micromedex regarding Lovaza® (Marshfield Clinic) Thank you. The table has been corrected. Lovaza® has a variable effect on LDL, usually an increase. 43) Annotation Page 40, Appendix D - Recommend adding a statement from the ACC about ezetimibe products, e.g. remain a reasonable option for patients who cannot tolerate statins or who can only tolerate low dose statins. See attached ACC statement from January 15, 2008 (Marshfield Clinic) Thank you for your comments. Please see the response in item number 33. 44) Annotation Page 40, Appendix D – Ezetimibe now has an FDA approved indication with fenofibrate. Information from package insert: ezetimibe, administered in combination with fenofibrate is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL-C, Apo B, and non-HDL in adult patients with hyperlipidemia. (Marshfield Clinic) Thank you for your comments. The guideline has been updated to include this information. 45) Annotation Page 41, Appendix D - Bile acid sequestrants: under efficacy first bullet point CH should read CHD (Marshfield Clinic) Thank you. This change has been made. 46) Annotation Page 41, Appendix D - Bile acid sequestrants dosing: Paragraph is confusing regarding dosing. Consider rewriting this paragraph or making a table to clarify dosing information e.g. cholestyramine powder 24 gm/day, colestipol powder 30 gm/day, colestipol tablets 16 gm/day. (Marshfield Clinic) Thank you. The guideline has been revised. 47) Annotation Page 41, Appendix D - Bile acid sequestrants dosing: colesevelam maximum dose is listed in 2nd bullet point and then again in separate sentence just below second bullet point. Suggest a table to facilitate clarity. (Marshfield Clinic) Thank you. The guideline has been revised. 48) Annotation Page 43-44, Appendix D - Drug Companion Document: Consider adding this information somewhere in the drug companion document:
Thank you for your comment. This ICSI Health Care Guideline should not be construed as medical advice or medical opinion related to any specific facts or circumstance. This ICSI Health Care Guideline is designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and is not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. 2. Omega-3 fatty Acids can increase LDL. Recommend changing all name brands to generic throughout the guideline with the exception of Omega-3 Fatty Acids to reduce confusion with OTC supplements. (Marshfield Clinic) Thank you. These have been addressed in previous responses. 49) Appendix D - Also welcome: more discussion of the evidence for/against Zetia®. (Allina Medical Clinic) Please see earlier comments. Thank you. 50) Appendix D – Drug Companion Document – Hopefully the statins chart can be updated. It is three years old and inaccurate. (Lakeview Clinic, Ltd.) This table has been updated. Thank you. 51) Appendix D - The cost data is outdated. Simvastatin and pravastatin are now available as generics and the costs are must less than reported in current guideline. Thank you. The table has been updated. PRIORITY AIMS AND SUGGESTED MEASURES: None SUPPORT FOR IMPLEMENTATION: 52) Clinical Highlights and Recommendations page 3 Dot point # 1 - Please add ‘risk’ to CHD equivalent Thank you. The changes have been made. Dot point # 7 – LDL goal less than 70 mg/dl is recommended for patients with established CAD, non-cardiac atherosclerosis or CAD equivalent (i. e., diabetes). Recommend that this statement be clarified. 1. Please add an ‘s’ to the word patient. Thank you. The changes have been made. 3. Recommend clarifying the statement. Please see below. According to the 2004 update, the overall goal for high-risk patients is still an LDL less than 100 mg/dl, there is a therapeutic option to set the LDL goal less than 70 mg/dl for very high-risk (those who have had a recent heart attack or those who have CVD combined with either diabetes, or severe poorly controlled risk factors, such as continued smoking, or metabolic syndrome). NIH/NHLBI Thank you. We agree and the guideline reflects this. 53) Mention should be made of the ENHANCE study, published in NEJM, April 2008. This was an outcomes study comparing Vytorin® (ezitimibe/simvastatin) to simvastatin alone and showed no difference between the two therapies in the selected outcome (significant differences in changes of intima-media thickness). Copy of article was sent electronically. (HealthPartners) Thank you. This has been addressed in previous comments. 53) Article from Circulation published by American Heart Association: Aggressive Versus Moderate Lipid-Lowering Therapy in Hypercholesterolemic Postmenopausal Women: Beyond Endorsed Lipid Lowering with EBT Scanning (BELLES) at http://ovidsp.tx.ovid.com/spb/ovidweb.cgi (Copy of article was sent electronically) (HealthPartners) Thank you. This has been addressed in a previous comment. 55) The following sections of the guideline or issues present barriers in implementation: No stand on NSAIDS for pain relief in those at risk for CAD; (HealthPartners) Thank you for your comments. This outside the scope of this guideline. We will refer your comment to the next revision of the SCAD guideline. 56) Include any patient education or implementation resources for the Support for Implementation section. (CentraCare Health System) Thank you for your comments. Please see the Resouces section of the guideline. |