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Archive for June, 2014

Ramadan and Diabetes

27 Jun, 14 | by crichards

Dr Noma Salman is a Senior Tutor for Diabetes Qualifications from BMJ and University of Leicester. She is a GP who practices in Canada, and before that the UAE.

Fasting the holy month of Ramadan is one of the five pillars in the religion of Islam. The adult Muslim is expected to observe this special month by fasting, praying and devoting additional time in service of God. When fasting, Muslims are expected to stop eating, drinking and smoking from dawn till sunset. Ramadan lasts for one lunar month and ends with 3 days feast where Muslims break their fast and enjoy a variety of different social activities and food invitations; sweets constitute a major part of it.

The Muslim population is increasing and expected to rise from the current 1.6 billion to 2.2 billion by the year 2030. Adults and adolescents above the age of 14 are expected to observe Ramadan. They constitute approximately 1.2 billion (1), of which 77 million are estimated to have diabetes (2). Only healthy people are asked to fast. The sick, travelers, debilitated elderly people, and pregnant and lactating women, are exempt from this obligation. Despite this, many persons with diabetes insist on fasting which is sometimes against medical advice.

What is the effect of fasting on the glycemic control of people with diabetes? Who can fast? What are the contraindications of fasting? What kind of medical adjustments must be done before, during and after Ramadan? And how effective is patient education in achieving safe fasting and afterward feasting?

The main concerns and adverse effects of fasting are: Dehydration, Hypo and hyperglycemia attacks, Thrombosis and ketoacidosis.

Health care providers usually categorize patients into main 4 groups (3):
• Low risk group: where patients are well-controlled and treated with diet alone or diet and metformin;
• Moderate risk: Well-controlled patients treated with short-acting insulin secretagogues such as repaglinide or nateglinide, DPP4 inhibitors;
• High risk: Patients with moderate hyperglycemia (average blood glucose between 150 and 300 mg/dl, A1C 7.5–9.0%), renal insufficiency, advanced macrovascular complications, people living alone that are treated with insulin or sulfonylureas, old age or on other medication that affect mental status;
• Very high risk: where patients have experienced severe hypoglycemia or Hyperosmolar hyperglycemic coma or Diabetic Ketoacidosis within the last 3 months prior to Ramadan or have hypoglycemia unawareness, poor glycemic control, acute illness, pregnancy, kidney failure on dialysis.

The current recommendation is to start with a proper counseling 1-2 months before the onset of Ramadan and to do full assessment which includes fasting glucose level, HbA1c, lipids profile, blood pressure and detection of complications. A session of Ramadan-focused education is also mandatory and is found to minimize the risk of hypoglycaemic events and prevents weight gain during this festive period for Muslims, which potentially benefits metabolic control (4). After that, the physicians should work with their patients to prepare an appropriate and individualized life-style, diet and drug plan.

In terms of medication, dose and timing need to be adjusted and blood glucose need to be frequently monitored by SMBG. Metformin alone can be used safely during the fast with minimal possibility of severe hypoglycemia; however, consensus recommendations suggest the dosage can be modified such that two-thirds of the total daily dose is taken with the sunset meal and the other one-third is taken before the pre-dawn meal. Sulfonylureas should be avoided during Ramadan fasting because of the risk of hypoglycemia. When Insulin is involved, always consider intermediate-acting or long-acting insulin preparations plus short-acting insulin before meal (5).

In my clinical practice, every Ramadan I face a major challenge which is the tendency and the deep desire to fast in most of my patients regardless of their risk status. This is mainly to do with patients’ cultural and religious values and usually it is difficult to modify.

The other challenge is having Ramadan in July, the hottest month of the year in most parts of the Middle East. Furthermore in the northern hemisphere, Ramadan day will be the longest and can go up to 19 hours in some countries. These reflect on the possibility of increasing adverse effects and the need for further education.

Eating healthy food during Ramadan and Eid time is a cornerstone as well as doing light physical activity and proper frequent SMBG testing. Education about how to react to low or high readings and staying in close contact with the physician are all essential strategies to reach the goal of safe fasting for people with diabetes.

References:
1- http://www.pewforum.org/2011/01/27/the-future-of-the-global-muslim-population/ (accessed June 24-2104)
2- http://www.idf.org/diabetesatlas (accessed June 24-2014)
3- 1. Al-Arouj M, Bouguerra R, Buse J, Hafez S, Hassanein M, Ibrahim MA, et al. Recommendations for Management of Diabetes During Ramadan. Dia Care. 2005 Sep 1;28(9):2305–11.
4- Bravis V, Hui E, Salih S, Mehar S, Hassanein M, Devendra D. Ramadan Education and Awareness in Diabetes (READ) programme for Muslims with Type 2 diabetes who fast during Ramadan. Diabet Med. 2010 Mar;27(3):327–31.
5- Hui E, Bravis V, Hassanein M, Hanif W, Malik R, Chowdhury TA, et al. Management of people with diabetes wanting to fast during Ramadan. BMJ. 2010;340:c3053

 

 

Management of Diabetic Dyslipidemia: Controversies generated by new guidelines and the physicians’ dilemma.

26 Jun, 14 | by sghosal

Introduction:

  • An individual patient may have multiple cardiovascular risk factors. Apart from addressing them individually reducing the overall CV (cardiovascular) burden is essential.
  • Elevated LDL (low density lipoprotein) cholesterol and low HDL (high density lipoprotein) cholesterol are the classical CV risk biomarkers.
  • However with time it has become clear that targeting LDL-C is beneficial and not HDL-C.
  • As a result statins have become the backbone of reducing overall CV risk.

Traditional Approach:

  • It was the NCEP/ATP III (National Cholesterol Education Panel’s Adult Treatment Program-3) in 2002[1], which set the stage for the management of dyslipidemia. LDL-C remained the primary target with TG (triglyceride) the secondary target. Elevation of TG above 500mg% warranted treatment with a fibrate and values between 200-499mg% being further evaluated with non-HDL-C and additional drugs considered if it was 30mg% above the LDL-C target [1]. However this was not supported by adequate evidence.
  • In the 2011 AHA (American Heart Association) reviewed the whole issues surrounding TG & CV risk [2]. They concluded that TG was not an independent risk factor for CV events and hence should not be included in the therapeutic agenda for CV risk reduction.
  • This was reflected in the subsequent ESC/EAS (European Society of Cardiology/European Atherosclerosis Society) 2011 [3] & AACE (American Association of Clinical Endocrinologists) 2012 [4] guidelines. According to the former, LDL-C was the solo target for lipid disorder therapy. Triglyceride did not feature as a therapeutic option in any of these guidelines.

The beginning of a controversy…

  • This year we came across the ACC/AHA guidelines based on the available evidence on lipid lowering therapy and reduction of atherosclerotic burden [5].
  • None of the important studies done till date with a statin was conducted in a treat-to-target fashion chasing LDL-C to lower targets. We did not have any evidence that LDL-C in a lower quintile was associated with lower CV events.
  • As a matter of fact the landmark HPS (Heart Protection Study) concluded that we can achieve a 34% relative risk reduction for CV events VS placebo by using a fixed dose of simvastatin (40mg/day) “irrespective of the end-of-study” LDL-C level, a finding replicated in the CARDS trial [6,7].
  • ACC/AHA recommendations as a result did away with LDL-C targets and stressed on using moderate intensity statin therapy as primary prevention and high-intensity statin for all secondary prevention scenarios except heart failure (NYHA II-IV) & CKD (chronic kidney disease) patients on dialysis.
  • This strategy is supported by the NHS 2010 lipid lowering guideline where a “treat and forget strategy” is advocated especially for primary prevention [8].
  • However in the same month we came across a couple of dissenting position papers from the NLA (National Lipid Association) & EAS [9]. They did not advocate this lipid management strategy citing several grounds. The usage of a different CV risk scoring chart with questionable utility for the European or other ethnicity; doing away with lipid therapeutic targets when others existed for BP (blood pressure) & glucose; exclusion of some important RCTs; lack of recommendations for those above 75 years of age; no mention of strategies in those with statin intolerance were some of the criticisms.

Statin use in patients with CKD

  • We are all aware about the several fold increased CV risk in patients with CKD.
  • The CV risk is high even amongst those with early nephropathy with large number of patients dying before developing advanced stages of CKD [10].
  • Most of the meta-analyses found utility of adding or continuing with statins in CKD except for those on dialysis [11].
  • The very recent IAS recommendations as well as the 2013 KDIGO guidelines recommends statins for CKD except for those on dialysis in line with the above-mentioned meta-analyses [12,13]. However they did stop short of recommending in favor of withdrawing a statin when a CKD patient progresses to dialysis.
  • In tune with the ACC/AHA recommendations the KDIGO does not support testing for LDL-C routinely prior to initiating a statin or after it is started. Follow up lipid measurements are only indicated once there is an issue with treatment adherence; change in renal replacement therapy; suspicion of a new secondary cause of dyslipidemia or a high CV-risk estimate in individuals below 50 years of age not on statin therapy.

Statins in the elderly

  • Most of the randomized controlled trials excluded the elderly age group most probably due to increased anticipatory co-morbidities, drop-out rates, poly-pharmacy & and risk of drug interaction.
  • This has erroneously resulted in a conclusion that the elderly do not require cholesterol-lowering treatments.
  • Epidemiological data on the other hand points towards an increased CVD risk in the elderly [14].
  • The PROSPER (Prospective Study of Pravastatin in the Elderly at Risk), SAGE (subjects – the Study Assessing Goals in the Elderly) & GREACE (GREek Atorvastatin and Coronary-heart-disease Evaluation) studies pointed at CVD benefits of statins in the elderly age groups [15,16,17]. PROSPER & SAGE confirmed that statins do have a role in reducing the high baseline CV risk in the elderly. GREACE on the other hand demonstrated an increased CV risk in older patients on usual care, which was significantly reduced with structured statin-based care.
  • The ACC/AHA/NHLBI & ESC/EAS guidelines acknowledges the need to treat the elderly with a statin especially in the backdrop of CVD or more than one CV risk factor (apart from age) [18].
  • The use of a statin in the elderly as a primary preventive strategy remains a grey area pending well-conducted trials. The recommending authorities leave this decision on the discretion of the physician considering the individual risk profile of the patients.

The Physicians Dilemma

  • So where do we stand on this issue?
  • We have clear-cut recommendations based on well-conducted evidences on certain areas and have a vast clinical field left uncovered.
  • One thing is for certain that statins remain as one of the most important tools for reducing the overall CVD burden both as a primary as well as a secondary strategy.
  • The clinician is then left to decide whether to follow the treat-to-target policy or the CV risk-based strategy.
Treat-to-target Risk-based
Primary Prevention LDL-C<100mg% Moderate-intensity statin
Secondary Prevention LDL-C<70mg% High-intensity statin

 

  • There are no recommendations from most of the major bodies for using any other lipid-lowering agent for the reduction of the residual CV risk.
  • The ADA 2014 recommendations however gives us the option of considering a fibrate faced with statin intolerance in a patient with HDL-C <40mg% & LDL-C 100-129mg% [19].
  • There is definitive indication to use a statin even in the elderly especially in the backdrop of high CV risk (secondary prophylaxis).
  • Statins should be used to reduce the CVD burden in patients with CKD (not on dialysis). There is no evidence in favor of a treat-to-target approach in this area. We can continue with the statin if the patient is already on one while progressing to advanced stage of CKD necessitating dialysis.

Research Recommendations:

  • The issue of estimating CV risk with the help of a risk score especially in the Asians (ethnicity issue).
  • A dedicated trial designed in the treat-to-target fashion looking into the different quintiles of LDL-C and CV risk reduction.
  • Statin and CV risk reduction in the elderly as a primary preventive strategy.
  • Doing away with the indirect means of assessing atherogenic dyslipidemia (non-HDL-C; apoB) and introducing direct lipoprotein sub fraction analysis methods e.g. electrophoretic method. This will help us in answering whether the residual CV risk is from the other lipid sub fractions (excluding LDL-C) or related to the dysfunctional LDL-C per se.
  • Recommendations faced with statin intolerance.
  • Utility of a combined anti-dyslipidemic therapy (statin & fibrate) on CV outcomes especially in the backdrop of a low HDL-C & a high TG.
  • Impact of lipid lowering strategy in patients with CKD on dialysis.

References:

[1]. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). (2002). [Online] Available at: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3full.pdf

[Accessed on: 5th March 2014]

[2]. Miller M, Stone MJ, Ballantyne C, Bittner V, Criqui MH, Ginsberg HN, et al. Triglycerides and Cardiovascular Disease: A Scientific Statement From the American Heart Association. 2011; 123(20): 2292-2333.

[3]. ESC/EAS Guidelines for the management of dyslipidaemias. European Heart Journal 2011; 32:1769–1818.

[4]. American Association of Clinical Endocrinologists’ Guidelines for Management of Dyslipidemia and Prevention of Atherosclerosis. Endocrine Practice 2012; 18(Suppl 1): S1-S78.

[5]. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. (2013). [Online] Available at: https://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a.full.pdf

[Accessed on: 5th March 2014].

[6]. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomized placebo controlled trial. Lancet 2002; 360: 7–22.

[7]. Colhoun HM, Betteridge DJ, Durrington PN, Hitman GA, Neil HAW, Livingstone SJ, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative

Atorvastatin Diabetes Study (CARDS): multicenter randomised placebo-controlled trial. Lancet 2004; 364: 685–96.

[8]. NHS. FORTH VALLEY LIPID LOWERING GUIDELINES (2010). [Online] Available at: http://nhsforthvalley.com/wp-content/uploads/2014/02/Clinical-guidelines-for-lipid-lowering.pdf

[Accessed on: 5th March 2014]

[9]. NLA Statement on the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic

Cardiovascular Risk in Adults. (2013). [Online] https://www.lipid.org/nla/2013-accaha-guideline-treatment-blood-cholesterol-reduce-atherosclerotic-cardiovascular-risk

[Accessed on: 5th March 2014]

 

[10]. Olechnowicz-Tietz S, Gluba A, Paradowska A, Banach M, RyszJ . The risk of atherosclerosis in patients with chronic

kidney disease. Int Urol Nephrol 2013; 45(6):1605–1612.

[11]. Nikolic D, Nikfar S, Salari P, Rizzo M, Ray KK, Pencina MJ.

Lipid and Blood Pressure Meta-Analysis Collaboration Group. Effects of statins on lipid profile in chronic kidney

disease patients: a meta-analysis of randomized controlled trials.

Curr Med Res Opin 2013;29(5):435–451.

[12]. An International Atherosclerosis Society Position Paper:

Global Recommendations for the Management of Dyslipidemia. (2013). [Online] Available at: http://www.athero.org/download/IASPPGuidelines_FullReport_2.pdf

[Accessed on: 5th March 2014].

[13]. KDIGO clinical practice guideline for lipid management in chronic kidney disease. 2013; Kidney Int Suppl 3:259–305.

[14]. Szadkowska I, Stanczyk A, Aronow WS, et al. Statin therapy in the elderly: a review. Arch Gerontol Geriatr 2010; 50: 114-8.

[15]. Shepherd J, Blauw GJ, Murphy MB. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360: 1623-30.

[16]. Deedwania P, Stone PH, Bairey Merz CN. Effects of intensive versus moderate lipid-lowering therapy on myocardial ischemia in older patients with coronary heart disease: results of the Study Assessing Goals in the Elderly (SAGE). Circulation 2007; 115: 700-7.

[17]. Athyros VG, Katsiki N, Tziomalos K. Statins and cardiovascular outcomes in elderly and younger patients with coronary artery disease: a post hoc analysis of the GREACE study. Arch Med Sci 2013; 9: 418-26.

[18]. Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C. ACC/AHA/NHLBI Clinical Advisory on the Use and Safety of Statins. Circulation 2002; 106: 1024-8.

[19]. Standards of Medical Care in Diabetes-2014. American Diabetes Association. Diabetes Care 2014; 37(Suppl 1): S14-S80.

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