Jothydev Kesavadev, MD
CEO & Director
Jothydev’s Diabetes Research Center
Trivandrum, Kerala
www.jothydev.net
jothydev@gmail.com

Dyslipidemia is recognized as an integral component both in the pathogenesis and management of diabetes. Diabetes is a cardiovascular equivalent. Diagnosis of diabetes itself carries a higher risk of developing Coronary Artery Disease. Atherogenic dyslipidemia is constituted by elevated total cholesterol, LDL cholesterol, triglycerides and low HDL cholesterol. Atherogenesis ultimately contributes to plague formation, luminal narrowing, resulting in angina, claudication or infarction. The target of treatment in dyslipidemia remains LDL cholesterol. The gold standard treatment is with statins. It is recognized that small dense LDL particles are responsible for the process of atherosclerosis. Even after treating to a target of LDL goal there still remains a residual cardiovascular risk. This has led to the inclusion of 'non HDL cholesterol' in most of the newer recommendations. Non HDL cholesterol=total cholesterol-HDL cholesterol. This parameter is found to be equally good rather than measuring apo B Lipoprotein, LP(a) etc.etc. which are not only expensive but also not widely available.

In type 2 diabetes, management of dyslipidemia is considered to be critical in avoiding the long term complications of disease. The patients should be advised on Therapeutic Lifestyle Changes (TLC) which include medical nutrition therapy and reduction in the body weight and waist circumference. However in all high risk patients or those subjects with existing cardiovascular disease, statin should be administered along with the existing therapy for diabetes. All diabetes patients above the age of 40 years with risk factors should also be administered statin.

Several studies on diabetes dyslipidemia have been published from Jothydev’s Diabetes Research Center(JDC). The prevalence of dyslipidemia among the population in Kerala is found to be more than 58% which is truly shocking. Yet another study presented from JDC at International Diabetes Federation Montreal Convention underscores the importance of continuing education and generation of awareness among the public since more than 75% of patients being started on statin therapy discontinue the drug for fear of adverse events and the wrong belief that they are unnecessary on an extra drug. Several clinical trials have shown not only the efficacy of statins in reducing cardiovascular events and deaths but also the long term safety.

There is a recent concern on the occurrence of new onset type 2 diabetes in patients on statins. There is evidence that statins can produce an elevated HbA1c. However one new case of diabetes occurs when 255 patients are being treated with statins for 4 years. Moreover statins prevent 5.4 episodes of heart attacks for each mmol/L reduction in LDL cholesterol. Hence the FDA has strongly advocated continued use of statins both in prevention and treatment considering the fact that the benefits clearly outweigh the risks involved with the use of statins. The frequency of adverse events with statins is rare and in the case of myopathy or rhabdomyolysis, drug interactions in the majority occur with a higher-than-standard dose of statin.

A study from Jothydev's Diabetes Research Centre presented at EASD, Berlin in 2012 indicates that lower doses of statins are sufficient for the Indian population to reach LDL goals of therapy. Atorvastatin, Rosuvastatin, Simvastatin are all popular in India. These drugs have to be given to reach an LDL goal below 100 mg/dl. However in those at higher risk of developing heart disease or those who are already having a heart disease should have an LDL value below 70mg/dl. The non HDL goal should be 30 mg/dL above the LDL goal specified for a particular individual. For eg. for somebody with an LDL goal of below 70mg/dl the non HDL goal should be 70+30 that is below 100mg/dL.

Statins have been recommended even in type 1 diabetes subjects with higher risk of cardiovascular episodes. Therapies to elevate HDL cholesterol have been found to be either having adverse events or not providing sufficient clinical benefits. Combination of statins with Gemfibrozil can produce serious adverse events. Fibric acid derivatives need to be advised only in situations where the triglycerides are more than 1000 mg/dl. Whenever possible combination drugs should be avoided. If the LDL goal is not reached it is better to increase the dose of statins rather than combining it with ezetimibe or with fenofibrate since recent clinical trial data doesn’t prove this to be statistically significant in preventing outcomes. Field trial (Fenofibrate Intervention and Event Lowering in Diabetes) couldn’t prove the benefit of fenofibrate over placebo. In fact there was even a statistically non significant increase in the coronary heart disease deaths. Because of this reason statins still continue to remain as the gold standard therapy for dyslipidemia.

Patients with diabetes or with other risk factors of cardiovascular disease should never be denied the beneficial effects of stains on the basis of minor adverse events or on the onset of diabetes. Though the benefits of statins in primary prevention is well proved there still exits ignorance among physicians and non compliance among patients which ultimately translates to the present unprecedented increase in the cardiovascular events in India.