CPG DM 2016

Facts about this edition of the CPG: 1. First in Asia to advocate A1c as a diagnostic tool to diagnose diabetes* 2. It’s among the first in the world to have a different A1c cutoff point (6.3%) for

diabetes 3. Among the first in the world to advocate 4 oral anti-diabetic agents before

initiating insulin therapy (provided A1c < 10%) 4. Among the first in the world to produce patient specific algorithm 5. Among the first in the world to offer GLIP-1 RA as an alternative to initiating

insulin therapy with basal insulin (provided A1c < 10%)

Other notable changes;

6. BP target for diabetes 135/75 7. Aspirin for primary prevention of CVD for those above 65 years of age 8. Universal screening for gestational diabetes

* The Japanese advocates A1c as a diagnostic test but it must be accompanied by FBG or oGTT from the same blood sample.

PREFACE

Three main issues confronted the Development Group when revising the Clinical Practice Guidelines (CPG) for the Management of Type 2 Diabetes Mellitus (T2DM). First was the issue of increasing prevalence of diabetes followed by the increasing percentage of silent or undiagnosed diabetes especially in the young and finally the poor state of glycaemic control in our patients.

Diagnosing T2DM with Fasting Blood Glucose (FBG) or oral Glucose Tolerance Test (oGTT) is fraud with problems. FBG and especially oGTT are very cumbersome. Based on the NHMS 2015 report, 9.2% of those above the age of 18 years did not know they have diabetes compared to a mere 8.2% who knew. This is worse in those below 30 years old where 88% of those with diabetes did not know they have the disease. Based on the Metabolic Syndrome Study of Malaysia data, an A1c of 6.3% produced a positive predictive value of 58% and negative predictive value of 84% with an ROC curve of 0.85 in diagnosing diabetes. This is also supported by the retinopathy study in neighbouring Singapore and data from mainland China and Hong Kong. By being one of the first few countries in Asia to utilise A1c as a diagnostic tool we hope to be able to bring down the number of undiagnosed diabetes in this country.

On the issue of poor glycaemic control several contributing factors come to mind; first and foremost is the issue of compliance to medications especially that to insulin. Two basic concerns underlie the problem of compliance, that of the fear of hypoglycaemia and weight gain. Hypoglycaemia as we come to understand is no more a one off phenomenon. It has long term repercussions. Patients who develop severe hypoglycaemia have a 20% chance of developing cardiovascular disease in the following year. Similarly, weight gain which tends to be associated with conventional therapies such as insulin secretagoues and insulin could very well explain our inability to improve cardiovascular outcomes when it comes to treating hyperglycaemia in diabetes. The treatment algorithm, follow-up algorithm and patient specific algorithm (which is a first for any CPG on T2DM) were tailored to minimise hypoglycaemia and the undesirable effect of weight gain.

Another important point that calls for our attention is the need to manage the various individual abnormalities that contribute to hyperglycaemia in diabetes. The Ominous Octet (its illustration is on the front cover of the CPG) has to be addressed if we are to make any headway in slowing the disease progression of diabetes. Tackling blood glucose alone is insufficient. Study by DeFronzo which initiated triple therapy with metformin, thiazolidinedione and GLIP-1 RA at the onset of diabetes was shown to be effective in slowing the progression of diabetes. Despite its publication in 2014, no guideline on T2DM has found it necessary to include such an approach in any of its treatment algorithms. Perhaps it is we, the diabetes caregiver or the newly-diagnosed patients who are overwhelmed by the idea of starting all three agents at the same time or even the health financing systems which are not ready for it. In this respect the CPG has taken a middle path by being the first in the world to allow the use of up to 4 anti-diabetic agents before initiating insulin therapy provided the A1c is below 10 %. Though it is a far cry from the triple therapy of De Fronzo, it still holds true to the spirit of treating the various pathologies that go wrong with diabetes by allowing up to 4 agents to try and correct if not all, at least some of these pathologies.

The CPG has also taken the brave stand by being the first to recommend GLIP-1 RA as an alternative to basal insulin in those who are about to be initiated with insulin therapy (provided the A1c is < 10 %). Despite most other CPGs advocating aspirin in those above the age of 40-50 years with high Framingham Risk scores based on multitude of meta-analysis and systematic analyses, we believe in the well tested principle that no amount of meta-analysis can outperformed a well conducted RCT. Thus we are sticking our necks out with the JPAD Study, the only study on primary prevention with aspirin in diabetes which only advocates the anti-platelet in those above the age of 65 years. As recommended by WHO we also support universal screening for GDM with oGTT for all pregnant women though we acknowledged the scarcity of manpower and resources in some places.

Nor Azmi Kamaruddin

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