Assessment of Unmet Clinical Need in Type 2 Diabet

Authors: Hayley Bennett Phil McEwan Klas Bergenheim Jason Gordon

Publish Date: 2014/09/04

Volume: 5, Issue: 2, Pages: 567-578

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Abstract

Type 2 diabetes mellitus T2DM is an increasing problem worldwide and a leading risk factor for cardiovascular disease As beta cell function declines the management of T2DM typically comprises of escalations in treatment from diet and exercise to oral therapies and eventually insulin Treatment algorithms based on the attainment of blood glucose targets may not account for changes in other cardiovascular risk factors The objective of this study is to describe unmet clinical need defined as failure to reduce weight or meet targets for blood pressure total cholesterol or glycated hemoglobin HbA1c levelsAnonymized UK patient data for those 1 initiating oral antidiabetic drug OAD monotherapy 2 escalating to dual therapy 3 escalating to triple therapy and 4 escalating to insulin therapy over the study period 01/01/2005–31/12/2009 were obtained from The Health Improvement Network THIN Changes in risk factors were evaluated before and after therapy escalation and the attainment of targets assessed at the last recorded measurement as follows HbA1c 75 systolic blood pressure SBP 140 mmHg total cholesterol TC 5 mmol/L and reduction in weightPrior to therapy escalation mean HbA1c in each subgroup exceeded 75 and was higher respective to the number of OADs being used monotherapy 803 double 848 triple 871 Insulin users displayed the highest HbA1c prior to treatment escalation 978 Following escalation a decline in HbA1c was observed in all subgroups By contrast mean SBP and TC levels decreased prior to the addition of a second and third oral therapy Consistent improvements following treatment escalation were not observed across the other risk factors following therapy escalation Overall the proportion of subjects that attained all four targets ranged from 3 monotherapy and insulin to 6 dual therapyThe potential unmet clinical need among conventionally treated T2DM patients is significant with respect to the control of blood glucose and other cardiovascular risk factors SBP TC and weight There clearly remains the need for new therapeutic approaches to alleviate the burden associated with T2DMDiabetes is an increasing problem in both developed and developing countries and is a leading risk factor for vascular disease 1 Recent estimates indicate that the prevalence of type 2 diabetes mellitus T2DM in the UK is around 43 2 Rising obesity and the demographic shift to an older population suggest that this prevalence will increaseThe treatment of T2DM comprises a combination of lifestyle changes and drug therapy Care pathways for people with T2DM aim to address a decline in beta cell function typically via escalation from diet and exercise regimens to oral therapies and eventually insulin 3 Oral antidiabetic drugs OADs are the mainstay of therapy for many T2DM patients but many do not achieve the optimal reductions in weight blood pressure or glycated hemoglobin HbA1c and might benefit from additional therapy Consensus algorithms advocate the addition of a second OAD or basal insulin to metformin monotherapy based on their glucoselowering properties 4 5 While international organizations recommend a range of options for secondline therapy 5 the National Institute for Health and Care Excellence NICE recommends addition of a sulphonylurea SU as the preferred secondline option 4Recommended treatment algorithms that are based on the attainment of blood glucose targets may not account for changes in other cardiovascular risk factors in patients escalating from firstline monotherapy This study aims to describe the unmet clinical need defined as failure to reduce weight or meet targets for systolic blood pressure SBP total cholesterol TC or HbA1c levels in T2DM patients taking commonly prescribed OADs

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