Issue 48 October 2012
1. Optimal statin dosages and compliance: a five year retrospective cohort analysis in South Indian type 2 diabetes subjects
This study was presented at EASD(European Association for the Study of Diabetes) from Jothydev’s Diabetes & Research Center by the team led by Dr.Jothydev Kesavadev. The optimal dosage of Atorvastatin and Rosuvastatin required for an LDL reduction below 100 mg/dl were found to be 14.7 mg and 7.2 mg respectively. Undoubtedly, compliance with statin is an extremely cost effective modality in preventing cardiovascular events in diabetes. The study is of profound public health importance in Kerala.
This retrospective cohort study of patients presenting in our clinic in years 2006 and 2007 was carried out to examine trends of lipid parameters, dosage requirements and compliance patterns. In our center T2DM patients with high risk are prescribed statins with a treat to target LDL goal below 70 mg/dl. Compared to other ethnicities the average statin dose requirement in Asians required to reach LDL goals may be less making it a cost effective option. One major reason for the alarming rise in cardiovascular disease epidemic in India could be attributed to irregularities in statin usage. We have earlier reported non-compliance to statin therapy in more than 60% of defaulters which is subsequent to fear of adverse effects or due to the misconception of being unnecessarily on an extra drug.

We examined de-identified records of 1279 T2DM patients above 25 years of age who were treated for dyslipidemia (65% males, mean age 51.9 ±11.1 years; 35% female, mean age 52.6 ±10.8 years). Patients were followed up via a Diabetes Tele Management System (DTMS®) by a multi-disciplinary team of doctors, dieticians, pharmacists, psychologist etc. where in addition to the glycemic management, compliance to statins and anti-hypertensives are ensured. Follow-up rates showed sharp dropout after one or two visits to the clinic (37% males, 26% females), followed by relatively steady pattern in subsequent years. Lipid parameters of both dropouts and followed-up patients were similar initially, with average LDL levels of 135mg/dL in females and 124mg/dL in males(Fig.1).

All patients with regular follow-up showed significant improvement in all lipid parameters, with those with 5-year follow-up showing most changes. The top three drug/dose combos and associated LDL patters were : atorvastatin 10mg (30%; mean LDL 74 ±30 mg/dL), atorvastatin 5mg (13% subjects; 66 ±22mg/dL) and rosuvastatin 5mg (10%; 61 ±28mg/dL). The mean dose of atorvastatin as monotherapy among patients with LDL <100mg/dL was 14.7mg and that of rosuvastatin monotherapy was 7.2mg.

The study shows that average dosage requirements of statins in South Indian populations titrated to target lipid parameters are low, and the low compliance rate that seems to exist, pose a significant public health concern. Considering the low optimal dose of statins required in the majority of T2DM subjects to keep LDL levels at goals, this is undoubtedly a cost effective option. Widespread public health campaigns have to be promoted to maintain statin compliance among diabetes patients.

Fig. 1

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