Response to Tseng
We agree with current recomendations (1, 2) that the use of statins should be based on absolute risk rather than lipid levels. All those with diabetes and hypertension who are >50 years old and/or have had diabetes for ≥10 years are at ≥20% risk of a major cardiovascular event in the next 10 years and as such are above the currently recommended threshold for statin therapy (1, 2).
In the diabetic subgroup of the Heart Protection Study (3), those allocated simvastatin 40 mg who had an LDL cholesterol <3 mmol/l at baseline did at least as well in terms of major vascular events prevented as those with higher LDL cholesterol. Furthermore, mean levels in this diabetic group overall fell to 1.8 mmol/l on statin treatment. Hence, the LDL levels of about half of the diabetic subjects fell to <1.8 mmol/l. In the Collaborative Atorvastatin Diabetes Study trial (4), 84% of the diabetic patients were also hypertensive, and the striking cardiovascular benefits observed were equally large (38 and 37% reduction in the primary end point) among those with LDL cholesterol ≥3.1 mmol/l and <3.1 mmol/l, respectively.
These results are commensurate with those reported for the diabetic subgroup of ASCOT-LLA stratified by baseline total cholesterol (28, 26, and 16% reductions in total cardiovascular events and procedures for those with baseline cholesterol concentrations of <5.0, 5.0 to <6.0, and ≥6.0 mmol/l, respectively) (5).
These three datasets provide compelling evidence that the benefits of statin therapy are likely to be realized across the full range of LDL cholesterol. For optimal effect, statins should be targeted at those above a given level of absolute risk rather than above an arbitrary lipid level so that the reductions in relative risk of cardiovascular events will generate sufficient absolute benefit. The threshold for cardiovascular risk currently recommended is ≥20% over 10 years (1, 2); hence, we feel the final concluding statement of our article (5) is fully justified and commensurate with best evidence.
References
N.R.P. and P.S.S. are members of an advisory panel for and have received honoraria and grants from Pfizer. B.D. has received honoraria from Pfizer, Novartis, Boehringer, Merck, Astra-Zeneca, Bayer, Bristol-Myers Squibb, and Servier. H.W. has received honoraria from Pfizer.