June 21st, 2011
Meta-Analysis Examines Risk of Diabetes Associated with Statins
Larry Husten, PHD
Although the cardiovascular benefits of statin therapy are well-characterized, recent studies have raised concerns that intensive statin therapy increases the risk for developing type 2 diabetes. Now, a new meta-analysis published in JAMA provides a more precise estimate of the risk for diabetes associated with statin therapy and also weighs that risk against the cardiovascular benefits of statins.
David Preiss and colleagues analyzed data from 5 clinical trials (PROVE IT-TIMI 22, A to Z, TNT, IDEAL, and SEARCH) that compared intensive-dose statin therapy with moderate-dose statin therapy. The trials randomized 32,752 subjects who did not have diabetes at baseline.
- 2749 patients developed diabetes during the trial: 8.8% in the intensive-dose groups vs. 8.0% in the moderate-dose groups (OR 1.12; 95% CI, 1.04-1.22).
- 6684 patients had cardiovascular events: 19.1% in the intensive-dose groups vs. 21.7% in the moderate-dose groups (OR 0.84; 95% CI, 0.75-0.94).
The authors calculated that intensive statin treatment resulted in:
- 2 additional cases of diabetes per 1000 patient-years, representing a number needed to harm of 498 per year to cause 1 case of diabetes; and
- 6.5 fewer first major CV events per 1000 patient-years, representing a number needed to treat of 155 to prevent 1 CV event per year.
In their conclusion, the authors speculate that “given that cardiovascular risk from diabetes is modest in the first decade after diagnosis, and as the benefit of statin therapy increases over time and in absolute terms with increasing age, net cardiovascular benefit in high-risk individuals will still strongly favor statin therapy.”
This is very disturbing data. For every 3.2 CV events prevented there is one new case of DM. CV events also include soft end points. The development of DM does not only imply a worse CV prognosis, but other non- cardiac morbidities contributing to mortality. To say that over time, the the benefit of high dose statins will increase is by no means certain with cumulative cases of new onset DM and the associated morbidity and mortality of this disease. Certainly in primary prevention, there can be no justification for high- dose statin therapy.
Competing interests pertaining specifically to this post, comment, or both:
No conflicts of interest.