Was caution the best advice?

Journal of Family Practice, Feb, 2007 by Michael L. Parchman, Dave Congdon

To the editor:

I was quite disappointed with the October Clinical Inquiry on steatohepatitis that advised readers to "remain cautious in prescribing statins for those with non-alchoholic steatohepatitis" ("Can patients with steatohepatitis take statins? J Faro Pract 2006; 55:905-906).

None of the studies cited support this conclusion. Also, several randomized placebo-controlled trials of statins over the past decade--specifically in patients with conditions that predispose them to nonalcoholic steatohepatitis (NASH).: obesity and type 2 diabetes--revealed no difference between statins and placebo in the incidence of liver problems? In fact, in people with normal baseline transaminases, at least 1 professional organization's clinical practice guideline recommends that routine testing of transaminases is no longer necessary. (2)

Why is this important? Up to 80% of people with type 2 diabetes will develop or die from cardiovascular disease (CVD). Lipid therapy can reduce the incidence of CVD in people with type 2 diabetes by 22% to 24%, according to a recent meta-analysis. (3) In fact, the Heart Protective Study suggests that all patients with type 2 diabetes benefit from statin use, regardless of baseline low-density lipoprotein (LDL) cholesterol levels. (4)

If one compares these result to those of the United Kingdom Prospective Diabetes Study (UKPDS), where tight control of glucose was not associated with a reduction in risk for CVD, we must ask ourselves why we spend so much of the encounter time focused on glucose control rather than lipid or blood pressure control. (5)

In a recent study of national data, only 33.8% of people with type 2 diabetes were at current guideline recommended level of LDL-cholesterol (<100 mg/dL). (6) Since 90% of patients with type 2 diabetes receive their diabetes care from primary care clinicians, the onus is on us to improve this number. (7)

Although the term "clinical inertia" in no way describes what occurs during my encounters with patients with Type 2 diabetes, if we use NASH as a "soft reason" to avoid statins or to discontinue them, then clinical inertia is the only term that accurately describes our behavior. (8) We must ask ourselves if our unfounded fear of statins in people with NASH is really in the best long-term interest of our patients with type 2 diabetes.

Michael L. Parchman, MD, MPH

Department of Family and Community Medicine, University of Texas Health Science Center, San Antonio

The author responds:

You've cited stimulating references that would compel any primary care clinician to review the current evidence on the management of lipids in diabetes and alter practice patterns as necessary to provide the best care possible to our patients. Regarding this clinical inquiry of statin use in steatohepatitis, you've noted that the studies presented did not discover significant complications from statin use. This is indeed very encouraging as steatohepatitis is also increasing in our practices, and understanding how to treat patients with this condition is important.

However, these studies were of short duration (six months or less) and had low patient numbers. Given the limited nature of published evidence on this topic, caution is prudent when prescribing statins for our patients with steatohepatitis.

Until larger and longer length studies are published, Dr. Oh's statement is a reasonable and responsible approach to the management of patients in this category. Hopefully, future larger studies will reinforce these early studies, and that could establish statin Use in steatohepatitis as the standard-of-care. We are not there yet.

Dave Congdon, MD

University of Washington, Seattle

REFERENCES

(1.) de Denus S, Spinier SA, Miller K, Peterson AM. Statins and liver toxicity: a meta-analysis. Pharmacotherapy 2004; 24:584-591.

(2.) Snow V, Aronson MD, Hornbake ER, et al. Lipid control in the management of type 2 diabetes: a clinical practice guideline from the American College of Physicians. Ann Intern Med 2004; 140:644649.

(3.) Vijan S, Hayward RA. Pharmacologic lipid-lowering therapy in type 2 diabetes mellitus: background paper for the American College of Physicians. Ann Intern Med 2004; 140:650-658.

(4.) MRC/BHF Heart Protection study of cholesterol lowering with simvistatin in 20,536 high risk individuals: a randomized placebo-controlled trial. Lancet 2003; 361:2005-2016.

(5.) UKPDS 35 Association of glycaemia with macrovascular and microvascular complications of Type 2 diabetes: prospective observational study. BMJ 2000; 321:405-412.

(6.) Saaddine JB, Cadwell B, et al. Improvements in diabetes processes of care and intermediate outcomes: United States, 1988-2002. Ann Intern Med 2006; 144:465-474.

(7.) Institute of Medicine. Division of Health Services. Committee on the Future of Primary Care. Primary care: America's Health in a New Era. Washington: National Academy Press; 1996.

(8.) Phillips LS, Branch WE, Cook CB. et al. Clinical inertia. Ann Intern Med 2001; 135:825-834.