Some diabetes experts have expressed concerns about recent national guidelines on lipid management, criticizing a lack of LDL cholesterol targets and little direction for management with drugs beyond statins….
Henry Ginsberg, MD, of Columbia University in New York City, argued during a debate at the American Diabetes Association meeting that the American College of Cardiology/American Heart Association (ACC/AHA) guidelines should offer specific levels for LDL cholesterol lowering, probably around 70 mg/dL, especially for patients with diabetes.
The guideline authors also should have recommended what drugs and agents to use, such as ezetimibe or fibrates when patients are no longer achieving proper LDL lowering with statins alone, Ginsberg said.
He blamed the absence of these recommendations on the "rigidity of the Institute of Medicine" and on the requirements of the National Heart, Lung and Blood Institute (NHLBI) to rely on randomized controlled trials.
He added that, "It left the committee with an inability to use 100 years of data from animal models, cohort studies, population studies, clinical trials, and small studies. That’s an error the committee was forced into."
Ginsberg agreed with the committee’s decision to create four high-risk groups. But beyond those groups, the committee used the evidence-based construct much too narrowly and went in the wrong direction by stopping at those groups, he added.
"For goals for LDL cholesterol, diabetics should be on the highest dose they can tolerate and patients above 75 should be treated," Ginsberg said. "A target of 70 mg/dL came out of the ATP-3 guidelines, although it was chosen somewhat arbitrarily based on the PROVE-IT trial."
Still, he noted that LDL levels in diabetics "should be as low as you can get it based on epidemiological and animal studies and clinical trials without causing harm or causing adverse events."
The ACC/AHA guidelines, which were released in November 2013 and followed by a storm of criticism — mainly for the likelihood that they will increase the number of patients being treated with statins — identified four groups deemed to be at high cardiovascular risk and for whom statin therapy should be initiated:
- Those with LDL cholesterol levels higher than 190 mg/dL
- Those with diabetes who are ages 40 to 75
- Patients with cardiovascular disease
- Patients with an estimated cardiovascular risk greater than 7.5% based on a new calculator
Robert Eckel, MD, said during a press release that he defended the committee’s decision to not dictate specific LDL targets because they adhered to requirements to make only evidence-based recommendations. He added that, "The evidence is not based on achieving certain levels of cholesterol." "The evidence is based on statin therapy in high-risk people being treated with high-end statins at the maximum or moderate doses. That’s where the trials have been in diabetes."
Eckel also noted that the committee "did not have sufficient evidence from clinical trials to make strong statements about ezetimibe, niacin, fibrates, or other lipid-lowering drugs. We are resting on statin therapy because that’s where the evidence is." He added that it is important for practicing clinicians to understand that achieving LDL targets is not precluded by the guidelines.
"In my own clinic, if I think the LDL is not low enough, I’ll set an LDL cholesterol goal under 70 mg/d." "I’m on the guideline committee and we’re not setting goals that aren’t evidence based, but I’m setting them in my own clinic because I believe we need to have a target to shoot for." Eckel said about 80% of his clinical decisions regarding lipid-lowering therapies go beyond the guidelines.
Currently, ADA recommends diabetics achieve LDL levels of 100 mg/dL, and that diabetics with heart disease achieve targets of 70 mg/dL or less. The next annual guidance will be available in January 2015, The ACC/AHA guidelines were initially commissioned by the NHLBI in 2008, and the ACC and AHA were brought in last year to facilitate completion and publication of the documents, which were published in the Journal of the American College of Cardiology and Circulation: Journal of the American Heart Association.
Guidelines released last month by the National Lipid Association preserve hard targets in cholesterol management, recommending a non-HDL treatment goal of less than 130 mg/dL or 100 mg/dL for those at very high cardiovascular risk. Guidelines from the American Association of Clinical Endocrinologists also set specific cholesterol targets.
- Understand that the author of the ACC/AHA guidelines defended the committee’s decision to not dictate specific LDL targets because they adhered to requirements to make only evidence-based recommendations.
- Some diabetes experts expressed concerns about recent national guidelines on lipid management, criticizing a lack of LDL cholesterol targets and little direction for management with drugs beyond lipids.