Lots of Patients Treated With Statins, Not a Lot Treated to Target

August 25, 2012

August 25, 2012 (M unich, Germany) — Physicians filled a room to capacity here at the European Society of Cardiology (ESC) 2012 Congress today to listen to experts discuss the use of statin therapy in primary and secondary prevention. The session included discussions on adverse effects and adequate dosing and emphasized the need for physicians to treat patients to target rather than simply prescribing lipid-lowering medications.

Dr David Wood (Imperial College London, UK) presented data from the European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EuroASPIRE III) survey showing that while 80% of patients with cardiovascular disease were treated with lipid-lowering therapy, just 34% had total-cholesterol levels considered to be at goal. Results were similar among more than 4000 primary-prevention patients who were included in the survey. Of these high-risk patients without cardiovascular disease, just 42% were treated with statins. Slightly more than one in 10 primary-prevention patients had total-cholesterol levels within the recommended treatment targets.

"It's important to emphasize that risk factors should not be managed in isolation," said Wood. "We base our prioritization of treatment and treatment thresholds on total cardiovascular risk, and that implies the need for total risk management. That includes smoking cessation, promoting healthy eating, and encouraging physical activity." In addition to promoting lifestyle and prescribing statins, Wood told the ESC audience that other risk factors, such as hypertension or elevated blood glucose levels, should be checked, and that physicians have an obligation to follow up with patients to make sure they are taking their lipid-lowering medications.

The recommendations from Wood, as well as Dr Per Anton Sirnes (ESC Council of Cardiology Practice, Oslo, Norway), who highlighted the new cardiovascular prevention guidelines, are taken from the European Joint Societies Task Force on Cardiovascular Disease Prevention in Clinical Practice. Like previous iterations, LDL cholesterol is the primary treatment target. In patients at very high risk for cardiovascular disease, LDL-cholesterol levels should be reduced to < 70 mg/dL or by more than 50% when the target LDL cholesterol can't be reached. For high-risk patients, target LDL cholesterol is less than 100 mg/dL. For both Wood and Dr Giuseppe Marazzi (IRCCS San Raffaele, Rome, Italy), optimal clinical practice requires more than simply prescribing a drug used in a clinical trial but rather tailoring therapy based on LDL-cholesterol levels and the European risk score.

"The recommendation is to prescribe a statin to the highest recommended dose or the highest tolerable dose to reach the target level," said Sirnes. "For patients with statin intolerance, physicians should consider nicotinic acid. The recommendation with respect to adherence is that we should assess adherence to medication and try to identify the reasons for nonadherence, so that we can tailor the therapy to the individual needs of the patients."

The Diabetes Question

The session also addressed the potential risks of diabetes in statin-treated patients. In February 2012, the US Food and Drug Administration mandated a label change to all statins to warn of an increase in blood sugar and glycosylated hemoglobin A1c levels. As reported previously, the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) trial showed a 27% increase in diabetes mellitus in patients taking rosuvastatin compared with placebo, while the Pravastatin or Atorvastatin Evaluation and Infection Therapy: Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy showed that high-dose atorvastatin can worsen glycemic control.

Recently, however, the JUPITER investigators, led by Dr Paul Ridker (Brigham and Women's Hospital, Boston, MA) reanalyzed the trial data and reported that the risk of developing diabetes mellitus with statin therapy was limited to patients already at a high risk for developing diabetes, such as those with impaired fasting glucose, metabolic syndrome, severe obesity, or raised hemoglobin A1c levels.

Presenting data during the ESC meeting, Marazzi noted that the risk of diabetes mellitus increased at a rate of 0.1% per year and that data from a recent meta-analysis showed the risk of diabetes to be approximately one in 255 statin-treated patients. According to Marazzi, given the reduced benefit of statins in patients without a history of cardiovascular disease, coupled with the risks of diabetes, it could be argued that statins might be overused in patients without cardiovascular risk factors, such as younger patients. He noted that most patients over 50 years of age have a 10-year risk of cardiovascular disease exceeding 10%, so it might be easier simply to use age, rather than vascular screening, as threshold for treatment.

On the whole, the session provided physicians with an opportunity to ask practical questions, including questions to nephrologist Dr Markus Mohaupt (University of Berne, Switzerland), such as the potential benefits of using coenzyme Q10 to offset muscle-related side effects (there is no conclusive evidence to suggest a benefit), how long to stop statins to determine whether muscle pain is related to the statin (stopping the drug for two to four weeks clears up most statin-related myalgias), and which patients are at a higher risk of developing statin-related side effects (the elderly, females, frail or small individuals, and patients with hyperthyroidism, among others).

Marazzi, Mohaupt, and Sirnes reported no conflicts of interest, while Wood disclosed relationships with Pfizer, AstraZeneca, and Bayer, among others.