Heart & Vascular Institute Physician eNewsletter - Fall 2012
Before you label a patient as statin-intolerant, consider this: many patients have success using a different statin, lower dosing or a combination of prescriptive and over-the-counter therapies that can produce the desired results. Cleveland Clinic ushers patients through the complex process of finding a comfortable, effective regimen that, for many, produces the same positive reductions in low-density lipoprotein (bad) cholesterol, with presumed benefits similar to that seen with traditional statin use.
About Statins & Statin-Intolerance
Most patients who are prescribed lipid-lowering medications can tolerate statins. This abundantly used class of drugs is effective at reducing cardiovascular events. “They save more lives than virtually any other medication,” says Stanley Hazen, MD, PhD, chair of the Department of Cellular and Molecular Medicine, and co-section head of Preventive Cardiology & Cardiac Rehabilitation at Cleveland Clinic.
"Aside from vaccines, statins are the most commonly used prescription drug in the world," Dr. Hazen says. In 2009, 36 million Americans obtained a prescription for the use of statin drugs, according to the Agency for Healthcare Research and Quality, Department of Health and Human Services.
Despite that they may be well tolerated by most who take them, with so many taking statins, even a small percentage of patients who find that they cannot or think they cannot tolerate this class of medicines, translates into a large group of subjects. “True statin-intolerance is rare and affects probably less than 5 percent of patients taking the drugs,” says Leslie Cho, MD, co-section head of Preventive Cardiology & Cardiac Rehabilitation, and Director, Women’s Center for Cardiovascular Medicine at Cleveland Clinic. “And, there is almost always a cause for statin-intolerance," Dr. Cho adds.
For some, the cause of statin-intolerance may be genetics or patients may be taking another drug that does not “mix” well with a statin.
“Just because you experience adverse symptoms with taking a statin once does not mean you will be forever,” Dr. Cho adds, noting that in a recent study of statin-intolerance she spearheaded that included a patient population of 1,700 who were documented to be unable to tolerate at least two different statins, 60 percent could tolerate a repeat statin. “You just have to figure out the reason for the statin-intolerance and go from there,” she says, emphasizing the importance of a re-challenge.
So, why the talk of statin-intolerance today? There may seem to be more cases of statin-intolerance simply because the use of this drug class is up. Our aging population is one factor related to increased usage, as is the efficacy of these drugs. More people can benefit—and therefore, more people could discover they are intolerant to one or more statin, or all of them.
“But don’t be quick to label a patient as statin-intolerant,” Dr. Cho warns. In fact, true intolerance is quite rare.
“A lot of patients who benefit from these drugs have been labeled as statin-intolerant, and it becomes a big problem because they really need the medicine and they can take it – we just have to sometimes get creative with dosing, and frequency of the agents” Dr. Cho says. “It’s important to do a thorough history.”
Treating Statin-Intolerant Patients
The reality is, statin-intolerant patients can require lots of hand-holding as side effects are examined, dosing regimens are altered and alternative lipid-lowering therapies are sampled. Cleveland Clinic is equipped to manage statin-intolerant patients within its Preventive Cardiology Clinic. “It takes a lot of patrolling and interaction with the patient, and a slow and patient approach to increase upon a stable, optimal regimen that the individual will tolerate without having any adverse side effects,” Dr. Hazen says. And because these “statin-intolerant” patients have suffered side effects—typically muscle weakness or aching, and much less frequently, perceived reduction in memory —many are anxious about trying statins again.
When treating patients who believe they are statin-intolerant, physicians must conduct a thorough history and determine if there are obvious reasons for the symptoms. “For 60 percent of these patients, there is a cause,” Dr. Cho says. After ruling out causes, symptoms are examined to tease out the type of intolerance. “Depending on the symptoms, some people can tolerate different types of statins better than others,” Dr. Cho says. A different structural class of statins may be prescribed.
Also, dosage is analyzed. “Side effects are often dosage-related,” Dr. Hazen says. “So we work out regimens with agents that have a longer half life to keep the level of drug low. We will often use pediatric doses in adults or infrequent dosing with a longer-acting formula as a way of minimizing the blood level.”
By combining lower doses of both prescription and over-the-counter medications, and focusing on global cardiovascular risk-reducing efforts such as diet and exercise, and over the counter agents even, physicians in the Preventive Cardiology Clinic at the Cleveland Clinic can practically match the efficacy of popular high-potency statins. Dr. Hazen says the program has had tremendous success with “intolerant” patients, showing on average a 35-percent reduction in LDL cholesterol. Compare this with about a 40-percent reduction in the statin Lipitor®.
Coordinated Care at Cleveland Clinic
Dr. Hazen reminds that statins are part of the bigger picture of lowering a patient’s cardiovascular risk. “We work with a team, including the primary care doctor, nurse practitioners, dieticians, exercise physiologist, and even psychiatrists if anxiety and depression issues are present, to get patients to their optimized blood pressure, cholesterol, inflammation, weight, diet, exercise, smoking cessation, sleep apnea related and other potential relevant goals,” he says. “We get to know our patients well, like family—it takes a lot of time, energy and effort, and most importantly, follow-up, to make sure things stay on track.”
Cleveland Clinic is equipped to manage the special needs of these patients and find solutions to lower cholesterol with or without the use of common statins. “The problem is, everyone thinks they can treat high cholesterol—it just takes medication. It’s much more complicated than that,” Dr. Cho says.
Cleveland Clinic is currently running a trial for statin-intolerant patients involving the use of a brand-new (non-statin) compound of medicine that has effectively lowered LDL cholesterol. “Patients who really cannot tolerate statins should consider getting involved in the trial,” Dr. Cho says.
For more information or to enroll a patient in a clinical trial, please contact: