More focused, pragmatic randomized studies on atrial fibrillation needed, study finds

December 15, 2016 – Researchers call for more studies addressing the clinical management of atrial fibrillation while examining the quality of evidence underlying the AHA/ACC/HRS clinical practice guidelines on atrial fibrillation, and how they have changed over time.

A recent study by DCRI researchers and colleagues published online December 14 in JAMA Cardiology describes the changes over time in the joint American College of Cardiology (ACC), American Heart Association (AHA) and Heart Rhythm Society (HRS) guidelines on the management of atrial fibrillation and the distribution of recommendations across classes and levels of evidence.

Both the ACC and the AHA have published clinical practice guidelines on atrial fibrillation, which are used widely to guide patient care in the United States, since 2001. In 2011, the Heart Rhythm Society came on board as a primary author and stakeholder. This study was intended to determine whether there have been meaningful changes in the strength of recommendations and quality of evidence used in the guidelines since 2001.

Classes of recommendations and levels of evidence are organized in a ranking system used in evidence-based practices in medicine to define and denote the strength of the results measured in a clinical trial or research study. Level A recommendations represent the highest quality evidence backed by multiple randomized controlled trials or meta-analyses. This is followed by level B, which represents findings from a moderate-quality trial or analysis, and level C, which is derived from non-randomized, less robust studies.

This study examined recommendations from the AHA/ACC/HRS clinical practice guidelines on atrial fibrillation from 2001, 2006, 2011 and 2014. For each recommendation, the researchers documented class of recommendation, level of evidence, and atrial fibrillation category. Even with a noteworthy increase ( more than 200 percent) in the number of published randomized trials focused on atrial fibrillation between 2001 and 2014, there was no notable change in the use of level A evidence.

“The ACC/AHA/HRS AF Guidelines play a critical role in providing recommendations for the treatment of atrial fibrillation,” said the DCRI’s Jonathan Piccini, MD, MHS, the study’s senior author. “Health systems, practices, and providers use them not only to guide clinical care, but also to help assess quality of care. However, guidelines are only as good as the evidence underlying them. Despite great advances in the treatment of atrial fibrillation, a lot of important clinical questions remained unanswered. For example, rate control – a key component of AF care – does not have any treatment recommendations supported by the highest level of evidence. Thus, as we design new trials in the future, we need to make sure they address practical treatment decisions in a pragmatic way that helps practicing clinicians.”

The researchers also pointed out that the atrial fibrillation guidelines lag when compared to those of other common diseases, such as unstable angina and heart failure, due to the unique challenges posed by the study and treatment of atrial fibrillation. The study did not consider any revisions to the aims and methodology used by ACC/AHA/HRS over the study period and did not use clinical practice guidelines from other organizations, such as the European Society of Cardiology or the American College of Chest Physicians.

These findings, the researchers concluded, do not diminish the value of the AHA/ACC/HRS guidelines but instead highlight the need for additional high-quality studies targeted to specific and pragmatic clinical questions in atrial fibrillation.

In addition to Piccini, other contributing authors included Adam S. Barnett, William R. Lewis, Michael E. Field, Gregg C. Fonarow, Bernard J. Gersh, Richard L. Page, Hugh Calkins, Benjamin A. Steinberg, and Eric D. Peterson.

Most AF patients receive proper dose of NOACs, but risks exist for others

December 13, 2016 – Patients who receive more or less than the recommended dosage may be at increased risk of death and hospitalization.

Physicians should take care when prescribing non-vitamin K antagonist oral anticoagulants (NOACs) to patients with atrial fibrillation (AF), according to a new study by DCRI researchers.

The study found that although most AF patients prescribed NOACs for stroke prevention received a dosage consistent with U.S. Food and Drug Administration (FDA) recommendations, a significant minority of patients did not.

The study, which was published online this week in the Journal of American College of Cardiology, also found that patients who received NOAC doses that were larger or smaller than those recommended by the FDA were at greater risk of adverse events.

In recent years, NOACs have begun to supplant warfarin as the treatment of choice for preventing stroke in AF patients. Clinical trials have established the safety and efficacy of these drugs, and the FDA has provided recommended dosing levels for each one. However, up to this point, it has been unclear to what extent physicians adhere to these recommendations when prescribing NOACs for AF patients.

In this study, former DCRI Fellow Benjamin Steinberg, MD, MHS, and his colleagues analyzed data from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II (ORBIT-AF II). ORBIT-AF II is a multicenter, national registry of patients with AF. The researchers evaluated 5,738 patients treated with a NOAC at 242 ORBIT-AF II sites across the United States. Each patient’s NOAC dosage was classified as either overdosed, underdosed, or consistent with FDA recommendations.

The researchers found that 541 NOAC-treated patients (9.4 percent) were underdosed, 197 were overdosed (3.4 percent), and 5,000 were dosed according to FDA labeling (87 percent). Patients who were over- or underdosed tended to be older, female, and less likely to be treated by an electro physiologist. These patients also had higher CHA2DS2-VASc scores and higher ORBIT bleeding scores. Adjusted results showed that NOAC overdosing was associated with increased all-cause mortality compared with recommended doses, whereas underdosing was associated with increased cardiovascular hospitalization.

Although these findings show that most AF patients receive the recommended dosage of NOACs, the adverse effects associated with higher or lower doses are a cause for concern, the researchers concluded. Physicians should pay careful attention to recommended doses and additional studies of these agents in patients under-represented in clinical trials are needed, they said.

In addition to Steinberg, the study’s authors included Peter Shrader, MA; Laine Thomas, PHD; Jack Ansell, MD; Gregg C. Fonarow, MD; Bernard J. Gersh, MB, CHB, DPhil;  Peter R. Kowey, MD; Kenneth W. Mahaffey, MD; Gerald Naccarelli, MD; James Reiffel, MD; Daniel E. Singer, MD; Eric D. Peterson, MD, MPH; and Jonathan P. Piccini, MD, MHS.

New study to evaluate virtual rehabilitation platform for physical therapy after total knee replacement surgery

November 29, 2016 –  Enrollment has begun for VERITAS, which will evaluate costs and outcomes for a rehabilitation assistant for patients undergoing total knee replacement surgery.

Reflexion Health, Inc., a digital healthcare company, in conjunction with the DCRI, announced the enrollment of the first patients in Virtual Exercise Rehabilitation In-home Therapy: A Research Study (VERITAS), which is designed to evaluate the cost and outcomes of using a virtual rehabilitation platform to deliver physical therapy following total knee replacement (TKR) surgery.

According to the Centers for Disease Control and Prevention, 700,000 total knee replacements are performed each year in the United States. TKR is the most frequently performed procedure in the hospital and is more common among women than men. The average Medicare expenditure for surgery, hospitalization, and recovery ranges from $16,500 to $33,000 across geographic areas. With a significant growth in TKR among younger adults with knee osteoporosis3, an aging population working longer, and a shift to value-based care, the demand for TKR surgery is expected to exceed three million by the year 2030 while at the same time, healthcare systems will continue to optimize costs.

Janet Prvu Bettger“Physical therapy is often a critical component of care for patients who have TKR surgery. Digital health technology, including virtual and telehealth options, may increase access, improve quality, and lower healthcare costs,” said Janet Prvu Bettger, ScD, associate professor with the Duke Department of Orthopedic Surgery and principal investigator for the study at the DCRI. “Extending the reach of physical therapists into the home using a digital healthcare platform like VERA can provide remote guidance and supervision for a home-based therapy program; however, implementation in the U.S. has not been widely evaluated until now.”

VERITAS is a multi-center, randomized controlled trial and will enroll approximately 300 adult participants scheduled for TKR surgery at six U.S. sites. The treatment group will include 150 adults who will receive Reflexion Health’s proprietary virtual exercise rehabilitation assistant, VERA™, both pre- and post-surgery, compared with a control group of 150 adults who will receive traditional in-home or clinic-based physical therapy at participating sites. Clinical outcomes, health service use, and costs will be examined for three months after surgery.

“With VERITAS, we are eager to confirm what we’ve already demonstrated with hospitals and clinicians in pilot studies — VERA is a cost-effective, scalable, and effective option for improving compliance and recovery in home-based physical therapy following total knee replacement surgery,” said Joseph (Joe) Smith, MD, PhD, President and CEO of Reflexion Health. “VERA embodies our commitment to delivering solutions that improve the patient experience by saving time, travel and costs for both patients and healthcare systems.”

AHA 2016: IRONOUT HF finds limited impact of oral iron supplementation on functional capacity in chronic HF patients

November 16, 2016 – A randomized, double-blind study found high-dose oral iron had little effect in replacing iron stores and did not improve peak exercise capacity in anemic heart failure patients with reduced left ventricular ejection fraction.

Iron deficiency in present in approximately 50 percent of patients with chronic heart failure with reduced ejection fraction (HFrEF), and is an independent predictor of mortality. Two earlier trials had found that intravenous iron increased six-minute walking distance, improved quality of life, and reduced hospitalization in in patients with HFrEF. However, regular administration of IV iron poses logistical challenges and is expensive. The utility of inexpensive, readily available oral iron supplementation in heart failure was unknown.

Adrian HernandezCarried out in 225 patients, the Oral Iron Repletion effects on Oxygen UpTake in Heart Failure (IRONOUT HF) trial investigated the effect of oral iron polysaccharide (150 mg twice daily) compared with matching placebo. IRONOUT HF is an NIH-sponsored multi-center, randomized, double-blinded, placebo-controlled trial, which enrolled patients between September 2014 and November 2015 at 23 U.S. sites.

The primary endpoint was the change in exercise capacity as measured by peak oxygen consumption from baseline to week 16. Secondary endpoints included changes in distance walked in six minutes, oxygen kinetics, ventilatory efficiency, and a quality of life score. Neither primary nor secondary endpoints differed significantly between groups.

The results of this study were presented Wednesday at the 2016 American Heart Association (AHA) Scientific Sessions in New Orleans.

“Heart failure is a condition with multiple contributing factors, and the question remains of the best approach for improving iron deficiency and anemia that would be clinically significant,” said author Adrian F. Hernandez, MD, MHS; Director, Health Services Outcomes Research; DCRI Faculty Associate Director; and Professor of Medicine, Cardiology. “Our study found that oral iron supplementation had its limitations. Additional studies will be needed, in a larger population, to determine whether a different oral formulation might be effective, or whether IV iron is needed to improve anemia and the ability of these patients to exercise.”

In addition to Hernandez, DCRI authors of the presentation were Kevin J Anstrom, PhD and Steven McNulty, MS.

AHA 2016: ATHENA-HF suggests routine use of spironolactone in acute heart failure patients is not warranted

November 16, 2016 – The study found that high-dose spironolactone was well tolerated in acute heart failure patients but did not improve the study’s primary or secondary efficacy endpoints.

Heart failure (HF) accounts for more than 1 million hospitalizations in the United States annually. Although therapy for chronic HF with reduced ejection fraction has evolved over time, favorably affecting survival, outcomes for patients with acute heart failure (AHF) have not changed much in the past two decades. There remains a pressing need to develop interventions to improve outcomes safely in this high-risk group of patients.

Adrian Hernandez
Adrian Hernandez

Persistent congestion is associated with worse outcomes in AHF. Some evidence suggests that mineralocorticoid receptor antagonists such as spironolactone at high doses might relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. This had not been studied in hospitalized patients, however.

The Aldosterone Targeted NeuroHormonal CombinED with Natruiresis TherApy in Heart Failure (ATHENA-HF) trial set out to assess the impact of high dose spironolactone in addition to usual care on N-terminal pro-B-type natriuretic peptide (NTproBNP) levels – which are used to diagnose and monitor heart failure – compared to usual care alone. The study, a double-blind, multicenter, randomized multicenter trial, enrolled 360 patients at 22 acute care hospitals.

Participants received 100 mg spironolactone daily for four days.

The results of the study were presented Wednesday at the 2016 American Heart Association (AHA) Scientific Sessions in New Orleans, Louisiana.

The primary endpoint was change in NTproBNP levels. Secondary endpoints included clinical congestion score, dyspnea assessment, net urine output, and net weight change. Safety endpoints included hyperkalemia and renal dysfunction. There was no significant difference in these endpoints, nor in 30-day clinical outcomes, between patients receiving spironolactone and placebo.

“There remains a high level of interest in identifying the best therapy to improve outcomes and reduce hospitalizations in acute heart failure patients,” said author Adrian F. Hernandez, MD, MHS; Director, Health Services Outcomes Research; DCRI Faculty Associate Director; and Professor of Medicine, Cardiology. “This study shows that there’s still more work to be done. Future research should focus on studying higher doses, patients with diuretic resistance, and exploring differences between patients with preserved vs. reduced ejection fraction.”

The trial was sponsored by the National Heart, Lung, and Blood Institute and conducted by the Heart Failure Clinical Research Network.

In addition to Hernandez, DCRI authors of the presentation included G. Michael Felker, MD, MHS, Steven McNulty, MS, and Kevin J Anstrom, PhD.

AHA 2016: Women with CAD symptoms receive different treatment, but have similar outcomes

November 15, 2016 – Researchers say the reasons for the disparity remain unclear.

Women with symptoms of coronary artery disease (CAD) often receive different care than their male counterparts, according to the results of a study presented today at the Scientific Sessions of the American Heart Association in New Orleans.

However, these differences do not appear to result in worse outcomes for women, the researchers reported.

neha-pagidipatiAlthough sex differences in the management of acute coronary syndromes have been documented by previous studies, potential differences in the management of possible CAD have been under-studied to date.

To explore this question, the DCRI’s Neha Pagidipati, MD, MPH, Pamela Douglas, MD, and colleagues examined data from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) to assess the relationships between sex and referral for catheterization, revascularization, and aspirin/statin therapy.  PROMISE was a pragmatic randomized trial that compared computed tomographic angiography (CTA) to functional stress testing in patients with stable symptoms of CAD.

“PROMISE was an ideal setting in which to study this question, because it was a pragmatic trial in which physicians were allowed to care for patients as they saw fit,” Pagidipati. “It also had one of the largest proportions of women in the trial population of any of the recent major cardiovascular trials.”

The researchers identified 8,966 PROMISE patients with stable symptoms of CAD. Of these, 4,500 (52 percent female) received CTA and 4,466 (53 percent female) received stress testing. The researchers found that 13 percent of men were referred for catheterization, compared to 8 percent of women. Of those who underwent catheterization (358 women, 534 men), fewer women than men underwent revascularization (35 percent versus 54 percent). After adjustment, however, this result was not significant. Among women and men with an indication for aspirin or statin, there were no significant differences in use at 60 days.

Outcomes for women with CAD symptoms were actually better overall than for men, a result driven largely by the patients who did not undergo catheterization, Pagidipati said.

“We found that there are certainly differences in care for these patients, but they don’t appear to translate into worse outcomes for women,” she said. “It’s unclear if that’s due to intrinsic differences in the pathophysiology of coronary artery disease in women and men, or other processes.”

The study’s other authors included Adrian Coles, PhD; Kshipra Hemal; Kerry L. Lee, PhD; Rowena J. Dolor, MD, MHS; Patricia A. Pellikka, MD; Daniel B. Mark, MD, MPH; Manesh R. Patel, MD; Sheldon E. Litwin, MD; Melissa A. Daubert, MD; Svati H. Shah, MD; and Udo Hoffmann, MD, MPH.

AHA 2016: Hospitals participating in AHA’s Get With The Guidelines program for AF had better adherence to stroke prevention measures

November 15, 2016 – Quality of care for patients with atrial fibrillation improved over the first three years at participating hospitals.

Atrial fibrillation, a common type of heart arrhythmia, affects between 2.7 and 6.1 million Americans, often leading to heart-related complications as well as increasing the risk for stroke fivefold. Quality improvement efforts to increase anticoagulation for stroke prevention in patients with atrial fibrillation have had limited success in improving guideline adherence.

jonathan-picciniThe American Heart Association’s Get With The Guidelines (GWTG) program is a quality improvement initiative that has yielded quality improvement in treatment of several cardiovascular diseases, including heart failure, myocardial infarction and stroke. This study aimed to assess use of guideline-recommended stroke prevention in Get With The Guidelines-Atrial Fibrillation (GWTG-AFIB), using the new American College of Cardiology Foundation/American Heart Association atrial fibrillation performance measure indications.

Among hospitals participating in GWTG-AFIB, use of stroke prevention therapy at discharge in eligible guideline-indicated patients was high and improved over time. The rate of oral anticoagulation at hospital discharge in eligible patients with a CHA2DS2-VASc score of 2 or greater was 92.3 percent in the overall population. This scoring method takes account of factors including the patient’s history of congestive heart failure, hypertension, stroke, transient ischemic attack, thromboembolism and vascular disease, and whether they have diabetes. Rates of anticoagulation were similar by race and coronary artery disease status. However, anticoagulation was more frequent in men and those with heart failure.

Utilization of oral anticoagulation at discharge in eligible patients with CHA2DS2-VASc of 2 or greater improved over the first three years of the registry. This resulted in more than 90 percent utilization after the second year and continues to increase, with utilization reaching 95.6 percent in the last quarter of enrollment.

The study results were presented Tuesday at the 2016 American Heart Association (AHA) Scientific Sessions in New Orleans.

“This is a game-changing result, showing that if a health system engages in this quality improvement initiative, oral anticoagulation at hospital discharge can be achieved in over 95 percent of eligible patients – an achievement that is unheard of in this field,” said lead author Jonathan P. Piccini, MD, MHS, of the DCRI. “This contrasts sharply with earlier observational studies that found fewer than 50 percent of eligible patients receiving oral anticoagulation. Given that in older individuals, one in five strokes is due to atrial fibrillation, the sustained improvement seen in our study could have a tremendous impact on patient outcomes.”

The study cohort included 20,342 atrial fibrillation admissions across 79 sites since the inception of the GWTG-AFIB program. The median patient age was 71 years, and 48 percent were female. The median CHA2DS2-VASc score was 4. One in five patients admitted with atrial fibrillation has a contraindication to oral anticoagulation.

In addition to Piccini, the DCRI’s Margueritte Cox, MS, was an author on this paper.

AHA 2016: Misperceptions about cardiovascular risk drive treatment disparities

November 15, 2016 – An analysis of data from more than 7,000 patients finds that African Americans are less likely to receive proper cardiovascular care

African-American patients are less likely than whites to receive statins at the recommended stages and dosing levels — in part because of differences in the perceived risk of cardiovascular disease and the benefits of statin therapy.

The findings were reported Nov. 15 by DCRI scientists at the American Heart Association’s Scientific Sessions 2016 meeting in New Orleans.

“This study, using data from a registry of more than 7,000 patients throughout the United States, provides important insights behind a problem we have recognized for quite some time – notably, that African Americans are less likely to be properly treated,” said lead author Tracy Y. Wang, MD, MHS, MSc, director of DCRI Education.

tracywang_tallWang and colleagues analyzed data from the Patient and Provider Assessment of Lipid Management Registry. The database includes clinical information of a diverse group of patients with or at risk of cardiovascular disease, along with responses those patients provided to tailored questionnaires.

The researchers asked patients to describe their beliefs about statins, cholesterol and cardiovascular risk, plus note whether they had experienced any side effects or barriers to therapy if they had taken statins. Patient responses were analyzed by race and adherence to recommended treatment guidelines.

As expected, the researchers found that African-Americans were more likely to be undertreated compared to whites.

But the patient questionnaires provided key insights into why that was. African-American patients tended to perceive that they were at lower risk of cardiovascular disease compared to white patients with a similar health profile. At the same time, African-Americans were less willing to try medications for risk reduction than white patients, but not because of adverse side effects. These results suggest that the perception of risk drove treatment trends.

“These perceptions give us an avenue to make headway on an issue that has been identified time and again,” Wang said. “We need to develop better strategies that are focused on accurately communicating risks. We don’t need to be pushing pills, but having conversations to inform people what it means to be at risk. It’s a matter of changing the conversation.”

In addition to Wang, the study’s research team included Ann Marie Navar, Pearl Zakroysky, Shuang Li, Anne C. Goldberg, Jennifer G. Robinson, Veronique L. Roger, Salim S. Virani, Peter W.F. Wilson, L. Veronica Lee, Joseph Elassal, and Eric D. Peterson.

AHA 2016: Potential heart attack treatment shows promise in safety study

November 15, 2016 – Outcomes from the AEGIS-I trial reveal that CSL112 may reduce the early recurrent rate of cardiovascular events following an acute myocardial infarction.

A potential new heart attack treatment is safe and may be able to safely reduce the risk of recurrent heart attacks, according to the results of a late-breaking trial presented today at the annual Scientific Sessions of the American Heart Association in New Orleans.

The ApoA-1 Event Reduction in Ischemic Syndromes I (AEGIS-I) trial is a randomized clinical trial to examine the safety and tolerability of CSL112, a reconstituted, infusible, human apolipoprotein A-1 (apoA-1) infusion, after an acute heart attack. Coronary heart disease is the result of cholesterol plaque accumulation in the walls of the arteries and plaques that are cholesterol rich are more likely to be unstable and cause an acute myocardial infarction. CSL112, through its effect on reverse cholesterol transport, might be able to reverse cholesterol buildup, make plaques more stable, and prevent future heart attacks.

The AEGIS-I trial evaluated the hepatic and renal safety of four weekly infusions of two doses of CSL112 compared to placebo among patients with recent myocardial infarction and either normal renal function or mild renal impairment.

Pierluigi TricociDeveloped by CSL Limited, CSL112 is an innovative formulation of apoA-1. The primary functional component of high-density lipoprotein (HDL), also known as “good cholesterol,” apoA-1 has been found to support the rapid removal of cholesterol from plaque. The apolipoprotein is purified from human plasma and reconstituted to form HDL particles suitable for intravenous infusion.

According to the findings of the AEGIS-I trial, upon infusion, CSL112 produces an immediate and robust increase in cholesterol efflux capacity. Efflux is the first step of reverse cholesterol transport, the process by which HDL transports excess cholesterol to the liver for removal from the body.

“A single infusion of reconstituted apoA-1 increases cholesterol efflux capacity by more than 100 percent and in a prior study in patients with peripheral arterial disease reduced femoral plaque lipid more than 50 percent in five to seven days,” said the DCRI’s John Alexander, MD, one of the trial’s researchers.

The trial revealed that CSL112 enhances cholesterol efflux equally in patients with high and low HDL baseline functionality. Patients with cardiovascular disease develop lower cholesterol efflux capacity over time, and data from the trial suggests that CSL112 may effectively elevate efflux in patients with either normal or impaired HDL function.

“CSL112 is an improvement on the early formulation of the drug that has improved its hepatic safety,” said the DCRI’s Pierluigi Tricoci, MD (pictured), another member of the research team. “Now that we are reassured about safety of CSL112, the time has come to test the hypothesis that by increasing cholesterol efflux we can achieve a reduction in recurrent cardiac event in patients presenting with a heart attack.”

The infusion of the novel CSL112 in addition to standard of care in subjects following acute coronary syndrome does not cause meaningful changes in either liver or kidney function, he added. The drug may reduce recurrent major adverse cardiovascular events, including include cardiovascular death, heart attack, ischemic stroke, however, more additional trials are needed to define the efficacy of CSL112, Alexander said.

In addition to Alexander and Tricoci, the researchers included C. Michael Gibson, Serge Korjian and Yazan Daaboul of Beth Israel Deaconess Medical Center; Philippe Steg of Hôpital Bichat, Assistance Publique-Hôpitaux de Paris; Michael Lincoff of the Cleveland Clinic; John Kastelein of the Academic Medical Center of the University of Amsterdam; Roxana Mehran of Mount Sinai Medical Center; Denise D’Andrea of CSL Behring, LLC; Bela Merkely of Semmelweis University Heart Center; Maciej Zarebinski of Warsaw Medical University; Ton Oude Ophius of Canisius Wilhelmina Ziekenhuis; and Robert Harrington of Stanford University.

AHA 2016: Over one quarter of patients recommended for statins do not take them

November 15, 2016 – Concern about side effects was the top reason given by patients who were not on statins.

Most patients recommended for statin therapy are taking a statin, but those who are not are often concerned about potential side effects, according to a new study by DCRI researchers and their colleagues.

The study, based on data from the Patient and Provider Assessment of Lipid Management (PALM) Registry, was presented Tuesday in a poster presentation at the annual Scientific Sessions of the American Heart Association in New Orleans.

ann-marie-navarStatin therapy has been proven to reduce the risk of cardiovascular disease in high-risk adults. However, overall statin utilization among U.S. adults is low. At the time of the 2013 ACC/AHA Guideline release, less than half of eligible adults were on statin therapy. The reasons for lack of statin utilization among adults with access to health care are not well understood.

PALM enrolled approximately 7,900 patients from 140 sites across the United States with cardiovascular disease or at high risk for cardiovascular disease. In addition to clinical information on the patients, the registry also collected patient-reported information on current and prior statin experience, patients’ perceived risk of heart disease, beliefs about statin therapy and cholesterol, and willingness to re-try statins.

In this study, the DCRI researchers used the registry to examine statin utilization, describe patient-reported reasons for lack of statin utilization among adults recommended for statin therapy who were not on treatment, and assess willingness to initiate statin therapy among untreated adults.

Overall, statin utilization was high among patients whose physicians recommended the therapy. Of these patients, 73 percent were on a statin, 8.1 percent were previously but not currently on a statin, and 18.9 percent had never been on a statin. Among patients who had previously been on statin therapy, more than half (54.7 percent) were on a statin for a year or more. Only 13.3 percent tried a statin for less than one month. The most commonly reported reason for discontinuing statin therapy was fear of side effects such as muscle pain (54.9 percent).

For patients who had never been on statin therapy, 71.1 percent reported never being offered a statin by their doctor. Concern about potential side effects was again the most commonly reported reason for declining statin therapy (36.8 percent). However, 46.3 percent of adults never on a statin reported they would be willing to try a statin if their doctor recommended it to lower their risk of heart disease.

According to lead author Ann Marie Navar, MD, PhD, these findings suggest that patient-provider interactions are key to improving statin use and retention rates.

“Despite high reported rates of sides effects or fear of side effects, many adults not on statins would be willing to try or re-try one,” she said. “It’s up to physicians to talk with their patients and offer, or re-offer, statin therapy to their high risk patients who are currently not on treatment.”

In addition to Navar, the study’s other authors included Eric Peterson, Shuang Li, Anne Goldberg, Jennifer Robinson, Veronique Roger, Salim Virani, Peter W.F. Wilson, L. Veronica Lee, Joseph Elassal, and Tracy Wang.