Lauren Pass, an MPH student in community and behavioral health, is the principal investigator of a new study examining how anxious and depressive disorders are managed in rural cardiovascular disease patients. Under the guidance of Dr. Korey Kennelty, assistant professor in the UI College of Pharmacy and co-investigator, the study utilizes patient interviews to identify mental health care needs in high-risk rural Iowa populations.
“Cardiovascular disease and mood disorders often go hand-in-hand,” says Pass. “Patients with mood disorders are at higher risk for developing cardiovascular disease and often have poorer cardiac outcomes than those without mood disorders. For rural patients, access to mental health care can be scarce, so it’s important that we identify ways of improving the delivery of mental health care within the settings most widely available to patients — their primary care clinics.”
The study is sub-project of the Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE) clinical trial lead by Dr. Barry Carter in the UI College of Pharmacy. The study examined whether clinical pharmacists can be implemented in primary care offices to improve the care of patients at risk for developing cardiovascular disease.
Heart disease patients taking an investigational class of drugs to achieve very low levels of cholesterol do not experience an increase in adverse events, including memory impairment or nervous system disorders, but may have an increased risk of cataracts, according to a study led by a UI College of Public Health researcher.
However, the researcher says the results will not likely change the use of statins as the primary tool to reduce cholesterol levels and other cardiovascular risks.
The new class of drugs – called PCSK9 inhibitors – were studied in combination with statins to lower LDL cholesterol, or bad cholesterol, in high-risk patients who were unable to achieve desired cholesterol levels using only statins or other lipid-lowering therapies.
The study, led by Jennifer Robinson, UI professor of epidemiology and medicine and director of the UI Preventive Intervention Center, sought to address concerns about how very low levels of LDL cholesterol effect body functions that rely on cholesterol, including hormone production, digestion, and healthy cell structure.
“The safety of these new drugs is critical to patients who have no other means by which to control their life-threatening high cholesterol,” says Robinson. “The long-term effects of very low levels of LDL cholesterol are under evaluation in ongoing large clinical trials.”
The study appears in the Feb. 7, 2017, issue of the Journal of the American College of Cardiology, which was published online Jan. 30, 2017.
Researchers pooled data from 14 randomized, controlled studies that included 5,234 patients treated with the PCSK9 alirocumab for up to two years. They looked for the occurrence of adverse events in patients who achieved two or more consecutive LDL cholesterol values of less than 25 mg/dL or less than 15 mg/dL. An LDL level of 25 md/dL was used because it has been suggested to be the level needed for normal cell function.
The overall incidence of adverse events was similar in patients taking alirocumab versus those taking placebo. Adverse symptoms monitored included musculoskeletal disorders, neurologic and neurocognitive conditions (including memory), and renal or liver problems. There was not an increased incidence of diabetes, despite previous studies showing an excess of diabetes in patients with LDL cholesterol lower than 30mg/dL on statin therapy.
Analyses did show an increased incidence of cataracts in patients with LDL less than 25 versus greater than 25. It was not clear what caused this increase, although researchers said it could be because reducing cholesterol accelerates underlying aging-related changes, contributing to cataracts.
While the investigation suggests the very low levels of LDL cholesterol were well-tolerated in limited trials, the long-term effects of PCSK9 inhibitors remain unknown, according to Robinson. As a result, she says statins remain the mainstay of cardiovascular risk reduction therapy.
“Statins have an excellent record of safety in properly selected patients,” says Robinson. “Therefore, every effort should be made to maximize statin therapy before considering adding a nonstatin such as alirocumab to further reduce LDL-C levels.”
Editor’s Note: This release is adapted from a release prepared by the Journal of the American College of Cardiology.
Since 2012, an evaluation team from the RUPRI Center has been involved in qualitative program evaluation of the American Heart Association’s “Mission: Lifeline” programs through funding from The Leona M. and Harry B. Helmsley Charitable Trust.
Mission: Lifeline strives to develop statewide systems of care for heart attack patients, especially those experiencing the most deadly type, ST-elevation myocardial infarctions (STEMIs). In March 2016, the team concluded its four-state series of program evaluations. It was contracted first to evaluate Mission: Lifeline in South Dakota, then in North Dakota, Wyoming, and rural Minnesota. Each team effort involved onsite visits to the states and scores of telephone calls and interviews with hospital and Emergency Medical Services representatives as well as other stakeholders throughout each state.
“Each Mission: Lifeline state program had its own characteristics, and we could see progressive changes in each subsequent state,” says Marcia Ward, CPH professor of health management and policy and principal investigator for the four projects. “It was rewarding to see positive outcomes, especially in rural communities that were generously provided equipment and education by The Helmsley Charitable Trust. By virtue of Mission: Lifeline’s efforts to systemize heart health care statewide and collaboration at all levels of care, lives were being saved.”
Jennifer Robinson, CPH professor of epidemiology, has been appointed to fill a vacancy on the National Forum for Heart Disease & Stroke Prevention’s Board of Directors. The National Forum is a multidisciplinary, non-profit health organization addressing cardiovascular health. Its members represent more than 80 national and international organizations from public and private health care organizations, as well as faith, advocacy, academic, and policy settings.
Robinson is a professor in the Departments of Epidemiology and Medicine (Division of Cardiology) and the director of the Prevention Intervention Center at the University of Iowa. She has performed numerous clinical trials sponsored by the National Institutes of Health and the pharmaceutical industry and conducted extensive research on a wide range of anti-atherosclerotic and metabolic agents, including lipid-modifying, anti-inflammatory, antihypertensive, weight loss and diabetic treatments, as well as postmenopausal hormone therapy.
Dr. Robinson is the principal investigator for the Women’s Health Initiative (WHI) at the University of Iowa and has published over 150 peer-reviewed articles in the area of lipids-modifying drugs, cardiovascular risk stratification, and cardiovascular prevention. She is also the chair for the National Forum Cholesterol Risk Awareness Initiative. Prior to her current work, she was vice-chair for the 2013 American Heart Association/American College of Cardiology Cholesterol Guidelines and a member of the 2013 American Heart Association/American College of Cardiology Risk Reduction Guidelines.