Medlior’s RWE study examining the treatment landscape and clinical outcomes for patients with atherosclerotic cardiovascular disease in Alberta
Introduction
Medlior Health Outcomes Research Ltd. was engaged by Amgen Inc., one of the world’s leading biopharmaceutical companies, to examine the treatment landscape and clinical outcomes for patients with atherosclerotic cardiovascular diseases (ASCVD) in the real-world setting.
“Real-world data is becoming increasingly important to understand treatment patterns and associated clinical outcomes in large, diverse populations over longer time periods than typically seen in clinical trials,” said Tara Cowling, Direct and Managing Principal of Medlior Health Outcomes Research.
Challenges
ASCVD is a leading cause of morbidity and mortality worldwide. The management of low-density lipoprotein cholesterol (LDL-C), commonly known as dyslipidemia, has been found to reduce the incidence of heart attacks and strokes in patients with ASCVD. Lipid-lowering therapies are currently prescribed to manage LDL-C levels in patients with ASCVD. These most commonly include statins, but more recently, novel therapies such as ezetimibe and proprotein convertase subtilisin-kexin type 9 inhibitors (PCSK9i) are being prescribed.
“Optimal management of chronic conditions is vitally important for both patients and the health system. Understanding the challenges associated with managing these conditions, in a real-world population, can have a major impact on patient care delivery,” said Cowling.
Solution
The Alberta ASCVD real-world evidence study, now published in the Canadian Journal of Cardiology, linked five province-wide administrative datasets to analyze a population-based sample of 281,665 patients with ASCVD in Alberta. This study highlighted an important management and treatment gap for patients with ASCVD. Specifically, Medlior’s results showed that only 78% of patients had an LDL-C test after ASCVD, and of those, 66% were prescribed lipid-lowering therapy within one year. Of note, for patients who were prescribed lipid-lowering therapies, most received moderate- or high-intensity statins, which is aligned with treatment guideline recommendations. However, when examining LDL-C levels, among the patients who had two LDL-C tests, 49% did not achieve LDL-C levels less than 2.0 mmol/L at the first test following their ASCVD index date, whereas 37% did not achieve LDL-C levels less than 2.0 mmol/L or a 50% reduction at the follow-up test within one year of their index date.
“This study not only highlighted an important gap in care for patients with ASCVD, but also provided evidence that current treatments may not be effectively lowering LDL-C levels in a population-based sample,” said Cowling.
In addition, the assessment of province-wide laboratory data is unique and novel to the Alberta health system data offerings that Medlior can utilize in real-world evidence studies.
Result
The results of the Alberta ASCVD real-world evidence study have been presented at different conferences and published in an academic journal. In addition, the Canadian Journal of Cardiology featured Medlior’s publication in an editorial and journal press release in July 2019.
“These results have provided evidence supporting the need for novel therapies, such as PCSK9i’s, to manage and treat patients with ASCVD,” said Cowling.
With the overly positive response to our study results from our collaborators, including our Expert Clinical Advisor, Dr. Todd Anderson (Senior Associate Dean, University of Calgary), additional analyses are underway to continue the research on this cohort of patients with ASCVD in Alberta.
Read more Insights from Medlior here.
Please see below for all of the publications associated with this research study (Medlior co-authors bolded):
Academic journal publication:
- Chen G, Farris MS, Cowling T, Colgan S, Xiang P, Pericleous L, Rogoza RM, Tai MH, Anderson TJ. Treatment and Low-density Lipoprotein Cholesterol management in patients diagnosed with clinical Atherosclerotic Cardiovascular Disease in Alberta. Can J Cardiol. 2019; 35:7:884-894
Conference presentations:
- Scory T, Chen G, Farris MS, Shih YH, Pinto L, Cowling T. Lipid-lowering therapy patterns and low-density lipoprotein-cholesterol management among patients with acute myocardial infarction in Alberta, Canada. American College of Cardiology (ACC).20/World Congress of Cardiology (WCC) Virtual; March-June 2020; Virtual.
- Chen G, Farris MS, Cowling T, Tai M, Pinto L, Colgan S, Rogoza RM, Anderson TJ. Low-density Lipoprotein Cholesterol Management in Patients with Atherosclerotic Cardiovascular Diseases and Pre-existing Diabetes in Alberta, Canada. American Diabetes Association (ADA) 79th Scientific Sessions 2019; June 8, 2019; San Francisco, California
- Chen G, Farris MS, Cowling T, Colgan S, Xiang P, Pericleous L, Rogoza RM, Anderson TJ. Atherosclerotic Cardiovascular Diseases and Low-Density Lipoprotein Cholesterol Management in Alberta, Canada. Presented at the American Heart Association Scientific Sessions, November 2018; Chicago, USA.
Journal editorial:
- Sparrow, RT., Ferreira-Legere, L., Udell, JA., Waters, DD. (2019). Improving statin noncompliance: if you build it, will they come?. Can J Cardiol. 2019; 35:7:813-815.