CINCINNATI—Physicians who routinely review with their patients the medications they should be taking are more likely to have patients adhere to their medications and achieve health goals, according to a University of Cincinnati (UC) heart researcher.
The findings were reported by Dylan Steen, MD, assistant professor and director of clinical trials and population health research in the UC Division of Cardiovascular Health and Disease, at the American College of Cardiology Scientific Sessions held Saturday, March 14, 2015, in San Diego.
"Discontinuation of the most important medications is common early after serious cardiovascular events, such as heart attacks and strokes, and those patients who stop taking their medication have a much higher incidence of adverse health outcomes,” says Steen. "We implemented guideline-based performance reports to improve adherence to the most important medications during the course of a large, international clinical trial.”
Steen, also a UC Health cardiologist, was a lead investigator for the SOLID-TIMI 52 trial, which enrolled 13,026 patients within 30 days of hospitalization with an acute coronary syndrome, like a heart attack, at 858 hospital/medical sites in 36 countries including the United States. The trial was conducted between 2008 and 2013 and patients were followed on average for a period of 30 months.
Steen and his team of researchers tracked the use of aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers—standard medications prescribed following coronary events—and all of which reduce the progression of cardiovascular disease. He said that tracking reports in previous trials have demonstrated excellent use of these medications for 12 months. The SOLID-TIMI 52 trial extends these findings by demonstrating excellent utilization out to 30 months.
At baseline in the trial, 97 percent of patients were prescribed aspirin while the numbers for those on statins, beta-blockers, and either an ACE inhibitor or ARB were 95 percent, 87 percent, and 85 percent, respectively.
The study found that after 30 months in the trial 94 percent of patients were still on aspirin, while for statins and beta-blockers, the numbers were 95 percent and 85 percent respectively. About 82 percent of patients were on an ACE inhibitor or ARB.
"This is a demonstration that in a broad population, excellent medication utilization can be achieved,” says Steen. "It supports the randomized clinical trial data that shows that these medicines are well tolerated. The reasons patients stop their medications in the vast majority of cases include inadequate understanding of their health benefits, perception of tolerability issues, and having to deal with complex medical, pharmacy and insurance issues.
"By having a mechanism to consistently identify patients who are not taking these medications, health care providers can initiate a discussion with these patients to identify what concerns each may have and potentially come up with solutions,” says Steen.
The study also found that at the baseline visit (median 14 days after acute coronary syndrome), LDL cholesterol goals of 70 mg/dL (optimal) and 100 mg/dL (minimum) were achieved in 42 percent and 77 percent of patients. In patients with coronary artery disease, lowering cholesterol primarily using statin medications is the most important means to reduce the risk of future events. The proportion of patients achieving these goals was largely unchanged at the end of the study (39 percent and 76 percent respectively.)
Overall, clopidogrel use was present in 88 percent at baseline. Steen says that regional variation was observed in regards to the timing of P2Y12 inhibitor discontinuation.
"The evidence suggests that someone from Japan, versus another from Argentina, versus someone in the U.S. should receive similar lengths of treatment with this drug,” says Steen. "The differences between world regions are largely due to practice patterns; dissemination of research findings and guideline recommendations will help to standardize treatments in cases where this is appropriate.”
Affordability of clopidogrel across the world during the time period of the study probably affected its utilization. In addition, physicians in different parts of the world use different types of heart stents and have different views on the necessary length of treatment with each type of stent, explains Steen.
"What we call bare-metal stents tend to be more commonly used in Europe, while in the United States we use drug-eluding stents more commonly,” says Steen. "Clopidogrel is now generic, so affordability should be much, much less of an issue.”
Semiannual performance feedback reports were provided to each site and its monitoring team and they included four levels of data for the purpose of comparison (overall, region, country and site). Subject-level information at each site was also included. Monitors were charged with reviewing the data with the local site researchers.
In addition, quarterly reports were provided to each national lead investigator who had discretion to contact sites where patients were not being treated with these medications consistently. The reports included the frequency of use of standard of care medications after acute coronary syndrome and data regarding blood pressure, blood glucose and achieved LDL. In diabetic patients, information was provided on HgbA1c.
Other co-investigators participating in the SOLID-TIMI 52 trial include: Christopher Cannon, MD, Brigham and Women’s Hospital; Shruti Daga MD, and Mary Ann Lukas, MD, GlaxoSmithKline; Ton Oude Ophuis, MD, PhD, Canisius-Wilhelmina Hospital; Nikolay Gratsiansky MD, Moscow State University; Sharon Crugnate, MS, Jennifer Shannon, MS, and Michelle O’Donoghue, MD, Brigham and Women’s Hospital.
Steen received consultant fees/honoria from Sanofi-Aventis and Regeneron.
Cannon received consultant fees/honoria from BMS, BI, CSL Behring, Essentials, GSK, Kowa, Lipimedix, Merck, Pfizer, Regeneron, Sanofi-Aventis and Takeda. Cannon received research grants from Accumetrics, Arisaph, AstraZeneca, BI, GSK, Janssen, Merck and Takeda.
Daga received salary from GSK. Lukas received salary from GSK. Gratsiansky received research grants from Eli Lilly, GSK and Merck. Shannon received salary from GSK. O’Donoghue received consultant fees/honoraria from DiaDexus and research grants from AstraZeneca, Eisai, GSK and Merck.