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CMHC PULSE

Cardio Metabolic Health Congress – Official Blog

Reducing Cardiovascular Disease Risk with Polypills and Aspirin

Lifestyle interventions and preventative medications are central components of prevention strategies targeting cardiovascular disease (CVD) as well as attempts at lowering patient health risk factors. One possible pharmacologic intervention is the use of polypills, which has been found to improve adherence to preventive medications. Fixed-dose combination therapy in the form of a polypill is frequently used to control more than one health risk factor – such as combinations of heart disease, hypertension, type 2 diabetes, and stroke.

As part of a comprehensive strategy, reducing the risk of cardiovascular disease may be possible with the use of a polypill and aspirin combination. Emerging research published in The New England Journal of Medicine suggests that a polypill comprised of statins, multiple blood-pressure-lowering drugs, and aspirin may reduce the risk of cardiovascular disease.

Assessing Polypill Efficacy

As part of the large, international trial, a team of researchers randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive one of several therapeutic options or placebo. The study included a total of 5713 participants, with an average age of 64 years and 47% were males. The follow-up period was an average of 4.6 years during which the investigators monitored for the first occurrence of a major cardiovascular event or death.

The researchers used a 2-by-2-by-2 factorial design which involved a polypill, a polypill-plus-aspirin combination, or placebo drug. The polypill contained 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril. Along with the polypill or placebo, participants took either 75 mg of aspirin or placebo as well as vitamin D or placebo daily.

The study’s authors investigated the outcomes and safety of the administration of the polypill alone compared with matching placebo conditions; for aspirin alone as compared with matching placebo; and for the polypill-plus-aspirin combination compared with double placebo. In the case of polypill-only and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome measured was death from cardiovascular causes, myocardial infarction, or stroke.

Polypill-Plus-Aspirin Benefits

The analysis revealed that the primary outcome for the polypill comparison occurred in 126 participants (4.4%) of the polypill group and in 157 (5.5%) individuals in the placebo group. The researchers found that the use of the polypill alone was able to reduce cardiovascular disease by up to 21%.

Additionally, the primary outcome for the aspirin comparison occurred in 116 participants (4.1%) of the aspirin group and in 134 participants (4.7%) of the placebo group. Aspirin alone was able to reduce rates of cardiovascular death, heart attack, and stroke by 14%.

Finally, the primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and 83 (5.8%) of the double-placebo group. The polypill-plus-aspirin reduced cardiovascular disease most significantly by 31%.

The study’s authors also found that low-density lipoprotein cholesterol levels were lower by approximately 19mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg in the polypill and polypill-plus-aspirin cohort than in patients receiving the placebo. However, they noted that the incidence of hypertension or dizziness was higher in groups receiving polypill than those in placebo, which will require further investigation.

Clinical Implications

As the latest findings indicate, the combination treatment comprised of a polypill plus aspirin may lead to a lower incidence of cardiovascular events among individuals without cardiovascular disease who experience an intermediate risk for cardiovascular conditions.

“Aspirin should be prescribed with a polypill in primary prevention for patients at intermediate risk of heart disease,” Salim Yusuf, M.D., B.S., D. Phil., co-author of the study told Science Daily. “Our study results provide important data regarding the role of the polypill in preventing the development of heart disease.”

Co-author Prem Pais, MBBS, MD, professor in the division of clinical research and training at St. John’s Research Institute in Bangalore, India, added, “We were also interested in evaluating if combining blood pressure and cholesterol reduction medications in a single pill would be effective for this population. This is a cost-effective strategy that could help meet global targets of reducing CVD by 30% by 2030.”

The combination therapy method could potentially avert between 3 and 5 million cardiovascular deaths across the globe and have a profound impact on the cardiovascular health outcomes of the population. In the future, polypills comprised of newer statins may be able to further reduce LDL cholesterol, blood pressure, and cardiovascular disease risk by over 50%, the researchers concluded.

The Efficacy of Virtual Cardiac Rehabilitation Programs 

Centered around education and lifestyle interventions, standardized outpatient cardiac rehabilitation programs are designed to assist patients with cardiovascular disease (CVD) and those after hospitalization for CV events or surgeries. Such programs have been found to significantly reduce the risk of death from heart disease, hospital and emergency visits, as well as future cardiovascular problems. However, many patients have limited access to such services due to limited availability, transportation challenges, and high costs.

Providing on-site outpatient cardiac rehabilitation has become a significant challenge in light of the COVID-19 pandemic as non-essential services have largely been halted and social distancing requirements prevent group activities from occurring. Although, healthcare systems rapidly adapted to these obstacles by shifting to telehealth services and delivering care remotely. Similarly, cardiac rehabilitation programs transitioned to a virtual care model during the pandemic. Recent research reports that these programs were able to maintain levels of patient acceptance, treatment adherence, and referrals observed with traditional in-person outpatient rehabilitation programs.

Shifting to Virtual Care 

During the nationwide March lockdown in Canada, the Central East Cardiovascular Rehabilitation center in Toronto transitioned from an on-site cardiac rehabilitation model to virtual programming within 1 week. This evidence-based program included telemedicine visits conducted via telephone, email, mobile apps, as well as web-based video programs. Overall, the program serves patients across 17 communities with more than 3,600 patients per year and reports acceptance rates of 70% and completion rates of 60%. Findings of recent research exploring the efficacy of this virtual cardiovascular rehabilitation intervention were presented at the American Heart Association (AHA) Scientific Sessions.

Attendance and Completion Rates

A team of researchers from the center compared attendance and completion of the virtual program with a matched 6-week period from the preceding year. The total number of referrals increased by 32.8% during the lockdown period compared with the same period in 2019. Meanwhile, community referrals reduced by 87.7% in 2020 compared with prior year.

The researchers reported that attendance was stable during the virtual rehabilitation program; the attendance rate of scheduled appointments was approximately 85% of that for the matched period and the patient acceptance rate was over 90%. Only 9% of patients declined to participate in the virtual cardiac rehabilitation program.

One disadvantage of the virtual cardiac program was the doubling of related costs compared with onsite care delivery; an increase primarily attributable to increased staffing costs related to higher numbers of 1-on-1 patient consultations and smaller group interactions.

As virtual cardiac rehabilitation programs were found to be as effective as in-person, outpatient rehabilitation services, they could be used on a wider scale to increase equitable access and participation rates for cardiac patient populations across different demographics. Ultimately, these methods could be used to improve outcomes for cardiovascular patients and address racial disparities in health and medical care.

“We anticipated that the pandemic response would negatively impact referral, acceptance and completion rates,” lead study author Joseph A. Ricci, MD, of the Central East Cardiovascular Rehabilitation Program in Toronto told The Cardiology Advisor. “Based on this experience, modern technologies should be integrated into traditional delivery models beyond the pandemic period, including exploration of hybrid in-person, on-site and virtual rehabilitation programs.”