Experts Offer Global Perspectives on Fixed-Dose Combination Regimens

Although there are myriad obstacles to implementing fixed-dose combination regimens globally for cardiovascular conditions, pharmacists can play an important role in educating patients and helping manage their regimens, according to a panel of international experts at the American College of Cardiology (ACC) 2023 Scientific Session.

The 2023 ACC meeting has a particularly international focus due to the ACC’s partnership with the World Congress of Cardiology. This was reflected in the panelists at the session, including experts from Kenya, South Africa, and Argentina. Tom Gaziano, MD, MSc, Chair of the Science Committee for the World Heart Federation, moderated the panel.

Gaziano started with an overview of the global burden of cardiovascular disease (CVD), noting that 18 million individuals die of CVD annually. Although there has been a modest reduction in age-adjusted cardiovascular mortality over recent decades, there are significant challenges, particularly regarding medication adherence.

In particular, Gaziano noted that 6 months after a myocardial infarction, many patients are no longer taking statins and blood pressure is uncontrolled. Additionally, less than one-third of patients at risk for CVD are adherent to medication. Combination therapies can be very successful at improving adherence, with therapies including aspirin, statins, angiotensin-converting enzyme (ACE) inhibitors, and more.

“We have medicines that are available for some people in some parts of the country to reduce CVD, but we don’t have enough people taking them,” Gaziano said.

Obstacles can include patient-specific issues, such as income and inability to get to the pharmacy or physician’s offices, as well as provider challenges, such as seeing patients frequently and remembering the various guidelines. Although international challenges may vary, the panelists noted that there is quite a bit of overlap, as well.

Elijah Ogola, MB ChB, MMed, president of the Pan-African Society of Cardiology, discussed his experiences in Kenya and throughout sub-Saharan Africa. Adherence is a constant issue, he said, with challenges on all levels.

“In our circumstances, the health care system issues are particularly prominent,” he said.

With regard to combination therapies and fixed-dose regimens, the main challenges are a lack of patient access to the health care system and economic challenges. Ogola also noted that many clinicians in Kenya do not understand which drugs to combine or how to manage these regimens. However, fixed-dose combinations are available in Kenya in some cases, and Ogola said the major remaining obstacle is to go beyond their limited use and implement them for other disease states.

Sarah Kraus, MD, PhD, a clinician in Capetown, South Africa, noted that fixed-dose combinations for heart failure pose a unique challenge because each patient has their own underlying comorbidities and associated challenges. In her experience, Kraus said the biggest roadblocks have been under-prescribing and patients’ resulting loss of faith when they do not improve.

Interestingly, Kraus noted that tuberculosis treatment approaches in South Africa may offer opportunities to learn when implementing fixed-dose combination regimens. Because of the major public health consequences for a tuberculosis outbreak, South Africa has a system in which clinicians often physically watch patients take their anti-tuberculosis medications each day at a local clinic.

“What we’ve learned through this system is that we can learn a lot, and there’s a role for this kind of approach in heart failure,” Kraus said. “Because it’s a patient-centered case management system, it fosters the ability for patients to have frequent interactions…at a community clinic level.”

In addition to improving adherence, this system creates a kind of camaraderie when patients interact with a nurse or other clinician on a daily basis, as well as other patients with the same condition. Although the costs of implementing such a program may be significant, Kraus noted that it is important to compare these costs with the costs of hospitalizations and complications of heart failure with less medication adherence.

Kraus also noted that pharmacists are essential team members who can be empowered to help initiate fixed-dose combinations. For example, when seeing a patient who is on a handful of medications such as aspirin, statins, and an ACE inhibitor, pharmacists can take the initiative to recommend a fixed-dose regimen instead. She did note, however, that pharmacists are very often over-stretched, so all of these efforts must be interdisciplinary.

REFERENCE

Kraus S, Ogola E, Gaziano T. Improving Adherence: The Promise of Fixed-Dose Combination Therapies. Presented at: American College of Cardiology 2023 Scientific Session. March 4, 2023.