The use of the CNIC-Polypill in real-life clinical practice: opportunities and challenges in patients at very high risk of atherosclerotic cardiovascular disease – expert panel meeting report

Abstract

Although the cardiovascular (CV) polypill concept is not new and several guidelines state that a CV polypill should be considered an integral part of a comprehensive CV disease (CVD) prevention strategy, there are still some barriers to its implementation in the real-world setting, mainly in secondary CV prevention. As the CNIC-polypill is the only one approved for secondary CV prevention in patients with atherosclerotic CVD in 27 countries worldwide, a panel of four discussants and 30 participants from 18 countries conveyed in a virtual meeting on April 21, 2022, to discuss key clinical questions regarding the practical use of the CNIC-Polypill and barriers to its implementation.Data presented showed that, although the use of the CV polypill is not explicitly mentioned in the current 2021 European Society of Cardiology guidelines on CVD prevention, it may be used in any patient for secondary CVD prevention tolerating all their components to improve outcomes through different aspects. The favourable results of the Secondary Prevention of Cardiovascular Disease in the Elderly (SECURE) trial now reinforce this recommendation. The panellists presented algorithms on how to switch from any baseline regimen when starting treatment with the CNIC-polypill in different situations, including patients with hypertension, dyslipidaemia, and a previous CV event; at discharge after a cardiovascular event; in chronic ischemic conditions; and in cases of polypharmacy. The panellists and expert discussants did agree that available studies conducted so far with the CNIC-polypill demonstrate that it is as efficacious as the monocomponents, equipotent drugs, or other therapies; reduces the risk of experiencing recurrent major CV events; improves medication adherence; reduces health care costs and resources compared to patients treated with loose drugs; and the patients prefer it over the multipill strategy.In conclusion, the data presented by the participants provided the evidence behind the use of the CNIC-polypill to help fulfil the goal of encouraging its adoption by physicians.

The CNIC-polypill (acetylsalicylic acid, atorvastatin, and ramipril), an effective and cost-saving secondary prevention strategy compared with other therapeutic options in patients with ischaemic heart disease

“…For instance, to attain LDL-c goals, a combinatory approach like polypill + ezetimibe ± PCSK9 inhibitor, as needed, could be contemplated. 51–53 Similarly, for hypertension management, a regimen involving polypill + a beta-blocker ± a calcium channel blocker ± a diuretic tailored to individual needs may prove beneficial. 51–53 Lastly, while our study primarily reflects the current guideline-recommended use of aspirin in polypill strategies, it is noteworthy that ongoing discussions, supported by a meta-analysis, 54 suggest the potential benefits of P2Y 12 inhibitors for long-term secondary prevention in patients with coronary artery disease (CAD).…”

“… 51–53 Similarly, for hypertension management, a regimen involving polypill + a beta-blocker ± a calcium channel blocker ± a diuretic tailored to individual needs may prove beneficial. 51–53 Lastly, while our study primarily reflects the current guideline-recommended use of aspirin in polypill strategies, it is noteworthy that ongoing discussions, supported by a meta-analysis, 54 suggest the potential benefits of P2Y 12 inhibitors for long-term secondary prevention in patients with coronary artery disease (CAD). The consideration of future polypill formulations may need to account for evolving evidence and specific patient populations, such as those with a history of gastrointestinal bleeding or predisposing factors.…”

Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases

“…Additionally, based on the Irish Pharmaceutical Healthcare Association's 2021-2025 Framework Agreement, a yearly price reduction resulted in an even lower price for TRI-NOMIA (EUR 12.83) as of the 1st of March 2022 [54]. The negative incentivizing effect of such pricing policies is well demonstrated by the fact that the pivotal trial for TRINOMIA (SECURE trial) was funded by the EU [55,56]. With more adaptive pricing policies and a better price potential, a local pharmaceutical company might have been incentivized to run a trial for the FDC and supply the medicine in Ireland.…”

Correction: The use of the CNIC-Polypill in real-life clinical practice: opportunities and challenges in patients at very high risk of atherosclerotic cardiovascular disease – expert panel meeting report

“…Following publication of the original article [ 1 ], the authors reported that one of the authors listed in the consortia (Multinational Discussion Group) had their incorrect family name published. Adriana Barragan should be Adriana Puente.…”