World Heart Federation Cholesterol Roadmap 2022

• Conduct awareness and education campaigns to ensure that health professionals:

  • are aware of the continuous graded association between cholesterol blood levels and ASCVD risk: There is no normal cholesterol level, but adequate values based on ASCVD risk.

  • shift focus to the impact of cumulative long-term exposure to cholesterol and risk of ASCVD [52].

  • change to lifetime risk estimation rather than 10-year risk only [37, 77].

  • realise the importance of screening for elevated cholesterol including FH and Lp(a) in early life.

• Ensure multi-professional teams provide consistent and understandable information to patients [78].

• Provide tools showing the safety of cholesterol lowering drugs and low cholesterol levels including early use of combination therapies.

• Adapt evidence-based risk evaluation and guideline recommendations to local needs [78, 79].

Patients and general populations [78]

• Promote advocacy through greater interaction of patient organisations with healthcare professionals and policy makers.

• Implement a more inclusive approach in guidelines development, partnering in advocacy an policy influencing, clinical trials design and involvement in regulatory and the technical assessment process.

• Implement campaigns to raise awareness about the importance of screening for elevated cholesterol including FH and Lp(a).

• Provide educational programs/tools about lifelong exposure to cholesterol as cause of ASCVD overall. This includes differentiating between different needs among women and men, at different stage of life – childhood, adolescent, family planning phase – specially women [52].

• Develop educational tools for patients as reliable resources to counterbalance misinformation, e.g., websites; social media; apps.

• Develop tools to increase adherence to therapy (education, apps, text messaging).

• Support food reformulation efforts, in particular regarding eliminating artificial trans-fat.

  • Follow WHO recommendations to enact a mandatory 2% limit on industrially produced TFAs in foods or to ban PHOs. The WHO’s REPLACE action package and technical support in country should be leveraged by policymakers to protect their populations from the health harms of TFAs [80].

• Fully implement the WHO Framework Convention on Tobacco Control (FCTC), in particular: raising tobacco taxes, introducing comprehensive bans on tobacco advertising and sponsorship, placing large health warnings on packaging and legislating for smoke-free environments.

• Deliver education on healthy dietary patterns with focus on reducing consumption of ultra-processed unhealthy fat containing foods.

• Generate additional resources at national level, by enforcing adequate taxation policies on unhealthy commodities such as non-alcoholic beverages (e.g., sugar-sweetened beverages), tobacco and alcohol, and allocating these revenues for advancing the prevention and control of NCDs [81].

• Develop simplified locally-adapted guidelines [79] for whom and how to screen for ASCVD risk based on a total risk approach (consider previous ASCVD, family history and or presence of other risk factors like smoking, hypertension, diabetes, obesity, etc.) [77].

• Provide risk stratification tools in easy-to-use formats (apps; websites).

• Focus on lifetime rather than 10-year risk estimation to guide pharmacological therapy [37, 77].

• Set up point-of-care testing with inexpensive and easy-to-use technologies (e.g., cholesterol test strips).

Screening for FH and Lp(a)

• Develop and implement national policies for mandated screening; or adjust paediatric guidelines to promote routine universal screening and cascade screening [70]; as well as all guidelines to promote reverse cascade screening.

• Governments are encouraged to consider, in particular universal child-parent screening and cascade testing of first- and second-degree relatives [70, 82].

• Provide funds for genetic testing of FH [83].

• Create care pathways for sign-posting and directing referrals to lipid clinics or tertiary facilities for patients with severe forms of FH like HoFH or HeFH patients refractory to standard lipid lowering therapies.

Allocate sufficient resources for screening and diagnosis throughout the life-course, and risk stratification beginning in childhood on a fair basis, in the best interests of the child, similar to other genetic conditions.

• Ensure the affordability of essential cholesterol lipid lowering medicines [84]:

  • Ensure affordability of statin and non-statin therapies through free or subsidized drug provision, reducing taxes on pharmaceuticals.

  • Include LLTs, esp. statins, into essential medication packages [68].

  • Ensure the availability of generic potent lipid lowering drugs with WHO, particularly for low- and middle-income countries.

  • Ensure the use of generic statin+ ezetimibe single-pill combination therapies for potent cholesterol reduction, lessen therapy inertia, reduce pill burden, and cope with fear of possible adverse events of high-dose statins.

  • Guarantee access to PCSK9 lowering therapies for cases of severe hypercholesterolemia such as FH and or established ASCVD where cholesterol levels remain well above recommended local goals. Reducing the taxation of these medications, extending patent protection could make these affordable for health care systems.

  • Include a list of essential discounted medications, therapies for severe dyslipdaemia such as HoFH.

  • Provide recommendations towards funding prioritization for prevention and creation of national cardiovascular health programs with the inclusion of cholesterol awareness, testing, and management, and novel therapies accessibility.

• Reduce complexity of local guidelines to promote first line use of generic potent cholesterol lowering combination therapies (statin + ezetimibe) for those at highest risk.

• Support the use of polypills (combination pill including aspirin, a beta-blocker, a statin and an ACE inhibitor) among certain high-risk groups (e.g., post-MI, diabetics [85, 86]) reducing cost and promoting adherence.

• Support the engagement of pharmacists and non-physician health workers in patient support and counselling about drugs benefits, possible adverse events to increase adherence to drug therapy.

• Foster the use of novel technologies such as apps or text messaging to support patient adherence and cholesterol goal attainment.

• Develop and implement the use of smart decision support tools at the level of the healthcare system especially in those LMICs where EMR are available or being developed [79].

• Entering into carefully selected public-private collaborations.

• Monitor whether patients take recommended medications to reduce cholesterol and control other risk factors, and also if they renew their prescriptions.

  • Use of apps and internet-based resources linking patients, pharmacies, and health care professionals.

  • Creation of health care practitioner monitoring groups (pharmacists; nurses) to help patients with self-care.

• Monitor whether patients attain cholesterol goals as recommended.

  • Use of apps and internet-based resources.

• Collect epidemiological data to provide data-driven policies and assess the impact of care -this includes collection of surveillance data on cholesterol levels, ASCVD rates and dietary patterns.

• Develop reliable health information systems to monitor health behaviours, risk factors, and morbidity and mortality.

• Implement the WHO Global Monitoring Framework.

• Reach agreement among governments and intergovernmental agencies upon implementing international standards.

• Monitor stock outages for essential medicines such as statins.

• Financially support the development of FH registries to quantify current practices, identify knowledge-practice gaps, publish metrics for monitoring and standardizing care, identify areas for future resource deployment, dissemination and defining best practices as well as facilitating FH awareness and screening.

• Developing local patient-centred approaches including patient platforms for data entry and education should be considered, ensuring optimal privacy and confidentiality.

• Resolving aspects related to various insurance and genetic discrimination – stop penalizing, start incentivising adherence and other good behaviours.