Concerns Description Main challenges to be faced Many patients with CVDS consume HMs • Patients do not notify the use of HMs to the physician • Physicians do not routinely ask patients about the use of HMs • Information on HMs is not included in clinical charts • HMs reduce adherence to prescribed CV medications • Patients should inform their physicians about the use of HMs and not use HMs without medical advice and supervision • Physicians should routinely ask patients about the use of HMs through a non- judgmental approach; advise them not to replace prescribed medications by HMs; and include the information in medical charts. Lack of standardization and quality control of HMS • HMs contain multiple active ingredients but there are marked variations in active ingredients among preparations and manufacturers of the same HM. • Many HMs do not contain the active ingredients listed on the label; misidentifications, contaminations and adulterations are often reported • Misinformation persists in social media and labels of HMs • Use only standardized preparations. Avoid HMs when labels fail to specify the ingredients per dosage unit or to mention AEs/HDIS • Regulatory authorities should ensure that HMs are safe and of suitable quality • Harmonization of regulatory standards among states and a stricter regulation of the herbal industry Limited evidence of the efficacy of most HMS • The efficacy of most HMs remains uncertain • Many CTs present important methological problems • The composition, formulation and dosage of HMs tested in different CTs is rarely comparable. • HMs are less effective than prescribed CV and do not modify CV mortality • Well-designed RCTs are needed to determine the efficacy of HMs • Compare the efficacy and safety of HMs with prescribed CV drugs • CPG do not recommend HMs for the prevention/treatment of CVDs • Only a few HMs can be used as a complement with prescribed CV drugs (Table 1) HMs produce AES and HDIS • Patients are unaware of the risks of HMs. They do not report AEs because they consider that HMs are natural and safe • Their incidence and relevance remain uncertain, but safety risks increase in patients with multimorbidity • Safety profiles from HMs derive from pharmacokinetic trials, small CTs and case reports, but rarely from RCTs • The mechanisms involved are not fully understood • When a new sign/symptom appears in patients previously stable, it is worth ask the patient about the use of HMs • Well-designed RCTs are needed to quantify their incidence and severity Improve and standardize the pharmacovigilance for HMs • Active ingredient(s) responsible for AEs and HDis should be identified • Physicians should inform patients about the benefits/risks of HMs; educate patients to report the AEs; identify and report any suspected AEs and HDIS caused by HMs; and assess causality and clinical relevance • Avoid HMs: in patients treated with narrow therapeutic index CV drugs; during pregnancy or lactation and in children; before and after surgery HMs can be used with caution in elderly with multimorbidity Limited formation of physicians • HMs are not included in the medical sylabus in Western countries • Physicians have limited training/information on HMs • Poor interest of professional societies and major cardiovascular journals on HMs • Improve training of physicians. Develop courses integrated with continuing medical education (CME) on the efficacy and safety of HMs • EMA and FDA Websites provide reliable and updated information Los médicos deben informarse sobre las medicinas a base de hierbas de fuentes confiables, preguntar a los pacientes sin prejuicios sobre el uso de las medicinas a base de hierbas y registrar la respuesta, explicar los inconvenientes, considerar si las medicinas a base de hierbas podrían estar causando síntomas o alterar las respuestas a los medicamentos y enseñar a los pacientes a informar posibles eventos adversos. Además, la percepción generalizada de que, a diferencia de los medicamentos recetados, los HM son seguros es engañosa y algunos HM pueden causar eventos adversos e interacciones clínicamente relevantes, particularmente cuando se usan con medicamentos cardiovasculares prescritos de índice terapéutico estrecho (antiarrítmicos, antitrombóticos, digoxina). Los cardiólogos/médicos ya no pueden ignorar el problema. Deben mejorar su conocimiento sobre los HM que consumen sus pacientes para brindar el mejor asesoramiento y prevenir reacciones adversas e interacciones medicamentosas. Esta revisión narrativa aborda los supuestos mecanismos de acción, los usos clínicos sugeridos y la seguridad de los HM más utilizados. DESTACAR • Muchos pacientes con enfermedades cardiovasculares (ECV) combinan medicamentos a base de hierbas (HM) con medicamentos recetados, pero no notifican su uso y los médicos no preguntan sobre esta práctica común. • Los consumidores consideran que los HM son naturales y seguros, desconociendo sus posibles efectos adversos e interacciones graves con los medicamentos cardiovasculares prescritos. • La presencia de múltiples ingredientes activos, identificaciones erróneas de productos, contaminaciones y adulteraciones, falta de estandarización y control de calidad y desinformación pública son motivos de gran preocupación. • La evidencia científica actual no respalda el uso de HM para la prevención/tratamiento de ECV y los médicos juegan un papel fundamental en la minimización de los riesgos de HM. Deben advertir a los pacientes que los HM no deben reemplazar los medicamentos cardiovasculares prescritos recomendados en las guías de práctica clínica. 17 ATEROMA - Resúmenes
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