{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:35:20Z","timestamp":1787016920686,"version":"build-2736575974"},"reference-count":59,"publisher":"BMJ","issue":"10","license":[{"start":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T00:00:00Z","timestamp":1633046400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,9,9]]},"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Scoping review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Out of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statin-versus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We identified differences in the frequency of ADRs in both observational studies and RCTs from LATAM countries. This could be due to the absence of standard definitions and reporting of ADRs as well as differences among the study\u2019s interventions, population characteristics or design. The variability of ADRs and the absence of definitions are similar to studies from other geographical locations. Further placebo-controlled trials and real-world data registries with universal definitions should follow.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-050675","type":"journal-article","created":{"date-parts":[[2021,10,1]],"date-time":"2021-10-01T11:06:38Z","timestamp":1633086398000},"page":"e050675","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":10,"title":["Statin associated adverse reactions in Latin America: a scoping review"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1119-3181","authenticated-orcid":false,"given":"Manuel","family":"Urina-Jassir","sequence":"first","affiliation":[{"name":"Clinical Research Department, Fundaci\u00f3n del Caribe para la Investigaci\u00f3n Biom\u00e9dica, Barranquilla, Atlantico, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatiana","family":"Pacheco-Paez","sequence":"additional","affiliation":[{"name":"Evidence-Based Therapeutics Group, Clinical Pharmacology, Universidad de La Sabana, Chia, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Paez-Canro","sequence":"additional","affiliation":[{"name":"Sexually Transmitted Infections Group, Cochrane Collaboration, Universidad Nacional de Colombia, Bogota, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6003-4622","authenticated-orcid":false,"given":"Miguel","family":"Urina-Triana","sequence":"additional","affiliation":[{"name":"Clinical Research Department, Fundaci\u00f3n del Caribe para la Investigaci\u00f3n Biom\u00e9dica, Barranquilla, Atlantico, Colombia"},{"name":"Facultad de Ciencias de la Salud, Universidad Sim\u00f3n Bol\u00edvar, Barranquilla, Atl\u00e1ntico, Colombia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,10,1]]},"reference":[{"key":"2025121514543166000_11.10.e050675.1","doi-asserted-by":"crossref","unstructured":"Arnett DK , Blumenthal RS , Albert MA , et al . 2019 ACC\/AHA guideline on the primary prevention of cardiovascular disease: Executive summary: a report of the American College of Cardiology\/American heart association Task force on clinical practice guidelines. 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