{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,19]],"date-time":"2026-04-19T04:18:42Z","timestamp":1776572322262,"version":"3.51.2"},"reference-count":47,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,11,12]],"date-time":"2016-11-12T00:00:00Z","timestamp":1478908800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cardiovascular Therapeutics"],"published-print":{"date-parts":[[2016,12]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Data on statin safety in Asian patients are limited compared with evidence from Western populations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>This study assessed atorvastatin safety among Asian patients enrolled in 58 randomized clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Data from 52 short\u2010term trials (median exposure 4\u201372\u00a0weeks) and six long\u2010term cardiovascular outcomes trials (median exposure 3.1\u20134.9\u00a0years) conducted across the atorvastatin 10\u201380\u2010mg dose range were analyzed retrospectively to assess the incidence of safety endpoints.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 77\u00a0952 patients were identified (49\u00a0974 received atorvastatin), among whom 3191 were Asian (2519 received atorvastatin). In the short\u2010term trials, the incidence of all\u2010causality adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) and serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s) in Asian patients treated with atorvastatin was similar to or lower than that observed with other statins or placebo, and discontinuations due to treatment\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s\/<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s were infrequent (2.0% across all doses). These observations were confirmed in the long\u2010term trials. Treatment\u2010related <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s were rare (n\u00a0=\u00a04) among Asian patients receiving atorvastatin. No cases of rhabdomyolysis were observed in atorvastatin\u2010treated Asian patients, and the incidence of myalgia was 1.8% in the short\u2010term studies and 6.7% in the long\u2010term trials. Elevations (&gt;3\u00d7 the upper limit of normal) in liver transaminases were observed in ~2% of Asian patients receiving atorvastatin; renal <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s occurred in &lt;2%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The incidence of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s\/<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s with atorvastatin 10\u201340\u2010mg in patients of Asian origin was low and comparable to placebo. Further evaluation of atorvastatin 80\u2010mg is required owing to the limited number of Asian patients (n\u00a0=\u00a0281; 11.2%) who received this dose.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1755-5922.12214","type":"journal-article","created":{"date-parts":[[2016,8,13]],"date-time":"2016-08-13T07:02:40Z","timestamp":1471071760000},"page":"431-440","source":"Crossref","is-referenced-by-count":17,"title":["Safety of atorvastatin in Asian patients within clinical trials"],"prefix":"10.1111","volume":"34","author":[{"given":"Juliana C. N.","family":"Chan","sequence":"first","affiliation":[{"name":"Department of Medicine and Therapeutics Hong Kong Institute of Diabetes and Obesity The Chinese University of Hong Kong Prince of Wales Hospital  Shatin NT, Hong Kong SAR China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice P. S.","family":"Kong","sequence":"additional","affiliation":[{"name":"Department of Medicine and Therapeutics Hong Kong Institute of Diabetes and Obesity The Chinese University of Hong Kong Prince of Wales Hospital  Shatin NT, Hong Kong SAR China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weihang","family":"Bao","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rana","family":"Fayyad","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Laskey","sequence":"additional","affiliation":[{"name":"Pfizer Inc  New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,11,12]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"World Health Organization [Internet].Cardiovascular diseases (CVDs); June2016.http:\/\/www.who.int\/mediacentre\/factsheets\/fs317\/en\/index.html. Accessed July 11 2016."},{"key":"e_1_2_7_3_1","unstructured":"World Health Organization [Internet].The impact of chronic disease in China; October2005.http:\/\/www.who.int\/chp\/chronic_disease_report\/media\/china.pdf. Accessed July 11 2016."},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.hjr.0000170264.84820.8e"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.105.537472"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67394-1"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61368-4"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.66.1087"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1253\/circj.66.1096"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)69472-5"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/1475-2840-9-77"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2011.06.028"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.11.002"},{"key":"e_1_2_7_14_1","first-page":"397","article-title":"Current statin use for patients with atherosclerotic cardiovascular disease in 39 large Chinese hospitals","volume":"39","author":"Zhang D","year":"2011","journal-title":"Zhonghua Xin Xue Guan Bing Za Zhi"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcma.2012.08.020"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007990802138731"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/1741826710397100"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040583"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(04)16895-5"},{"key":"e_1_2_7_20_1","first-page":"1772","article-title":"Clinical outcomes in managed\u2010care patients with coronary heart disease treated aggressively in lipid\u2010lowering disease management clinics: the ALLIANCE study","volume":"44","author":"Koren MJ","year":"2004","journal-title":"J Am Coll Cardiol"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa050461"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.294.19.2437"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)12948-0"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa061894"},{"key":"e_1_2_7_25_1","first-page":"1383","article-title":"Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S)","volume":"344","author":"Scandinavian Simvastatin Survival Study Group","year":"1994","journal-title":"Lancet"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)09327-3"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9149(03)00820-8"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2005.07.108"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc05-2415"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-014-1801-z"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.2217\/pgs.11.98"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9149(97)00092-1"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1536\/jhj.42.725"},{"key":"e_1_2_7_34_1","first-page":"478","article-title":"Comparing the efficacy and safety of atorvastatin and simvastatin in Asians with elevated low\u2010density lipoprotein\u2010cholesterol\u2014a multinational, multicenter, double\u2010blind study","volume":"101","author":"Wu CC","year":"2002","journal-title":"J Formos Med Assoc"},{"key":"e_1_2_7_35_1","doi-asserted-by":"publisher","DOI":"10.1185\/030079907X242809"},{"key":"e_1_2_7_36_1","doi-asserted-by":"publisher","DOI":"10.5551\/jat.E567"},{"key":"e_1_2_7_37_1","doi-asserted-by":"publisher","DOI":"10.3904\/kjim.2010.25.1.27"},{"key":"e_1_2_7_38_1","doi-asserted-by":"publisher","DOI":"10.4103\/0366-6999.149226"},{"key":"e_1_2_7_39_1","doi-asserted-by":"publisher","DOI":"10.2147\/vhrm.2005.1.4.351"},{"key":"e_1_2_7_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2007.01.028"},{"key":"e_1_2_7_41_1","first-page":"72","article-title":"The Atorvastatin Goal Achievement Across Risk Levels (ATGOAL) study in Thailand","volume":"90","author":"Deerochanawong C","year":"2007","journal-title":"J Med Assoc Thai"},{"key":"e_1_2_7_42_1","doi-asserted-by":"publisher","DOI":"10.4103\/0973-3930.53124"},{"key":"e_1_2_7_43_1","first-page":"807","article-title":"Efficacy of low dose atorvastatin in diabetic dyslipidaemia","volume":"107","author":"Pola P","year":"2009","journal-title":"J Indian Med Assoc"},{"key":"e_1_2_7_44_1","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1M522"},{"key":"e_1_2_7_45_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011407196"},{"key":"e_1_2_7_46_1","doi-asserted-by":"publisher","DOI":"10.5551\/jat.15792"},{"key":"e_1_2_7_47_1","first-page":"390","article-title":"Chinese guidelines on prevention and treatment of dyslipidemia in adults","volume":"35","author":"Joint Committee for Developing Chinese Guidelines on Prevention and Treatment of Dyslipidemia in Adults","year":"2007","journal-title":"Zhonghua Xin Xue Guan Bing Za Zhi"},{"key":"e_1_2_7_48_1","doi-asserted-by":"publisher","DOI":"10.12997\/jla.2012.1.2.45"}],"container-title":["Cardiovascular Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1755-5922.12214","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1755-5922.12214","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1755-5922.12214","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1755-5922.12214","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1755-5922.12214","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T15:38:56Z","timestamp":1696347536000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1755-5922.12214"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,11,12]]},"references-count":47,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2016,12]]}},"alternative-id":["10.1111\/1755-5922.12214"],"URL":"https:\/\/doi.org\/10.1111\/1755-5922.12214","archive":["Portico"],"relation":{},"ISSN":["1755-5914","1755-5922"],"issn-type":[{"value":"1755-5914","type":"print"},{"value":"1755-5922","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,11,12]]}}}