Generic placeholder image

Current Vascular Pharmacology


ISSN (Print): 1570-1611
ISSN (Online): 1875-6212

General Research Article

The Incidence of Adverse Drug Reactions in Patients Treated with Statins in the Emirates: A Retrospective Cohort Study

Author(s): Abdulla Shehab*, Akshaya S. Bhagavathula, Asim A. Elnour, Khalid Al-Rasadi and Saif Al-Shamsi

Volume 18, Issue 2, 2020

Page: [193 - 199] Pages: 7

DOI: 10.2174/1570161117666190408164908

Price: $65


Aim: We investigated the incidence of adverse drug reactions (ADRs) in patients treated with statins for cardiovascular (CV) risk among the United Arab Emirates (UAE) population.

Methods: This is a retrospective cohort study conducted among statin users attending 2 tertiary care centres: Al Ain and Tawam hospitals in Al Ain city, UAE. We retrieved the clinical profile of all the patients taking statins from January 2011 to January 2015 using our electronic database (Cerner®).

Results: Among 556 patients (418 men; 138 women) taking statins, 237 ADRs were reported (186 men; 51 women). The incidence of ADRs was 40.7%, and was more frequent among patients at “high CV disease (CVD) risk” and “moderate CVD risk” than other risk categories. High CVD risk (odds ratio, 1.67; 95% confidence interval [CI], 1.19-2.34), vitamin D deficiency 1.45 (95% CI, 0.89-2.38), type 2 diabetes 1.22 (95% CI, 0.84-1.77) and hypertension 1.13 (95% CI, 0.70-1.83) are some of the factors that were associated with statin ADRs.

Conclusion: The incidence of ADRs among statin users was 42.6%, and frequent ADRs (49%) were noted in patients with high CVD risk. Early identification of these ADRs should improve patient adherence to life-saving statin treatment.

Keywords: Statin, adverse drug reactions, drug safety, hyperlipidaemia, incidence, Middle East.

« Previous
Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of The third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001; 285: 2486-97.
Sirtori CR. The pharmacology of statins. Pharmacol Res 2014; 88: 3-11.
Smith S. The 2013 ACC/AHA guidelines on treatment of blood cholesterol to improve cardiovascular outcomes: Implications for statin use and dose vs. target. Cardiovasc Innov Appl 2016; 1: 465-7.
Hadjiphilippou S, Ray KK. Choesterol-lowering agents. Circ Res 2019; 124: 354-63.
Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy. Circulation 2006; 114: 2788-97.
Collins R, Reith C, Emberson J, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet 2016; 388: 2532-61.
Stroes ES, Thompson PD, Corsini A, et al. Statin-associated muscle symptoms: Impact on statin therapy-European Atherosclerosis Society consensus panel statement on assessment, aetiology and management. Eur Heart J 2015; 36: 1012-22.
Joy TR, Hegele RA. Narrative review: Statin-related myopathy. Ann Intern Med 2009; 150: 858-68.
McKenney JM, Davidson MH, Jacobson TA, et al. Final conclusion and recommendations of the National lipid association statin safety assessment task force. Am J Cardiol 2006; 97: 89-94.
Maji D, Shaikh S, Solanki D, et al. Safety of statins. Indian J Endocrinol Metab 2013; 17: 636.
Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 97(Suppl.): 52C-60C.
Chodick G, Shalev V, Gerber Y, et al. Long-term persistence with statin treatment in a not-for-profit health maintenance organization: a population-based retrospective cohort study in Israel. Clin Ther 2008; 30: 2167-79.
Banach M, Rizzo M, Toth PP, et al. Statin intolerance - an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci 2015; 11: 1-23.
Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomized statin trials. Lancet 2010; 375: 735-42.
Mills EJ, Wu P, Chong G, et al. Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials. QJM 2011; 104: 109-24.
Crandall JP, Mather K, Rajpathak SN, et al. Statin use and risk of developing diabetes: results from the Diabetes Prevention Program. BMJ Open Diabetes Res Care 2017; 5: e000438
Newman CB, Preiss D, Tobert JA, et al. Statin safety and associated adverse events: a scientific statement from the American Heart Association. Arterioscler Thromb Vasc Biol 2019; 39: e38-81.
Goff DC, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63(25 Part B): 2935-59.
Reiner Z, Catapano AL, De Backer G, et al. ESC/EAS guidelines for the management of dyslipidemias: the task force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J 2011; 32: 1769-818.
Pasternak RC, Smith SC Jr, Bairey-Merz CN, et al. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol 2002; 40: 567-72.
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation classification, and stratification. 2000. Available at Accessed May 23,2015.
Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63(25 Part B): 2889-934.
US Food and Drug Administration. FDA drug safety communication: Important safety label changes to cholesterol-lowering statin drugs. US Food and Drug Administration Web site. Available at: http: // Accessed June 23,2015.
US Food and Drug Administration. FDA drug safety communication: Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. US Food and Drug Administration Web site. Available at: February 15, 2012. Accessed November 10, 2015.
Mansi I, Frei CR, Pugh MJ, et al. Psychologic Disorders and Statin Use: A Propensity Score‐Matched Analysis. Pharmacotherapy 2013; 33: 615-26.
Rojas-Fernandez CH, Cameron JC. Is statin-associated cognitive impairment clinically relevant? A narrative review and clinical recommendations. Ann Pharmacother 2012; 46: 549-57.
McAlister FA, Straus SE, Guyatt GH, Haynes RB. Evidence-Based Medicine Working Group. Users’ guides to the medical literature, XX: integrating research evidence with the care of the individual patient. JAMA 2000; 283: 2829-36.
Indumathi C, Anusha N, Vinod KV, et al. Atorvastatin Induced Adverse Drug Reactions among South Indian Tamils. J Clin Diagn Res 2017; 11: FC01.
Bruckert E, Hayem G, Dejager S, et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients–the PRIMO study. Cardiovasc Drugs Ther 2005; 19: 403-14.
Ganga HV, Slim HB, Thompson PD. A systematic review of statin-induced muscle problems in clinical trials. Am Heart J 2014; 168: 6-15.
Siegel AJ, Silverman LM, Lopez RE. Creatine kinase elevations in marathon runners: relationship to training and competition. Yale J Biol Med 1980; 53: 275-9.
Golomb BA, Kane T, Dimsdale JE. Severe irritability associated with statin cholesterol-lowering drugs. QJM 2004; 97: 229-35.
Manfredini R, Caracciolo S, Salmi R, et al. The association of low serum cholesterol with depression and suicidal behaviors: new hypotheses for the missing link. J Int Med Res 2000; 28: 247-57.
Tatley M, Savage R. Psychiatric adverse reactions with statins, fibrates and ezetimibe: implications for the use of lipid-lowering agents. Drug Saf 2007; 30: 195-201.
Takada M, Fujimoto M, Yamazaki K, et al. Association of statin use with sleep disturbances: data mining of a spontaneous reporting database and a prescription database. Drug Saf 2014; 37: 421-31.
Broncel M, Gorzelak-Pabiś P, Sahebkar A, et al. Lipid and Blood Pressure Meta-analysis Collaboration. Sleep changes following statin therapy: a systematic review and meta-analysis of randomized placebo-controlled polysomnographic trials. Arch Med Sci 2015; 11: 915-26.
US Food and Drug Administration. The center for health and wellness. http: // Accessed June 22, 2018.
Marcella A, Evans BS, Beatrice A, et al. Statin-associated adverse cognitive effects: survey results from 171 patients. Pharmacotherapy 2009; 29: 800-11.
Richardson K, Schoen M, French B, et al. Statins and cognitive function. Ann Intern Med 2013; 159: 688-97.
Etminan M, Gill S, Samii A. The role of lipid-lowering drugs in cognitive function: a meta-analysis of observational studies. Pharmacotherapy 2003; 23: 726-30.
Sparks DL, Kryscio RJ, Sabbagh MN, et al. Reduced risk of the incident AD with elective statin use in a clinical trial cohort. Curr Alzheimer Res 2008; 5: 416-21.
Arvanitakis Z, Schneider JA, Wilson RS, et al. Statins, incident Alzheimer disease, change in cognitive function, and neuropathology. Neurology 2008; 70: 1795-802.
Szwast SJ, Hendrie HC, Lane KA, et al. Association of statin use with cognitive decline in elderly African Americans. Neurology 2007; 69: 1873-80.
Wagstaff LR, Mitton MW, Arvik BM, et al. Statin‐associated memory loss: analysis of 60 case reports and review of the literature. Pharmacotherapy 2003; 23: 871-80.
Rosenson RS, Baker SK, Jacobson TA, et al. An assessment by the statin muscle safety task force: 2014 update. J Clin Lipidol 2014; 8: 558-71.

Rights & Permissions Print Export Cite as
© 2023 Bentham Science Publishers | Privacy Policy