Huabing Zhang, MD; Jorge Plutzky, MD; Maria Shubina, ScD; Alexander Turchin, MD, MS
Note: Dr. Turchin had full access to all study data and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Grant Support: In part by the Chinese National Key Program of Clinical Science (WBYZ2011-873), National Natural Science Foundation of China (71432004), and Young Scientific Research Fund of Peking Union Medical College Hospital (PUMCH-2013-060).
Disclosures: Dr. Turchin reports grants from Sanofi-Aventis Groupe and Merck outside the submitted work. Dr. Plutzky reports serving as a consultant to Amgen, AstraZeneca, Merck, Pfizer, and Sanofi. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0838.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Not available. Statistical code: Available from Dr. Turchin (e-mail, firstname.lastname@example.org). Data set: Deidentified data set used in the analysis is available from Dr. Turchin (e-mail, email@example.com). Data use agreement is required to obtain the data set.
Requests for Single Reprints: Alexander Turchin, MD, MS, Division of Endocrinology, Brigham and Women's Hospital, 221 Longwood Avenue, Boston, MA 02115; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Zhang: Department of Endocrinology, Peking Union Medical College Hospital, 1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing 100730, China.
Dr. Plutzky: Harvard New Research Building, 77 Avenue Louis Pasteur, Boston, MA 02115.
Drs. Shubina and Turchin: Division of Endocrinology, Brigham and Women's Hospital, 221 Longwood Avenue, Boston, MA 02115.
Author Contributions: Conception and design: H. Zhang, M. Shubina, A. Turchin.
Analysis and interpretation of the data: H. Zhang, M. Shubina, A. Turchin.
Drafting of the article: H. Zhang.
Critical revision for important intellectual content: H. Zhang, J. Plutzky, M. Shubina, A. Turchin.
Final approval of the article: H. Zhang, J. Plutzky, M. Shubina, A. Turchin.
Statistical expertise: M. Shubina.
Obtaining of funding: H. Zhang.
Administrative, technical, or logistic support: H. Zhang.
Collection and assembly of data: H Zhang, A. Turchin.
Many patients discontinue statin treatment, often after having a possible adverse reaction. The risks and benefits of continued statin therapy after an adverse reaction are not known.
To examine the relationship between continuation of statin therapy (any prescription within 12 months after an adverse reaction) and clinical outcomes.
Retrospective cohort study.
Primary care practices affiliated with 2 academic medical centers.
Patients with a presumed adverse reaction to a statin between 2000 and 2011.
Information on adverse reactions to statins was obtained from structured electronic medical record data or natural-language processing of narrative provider notes. The primary composite outcome was time to a cardiovascular event (myocardial infarction or stroke) or death.
Most (81%) of the adverse reactions to statins were identified from the text of electronic provider notes. Among 28 266 study patients, 19 989 (70.7%) continued receiving statin prescriptions after the adverse reaction. Four years after the presumed adverse event, the cumulative incidence of the composite primary outcome was 12.2% for patients with continued statin prescriptions, compared with 13.9% for those without them (difference, 1.7% [95% CI, 0.8% to 2.7%]; P < 0.001). In a secondary analysis of 7604 patients for whom a different statin was prescribed after the adverse reaction, 2014 (26.5%) had a documented adverse reaction to the second statin, but 1696 (84.2%) of those patients continued receiving statin prescriptions.
The risk for recurrent adverse reactions to statins could not be established for the entire sample. It was also not possible to determine whether patients actually took the statins.
Continued statin prescriptions after an adverse reaction were associated with a lower incidence of death and cardiovascular events.
Chinese National Key Program of Clinical Science, National Natural Science Foundation of China, and Young Scientific Research Fund of Peking Union Medical College Hospital.
Zhang H, Plutzky J, Shubina M, et al. Continued Statin Prescriptions After Adverse Reactions and Patient Outcomes: A Cohort Study. Ann Intern Med. 2017;167:221–227. [Epub ahead of print 25 July 2017]. doi: https://doi.org/10.7326/M16-0838
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Published: Ann Intern Med. 2017;167(4):221-227.
Published at www.annals.org on 25 July 2017
Cardiology, Coronary Risk Factors, Dyslipidemia.
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