Tramadol versus codeine and the short-term risk of cardiovascular events in patients with non-cancer pain: A population-based cohort study.
Analgesics, Opioid
/ adverse effects
Angina, Unstable
/ chemically induced
Brain Ischemia
/ chemically induced
Codeine
/ adverse effects
Cohort Studies
Humans
Ischemic Stroke
Myocardial Infarction
/ drug therapy
Proportional Hazards Models
Retrospective Studies
Stroke
/ chemically induced
Tramadol
/ adverse effects
cardiovascular safety
codeine
mortality
myocardial infarction
opioids
tramadol
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
revised:
30
06
2021
received:
13
11
2020
accepted:
13
09
2021
pubmed:
3
10
2021
medline:
27
4
2022
entrez:
2
10
2021
Statut:
ppublish
Résumé
The effect of tramadol on the cardiovascular system is largely unknown. There is concern that, with its multimodal mechanism of action to increase serotonin and norepinephrine levels in the body, it could increase the risk of arterial ischaemia and cardiovascular events. We aimed to compare the short-term risk of cardiovascular events with the use of tramadol to that of codeine among patients with non-cancer pain. We conducted a retrospective population-based cohort study using data from the Clinical Practice Research Datalink (CPRD) with new users of tramadol or codeine from April 1998 to March 2017. Exposure was defined using an approach analogous to an intention-to-treat, with a maximum follow-up of 30 days. The primary endpoint was myocardial infarction, and secondary endpoints were unstable angina, ischaemic stroke, coronary revascularization, cardiovascular death and all-cause mortality. Hazard ratios (HRs) were estimated using Cox proportional hazards models, adjusted for high-dimensional propensity score. The final cohort included 123 394 tramadol users and 914 333 codeine users. When tramadol was compared to codeine, the adjusted hazard ratio (HR) of myocardial infarction was 1.00 (95% CI 0.81-1.24). There was also no evidence of elevated risks of unstable angina (0.92; 95% CI 0.67-1.27), ischaemic stroke (0.98; 95% CI 0.82-1.17), coronary revascularization (0.97; 95% CI 0.69-1.38), cardiovascular death (1.07; 95% CI 0.93-1.23) or all-cause mortality (1.03; 95% CI 0.94-1.14) when tramadol was compared to codeine. Short-term use of tramadol, compared with codeine, was not associated with an increased risk of cardiac events among patients with non-cancer pain.
Substances chimiques
Analgesics, Opioid
0
Tramadol
39J1LGJ30J
Codeine
UX6OWY2V7J
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1824-1834Subventions
Organisme : CIHR
ID : PJT-152912
Pays : Canada
Informations de copyright
© 2021 British Pharmacological Society.
Références
Lewis KS, Han NH. Tramadol: a new centrally acting analgesic. Am J Health Syst Pharm. 1997;54(6):643-652.
McCarberg B. Tramadol extended-release in the management of chronic pain. Ther Clin Risk Manag. 2007;3(3):401-410.
Anekar AA, Cascella M. WHO Analgesic Ladder. [Updated 2021 May 18]. https://www.ncbi.nlm.nih.gov/books/NBK554435/. Accessed October 14, 2021.
Canadian Institute for Health Information. Pan-Canadian Trends in the Prescribing of Opioids, 2012-2016. Ottawa, ON: CIHI; 2017.
Manchikanti L, Helm S 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain Physician. 2012;15(3 Suppl):ES9-ES38.
Bigal LM, Bibeau K, Dunbar S. Tramadol prescription over a 4-year period in the USA. Curr Pain Headache Rep. 2019;23(10):76(1)-76(7).
Jani M, Birlie Yimer B, Sheppard T, Lunt M, Dixon WG. Time trends and prescribing patterns of opioid drugs in UK primary care patients with non-cancer pain: a retrospective cohort study. PLoS Med. 2020;17(10):e1003270.
Drug Enforcement Administration. Tramadol. 2014. https://www.deadiversion.usdoj.gov/drug_chem_info/tramadol.pdf. Accessed October 14, 2021.
Misuse of Drugs Act 1971 (Ketamaine etc.) (Amendment) Order 2014. https://www.legislation.gov.uk/uksi/2014/1106/contents/made?view=plain. Accessed October 14, 2021.
Grond S, Sablotzki A. Clinical pharmacology of tramadol. Clin Pharmacokinet. 2004;43(13):879-923.
Volpi-Abadie J, Kaye AM, Kaye AD. Serotonin syndrome. Ochsner J. 2013;13(4):533-540.
Vikenes K, Farstad M, Nordrehaug JE. Serotonin is associated with coronary artery disease and cardiac events. Circulation. 1999;100(5):483-489.
Frishman WH, Okin S, Huberfeld S. Serotonin antagonism in the treatment of systemic hypertension: the role of ketanserin. Med Clin North Am. 1988;72(2):501-522.
Larsson PT, Wallen NH, Hjemdahl P. Norepinephrine-induced human platelet activation in vivo is only partly counteracted by aspirin. Circulation. 1994;89(5):1951-1957.
Sloand JA, Hooper M, Izzo JL Jr. Effects of circulating norepinephrine on platelet, leukocyte and red blood cell counts by alpha 1-adrenergic stimulation. Am J Cardiol. 1989;63(15):1140-1142.
Itami T, Tamaru N, Kawase K, et al. Cardiovascular effects of tramadol in dogs anesthetized with sevoflurane. J Vet Med Sci. 2011;73(12):1603-1609.
Wagner R, Piler P, Bedanova H, Adamek P, Grodecka L, Freiberger T. Myocardial injury is decreased by late remote ischaemic preconditioning and aggravated by tramadol in patients undergoing cardiac surgery: a randomised controlled trial. Interact Cardiovasc Thorac Surg. 2010;11(6):758-762.
Solomon DH, Rassen JA, Glynn RJ, et al. The comparative safety of opioids for nonmalignant pain in older adults. Arch Intern Med. 2010;170(22):1979-1986.
Tavassoli N, Lapeyre-Mestre M, Sommet A, Montastruc JL. Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol). Br J Clin Pharmacol. 2009;68(3):422-426.
Li L, Setoguchi S, Cabral H, Jick S. Opioid use for noncancer pain and risk of myocardial infarction amongst adults. J Intern Med. 2013;273(5):511-526.
Wei J, Wood MJ, Dubreuil M, et al. Association of tramadol with risk of myocardial infarction among patients with osteoarthritis. Osteoarthr Cartil. 2020;28(2):137-145.
Herrett E, Thomas SL, Schoonen WM, Smeeth L, Hall AJ. Validation and validity of diagnoses in the General Practice Research Database: a systematic review. Br J Clin Pharmacol. 2010;69(1):4-14.
Khan NF, Harrison SE, Rose PW. Validity of diagnostic coding within the General Practice Research Database: a systematic review. Br J Gen Pract. 2010;60(572):e128-e136.
Herrett E, Gallagher AM, Bhaskaran K, et al. Data Resource Profile: Clinical Practice Research Datalink (CPRD). Int J Epidemiol. 2015;44(3):827-836.
Herbert A, Wijlaars L, Zylbersztejn A, Cromwell D, Hardelid P. Data Resource Profile: Hospital Episode Statistics Admitted Patient Care (HES APC). Int J Epidemiol. 2017;46(4):1093-93i.
Danaei G, Tavakkoli M, Hernán MA. Bias in observational studies of prevalent users: lessons for comparative effectiveness research from a meta-analysis of statins. Am J Epidemiol. 2012;175(4):250-262.
Bovelli D, Plataniotis G, Roila F, EGWG. Cardiotoxicity of chemotherapeutic agents and radiotherapy-related heart disease: ESMO clinical practice guidelines. Ann Oncol. 2010;21:v277-v282.
Grysiewicz RA, Thomas K, Pandey DK. Epidemiology of ischemic and hemorrhagic stroke: incidence, prevalence, mortality, and risk factors. Neurol Clin. 2008;26(4):871-895.
Yusuf S, Hawken S, Ounpuu S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004;364(9438):937-952.
Greenland P, Knoll MD, Stamler J, et al. Major Risk Factors as Antecedents of Fatal and Nonfatal Coronary Heart Disease Events. JAMA. 2003;290:(7):891-897.
Allen CL, Bayraktutan U. Risk factors for ischaemic stroke. Int J Stroke. 2008;3(2):105-116.
Zegkos T, Kitas G, Dimitroulas T. Cardiovascular risk in rheumatoid arthritis: assessment, management and next steps. Ther Adv Musculoskelet Dis. 2016;8(3):86-101.
Meisinger C, Doring A, Lowel H. Chronic kidney disease and risk of incident myocardial infarction and all-cause and cardiovascular disease mortality in middle-aged men and women from the general population. Eur Heart J. 2006;27(10):1245-1250.
Donaldson GC, Hurst JR, Smith CJ, Hubbard RB, Wedzicha JA. Increased risk of myocardial infarction and stroke following exacerbation of COPD. Chest. 2010;137(5):1091-1097.
Sacco RL. Risk factors and outcomes for ischemic stroke. Neurology. 1995;45(2 Suppl 1):S10-S14.
Normand ST, Landrum MB, Guadagnoli E, et al. Validating recommendations for coronary angiography following acute myocardial infarction in the elderly: a matched analysis using propensity scores. J Clin Epidemiol. 2001;54(4):387-398.
Schneeweiss S, Rassen JA, Glynn RJ, Avorn J, Mogun H, Brookhart MA. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology. 2009;20(4):512-522.
Greenland S, Finkle WD. A critical look at methods for handling missing covariates in epidemiologic regression analyses. Am J Epidemiol. 1995;142(12):1255-1264.
Alexander SP, Christopoulos A, Davenport AP, et al. The Concise Guide to PHARMACOLOGY 2021/22: G protein-coupled receptors. Br J Pharmacol. 2021;178(Suppl 1):S27-S156.
Alexander SP, Kelly E, Mathie A, et al. The Concise Guide to PHARMACOLOGY 2021/22: Transporters. Br J Pharmacol. 2021;178(Suppl 1):S412-S513.
Zeng C, Dubreuil M, LaRochelle MR, et al. Association of tramadol with all-cause mortality among patients with osteoarthritis. JAMA. 2019;321(10):969-982.
Jeong S, Tchoe HJ, Li J, Shin JY. All-cause mortality associated with tramadol use: a case-crossover study. Drug Saf. 2019;42(6):785-796.
Ferreira-Gonzalez I, Busse JW, Heels-Ansdell D, et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ. 2007;334(7597):786(1)-786(7).
Bégaud B, Martin K, Haramburu F, Moore N. Rates of spontaneous reporting of adverse drug reactions in France. JAMA. 2002;288(13):1588.
Lund JL, Richardson DB, Stürmer T. The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application. Current Epidemiol Rep. 2015;2(4):221-228.