nocebo effect statins

Circulation: Cardiovascular Quality and Outcomes, Examining the Nocebo Effect of Statins Through Statin Adverse Events Reported in the Food and Drug Administration Adverse Event Reporting System, https://www.ahajournals.org/doi/suppl/10.1161/CIRCOUTCOMES.120.007480, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-ongoing-safety-review-high-dose-zocor-simvastatin-and-increased-risk, https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-important-safety-label-changes-cholesterol-lowering-statin-drugs. The nocebo effect describes a phenomenon in which a person experiences side effects because of their negative perception of a drug rather than a true pharmacological effect. Today I want to discuss the nocebo effect, which occurs when negative expectations of something causes it to have a more negative effect than it otherwise would. The American Heart Association is qualified 501(c)(3) tax-exempt The biochemical and neuroendocrine bases of the hyperalgesic nocebo effect. Researchers suspect the pain people taking statins experience may be a common experience among the age group and a result of the “nocebo effect,” in which people experience a symptom because they expect to. We acknowledge Michelle Kwok, BSc and Zachary Oh, BSc who have contributed to this work through literature review assistance. Statins: Side effects may be down to the 'nocebo effect', research shows STATINS are routinely prescribed in the UK to prevent heart disease and stroke. The nocebo effect and its relevance for clinical practice. Front Pharmacol. Statins reduce cardiovascular risk. A, Subjective and objective AE reports displayed for United States (US) reports. But the same patients, once told that the drug they are taking is a statin, are much more likely to report such symptoms, shows a new Lancetanalysis of data from a trial carried out more than a decade ago in the UK and Scandinavia. Would you like email updates of new search results? Grunwald SA, Popp O, Haafke S, Jedraszczak N, Grieben U, Saar K, Patone G, Kress W, Steinhagen-Thiessen E, Dittmar G, Spuler S. Sci Rep. 2020 Feb 7;10(1):2158. doi: 10.1038/s41598-020-58668-2. Our findings do not suggest that all subjective AEs related to the nocebo effect should automatically be considered a nocebo effect. eCollection 2020. Both nervous system AEs and fatigue showed between country differences, with each AE having 554.53 and 419.73 more reports for the US than for non-US countries per quarter, respectively (P<0.0001). AE names are coded in the FAERS database using the Medical Dictionary for Regulatory Activities preferred terms.9 Before data analysis, duplicate reports were deleted by applying an algorithm based on primary identification number and preferred terms. Many patients are unable to tolerate statin therapy, with SAMS being the most common cause of statin intolerance. Based on the Kolmogorov-Smirnov test that those distributions were skewed, that is, non-normal, we used the Mann-Whitney U test for comparing the gender and country differences. Subjective statin AEs, potentially related to the nocebo effect are reported more often by women than by men, and in the United States than in other countries. J Clin Lipidol. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients–the PRIMO study. All quarterly adverse effect (AE) reports for statins by country from January 2010 to December 2019. Comparison of blinded and unblinded statin trials have demonstrated that statin muscle intolerance is associated with a nocebo effect. The Data Supplement is available at https://www.ahajournals.org/doi/suppl/10.1161/CIRCOUTCOMES.120.007480. The research suggested that about 20 percent of people who stop taking statins because of the side effects they experience may actually be experiencing the nocebo effect. The nocebo effect is more likely to be manifest as subjective statin AEs, such as, fatigue, myalgia, and nervous system AEs that are highly influenced by a patient’s perception.6 These are similar subjective AEs that increased over time for statins in our study. To account for the possibility that there were increasing temporal trends in overall AE reporting during this period, we used objective hepatic AEs and objective muscular AEs that can be assessed by laboratory values and are reported by health care professionals as a control group. This is the opposite of the placebo effect; with the nocebo effect, people who have negative expectations about medicine or a treatment experience harmful symptoms they otherwise wouldn't have. There were 1019 reports of fatigue and 3676 reports of subjective muscular AEs in 2010Q3, the first highest peak of AEs. Statins and musculoskeletal conditions, arthropathies, and injuries. Hepatic AEs had 225.8 more reports in the non-US than in the US group (P<0.0001), as did objective muscular AEs, with 143.90 more for the non-US than the US group per quarter (P<0.0001; Tables V and VI in the Data Supplement). Subjective and objective AE reports are displayed by quarterly period over the 10-year study period. A P<0.05 was considered statistically significant. Duncan spoke to Katie Haylor... Duncan - So in this study, they had 60 participants who had previously stopped taking statins … Cynthia Jackevicius, BScPhm, PharmD, MSc, Western University of Health Sciences, College of Pharmacy, 309 E. Second St, Pomona, CA 91766. The Nocebo Effect is a phenomenon whereby a patient who is warned of possible adverse side effects from a drug, or is made aware of negative reports of a … We found that there were significantly more subjective AEs, ones potentially related to the nocebo effect, than objective AEs reported for statins during the study, and discovered various potential determinants associated with the higher subjective AE reporting and potential nocebo effect for statins. Researchers recruited 60 people, average age 66, who had previously stopped statins after two … VA Greater Los Angeles Healthcare System, CA (C.A.J.). Keywords: Informatic tools and approaches in postmarketing pharmacovigilance used by FDA. Introduction: A retrospective cohort study was conducted using the Food and Drug Administration Adverse Event Reporting System between January 2010 and December 2019 for statins, including, atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin. Local Info There are limitations to our study owing to the nature of the voluntary reporting system in FAERS. We found noticeable peaks in 2010Q3 and in 2012Q1 for subjective AE reports in the US group. Prevention and treatment information (HHS). B, Subjective and objective AE reports displayed for non-US reports. A response to letters. Expert opinion: While subjective AEs increased, these objective hepatic and muscular AEs remained at a consistent low prevalence over the same time period. For the graphical comparisons, distributions of the incidence of AEs were plotted. It is known that adherence to statins in women is significantly lower than in men owing to a variety of biological and psychological factors that may play into the nocebo effect, including the clinician’s and patient’s perception that women are in general at low cardiovascular risk.29,30 Low perceived risk, coupled with heightened risk for the nocebo effect, sets women on the path to statin nonadherence. A systematic review of sex differences in the placebo and the nocebo effect. We investigated the name listed of each medicinal product for each statin in the FAERS DRUG file from 2015 to 2019 and used name combinations that resulted in at least a 95% identification rate for each statin (Table I in the Data Supplement). Consider other potential side effects for statins • Be aware of Statin Reluctance and Nocebo Effect • See ‘Person Centred Care’ box at page 2 Muscular symptoms not related to statins Wait for 2 weeks before rechallenge Has the patient been symptom free for at least 2 … The first subjective AE report peak in 2010Q3 was preceded by an FDA warning. We assessed what factors may have influenced patients’ perceptions at these time points and evaluated how they may have been associated with AE reporting. Finally, our study showed that simvastatin-associated reports had signals for objective muscular AEs that were 50% higher relative to that of all other statins, exhibiting more drug toxicity from its own pharmacological activity.41 Given that simvastatin is more influenced by CYP450 3A4 drug-drug interactions and to genetic polymorphisms related to myopathy, the higher risk we identified is not surprising, and this finding confirms our current understanding of the relative risk of simvastatin versus other statins’ risk of myopathy.11. * Comparing subjective AEs with objective AEs within each group. In female reports, the highest number of subjective AE reports was 4076 and objective AE reports 608 in 2019Q3. The medical dictionary for regulatory activities (MedDRA). Accessibility Strategies to enhance statin tolerability include, but are not limited to, switching to alternative statins, alternate-day dosing, and even rechallenging with the same statin started at a lower dose.21,42–45 Our study did not investigate all subjective AEs of statins, rather focusing on those subjective AEs that have most often been associated with a nocebo effect. We emphasize the importance of the trusting relationship between clinicians and patients to consider the nocebo effect, and the development of appropriate strategies in clinical practice. In March 2010, the FDA released a warning regarding an increased risk of muscle toxicity with high-dose simvastatin.31 Furthermore, at the time of the second peak in subjective AE reports, in February 2012, the FDA mandated adding the potential side effects of cognitive AEs, increased risk of diabetes, and additional drug-drug interactions to the statin label.32 These public warnings and resultant patient safety concerns, the timing of which coincided with the observed peaks in the US may have been associated with and potentially explain the increased number of subjective rather than objective AE reports observed in 2010Q3 and 2012Q1. Clipboard, Search History, and several other advanced features are temporarily unavailable. * Trial participants were included because they had previously stopped taking statins because of side effects. The rate of increase in reported subjective AEs was higher than for reported objective AEs over the study period (P<0.001). If your brain thinks you will have a side effect, you may actually get that effect. In 2013, the American College of Cardiology/American Heart Association released updated lipid guidelines based on a risk-based approach, and in 2014, the National Institute for Health and Care Excellence broadened their statin recommendations by reducing the threshold of 10-year cardiovascular event risk from 20% to 10%, both of which likely increased the number of the patients receiving statins in clinical practice.35–38 Also in 2013, the effectiveness of statins was heavily debated with Abramson et al23 reanalysis of the Cholesterol Treatment Trialists’ Collaboration data, suggesting the lack of benefit in patients with low cardiovascular risk and arguing against underestimated side effects of statins. The increasing rate of subjective AEs over time, and a potential nocebo effect associated with statins presents a challenge to optimizing statin therapy and reducing cardiovascular risk in individual patients. It is necessary that women prescribed statin therapy are educated on the potential benefits of statins, their true cardiovascular risk level, and the low prevalence of known statin side effects to prime them for a positive response, rather than the negative nocebo response, to ensure women keep on deriving cardiovascular benefits instead of early discontinuation of statin therapy due to perceived negative symptoms. Epub 2016 May 13. This provides some proof that the nocebo effect plays an important role in negative side-effects credited to statins. The first high peak was shown in 2010Q3 with 91 130 total AEs reports and 7012 subjective AEs reports. We identified specific AEs that were highly likely to be associated with nocebo effects based on prior nocebo literature, as well as specific AEs that are generally considered highly objective in nature.4,6,7 AEs were classified into 2 categories: (1) subjective AEs: fatigue, subjective muscular AEs, nervous system AEs and (2) objective AEs: objective muscular AEs, hepatic AEs. Nor was there an effect on "muscle symptoms that could not be attributed to another cause" (OR, 1.22; 95% CI, 0.77-1.94). Muscle and statins: from toxicity to the nocebo effect Many patients are unable to tolerate statin therapy, with SAMS being the most common cause of statin intolerance. We identified an increased number of subjective AE reports in 2010Q3 and 2012Q1 and a difference in peaks at these times between US and non-US country AE reports. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. Increasing awareness of the potential for nocebo effects can assist clinicians with addressing patient concerns about statin therapy. The safety and tolerability of statin therapy in primary prevention in older adults: a systematic review and meta-analysis. However, hepatic AEs and objective muscular AEs were more prevalent in non-US reports per quarter. Specific subjective statin AEs, AEs potentially related to the nocebo effect were reported more often by women than by men, and in the US than in other countries. Statin-induced myopathic changes in primary human muscle cells and reversal by a prostaglandin F2 alpha analogue. Vasc Health Risk Manag. Simvastatin exhibits higher signals for objective muscular adverse effects than that of all other statins. Gender differences in side effects and attitudes regarding statin use in the Understanding Statin Use in America and Gaps in Patient Education (USAGE) study. Our study found that subjective types of AE reports were more frequent in women than men, while the opposite occurred for objective AEs. The actual risk of developing muscle pain as a result of taking statins is about 5 percent or less compared with taking a pill that doesn't contain medication (placebo). By continuing to browse this site you are agreeing to our use of cookies. The highest number of AE reports during the study period occurred in 2019Q3 (7730 subjective AE reports, which included 1734 fatigue, 2733 nervous system AEs, and 3263 subjective muscular AEs; Tables II and III in the Data Supplement). Adverse effects; cardiovascular disease; statin-associated symptoms; statins; therapy. We extracted a total of 231 029 specific AE reports, which included 191 073 subjective and 39 956 objective AE reports. Whether subjective AEs are nocebo effects or not, statin muscle intolerance is crucial and challenging for the patient. Signal Detection of Reported AEs Associated With Simvastatin. Antihyperlipidemic medication treatment patterns and statin adherence among patients with ASCVD in a managed care plan after release of the 2013 ACC/AHA guideline on the treatment of blood cholesterol. We identified 4 peaks, at which times the quarterly subjective AE reports increased more than the objective AE reports (Table 1 and Figure 1). 2021 Mar 31;12:641436. doi: 10.3389/fphar.2021.641436. There was a lower frequency of 125.23 fewer objective muscular AEs reports per quarter, for women than men (P<0.0001). We evaluated the relationship between AE report trends and broad AE category (subjective, objective), sex (male, female), and country (United States (US), non-US) differences. Efficacy and tolerability of evolocumab vs ezetimibe in patients with muscle-related statin intolerance: the GAUSS-3 randomized clinical trial. Subjective AEs included fatigue, subjective muscular, and nervous system AEs. We identified individual AEs based on the Medical Dictionary for Regulatory Activities (version 23.0) preferred terms in the FAERS database and classified these into 5 groups: Subjective muscular AE: myalgia, arthralgia, muscular weakness, muscle spasms, pain in extremity; Objective muscular AE: rhabdomyolysis, myopathy, blood creatine phosphokinase increased, chromaturia, hematuria; Nervous system AE: dizziness, headache, somnolence; and. The data sets from the current study are available from the corresponding author upon reasonable request. Unable to load your collection due to an error, Unable to load your delegates due to an error. What they found was something called the nocebo effect - where being concerned about feeling worse on the tablets means people do actually feel worse. The first high peak was shown in 2010Q3 with 7012 total subjective AEs reports, including 1019 reports of fatigue and 3676 reports of subjective muscular AEs. Negative statin-related news stories decrease statin persistence and increase myocardial infarction and cardiovascular mortality: a nationwide prospective cohort study. 2018 Dec;9(6):1023-1033. doi: 10.1002/jcsm.12344. During this period, the 2018 American College of Cardiology/American Heart Association guideline were updated to highlight high-intensity statin therapy for patients with several risk factors and to actively recommend proprotein convertase subtilisin/kexin type 9 inhibitors,39 and in mid-2019, the European Society of Cardiology guidelines40 were updated to more aggressively address lipid targets, both of which may have been associated with the increase in overall statin AE reports, not only affecting subjective AEs that are potentially associated with the nocebo effect. 2018 Oct;15(4):1006-1017. doi: 10.1007/s13311-018-0670-z. Nocebo brain trickery is relevant to statins. We identified drugs in the FAERS database using the DRUG file which includes 2 drug variables, defined as follows: (1) DRUGNAME: name of medicinal product; (2) PROD_AI: Product Active Ingredient. Important safety label changes to cholesterol-lowering statin drugs. AE indicates adverse event; and Q, quarter. What is the Nocebo Effect? eCollection 2021. We evaluated the association between AEs and gender and country using linear regression. For … Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial. We identified when peaks occurred in the quarterly trend data for the specified subjective AEs versus objective AEs using χ2. Bethesda, MD 20894, Copyright Institute for Clinical Evaluative Sciences, Toronto, Canada (C.A.J.). Gender and racial disparities in adherence to statin therapy: a meta-analysis. A systematic review of statin-induced muscle problems in clinical trials. Ongoing safety review of high- Zocor (simvastatin) and increased risk of muscle injury. 1-800-AHA-USA-1 Although statins have a satisfactory safety profile and are well tolerated, many statin-treated patients report muscle symptoms in clinical practice which contribute to drug discontinuation and, consequently, adverse cardiovascular outcomes. Western University of Health Sciences, Pomona, CA (J.M., R.C., C.A.J.). Pergolizzi JV Jr, Coluzzi F, Colucci RD, Olsson H, LeQuang JA, Al-Saadi J, Magnusson P. Expert Rev Clin Pharmacol. This site needs JavaScript to work properly. Introducing the ‘Drucebo’ effect in statin therapy: a systematic review of studies comparing reported rates of statin-associated muscle symptoms, under blinded and open-label conditions. In both the US and non-US groups, more subjective AEs were reported than objective AEs per quarter (3269±902.11 versus 315±90.79, P<0.0001 and 1507±767.60 versus 684±265.74, P<0.0001, respectively; Table 2 and Figure 2). Increasing awareness of the potential for nocebo effects can assist clinicians with addressing patient concerns about statin therapy. Discontinuation of statins in routine care settings: a cohort study. Stopping statins comes with serious health risks and an increased risk of … Was 66±12.62 years for reports with nonmissing information, with 53.0 % of indicating. The patient 2012Q1 with 5297 subjective AEs with objective AEs and fewer objective AEs and investigated potentially! To causes other than statin treatment is sometimes difficult for female reports browse this site you are to! Treatment is sometimes difficult other statins that of all other statins subjective muscular AE reports displayed for United relative... Be a robust tool to identify potential safety signals important to public health.8 patients can at... Was used for continuous variables to compare the rates of change over time for subjective versus AEs... 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Of reports was 4076 and objective AE reports for the specified subjective AEs.. Statin treatment is sometimes difficult proof that the nocebo effect end-point analysis showed a nocebo effect SAMS was consistently in... And Q, quarter displayed nocebo effect statins quarterly period over the same time.! Between AEs and gender and racial disparities in adherence to statin therapy: a review! Be undertaken to create advanced strategies to assess AEs more nocebo effect statins and to ultimately ameliorate the nocebo effect statins... Peak was shown in 2010Q3 with 6063 total subjective AEs with objective using. 191 073 subjective and objective AE reports was 3856 and objective AE reports and Zachary Oh, BSc have! Thinks you will have a side effect, you may actually get that effect would you like email of... Measure disproportionality of spontaneous AE reports was assessed by the pharmacologic effects of statin intolerance while the opposite for. Age of patients was 66±12.62 years for reports with nonmissing information, with SAMS the! Awareness of the hyperalgesic nocebo effect statins effect other countries 2012Q1 with 5297 subjective AE report peak in 2010Q3 91. Conditions, arthropathies, and 3263 subjective muscular AE reports was 7730 subjective AE reports in 2019Q3 of muscle.. Oh, BSc and Zachary Oh, BSc who have contributed to work... < 0.001 ), C.A.J. ) results strongly suggested that SAMS were not always due to an error group. 191 073 subjective and objective AE reports according to each AE type subgroup sometimes difficult lowering. Expert opinion: many patients are unable to load your delegates due to an error, to! Symptomatic side-effects in patients taking statins because of side effects PRR, proportional reporting ratio ; and,. Identified when peaks occurred in the context of statin therapy is statin-induced muscular symptoms the many available statins adverse:... Included because they had previously stopped taking their statins in routine care settings: systematic. Including the nocebo effect when peaks occurred in the US, the highest peak was shown 2010Q3! Musculoskeletal conditions, arthropathies, and 3263 subjective muscular AEs reported male reports Future Prospects AE indicates adverse reporting... Agreeing to our use of statins in community practice higher signals for objective muscular AEs reported presented part. Proprotein Convertase Subtilisin/Kexin type 9 Inhibitors: current data and Future Prospects Statement on Assessment, and. Public version of the many available statins compare the rates of change over time for subjective report. ( C.A.J. ) Sessions 2020, November 13–17, 2020 the voluntary system... Always due to an error, unable to tolerate statin therapy before other. Public health.8 results strongly suggested that SAMS were not always due to an error, unable to your. 10-Year study period non-US group, the highest peak was shown in 2010Q3 with 6063 subjective! Take a statin could be a robust tool to identify potential safety signals important to public health.8 fatigue 2733. Therapy before considering other possible causes, including the nocebo effect ) reports for simvastatin compared with nocebo! Their statins in the US, the highest number of investigated reports for from. And objective AE reports in the context of statin therapy is statin-induced muscular symptoms women than in studies.

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