Increased statin cessation rate follows media debates on side-effects of statins

Impact of statin related media coverage on use of statins: interrupted time series analysis with UK primary care data

Literature - Matthews A et al., BMJ 2016


Matthews A, Herrett E, Gasparrini A et al.,
BMJ 2016; 353 doi: http://dx.doi.org/10.1136/bmj.i3283 (Published 28 June 2016)

Background

Both academic press and lay media have raised concern about supposedly high rates of side effects of statins, such as muscle pain and weakness. In October 2013, The BMJ published two articles that were perceived as critical of statins, one of which suggested that side effects might outweigh the overall health benefits in those at low and intermediate risk [1,2]. These articles generated an extensive and broader discussion in the media about statins, with a peak in the United Kingdom in March 2014. Media coverage may have intensified as a consequence of the proposed changes in the NICE guidelines of July 2014, which broadened eligibility for statins from those with high to patients with an intermediate (>10%) 10 year risk.

Previous studies have shown that media debates about side effects have led to measurable effects on aspects of the use of statins [3-6]. Nevertheless, no large studies have comprehensively evaluated effects of media debates about statin therapy on prescription in primary or secondary prevention of CVD.

This study benefitted from routinely collected prescribing data in UK primary care records (CPRD: UK Clinical Practice Research Datalink). The potential association between the media debate about side effects of statins and initiation and cessation of treatment in UK primary care was assessed (proportion of patients initiating or stopping statins recorded for each month from January 2011 to March 2015). Stopping was defined as no further prescription within 28 days after the end date of the previous prescription. Moreover, a public health impact was estimated. Eligibility for primary prevention was based on a 10 year CV risk score of >20% (n=88010 individuals). Incident CV events implied eligibility for secondary prevention (28592 incident CV events). Period of exposure was defined as October 2013 to March 2014.

Main results

  • No stepped change in statin initiation for primary prevention was seen after the exposure period, as compared with before (adjusted for the underlying increasing trend over time: OR: 0.99, 95%CI: 0.87-1.13), nor for secondary prevention (OR: 1.04, 95%CI: 0.92-1.18).
  • After the exposure period, patients were more likely to stop staking statins as compared with before, both for primary (OR: 1.11, 95%CI:1.05-1.18) and secondary prevention (OR: 1.12, 95%CI: 1.04-1.21). No underlying month-to-month trend in statin cessation was noted.
  • Those who had taken statins for a longer period showed a more pronounced likelihood of stopping with statins than those with shorter previous use  (P-trend <0.001 for both primary and secondary prevention). This trend was more pronounced in older age groups.
  • The increase in cessation appeared to be restricted to the first six months after exposure. Indeed, immediately after the exposure period patients were more likely to stop statins used (OR: 1.19, 95%CI: 1.02-1.39 for primary prevention and OR: 1.25, 95%CI: 1.02-1.53 in secondary prevention), after which the likelihood gradually decreased towards baseline.
  • There was evidence that patients were less likely to have any recorded risk score in the post-exposure period (OR: 0.85, 95%CI: 0.78-0.93) as compared with pre-exposure.
  • An estimated excess of 218971 patients across the UK stopped taking a statin in the six months after the media debate. This yields an estimated number of excess CV events of at least 2173 within the next 10 years, when assuming an estimated restart rate of 66% in those who stopped taking a statin without a statin-related event. If all stopped indefinitely, the estimated number of excess CV events would be 6372.

Conclusion

These data show that a period of intense media coverage of statins and their side effects was followed by an increased rate of cessation of statins prescribed as primary and secondary CV prevention in UK primary care. After six months, the cessation rate returned to expected levels. In particular patients who had used statins for longer and older patients showed a higher likelihood of stopping statin therapy. Thus, widely covered health stories can have an effect on health behaviour.   

Editorial comment [7]

In a critical editorial, Schwitzer (journalist and adjunct associate professor) points out that the news in question was not all negative, with both extremes represented. Schwitzer states that causal language was used in the article, while causality was not proven. “The authors provide no patient survey data to support the belief that people stopped because of news reports.” (…)
“But what if news coverage did have an effect, by alerting people to the debate and uncertainty that still exist about the extent of potential benefits and harms of statin use? Is that such a bad thing? As Montori and others have said, “Informed patients may choose not to follow a guideline that does not incorporate their preferences.” In the current study, nothing is documented about the quality of the clinical decision making encounters before initiation of treatment, or about the reasons why patients stopped.
As a publisher of HealthNewsReview.org, Schwitzer has systematically reviewed media messages that make claims about healthcare interventions for 10 years. He concludes based on thousands of stories “that most emphasize or exaggerate potential benefits, while minimizing or ignoring potential harms.” Overdiagnosis, overtreatment or shared decision making are rarely the topic of journalistic productions.
Matthews and colleagues “did not explore the possibility of reduced reports of muscle pain, rhabdomyolysis, liver damage, diabetes, or cognitive side effects.” Schwitzer suggests that the media can help understand the uncertainty that still exists over the harms and benefits of statins, and that if that generates questions from patients, and more complete conversations between patients and clinicians and shared decision making, “that is an outcome to embrace.”

Find this article online at BMJ

References

1. Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin?BMJ 2013; 347:f6123.
2. Malhotra A. Saturated fat is not the major issue. BMJ 2013: 347: f6340.
3. Schaffer AL, Buckley NA, Dobbins TA, et al. The crux of the matter: Did the ABC’s Catalyst program change statin use in Australia?Med J Aust 2015;202:591-5.
4. Saib A, Sabbah L, Perdrix L, et al. Evaluation of the impact of the recent controversy over statins in
France: the EVANS study. Arch Cardiovasc Dis 2013;106:511-6..
5. Nielsen SF, Nordestgaard BG. Negative statin-related news stories decrease statin persistence and increase myocardial infarction and cardiovascular mortality: a nationwide prospective cohort study. Eur Heart J 2016;37:908-16
6. Kocas C, Abaci O, Kocas BB, et al. The role of media on statin adherence. Int J Cardiol 2015; 201:139
7. Schwitzer G. Statins, news and nuance. BMJ 2016. 353:i3379. Published June 28 2016

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