"Bad Press" May Make Patients Stop Statins, Raise MI Risk
When the media was dominated by negative news stories about statins, patients who were newly prescribed these drugs were 9% more likely to not refill their initial prescriptions (instead of refilling them), in a Danish national cohort study[1]. Moreover, compared with patients who complied with therapy, those who stopped taking a statin early on were 26% more likely to have an MI and 18% more likely to die, during follow-up.
The study, by Drs Sune Fallgaard Nielsen and Børge Grønne Nordestgaard (University of Copenhagen, Denmark), was published December 2, 2015 in the European Heart Journal. Male sex, higher statin dose, living in a city, being non-Danish, and being prescribed a statin in more recent years were also linked with stopping statins.
"Our results are less driven by a single [news] story but rather by the overall 'image' of statins as presented in the media [including websites, radio, television, magazines and newspapers] that an individual could be exposed to in the first 6 months after beginning statin therapy," Dr Nordestgaard explained to heartwire from Medscape.
"This study is important, as it will hopefully bring focus to the issue of statin noncompliance in the general population, to clinicians as well as to the population at large," he added. It suggests that negative statin-related media coverage may convince some people to stop taking this medication.
"It's a very important study and very disturbing in many ways," Dr Steve Nissen (Cleveland Clinic, OH) echoed, in a comment to heartwire . People stop taking statins "on the basis of . . . generally poor-quality reporting on criticisms . . . coming from not-very-good scientific sources," he noted. "The most disturbing thing in the article is that these people who had early discontinuation had increased risk of myocardial infarction."
To address this, "major media outlets need to be more careful about how they cover stories generated by antistatin zealots," Nissen said, adding that the major cardiology societies should lead in providing public education about statin benefits and safety.
Probing Patient Compliance With Statins
"Statins represent a success story in modern medicine and [are] currently the most effective way to prevent cardiovascular disease," Nordestgaard said. There is a tremendous amount of evidence from randomized controlled trials involving hundreds of thousands of patients, Nissen concurred.
That said, when they begin taking a statin, patients may experience uncomfortable sore muscles, and negative news stories about statins may convince them to stop this medication.
"There has been interest in the slight increase in diabetes in people who take statins," Nissen noted. "But if you really want to see [the negative reporting], all you have to do is go to Google." A search for "statin benefits" results in 1,140,000 hits, whereas one for "statin side effects" gives 6,480,000 hits. Some negative stories are on websites that promote fad diets.
"People come in my office and I tell them they have very high LDL cholesterol and I want to treat them with a statin, and they're resistant because they've read . . . these [negative] stories," Nissen added.
What Factors Prompt Early Discontinuation of Statins?
Nordestgaard and colleagues aimed to see whether statin-related news stories, cardiovascular disease, diabetes, statin dose, calendar year, and sociodemographic status are associated with early statin discontinuation.
They identified 674,900 Danish adults aged 40 and older who received an initial statin prescription (for a maximum of 4 months, or <120 pills) from 1995 to 2010.
Of these, 91,551 patients stopped taking a statin and 583,349 patients continued taking a statin 6 months after their initial prescription began.
The researchers also identified 1931 statin-related news stories from January 1995 until 2011 in Danish media, which they classified as negative (110 stories), neutral (1090), or positive (731), and which were local or came from the UK.
Negative news stories usually came from comments from individual patients or from critics of cholesterol treatment in general, Nordestgaard said. "There has been a particular period of bad press concerning the 'cholesterol myth,' " which highlighted side effects without balanced reporting of the benefits of reduced morbidity and mortality, he noted. Positive stories tended to focus on new evidence from trial data published in major international medical journals.
From 1995 to 2010, the percentage of Danish adults (aged 40 and older) who received statins increased from <1% to 11%, and the percentage who discontinued this therapy increased from 6% to 18%. The number of negative news stories about statins rose from 30 to 400 from 1995 to 2009.
Patients who were exposed to more negative news stories were more likely to discontinue stain use early (odds ratio 1.09; 95% CI 1.06–1.12), after adjustment for multiple variables.
The odds of discontinuing statin therapy within 6 months increased 4% per increasing calendar year, 4% per increasing daily dose, 5% for being male, 13% for living in a city, and 67% for being non-Danish.
On the other hand, the odds of stopping therapy were 8% lower in patients exposed to positive statin news stories, 27% lower among patients with preexisting CVD, and 9% lower among patients with preexisting diabetes.
During up to 14 years of follow-up (median 4.3 years), in a matched study of 424,000 patients who continued statins and 84,800 patients who discontinued statins early on, 19,429 individuals developed MI and 19,173 died from CVD.
Patients who discontinued statins early were more likely to have an MI (HR 1.26, 95% CI 1.21–1.30) or die from CV causes (HR 1.18, 95% CI 1.14–1.23) during follow-up, after adjustment for multiple factors.
Strategies to Improve Compliance
"These findings suggest a need for protocols aimed at increasing early adherence to statin therapy," the authors conclude.
"It is important that clinicians continue to inform their patients on all known potential side effects, including muscle soreness . . . [and] about all the positive effect of statins on reduced cardiovascular morbidity and mortality and that the positive effects for the majority of patients outweigh minor side effects," Nordestgaard said. A recent consensus paper from the European Atherosclerosis Society provides detailed advice on how to deal with statin-associated muscle symptoms, he noted[2].
"Good centers come up with strategies, sometimes involving low doses of statin, given intermittently," Nissen said, adding that "the solution is certainly not to take away lifesaving medications."
This work was supported by the department of clinical biochemistry, Herlev and Gentofte Hospital, Copenhagen University Hospital. Nordestgaard has received consultancy fees and/or lecture honoraria from AstraZeneca, Pfizer, Merck, Amgen, Sanofi, Regeneron, Omthera, Dezima, ISIS Pharmaceuticals, Aegerion, Fresenius, B Braun, Kaneka, Lilly, Kowa, and Denka Seiden. Nielsen has no relevant financial relationships. Nissen consults for many pharmaceutical companies, which donate the honoraria/consulting fees directly to charity. Through the Cleveland Clinical Coordinating Center for Clinical Research, he has received research support but no personal remuneration from Pfizer, AstraZeneca, Novartis, Novo Nordisk, Roche, Daiichi Sankyo, Karo Bio AB, Takeda Pharmaceuticals, Sanofi, Resverlogix, Oregixen, Eli Lilly, Amgen, Vivus, and Omthera.
Of these, 91,551 patients stopped taking a statin and 583,349 patients continued taking a statin 6 months after their initial prescription began.
The researchers also identified 1931 statin-related news stories from January 1995 until 2011 in Danish media, which they classified as negative (110 stories), neutral (1090), or positive (731), and which were local or came from the UK.
Negative news stories usually came from comments from individual patients or from critics of cholesterol treatment in general, Nordestgaard said. "There has been a particular period of bad press concerning the 'cholesterol myth,' " which highlighted side effects without balanced reporting of the benefits of reduced morbidity and mortality, he noted. Positive stories tended to focus on new evidence from trial data published in major international medical journals.
From 1995 to 2010, the percentage of Danish adults (aged 40 and older) who received statins increased from <1% to 11%, and the percentage who discontinued this therapy increased from 6% to 18%. The number of negative news stories about statins rose from 30 to 400 from 1995 to 2009.
Patients who were exposed to more negative news stories were more likely to discontinue stain use early (odds ratio 1.09; 95% CI 1.06–1.12), after adjustment for multiple variables.
The odds of discontinuing statin therapy within 6 months increased 4% per increasing calendar year, 4% per increasing daily dose, 5% for being male, 13% for living in a city, and 67% for being non-Danish.
On the other hand, the odds of stopping therapy were 8% lower in patients exposed to positive statin news stories, 27% lower among patients with preexisting CVD, and 9% lower among patients with preexisting diabetes.
During up to 14 years of follow-up (median 4.3 years), in a matched study of 424,000 patients who continued statins and 84,800 patients who discontinued statins early on, 19,429 individuals developed MI and 19,173 died from CVD.
Patients who discontinued statins early were more likely to have an MI (HR 1.26, 95% CI 1.21–1.30) or die from CV causes (HR 1.18, 95% CI 1.14–1.23) during follow-up, after adjustment for multiple factors.
Strategies to Improve Compliance
"These findings suggest a need for protocols aimed at increasing early adherence to statin therapy," the authors conclude.
"It is important that clinicians continue to inform their patients on all known potential side effects, including muscle soreness . . . [and] about all the positive effect of statins on reduced cardiovascular morbidity and mortality and that the positive effects for the majority of patients outweigh minor side effects," Nordestgaard said. A recent consensus paper from the European Atherosclerosis Society provides detailed advice on how to deal with statin-associated muscle symptoms, he noted[2].
"Good centers come up with strategies, sometimes involving low doses of statin, given intermittently," Nissen said, adding that "the solution is certainly not to take away lifesaving medications."
Source: www.medscape.com
