In the JournalsPerspective

Half of patients on statins have suboptimal response at 2 years

More than half of patients undergoing statin therapy failed to achieve LDL reduction of more than 40% within 2 years, and these patients were at elevated CVD risk compared with optimal responders, according to findings published in Heart.

Ralph Kwame Akyea, MBChB, and colleagues assessed LDL response and future CVD risk in patients after initiation of statins.

“The positive correlation between the incidence of CVD and levels of [LDL] concentration has been well established,” Akyea, a research associate faculty of medicine & health sciences at the University of Nottingham in the United Kingdom, and colleagues wrote in the study. “Statins are recognized as being effective in lowering cholesterol and reducing the risk of future CVD events for both primary or secondary prevention.”

The researchers analyzed a cohort of 165,411 primary care patients from the UK Clinical Practice Research Datalink, who were free of CVD before statin initiation and had LDL assessed at least once within 1 year before statin initiation and at least once 2 years after.

Akyea and colleagues found 51.2% of patients had a suboptimal LDL response, defined as a decrease of more than 40%, to initiated statin therapy within 2 years.

During 1,077,299 person-years of follow-up (median follow-up, 6.2 years) 22,798 CVD events occurred (suboptimal responders, 22.6 per 1,000 person-years; optimal responders, 19.7 per 1,000 person-years), the researchers wrote.

In suboptimal responders, risk for incident CVD was higher than in optimal responders (HR = 1.17; 95% CI, 1.13-1.2), and the difference rose after adjustment for age and baseline untreated LDL (HR = 1.22; 95% CI, 1.19-1.25), Akyea and colleagues wrote.

More than half of patients undergoing statin therapy failed to achieve LDL reduction of more than 40% within 2 years, and these patients were at elevated CVD risk compared with optimal responders, according to findings published in Heart.
Source: Adobe Stock

When considering competing risks, CVD risk remained higher in the suboptimal group compared with the optimal group, but to a lesser degree (unadjusted HR = 1.13; 95% CI, 1.1-1.16; adjusted HR = 1.19; 95% CI, 1.16-1.23), the researchers wrote.

“These findings contribute to the debate on the effectiveness of statin therapy and highlight the need for personalized medicine in lipid management for patients,” Akyea and colleagues said in a press release.

Márcio S. Bittencourt, MD, MPH, PhD, of the division of internal medicine at University Hospital, Sao Paulo and the department of internal medicine at Brigham and Women’s Hospital and Fernando H.Y. Cesena, MD, PhD, of the Hospital Israelita Albert Einstein in Sao Paulo in a related editorial noted finding the right strategy is important in statin therapy.

“Effective implementation of guidelines among healthcare practitioners and the general population has been a challenge for a long time. Both physicians and patients should be targets for approaches aiming at improving adherence to guidelines,” they wrote. “Reassurance of statin safety should be emphasized to both doctors and patients in order to diminish excessive, unrealistic concerns.” – by Earl Holland Jr.

Disclosures: Akyea and the editorial writers report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

More than half of patients undergoing statin therapy failed to achieve LDL reduction of more than 40% within 2 years, and these patients were at elevated CVD risk compared with optimal responders, according to findings published in Heart.

Ralph Kwame Akyea, MBChB, and colleagues assessed LDL response and future CVD risk in patients after initiation of statins.

“The positive correlation between the incidence of CVD and levels of [LDL] concentration has been well established,” Akyea, a research associate faculty of medicine & health sciences at the University of Nottingham in the United Kingdom, and colleagues wrote in the study. “Statins are recognized as being effective in lowering cholesterol and reducing the risk of future CVD events for both primary or secondary prevention.”

The researchers analyzed a cohort of 165,411 primary care patients from the UK Clinical Practice Research Datalink, who were free of CVD before statin initiation and had LDL assessed at least once within 1 year before statin initiation and at least once 2 years after.

Akyea and colleagues found 51.2% of patients had a suboptimal LDL response, defined as a decrease of more than 40%, to initiated statin therapy within 2 years.

During 1,077,299 person-years of follow-up (median follow-up, 6.2 years) 22,798 CVD events occurred (suboptimal responders, 22.6 per 1,000 person-years; optimal responders, 19.7 per 1,000 person-years), the researchers wrote.

In suboptimal responders, risk for incident CVD was higher than in optimal responders (HR = 1.17; 95% CI, 1.13-1.2), and the difference rose after adjustment for age and baseline untreated LDL (HR = 1.22; 95% CI, 1.19-1.25), Akyea and colleagues wrote.

More than half of patients undergoing statin therapy failed to achieve LDL reduction of more than 40% within 2 years, and these patients were at elevated CVD risk compared with optimal responders, according to findings published in Heart.
Source: Adobe Stock

When considering competing risks, CVD risk remained higher in the suboptimal group compared with the optimal group, but to a lesser degree (unadjusted HR = 1.13; 95% CI, 1.1-1.16; adjusted HR = 1.19; 95% CI, 1.16-1.23), the researchers wrote.

“These findings contribute to the debate on the effectiveness of statin therapy and highlight the need for personalized medicine in lipid management for patients,” Akyea and colleagues said in a press release.

Márcio S. Bittencourt, MD, MPH, PhD, of the division of internal medicine at University Hospital, Sao Paulo and the department of internal medicine at Brigham and Women’s Hospital and Fernando H.Y. Cesena, MD, PhD, of the Hospital Israelita Albert Einstein in Sao Paulo in a related editorial noted finding the right strategy is important in statin therapy.

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“Effective implementation of guidelines among healthcare practitioners and the general population has been a challenge for a long time. Both physicians and patients should be targets for approaches aiming at improving adherence to guidelines,” they wrote. “Reassurance of statin safety should be emphasized to both doctors and patients in order to diminish excessive, unrealistic concerns.” – by Earl Holland Jr.

Disclosures: Akyea and the editorial writers report no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

    Perspective
    Rita F. Redberg

    Rita F. Redberg

    This observational study is not informative due to limitations in methodology that limit any conclusions.

    They do not account for who took their statin and who did not.

    It is very likely that all they are describing in this paper, is the already well-known fact that people who comply with their doctor’s recommendation, including taking their medications, are healthier and live better and longer than those that don’t. That is true even if the prescription is for a sugar pill.

    It is likely that “statin responders” are simply patients who are compliant with their medications and future CV risk has nothing to do with a so-called statin responder status.

    We need research on risks and benefits of statins, especially when we are thinking of prescribing medications, such as statins to healthy people.

    This paper, shockingly, makes no mention of adverse effects suffered by people who take statins.

    Thus, it is an unbalanced view and a missed opportunity to contribute to the sparse database on adverse effects associated with statins.

    I see patients in my practice every week who suffered needlessly from adverse events of statins such as muscular aches and pains, fatigue, memory loss, diabetes and feeling in a fog, while getting no health benefits.

    • Rita F. Redberg, MD, MSc, FACC
    • Cardiology Today Editorial Board Member
      UCSF Division of Cardiology
      Editor, JAMA Internal Medicine

    Disclosures: Redberg reports no relevant financial disclosures.