Most adults eligible for statins for prevention are not using them

Embargoed for release until 5:00 p.m. ET on Monday 4 December 2023 
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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent. 
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1. Most adults eligible for statins for prevention are not using them  

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1915   
URL goes live when the embargo lifts   
Many adults eligible for statin use to prevent cardiovascular disease are not receiving them. A brief research report describing trends in statin prescribing is published in Annals of Internal Medicine.   

In 2013, the American Academy of Cardiology/American Heart Association (ACC/AHA) guidelines expanded statin eligibility for primary prevention based on atherosclerotic cardiovascular disease (ASCVD) risk score. Previous studies have not assessed whether the expanded guidelines were associated with changes in statin use in the United States.  

Researchers from the University of Pittsburgh and Beth Isreal Deaconess Medical Center studied NHANES (National Health and Nutrition Examination Survey) data for adults aged 20 and older from 1999 to 2018 to describe trends in statin use for primary prevention across indication categories and ASCVD risk scores. They found that although overall statin use for primary prevention has increased over time, it plateaued between 2013 and 2018, with only 35 percent of eligible adults receiving statins. Furthermore, most adults with the strongest guideline recommendations for primary prevention statins are not receiving them, including those with diabetes, extremely high cholesterol, or 10-year risk of cardiovascular disease over 20%. This could be because even though indications for statin use have widened, decision-making complexity has also increased, requiring new multistep risk calculation. This is something that busy clinicians often do not have time to do. According to the authors, these findings suggest that innovative efforts are needed to target patients with the greatest risk.  

  
Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Timothy S. Anderson, MD, MAS, please contact Elaine Vitone at VitoneEG@upmc.edu. 

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2. Early albuminuria reduction beneficial in patients with CKD and diabetes  

Abstract: https://www.acpjournals.org/doi/10.7326/M23-1023     
URL goes live when the embargo lifts   
Finenerone-induced early albuminuria reduction can lead to tangible benefits for both kidney and cardiovascular health in patients with both chronic kidney disease (CKD) and type two diabetes.  The findings from a post hoc analysis of two phase 3 randomized controlled trials are published in Annals of Internal Medicine.   

In patients with CKD and type 2 diabetes, finerenone, a nonsteroidal mineralocorticoid receptor antagonist, reduces adverse cardiovascular and renal outcomes. Finerenone also lowers the urine albumin-to-creatinine ratio (UACR). Whether finerenone-induced change in UACR mediates the improved outcomes is unknown.  

Researchers from Indiana University School of Medicine and worldwide collaborators, analyzed pooled data from two phase 3 trials of finerenone to quantify the proportion of kidney and cardiovascular risk reductions seen over a 4-year period. Risk reduction was measured by a change in kidney injury indicated by the change in UACR from baseline to month four. The data showed that among patients with CKD and T2D, finerenone-induced improvement in kidney injury seemed to mediate a large proportion of long-term kidney outcomes and a modest proportion of cardiovascular outcomes. Specifically, compared with patients who had less than 30% reduction in UACR, those with 30% or greater reduction in UACR had fewer composite kidney and composite cardiovascular outcome events. According to the authors, these findings emphasize the importance of monitoring UACR after initiating treatment, as it can serve as a valuable surrogate indicator of early treatment efficacy and offer insights into potential long-term kidney and cardiovascular benefits.  

  
Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Rajiv Agarwal, MD, MS, please contact ragarwal@iu.edu 

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3. CAR-T not cost-effective as a second-line therapy for DLBCL at current prices  

Abstract: https://www.acpjournals.org/doi/10.7326/M22-2276  
URL goes live when the embargo lifts   
Chimeric antigen receptor T-cell therapy (CAR-T) has been proven effective as a second-line treatment for patients with relapsed diffuse large B-cell lymphoma (DLBCL), but the price must be lowered substantially to be considered cost-effective. The findings from a cost-effectiveness analysis are published in Annals of Internal Medicine.   

Compared with salvage chemoimmunotherapy with autologous stem cell transplantation (ASCT), the current standard of care for primary-refractory and early-relapsed (high-risk) DLBCL, CAR-T offers superior event-free survival and overall survival. However, at list prices exceeding $400,000 per infusion, cost-effectiveness could be an issue.   

Researchers from Dana-Farber Cancer Institute utilized data from several trials including ZUMA-7 and TRANSFORM to determine the cost-effectiveness of second-line CAR-T versus salvage chemoimmunotherapy with ASCT. They found that neither second-line CAR-T treatment with axi-cel nor liso-cel was cost-effective at a willingness-to-pay threshold of $200,000 per quality-adjusted life-year (QALY). Both survival and quality of life improved incrementally, but the data shows that costs of CAR-T must be lowered substantially to enable cost-effectiveness. The authors found that the price of CAR-T would have to be reduced by over $100,000 per patient for it to be cost-effective. Their budget impact analysis found that the US health sector would spend an additional $6.8 billion over 5 years with CAR-T as the new standard of care. 

According to the authors, these findings may be relevant to clinic and hospital administrators negotiating reimbursements, pharmaceutical companies balancing costs and profits, private and public insurers navigating negotiations, and policymakers seeking to rein in rising drug prices. The QALY data may also guide clinician–patient treatment discussions.  

  
Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Amar H. Kelkar, MD, MPH, please contact Nicole Oliverio at nicole_oliverio@dfci.harvard.edu. 

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Also New in this issue: 

An Ethical and Financial Obligation for Sickle Cell Disease Gene Therapy in the United States 

Austin Wesevich, MD, MPH; Monica E. Peek, MD, MPH, MSc; and Mark J. Ratain, MD   

Ideas and Opinions 

Abstract: https://www.acpjournals.org/doi/10.7326/M23-2428