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Use of fenofibrate on cardiovascular outcomes in statin users with metabolic syndrome: propensity matched cohort study

BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5125 (Published 27 September 2019) Cite this as: BMJ 2019;366:l5125

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Where's the Beef? Re: Use of fenofibrate on cardiovascular outcomes in statin users with metabolic syndrome: propensity matched cohort study

Where’s the Beef?

In the mid-1980s, Wendy’s had a commercial where an older women asked the question “Where’s the Beef?” We should all be asking ourselves a similar question today – “Where’s the evidence?”

The recent publication by Kim, et al [1] states that fenofibrate has a beneficial effect for individuals already taking a statin medication by lowering their risk of a cardiovascular event. The proof of this is based upon ICD-10 codes. It appears that the publication of manuscripts in medical journals no longer requires diagnostic proof but merely the referral to a billing code. I see this all to often myself as a reviewer for medical journals. There is nothing so convincing, as a retrospective analysis of CPT and ICD codes – not!

As most of us know, once a diagnosis is placed on a patient, it follows them for life – hence the term preexisting condition. Patients with elevated lipids, as in this case, will automatically be assigned the applicable CPT and ICD code(s) since this is how payment for medical care is determined – no matching ICD or CPT code equals no payment for services – and no payment for service interferes with reimbursement and provision of medical care – and that is of course, unacceptable.

Coronary artery disease (CAD) is an inflammatory process associated with a variety of mediators, which have different impacts on different people, determined by the genetics of the individual involved [2]. These mediators are measured via blood tests and include lipids (LDL, HDL, TG), homocysteine, lipoprotein (a), fibrinogen, c-reactive protein, interleukin-6, potential infectious agents, et cetera [2]. However, the measured changes in these blood tests do not correlate with the actually measured changes in CAD [3]. If you want to know if CAD changes, you actually need to measure it [4].

In reviewing the medical literature, it is clear that the primary methods for assessing the benefit of lipid lowering and dietary regimens, has been (A) the retrospective review of ICD and CPT codes - which fails as discussed, (B) blood tests - which do not correlate with changes in CAD [3] and (C) coronary arteriography - which is severely flawed as already established in the literature [5].

So once again, I ask, “Where’s the proof?” Where is the scientific evidence that statins or the fibric acid derivatives actually reverse or stabilize CAD and do more than merely change a blood test?

Acknowledgment: FMTVDM issued to author.

References:

1. Kim NH, Han KH, Choi J, Lee J, Kim SG. Use of fenofibrate on cardiovascular outcomes in statin users with metabolic syndrome: propensity matched cohort study. BMJ 2019;366:l5125.
2. Fleming RM. Chapter 64. The Pathogenesis of Vascular Disease. Textbook of Angiology. John C. Chang Editor, Springer-Verlag New York, NY. 1999, pp. 787-798.
3. Fleming RM, Harrington GM. "What is the Relationship between Myocardial Perfusion Imaging and Coronary Artery Disease Risk Factors and Markers of Inflammation?" Angiology 2008;59:16-25.
4. Fleming RM, Fleming MR, Chaudhuri TK. The Need to Actually Measure What We’re Talking about before We Put it All Together. Int J Nuclear Med Radioactive Subs 2019;2(1):000114.
5. Fleming RM., Kirkeeide RL, Smalling RW, Gould KL. Patterns in Visual Interpretation of Coronary Arteriograms as Detected by Quantitative Coronary Arteriography. J Am Coll. Cardiol. 1991;18:945- 951.

Competing interests: FMTVDM issued to author.

28 September 2019
Richard M Fleming, PhD, MD, JD
Physicist-Physician
FHHI-OI-Camelot
Los Angeles, CA