Paul M. Ridker, MD on Lodoco’s FDA approval for CV risk reduction.

Cardiology Pharmaceuticals

Agepha’s Lodoco FDA-Approved for CVD Inflammation

Agepha Pharma’s Lodoco (colchicine) just became the first anti-inflammatory drug to land FDA approval for reducing cardiovascular event risks, marking a major milestone in the emerging field of CVD inflammation treatment.

• The once-daily 0.5 mg tablet is approved for risk reduction of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established ASCVD or with multiple cardiovascular disease risk factors.

Lodoco can be used alone, but it’s expected to mainly be prescribed to patients who are already taking cholesterol-lowering medications and experienced a previous heart attack or stroke. If these patients’ high-sensitivity CRP tests show that their inflammation isn’t controlled, they might be even more likely to receive Lodoco.  

• Lodoco’s FDA approval is largely based on the LoDoCo2 trial, which showed that colchicine reduced CV death and MACE risks by 31% compared to placebo among a similar group of patients.
  
• Colchicine has also earned spots in the European and South American CVD guidelines, and has Health Canada approval for atherothrombotic risk reduction among adults with CAD.

Colchicine might ring a bell to some readers, since it’s been used to treat gout, pericarditis, and familial Mediterranean fever (in 0.6 mg tablets). However, Lodoco has reportedly been reformulated for long-term CVD treatment, and there’s no generic colchicine alternatives for CVD.

Lodoco’s role as the first anti-inflammatory for CVD risk reduction might prove to be a significant milestone, given the mounting evidence that inflammation is an independent contributor to ASCVD and CV events, and what appears to be growing business and academic interest in treating CVD inflammation.

• That said, the significance of Lodoco’s FDA approval will depend on how widely it’s adopted, requiring a strong commercialization push by Agepha, as well as Lodoco’s real world performance earning the trust of physicians and cardiology societies.

The Takeaway

It’s widely understood that inflammation contributes to ASCVD and drives CV events, and now for the first time US physicians have a way to treat CVD inflammation. That makes Lodoco’s FDA approval a significant milestone, and could make its future support by guidelines, physicians, and payors even more significant milestones.

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The Wire

• Eclampsia Tragedy, Awareness: The recent death of US Olympic sprinter Tori Bowie during childbirth brought eclampsia into the national spotlight, with NYT, Washington Post, CNN, and Smithsonian Magazine all headlining their coverage with some version of: “What is Eclampsia?” Tori Bowie’s autopsy attributed her death to “complications of childbirth,” and listed “respiratory distress and eclampsia,” as contributing factors. The subsequent news coverage detailed eclampsia’s rare and severe nature and explored troubling trends surrounding prenatal hypertension among black women.

• Anumana’s Amyloidosis Breakthrough Designation: The FDA granted Breakthrough Device Designation to Anumana’s ECG-AI algorithm, which analyzes ECGs to identify patients with cardiac amyloidosis. Anumana highlighted the solution’s potential to allow earlier amyloidosis detection, citing the challenges diagnosing the rare disease when it’s still early-stage, and noting that many amyloidosis patients with “nonspecific symptoms” undergo ECG exams well before being diagnosed. AI tools for cardiac amyloidosis detection appear to have the FDA’s attention, noting that Ultromics’ echo AI amyloidosis solution also recently landed Breakthrough Designation.

• ChatGPT Fabricates Medical References: Over two-thirds of medical references provided by ChatGPT are fabricated, according to researchers who asked the large language model 20 medical questions and measured its accuracy. ChatGPT’s references “looked credible” at first glance, but 69% were apparently made up. The findings reinforce concerns about ChatGPT’s “hallucination effect,” and raise questions about whether it’s ready for prime time when it comes to incorporation in patient-facing software.

• Philips & BIOTRONIK’s Outpatient Alliance: Philips and BIOTRONIK announced a new partnership that will make BIOTRONIK’s cardiovascular technology portfolio available in Philips’ SymphonySuite, a combination of products, solutions, and services targeting cardiovascular office-based labs (OBLs) and ambulatory surgery centers (ASCs). The alliance appears to specifically bolster SymphonySuite’s cardiac rhythm management capabilities, while also adding BIOTRONIK’s cardiovascular intervention and peripheral vascular intervention products.

• Beta-Blockers Out-Perform Calcium Channel Blockers: A JAMA Cardiology meta-analysis (10 studies, 13k patients) revealed that beta-blockers may reduce HFpEF patients’ risk of death and hospitalization more effectively than calcium channel blockers. Although both medications out-performed placebos, beta-blockers led to greater reductions in both death (risk ratios: 0.60 vs. 0.77) and hospitalization (RRs: 0.54 vs. 0.63) than calcium channel blockers.

• CorWave’s LVAD Funding: Left ventricular assist device startup CorWave announced that its Series C round reached $64M (total funding $144M), revealing plans to continue product development and open its manufacturing facility. CorWave’s wave membrane pump LVAD system is designed to mimic healthy hearts’ pulse and blood flow rates, which it suggests would reduce complications “associated with current devices” and improve heart failure patient management. CorWave is likely referring to Abbott’s HeartMate systems, which are the only LVAD devices available in the U.S.

• New Hope for ATTR-CM: In an unprecedented finding, scientists from University College London reported that three elderly men spontaneously recovered from cardiac transthyretin amyloidosis (ATTR-CM)–a universally fatal condition. The scientists found that all three men had specific antibodies that bind to amyloid deposits, a key feature of ATTR-CM. The other 350 patients in the cohort, whose disease progressed normally, did not have these antibodies. The authors are investigating if the antibodies can be recreated in a lab and used to cure ATTR-CM. 

• Two Sides to Physician Salary Growth: MGMA’s survey of almost 190,000 providers found that U.S. specialist physicians’ compensation growth might not be as good as it seems. Specialist compensation gains in 2022 (2.13% – 2.54%) were far outpaced by last year’s 6.5% inflation rate. Meanwhile, cardiology subspecialists (Invasive, Invasive-Interventional, Noninvasive) saw modest pay growth since 2018 (+7.57%, +4.89%, +5.69%), but mixed wRVU trends meant that most had to work harder for those gains (+2.38%, -3.35%, +5.79%).

• Finerenone Reduces CV Risk in Diabetic CKD Patients: Finerenone may reduce cardiovascular complications related to chronic kidney disease (CKD) in patients with type 2 diabetes (T2D). That’s from a JAMA Cardiology subanalysis of the FIDELITY trial. Among the 13k participants, finerenone significantly reduced composite CV risk for those with CKD, T2D, high albuminuria, and an estimated eGFR above 25 (hazard ratio: 0.86). A simulation of the data suggested that, in a single year, finerenone could prevent over 38k cardiovascular events, including approximately 14k HF hospitalizations. 

• Black Market Stolen Remains: The morbid story of the week goes to the Harvard Medical School morgue manager accused of stealing human body parts and pawning them on the black market. The federal indictment claims that the morgue manager was trafficking hearts, heads, bones, and skin through a “nationwide network,” and it’s particularly egregious that most of the cadavers were from bodies donated to research. Harvard’s been getting some backlash over its handling of the situation, which has yet to address its failures in oversight.

• Cardiac MRI for Chest Pain: Cardiac MRI can be a good alternative to invasive techniques for evaluating patients presenting to the ER with acute chest pain and mildly elevated troponin levels. The CMR-IMPACT study (N=312, 2013-2018) found that 58% of patients with negative CMRs were safely discharged without need for further intervention within 90 days. CMR also had no statistically significant difference in adverse events, and led to lower invasive angiography rates (52% vs. 74%).

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