A tweet from Michael Gibson, MD, in which he encourages the Twitterverse to sign a letter urging Medicare to cover obesity medication. 

Cardiology Pharmaceuticals

FDA Warns 7 Supplement Companies for Illegally Claiming CV Benefits

Just weeks after results from the SPORT trial showed no cholesterol benefit from common heart supplements, the FDA has issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease. The FDA is urging consumers not to use these or similar products because they have not been evaluated to be safe or effective for their intended use, and may in fact be harmful. 

The warning letters were issued to: 

• Iwi
• Essential Elements
• Calroy Health Sciences LLC
• BergaMet North America LLC
• Healthy Trends Worldwide LLC
• Chambers’ Apothecary
• Anabolic Laboratories, LLC. 

Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are subject to the regulatory requirements that apply to drugs, even if the products are labeled as dietary supplements. Calroy Health Sciences, for example, sells a one-month supply of a supplement that “strengthens the artery wall’s protective barrier” for $95. 

The FDA explains that the unapproved products have not been evaluated for effectiveness, proper dosage, potential drug interactions, or whether they have dangerous side effects or other safety concerns. The warnings come less than a month after the SPORT trial was published, which detailed the lack of benefit seen with various dietary supplements for reducing cholesterol compared with placebo therapy.

The FDA has given the companies 15 working days to either address their concerns or justify why they think the products are not in violation of the law. Failure to correct violations “may result in legal action, including product seizure and/or injunction.” 

The Takeaway

Over-the-counter heart supplements have played a big role in patients’ self-guided cardiology care for quite some time. Supplement companies have historically enjoyed looser FDA regulations, unlike drugs, which must be proven safe and effective before marketing. The FDA appears to now be cracking down on some of these companies, issuing seven warning letters that outline instances where the companies have illegally claimed to cure, treat, or prevent cardiovascular disease. 

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The Wire

• Bivalirudin Benefits in STEMI: An analysis of 6k patients with STEMI undergoing PCI revealed that anticoagulation with bivalirudin (Angiomax) during PCI improved mortality and bleeding risk compared with heparin. The bivalirudin therapy (including a pre-procedure bolus and high-dose infusion) reduced all-cause mortality and major bleeding by 31% compared with heparin at 30 days. 

• Defining Preventive Cardiology: The American Society for Preventive Cardiology published a clinical practice statement highlighting the key attributes of preventive cardiology. The authors discuss necessary areas of intervention, including primordial intervention (preventing disease early in life), primary prevention (improving modifiable cardiovascular risk factors), and secondary prevention (reducing disease among individuals with established CVD). The authors assert that advances in risk assessment and prevention are essential to quell the “approaching tsunami of cardiometabolic disease.”

• ACC & Osso VR Immersive Training: The American College of Cardiology is teaming up with surgical training virtual reality platform Osso VR to bring an immersive, VR-enabled training program to 56k cardiovascular professionals. The platform, designed to provide repeatable and measurable educational experiences, allows users to practice and improve their skills in real-life operating room scenarios. 

• Hospital EDs at “Breaking Point”: Hospital EDs across the US are at a “breaking point” according to the American College of Emergency Physicians, who wrote a letter to President Joe Biden pleading with the administration to find a solution to ED overcrowding. The letter urged the administration to convene a summit to identify ways to reduce boarding, where admitted patients are held in the ED due to a lack of inpatient beds, which the authors say has progressed to “becoming its own public health emergency.” 

• High-Risk AFib Patients Not on Anticoagulation: A decade of data from nearly half a million AFib patients in the US suggests 1 in 3 high-risk patients are not receiving any anticoagulants. While the overall anticoagulation rate increased from 56.3% to 64.7% (driven primarily by DOACs) from 2011 to 2020, one-third of patients with AFib and an elevated CHA2DS2-VASc score remain on no anticoagulation. 

• Reducing Lead-Related ICD Complications: Data from the ATLAS trial indicate that using a subcutaneous implantable cardioverter defibrillator (S-ICD) could reduce the risk of lead-related complications by more than 90% compared to using transvenous ICD (TV-ICD) without compromising ICD shock effectiveness. In the study, over 500 patients were randomized to receive either S-ICD or TV-ICD. Patients who received S-ICD were less likely to experience pre-operative, lead-related complications (0.4% vs. 4.8%), although patients in the S-ICD arm were more likely to experience inappropriate shocks (HR: 2.37). 

• Acute AFib Worsens Stroke Mortality: Acute ischemic stroke (AIS) patients who also experience acute AFib have more severe early neurological deficits and a higher 30-day mortality rate. Among 706 AIS patients, mortality at 30 days after stroke was significantly higher in those with acute AF than in those without acute AF (30.3% vs 10.1%). Patients with acute AF also had worse baseline neurological deficits (NIHSS scores: 16.1 vs. 8.7), and these baseline deficits were also independently tied to higher 30-day mortality (adjusted odds ratio: 1.18). 

• Mineralys Therapeutics’ Target-HTN Results: Mineralys Therapeutics announced encouraging results from its phase 2 Target-HTN trial investigating the effectiveness of its MLS-101 aldosterone synthase inhibitor as add-on therapy in individuals with resistant hypertension. MLS-101, at doses of 50 mg and 100 mg daily, reduced systolic and diastolic BP in the office and in 24-hour ambulatory monitoring. People taking MLS-101 saw placebo-adjusted reductions in SBP of 9.7 mmHg (50mg) and 7.9 mmHg (100mg). In patients whose background regimen included a thiazide diuretic, the benefits were even greater. 

• GenieMD & Hurdle Home Heart Panels: Virtual care provider GenieMD is partnering with Hurdle (formerly Chronomics) to give patients access to on-demand heart health panels from the comfort of their homes. Hurdle allows GenieMD to leverage its network of CLIA-certified labs to provide end-to-end specimen collection and diagnostics in order to help cut down on the one-third of diagnostic test orders that go unfulfilled due to accessibility and scheduling barriers.

• Ticagrelor vs. Prasugrel in CAD: In patients with chronic or acute coronary syndromes undergoing PCI, prasugrel and ticagrelor were similarly safe and effective at one year. In the study, 3.8k patients underwent PCI and were then prescribed either ticagrelor or prasugrel. There was no difference between the groups in the risk of MI or death (3.3% vs. 3.1%). While revascularization rates were lower in the ticagrelor cohort (9.3% vs. 14.0%), these patients did not have a greater risk of stroke or bleeding.

• MDLIVE Chronic Condition Expansion: Cigna-owned virtual care company MDLIVE is expanding its virtual primary care services with a chronic condition management program that leverages connected devices to provide physicians with real-time remote patient monitoring and reporting. MDLIVE will roll out the new program as a covered health benefit for hypertension patients next year, and it’s planning to expand eligibility to more chronic conditions.

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