Arnold Schwarzenegger

Cardiology

Statins’ Diabetes Risks and Benefits

A new Lancet study brought statins’ diabetes risks back into the headlines, showing that statins do indeed drive significant increases in new diabetes diagnoses, while arguing that statins’ cardiovascular benefits still far outweigh their diabetes risks.

Researchers from the Cholesterol Treatment Trialists’ Collaboration analyzed 19 RCTs comparing statins versus a placebo (n= 124k, 21% w/ diabetes, 4.3yr median follow up) and four RCTs comparing low and high-intensity statin therapies (n= 31k, 17% w/ diabetes, 4.9yr median follow up), finding that…

• Low- or moderate-intensity statin therapy drove a 10% relative increase in new-onset diabetes versus placebo (2,420 of 39,179 vs. 2,214 of 39,266 participants).
• High-intensity statin therapy drove a 36% relative increase in new-onset diabetes versus placebo (1,221 of 9,935 vs. 905 of 9,859 participants).

Those are concerning numbers at first glance, however further analysis revealed that future diabetes diagnoses were largely influenced by baseline HbA1c levels and follow-up testing.

• Among participants without baseline diabetes, mean glucose increased by just 0.04 mmol/L in statin-takers, while HbA1c increased by 0.06% in patients receiving low/moderate statins and by 0.08% in patients receiving high-intensity statins.
• Among patients with baseline glycaemia, 62% of new new-onset diabetes cases involved participants who were already in the top quartile of glycaemic levels.
• The rate of new-onset diabetes was mainly dependent on how many participants actually received follow-up HbA1c tests (so more testing drove more positives…), and the analysis’ high-intensity statin trials were much more likely to include follow-up HbA1c tests (explaining higher diabetes rates w/ high-intensity statins).

These results revived statin diabetes debates on MedTwitter, with one extremely prominent physician highlighting statins’ diabetes risks, and others suggesting that this study adds evidence that statins’ diabetes risks aren’t “clinically relevant” since statins are proven to reduce mortality.

The Takeaway

Although the link between statins and diabetes is widely known, this analysis shows that the majority of new diabetes diagnoses are happening in statin-takers who already had “baseline glycaemic markers that are close to the diagnostic threshold for diabetes.” 

That’s worth keeping in mind for the many borderline diabetic patients who are taking statins (or could be soon), but it’s also worth keeping in mind the authors’ primary message that statins’ absolute benefits “greatly outweigh any excess risks of diabetes.”

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Your Cardiology Data is Valuable. Put it To Work.

See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.

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The Wire

• Vascepa Works Regardless of Lp(a): A post-hoc analysis of the REDUCE-IT trial shows that icosapent ethyl (Amarin’s Vascepa) reduced major adverse CV event risks in patients regardless of their baseline lipoprotein(a) levels. In 7,026 participants with a median baseline Lp(a) of 11.6 mg/dL, Lp(a) concentration was significantly associated with first and total MACE, and Vascepa reduced events across the board. However, it didn’t actually reduce Lp(a), leaving room for new targeted Lp(a)-reducing therapies.

• A Tale of Two Regulatory Journeys: A TCTMD editorial by Sanjay Kaul, MD put a spotlight on the extremely different regulatory approval pathways for drugs and devices, which could be leading to dubious device approvals while keeping some potentially beneficial drugs off the market. This editorial is worth a read, but the gist is that devices generally don’t require the same level of evidence as drugs to gain FDA approval, and Dr. Kaul’s list of recent device approvals provides plenty of supporting evidence.

• Undertreated Heart Failure: A JACC registry study shows that many patients with newly-diagnosed HFrEF miss out on GDMT and could die early as a result. In about 33,000 Medicare HFrEF patients, 82% were eligible for quadruple therapy per guidelines but only 15.3% got it, while 93% were eligible for three drugs and 41.5% were treated appropriately. The 12-month mortality and HF hospitalization rates in beneficiaries eligible for quadruple therapy were 24.7% and 22.2%.

• Viz.ai & Medtronic Connect: Medtronic and AI-based care coordination company Viz.ai announced a collaboration focused on improving coordination between neurology and cardiology teams, and ensuring that cryptogenic stroke patients who are at risk of AFib receive necessary cardiology follow-ups. Although details aren’t completely clear, it appears that Medtronic will distribute Viz.ai’s Viz Connect solution, which is built to automate communications across hospital departments. Medtronic first became a distributor of Viz.ai’s Viz LVO stroke detection and coordination solution in 2019.

• GenAI Scandal Rocks Publishers: The academic publishing world was once again in the spotlight after new evidence surfaced that researchers are using generative AI models like ChatGPT to write papers. In multiple posts on Twitter/X, observers are sharing papers published in mainstream journals containing chatbot prompts that weren’t removed by authors despite making it through the peer-review process. Really makes you question peer-review when the chatbot prompt gets published as the first line of the introduction… 

• Abbott’s Assert-IQ CE Mark: Abbott’s Assert-IQ insertable cardiac monitor (ICM) landed its European CE Mark, roughly 10 months after the innovative monitoring device gained FDA clearance. The Assert-IQ ICM checks/transmits heart rhythm data every 20 seconds (usually to patients’ mobile phones), and includes lengthy three and six year batteries (the longest for a Bluetooth-connected ICM).

• Praluent’s Inflammation Effects: While the PCSK9i alirocumab (Regeneron’s Praluent) improves CV outcomes, it does not improve endothelial function in acute MI patients. In a substudy of the PACMAN-AMI trial featuring 173 patients on statins, the change in endothelial function as measured by brachial artery FMD at 52 weeks was similar for alirocumab and placebo (5.4 and 5.45). 

• Risk-Free Red Meat? Contrary to conventional wisdom and the results of many observational trials, a Mendelian randomization study found no causal association between red or processed meat and bad cardiovascular outcomes including coronary artery disease, high blood pressure, stroke, and type 2 diabetes. 

• The Pacemaker-nator: Arnold Schwarzenegger just became one of the 200k-plus Americans to receive a pacemaker each year, after routine testing revealed that his arrhythmia had become severe enough to require the device. The 76 year-old icon has a history of heart issues, starting with a bicuspid aortic valve that led to three open heart surgeries, the third of which led to the arrhythmia. In case you’re wondering, Arnold got his pacemaker implanted at the Cleveland Clinic. 

• Cardiology’s Industry Payments: Cardiologists raked in the fourth most industry payments across medical specialties, accumulating $1.29B in payments from 2013 to 2022, falling just behind orthopedic surgeons, neurologists, and psychiatrists ($1.36B,  $1.32B, $1.32B). Cardiovascular conditions were also closely aligned with several drugs and devices with the highest industry payments, including Bayer & Janssen’s Xarelto, BMS’ Eliquis, and Medtronic’s CoreValve Evolut ($176M, $102M, $44M).

• Life Expectancy Increases: Life expectancy for the US population in 2022 was 77.5 years, up over an entire year from 2021 (76.4). Although we’d love to point to a medical breakthrough for the progress, the CDC report attributes the increase to fewer deaths from COVID and drug overdoses. Heart disease and cancer remained the leading causes of death, while COVID was replaced by “accidental injuries” in the third slot. US life expectancy has yet to recover to its prepandemic peak of 78.8 years in 2019.

Nothing Is More Expensive Than a Missed Opportunity

The emergence of AI CAC detection and new CVD treatments could transform preventative CVD care. Check out this Johns Hopkins editorial in JACC detailing how solutions like Bunkerhill Health’s Incidental CAC algorithm can create opportunities for more effective preventative CVD care, but only if providers seize that opportunity.

Accurate and Efficient Remote Cardiac Patient Monitoring

The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.

The Resource Wire

• PIA Medical Processes It All: Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

• TeraRecon’s Structural Heart Enhancements: Detecting and addressing mitral valve and LAA conditions can be challenging. Check out TeraRecon’s Structural Heart white paper and discover how improving workflow and pretreatment planning can streamline these processes and potentially improve patient outcomes.

• Bringing AI Into Echo Workflows: Cardiovascular AI solutions are still far more commonly found in cardiology journal papers than in actual clinical workflows, but that’s changing fast and there’s a lot to learn from AI early adopters. Tune into the latest Cardiac Wire Show with Mount Sinai’s Jeffrey Bander, MD and Us2.ai’s Seth Koeppel to see how they launched and expanded their echo AI partnership, and learn how to “adopt echo AI the right way.”

• A CCTA-Based Approach to Heart Attack Prevention: Cardiologists are increasingly relying on cardiac CT angiograms as a heart disease diagnostic tool. See what’s driving this trend in this Cleerly report detailing the key attributes of CCTA exams, evidence of its effectiveness, and CCTA’s medical guideline support.