#307 Spooky Tofurkey Cakes: SGLT2 for HFpEF, Diverticulitis, VTE update, Rotator Cuff Disease

Fill up your plate with some spooky tofurkey cakes! Drs. Rahul Ganatra (@rbganatra) and Nora Taranto (@norataranto) help catch us up recent practice-changing articles and guidelines including EMPEROR-Reduced (SGLT2 inhibitors for HFpEF), the 2021 CHEST VTE guidelines update, whether or not antibiotics are needed for diverticulitis, and what treatments are most effective for rotator cuff disease!

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Credits

  • Written by: Nora Taranto MD; Rahul Ganatra MD, MPH; Matthew Watto MD, FACP
  • Show Notes: Matthew Watto MD, FACP
  • Cover Art: Beth Garbitelli
  • Hosts: Nora Taranto MD; Rahul Ganatra MD, MPH; Matthew Watto MD, FACP; Paul Williams MD, FACP   
  • Reviewer: Rahul Ganatra MD, MPH
  • Executive Producer: Beth Garbitelli
  • Showrunner: Matthew Watto MD, FACP
  • Editor: Clair Morgan of nodderly.com

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CME Partner: VCU Health CE

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Show Segments

  • Intro, disclaimer, 
  • Picks of the Week
  • EMPEROR-Reduced (SGLT2 inhibitors for HFpEF)
  • GRASP trial for rotator cuff disease (physiotherapy and steroid injections)
  • DINAMO trial (no antibiotics for outpatients with uncomplicated diverticulitis)
  • 2021 CHEST VTE Guidelines Update
  • Outro

Hotcakes

Deep dives on practice changing articles. 

EMPEROR-Preserved

Anker et al. EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. The New England Journal of Medicine. 2021; 385:1451-1461.  DOI: 10.1056/NEJMoa2107038. 

Question: Do SGLT2 inhibitors decrease mortality or the risk of hospitalization in patients with Heart Failure with Preserved Ejection Fraction (HFpEF)? 

Comparison:  Empagliflozin 10 mg once daily was compared with placebo, in addition to usual therapy, in this double-blind, randomized superiority trial that tracked outcomes for a median 26.2 months in patients with LVEF of at least 40%, an elevated BNP, and class II-IV heart failure symptoms.  

Results:  This trial was a positive trial. 

The primary outcome occurred in 13.8% in the empagliflozin group vs 17.1% in the placebo group (HR 0.79, CI 0.69-0.90, p < 0.001). Notably, the difference was primarily driven by a lower risk of hospitalization for heart failure in the empagliflozin group. Consistent with EMPEROR-Reduced (Packer, 2020), a difference was not seen between groups for all-cause or cardiovascular mortality. 

Listeners should realize that nearly 20% of patients in the empagliflozin and placebo group stopped the study medication. Various adverse events were common (approximately 86% in both groups) with hypotension, urinary tract infections, and genital infections more common in the empagliflozin group (see Supplement Table S6).

Bottom Line: Empagliflozin reduced combined risk of CV death or hospitalization for heart failure in pts with HFpEF, with or without diabetes. This effect was primarily in decreasing hospitalizations, and additionally, a reduced rate of renal function decline was noted in the empagliflozin cohort. This is one of the first drugs to show benefit in HFpEF. Notably, patients with moderately reduced EF seemed to derive the greatest benefit. 

Hotcakes rating: 4.5

Additional Reading: 

  1. EMPEROR-Preserved summary by Kumbhani DJ, American College of Cardiology  
  2. EMPEROR-Preserved summary, Wiki Journal Club
  3. The DELIVER Trial is ongoing with Dapagliflozin for HFpEF

Steroid Injection for Rotator Cuff Disease

Hopewell S, et al. GRASP Trial Group. Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 × 2 factorial, randomised controlled trial. Lancet. 2021 Jul 31;398(10298):416-428. doi: 10.1016/S0140-6736(21)00846-1. Epub 2021 Jul 12. PMID: 34265255; PMCID: PMC8343092. 

Question:  What is the most efficacious and cost effective intervention for adult patients with rotator cuff disorders of under 6 months duration? 

Comparison: Short and long-term scores of pain and function (SPADI score) were compared between four study groups in this 2×2 factorial, randomised controlled, open-label trial. Each patient was randomized to receive: 

  1. Multiple, progressive sessions with a physiotherapist vs a single session of “best practice” advice (included shoulder exam, advice booklet, videos, resistance band, simple home exercises 5 days per week) –see Supplement for exercises 
  2. Subacromial steroid injection was compared vs no steroid injection..

Results: This was a null trial. 

  1. No significant difference was noted between multi session groups and “best practice” groups at any time point up to and including 12 months.
  2. Subacromial steroid injections were associated with a 5.6 point improvement in SPADI score between groups (avg baseline scores were in the 50s on a 130 point scale) at 8 weeks compared with no steroids; however, this difference did not persist at 6 months or 12 months. This did not meet the minimum clinically important between-group difference for SPADI of at least 8 points.

Bottom Line: Single-session consultation with a therapist for “best practice” advice was as effective (and more cost-effective) than multi-session therapy. Subacromial steroid injections resulted in a measurable improvement in pain & function at 8 weeks that did not meet the minimum clinically important difference on the SPADI scale and did not persist at 6-12 months. 

Hotcakes rating: 3.5

Additional Reading: 

  1. BESS Guidelines on Shoulder Pain 
  2. https://bess.ac.uk/national-guidelines/#all_0-1421-wpfd-primary-intermediate-care-guidelines 
  3. NEJM JWatch editorial (subscription required): https://www.jwatch.org/na53854/2021/08/10/managing-rotator-cuff-disorders-randomized-trial 

Hot Takes

Brief discussion of recent articles, medical news, guidelines.

Are antibiotics needed for mild diverticulitis?

Mora-López L, et al; DINAMO-study Group. Efficacy and Safety of Nonantibiotic Outpatient Treatment in Mild Acute Diverticulitis (DINAMO-study): A Multicentre, Randomised, Open-label, Noninferiority Trial. Ann Surg. 2021 Nov 1;274(5):e435-e442. doi: 10.1097/SLA.0000000000005031. PMID: 34183510. 

Summary: Prior trials found that antibiotics are not necessary for inpatients with uncomplicated acute diverticulitis (SIRS negative) –(Chabok, 2012; Daniels, 2017). This multi-centre, randomized, open-label noninferiority trial found that “no-antibiotic therapy” was non-inferior to amox-clav (tid for 7 days) for reducing hospital admission, ED revisits, and pain control in nonpregnant, immunocompetent adults with CT-confirmed, uncomplicated diverticulitis (one or fewer SIRS criteria). Note: Patients spent up to 24 hours in the ED where they could receive pain medication and fluids. Additionally, they lacked significant comorbidities e.g. diabetes (with end organ damage), advanced kidney or liver disease, or active cardiac disease.

Bottom line: This trial adds to the clinical evidence (Chabok, 2012; Daniels, 2017) and colorectal surgery guidelines (Hall, 2020) reassuring clinicians that antibiotics can be avoided in immunocompetent, clinically stable patients with CT confirmed, uncomplicated diverticulitis.

2021 Update to CHEST VTE Guidelines

Stevens SM, et al. Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel Report. Chest. 2021 Aug 2:S0012-3692(21)01506-3. doi: 10.1016/j.chest.2021.07.055. Epub ahead of print. PMID: 34352278.

NEJM JWatch editorial (subscription required):

https://www.jwatch.org/na54097/2021/10/07/2021-update-chest-vte-treatment-guidelines

Highlights:

  • Isolated subsegmental PE (negative proximal DVT study): No need for anticoagulation if low risk progression, recurrence (i.e. no pregnancy, active cancer, immobility, hospitalization) –weak rec, low certainty.
  • DOACS are recommended 1st line over LMWH in cancer-associated VTE –strong rec, moderate certainty. Caveat: Use apixaban or LMWH (not rivaroxaban) if luminal GI malignancy (Ingason, 2021).
  • Vitamin K antagonists are recommended for confirmed antiphospholipid Ab syndrome (APS). Recommendation is “based on studies suggesting that DOACs are less effective than warfarin in preventing recurrent thrombosis in individuals with APS, especially for those patients with a history of arterial thrombosis” (Erkan, UpToDate 2021).
  • Extended-phase anticoagulation (beyond the initial 3 month treatment phase) is recommended for unprovoked VTE or VTE with persistent risk factors. Extended-phase therapy is not recommended if provoked by major or minor transient risk factors.
  • Use low dose apixaban (2.5 mg bid) or rivaroxaban (10 mg daily) for extended-phase anticoagulation –weak rec, very-low certainty.

In patients who choose to forgo extended-phase anticoagulation after unprovoked VTE, aspirin is recommended over no therapy (though the guidelines note aspirin is less effective than DOACs for VTE prevention and is not a recommended alternative)! Note: The guidelines do not mention a specific aspirin dose, but do mention “low-dose” aspirin in one spot.


Links

  1. Maid (Netflix series) -Nora’s pick
  2. Freakonomics MD (podcast) -Rahul’s pick
  3. A Man Named Scott (Documentary) -Watto’s pick
  4. Shia LaBeouf by Rob Cantor (video) 
  5. Roman Blood (book) by Steven Saylor
  6. Dune (film) on HBO Max

Goal

Listeners will review recent practice changing articles and medical news.

Learning objectives

After listening to this episode listeners will…  

  1. Discuss the utility of steroid injections for rotator cuff disease
  2. Recall changes to the 2021 VTE guidelines
  3. Explain risks and benefits of withholding antibiotics for mild diverticulitis
  4. Explore the benefits of SGLT2 inhibitors for heart failure with preserved ejection fraction

Disclosures

The Curbsiders report no relevant financial disclosures. 

Citation

Watto MF, Taranto N, Ganatra, RB, Williams PN. “#307 Spooky Tofurkey Cakes: SGLT2 for HFpEF, Diverticulitis, VTE update, Rotator Cuff Disease”. The Curbsiders Internal Medicine Podcast. https://thecurbsiders.com/episode-list Final publishing date November 24, 2021.


The post #307 Spooky Tofurkey Cakes: SGLT2 for HFpEF, Diverticulitis, VTE update, Rotator Cuff Disease appeared first on The Curbsiders.

#307 Spooky Tofurkey Cakes: SGLT2 for HFpEF, Diverticulitis, VTE update, Rotator Cuff Disease