From the Guidelines
I would not recommend initiating oral semaglutide (Rybelsus) in a patient with a history of cardiac disease and mitral valve replacement without careful evaluation by their cardiologist. While GLP-1 receptor agonists like semaglutide have shown cardiovascular benefits in some populations, patients with significant cardiac history require individualized assessment 1. The patient's specific cardiac condition, current medications (particularly anticoagulants), and overall clinical stability should be considered. Potential concerns include the medication's effects on heart rate, blood pressure, and possible drug interactions with cardiac medications. Additionally, nausea and vomiting, common side effects of semaglutide, could affect medication absorption, including critical cardiac medications.
Some key points to consider when evaluating the use of semaglutide in this patient population include:
- The cardiovascular effects of the oral formulation of semaglutide compared with placebo have been assessed in Peptide Innovation for Early Diabetes Treatment (PIONEER) 6, a pre-approval trial designed to rule out an unacceptable increase in cardiovascular risk 1.
- The Harmony Outcomes trial randomized 9,463 patients with type 2 diabetes and cardiovascular disease to once-weekly subcutaneous albiglutide or matching placebo, in addition to their standard care, and found that the GLP-1 receptor agonist reduced the risk of cardiovascular death, MI, or stroke 1.
- The FDA-approved indications and doses for GLP-1RAs, including semaglutide, are outlined in the 2018 ACC expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes and atherosclerotic cardiovascular disease 1.
- The 2020 expert consensus decision pathway on novel therapies for cardiovascular risk reduction in patients with type 2 diabetes provides guidance on opportunities to initiate an SGLT2 inhibitor or a GLP-1RA with demonstrated CV or renal benefit in patients with T2D 1.
If treatment is deemed appropriate after cardiology consultation, start with the lowest dose (3mg daily) taken on an empty stomach with no more than 4 ounces of water, at least 30 minutes before the first food or drink of the day. Close monitoring of cardiac parameters and gradual dose titration would be essential. Alternative diabetes management strategies might be more appropriate for this complex cardiac patient.
From the Research
Ozempic (Semaglutide) Oral Medication Initiation
- There are no research papers provided that directly discuss the initiation of Ozempic (semaglutide) oral medication in patients with a history of cardiac disease and mitral valve replacement.
- The provided studies focus on mitral valve replacement, mitral regurgitation, and transcatheter mitral valve repair, but do not mention Ozempic (semaglutide) or its use in patients with cardiac disease and mitral valve replacement 2, 3, 4, 5, 6.
- Therefore, there is no evidence available to assist in answering this question based on the provided studies.