It is Safe to Co-Prescribe Nitrates and Erectile Dysfunction Meds, indicates real world data
Presently, four PDE5 (phosphodiesterase type 5) inhibitors (sildenafil, vardenafil, tadalafil, and avanafil) are FDA approved in the US for the management of erectile dysfunction (ED), and these agents are widely used to treat patients with ED. Therapy with PDE5 inhibitors is generally considered safe; however, coadministration of PDE-5 inhibitors and nitrates has been implicated in cardiovascular (CV) related death.
But, a recent study suggests that co-prescription of nitrate pills increased 20-fold in Denmark without an accompanying increase in adverse CV events. The study findings were published in the journal Annals of Internal Medicine on April 19, 2022.
The subsequent overproduction of cGMP and the potential of a cumulative drop in BP is the basis for the absolute contraindication of concomitant use of PDE-5 inhibitors in patients receiving nitrates. The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend that nitrates should not be administered within 24–48 hours of PDE-5 inhibitor administration in patients with CAD.
To further explore, Dr Anders Holt and his team conducted a study and measured the temporal trends in the co-prescription of nitrates and PDE5 inhibitors and they further measured the association between cardiovascular outcomes and the co-prescription of nitrates with PDE5 inhibitors.
In a case-crossover nationwide study, the researchers included 249 541 male patients with International Classification of Diseases, 10th Revision (ICD-10) codes for ischemic heart disease (IHD), including those who had a continuing prescription for nitrates and a new, filled prescription for PDE5 inhibitors. The primary outcomes assessed were cardiac arrest, shock, myocardial infarction, ischemic stroke, or acute coronary arteriography. The researchers also assessed secondary outcomes such as incidence of syncope, angina pectoris, or drug-related adverse event.
Key findings of the study:
- Among 2,49,541 patients, the researchers observed that 42,073 patients had continuing prescriptions for nitrates.
- During this period, they found that the prescription rate for PDE5 inhibitors in patients with IHD who were taking nitrates increased from an average of 0.9 prescriptions per 100 persons per year in 2000 to 19.5 prescriptions in 2018.
- They observed no statistically significant association between the co-prescription of nitrates with PDE5 inhibitors and the risk for either composite outcome (odds ratio [OR], 0.58 for the primary outcome and OR, 0.73 for the second outcome).
The authors concluded, "From 2000 to 2018, the use of PDE5 inhibitors increased 20-fold among Danish patients with IHD who were taking nitrates. A statistically significant association between concomitant use of these medications and cardiovascular adverse events could not be identified."
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