A new study suggests that patients who took misoprostol for stomach ulcers along with NSAIDs significantly lowered their risks of such events, as well as stroke and kidney failure, compared with those who took NSAIDS alone. The research was scheduled for presentation at the American College of Cardiology’s 66th Annual Scientific Session in Washington, DC, March 17-19.
The study team from the University of Utah and the Salt Lake City Veterans Affairs Medical Center notes that NSAIDs are the most commonly used prescription and OTC analgesic medications worldwide, but their use is limited by an increase in cardio-renal morbidity and mortality risk.
“Withdrawal of the balancing vasodilatory prostaglandins on vascular, thrombotic, and renal physiological mechanisms by NSAIDs contributes to the cardio-cerebro-renal vascular event risk,” they point out, adding, “We hypothesized that restoration of prostanoids through the concomitant use of misoprostol with NSAIDs may reduce the adverse event risk.”
“Right now, clinicians have no direct treatment options to reduce the risk for these NSAID-induced cardio-renal complications, other than to advise against NSAID use, reduce the duration of use, or recommend alternative pain management agents, so we set out to discover a treatment to reduce the risk of these effects,” explained lead author Mark Munger, PharmD, professor of pharmacotherapy at the University of Utah College of Pharmacy. “Our data, from a large and well-characterized health care system, support a potentially safer NSAID alternative when NSAIDs are combined with misoprostol.”
The researchers conducted a historical cohort study using the U.S. Veterans Affairs database to compare new initiators of 11 different NSAIDs and/or misoprostol from 2005 through 2013, for a total of nearly 1.7 million subjects. The veterans were followed for 5 years, with a focus on development of cardiovascular, cerebrovascular, or renal-vascular events.
Essentially, patients taking NSAIDs and misoprostol together had a 44% lower risk of having a heart attack, suffering cardiac arrest, or having ventricular fibrillation, according to the study. At the same time, those taking both drugs also had a 25% lower risk of strokes or mini-strokes and a 34% lower risk of acute kidney failure compared with people taking NSAIDs alone.
Focusing on two treatment groups each containing 1,827 patients, results indicate that an NSAID plus misoprostol significantly reduced cardiovascular (hazard ratio [HR] of 0.56), cerebrovascular (HR of 0.75), and reno-vascular (0.66) events versus an NSAID alone. All-cause mortality was not statistically different between groups, however, with an HR of 1.05.
“Taking misoprostol in conjunction with a NSAID significantly reduced the risk of NSAID-induced cardiovascular, cerebrovascular, and reno-vascular adverse events associated with taking NSAIDS alone,” study authors conclude. “This data from a large and well characterized healthcare system database supports a safer analgesic, an NSAID combined with misoprostol.”