SAN DIEGO –
“Acute pancreatitis is a very common disease,” lead study author Yan Bi, MD, PhD, a senior associate consultant and assistant professor in the department of gastroenterology and hepatology at Mayo Clinic, Jacksonville, Fla., said in an interview in advance of the annual Digestive Disease Week. “It’s the number one GI cause for hospitalization. Unfortunately, even after decades of basic science and clinical research, there’s still no cure; there’s nothing to prevent it from happening. The only treatment we can offer is supportive care, which includes fluid hydration, pain control, and nutrition support.”
The pathogenesis of acute pancreatitis (AP) is complex, she continued, and represents a sequence of distinct and interconnected pathologic events. “Both animal data and human studies have shown that acute pancreatitis is a hypercoagulable state,” she said. “We hypothesize that coagulation plays important roles in the development of pancreatitis.”
To test their hypothesis, Dr. Bi and associates performed a retrospective study. They drew from the 2014 National Inpatient Sample to evaluate the effect of systemic anticoagulation prior to AP onset on outcomes of the condition. They used ICD-9 codes to identify patients with a primary diagnosis of AP as well as those who were taking systemic anticoagulation. The primary outcome was the odds of AP in patients taking systemic anticoagulation, compared with those who were not. Secondary outcomes were mortality, morbidity, length of hospital stay, and total hospitalization charges and costs. The researchers used propensity score matching to create a 1:1 matching population for sex, age, and Charlson Comorbidity Index, and multivariate regression to adjust for patient ZIP code, income, hospital region, location, size, and teaching status.
Dr. Bi presented results from 442,535 patients with AP. Of these, 12,735 were on systemic anticoagulation prior to AP. Their mean age was 66 and 47% were female. After adjustment for confounders, patients on systemic anticoagulation prior to AP onset displayed a decreased odds of AP occurrence, compared with those who were not on anticoagulation (OR 0.56; P less than .01). In addition, patients on anticoagulation displayed improved outcomes in a number of variables, compared with their counterparts who were not on anticoagulation: mortality (OR 0.65), shock (OR 0.68), acute kidney injury (OR 0.83), ICU admission (OR 0.57), multiorgan failure (OR 0.85), and hospital charges (a mean reduction of $9,275), as well as AP induced by alcohol use (OR 0.26; P less than .01 for all associations). “These data suggest that the majority of AP associated with alcohol was prevented by anticoagulation medication,” Dr. Bi said. “This is very striking. Anticoagulation may hold promise in both the prevention and treatment of AP.”
To further prove their points, Dr. Bi teamed with Baoan Ji, MD, PhD, a basic research scientist at Mayo Clinic, and developed a humanized AP animal model. With this model, they showed that Pradaxa, a Food and Drug Administration–approved anticoagulant, is effective in experimental AP prevention and treatment. “We are currently enrolling patients into a prospective clinical trial to further prove this in humans,” Dr. Bi said. The experimental therapeutic study will be reported at DDW on May 20.
She cautioned against using systemic anticoagulants in this patient population before results of the trial currently underway at Mayo Clinic’s Florida campus are known. “That should be sometime in mid-2020,” she said. “And the bleeding risk should be carefully monitored when using anticoagulants.”
The researchers were supported by funding from the Mayo Clinic and the Department of Defense.
SOURCE: Bi Y et al. DDW 2019, Abstract Sa1381.