by Jennifer Kowalewski

OU-COM’s role in a six-year study on postponing or preventing hypertension was cited in the April 20 article, “Feasibility of Treating Prehypertension with an Angiotensin-Receptor Blocker,” published in the prestigious New England Journal of Medicine. The pioneering research study, Trial of Preventing Hypertension or TROPHY, has shown the drug candesartan cilexetil, sold as Atacand^® by AstraZeneca, reduced the risk of developing hypertension. OU-COM was one of 71 sites participating in the nationwide clinical trial.

“The TROPHY study is groundbreaking because it’s the first study to examine the potential to change the natural history of hypertension through early pharmacological intervention in patients diagnosed with prehypertension,” says principal investigator Stevo Julius, M.D., professor of internal medicine and physiology at the University of Michigan, Ann Arbor.

Prehypertension, according to the National Institutes of Health, National Heart, Lung and Blood Institute, is defined as blood pressure between 120/80 and 139/89 mmHg.

Persons with prehypertension are at greater risk of advancing to hypertension. Hypertension or high blood pressure raises the risk for heart disease and stroke, leading causes of death in this country. About one in three adults in this country have hypertension.

Patients in the TROPHY study had blood pressures of 130–139 (systolic) and 89 or lower (diastolic); or 139 (systolic) and 85–89 (diastolic). Untreated patients, age 30 to 65, were enrolled in a four-year, multicenter, randomized study.

The study demonstrated that beneficial anatomic or physiologic changes were occurring in patients taking candesartan that lasted even after the medication was discontinued, says OU-COM Dean Jack Brose, D.O.

“Because of this study, I think we have shown we can compete with larger sites in terms of the number of patients we recruit and how well we follow the research protocols,” Brose says. Then assistant dean for clinical research, Brose served as principal investigator at OU-COM. Other participating physicians were Jay Shubrook, D.O. (’94); Robert Gotfried, D.O.; and Chris Simpson, D.O.

OU-COM managed its trial and made day-to-day decisions about patient health and participation, as did each of the other 70 sites. However, OU-COM so successfully recruited patients that Julius flew Brose and research nurse Lori Arnott to Michigan to meet with researchers from a select few other top recruitment sites. They discussed the ways they had recruited patients, which was shared with the other participating sites.

The college enrolled 25 patients in the study and retained 23 throughout the four-year process. Patients reported “excellent” satisfaction with their participation in the clinical trial. The reason for this, says Brose, was the first-rate care that the college’s research nurse staff — Arnott; Cammie Starner; Lynn Petrik, R.N.; and Rosemary Vance — provided.

The research nurses also administered routine blood pressure checks and educated patients on healthy living. Patients were evaluated every three months.

“Most loved being involved with the study,” says Starner. “We did a great job of following up on them. Any suspected adverse events were dealt with quickly.”

Prehypertension patients were identified with the help of local physicians. During the study, about half the patients received a placebo while the others received candesartan. After two years, those on candesartan were switched to a placebo.

In March, Brose and Starner flew to Atlanta to share in the unveiling of the results at the American College of Cardiology’s 55^th annual Scientific Session.

The study showed that after two years, patients who had received candesartan were almost 67 percent less likely to develop hypertension. After four years, when all patients had been on placebo for two years, patients who had been on candesartan were almost 16 percent less likely to develop hypertension. Brose says the study not only showed candesartan helped prevent hypertension, it showed that patients who went off the experimental drug after two years were still less likely to develop the potentially fatal condition.

“I’m very pleased that we helped contribute to this landmark study,” says Brose. “We rank right up there with the best clinical research sites in America.”

Currently, OU-COM is involved in other clinical trials, including several diabetes trials, a dyslipidemia trial and a prevention trial.