P-394: Assessment of the impact of valdecoxib on systolic blood pressure in clinial practice

Using a one-tailed paired t-test, the purpose of this study is to evaluate changes in systolic blood pressure (SBP) in hypertensive patients who are newly taking valdecoxib. Cardiovascular safety studies for patients at higher risk have not been conclusive. Hypertensive patients are defined as those with a mean SBP ≥140 mm Hg the year before taking at least one valdecoxib prescription. The SBP ≥140 mm Hg sample was split into those on antihypertensive medications and those who are not. The data set is the GE Logician® data file, which includes ambulatory electronic medical records since 1996 for a national sample of approximately 3 million patients. The change in mean SBP readings between the year before and the year following initiation on valdecoxib was computed. For the 1,442 patients who started antihypertensive medication at least 1 year before valdecoxib, with a mean baseline SBP ≥ 140 mm Hg, the mean of all readings in the year before starting valdecoxib is 150.3 (SD = 9.4). Each patient has an average of 6.1 BP readings during the year before starting valdecoxib and 5.2 BP readings during the year after initiating valdecoxib. Ninety percent of all valdecoxib users do not change their dose in the first year. There is no statistically significant increase in SBP; in fact, SBP decreases (delta = -5.8) among those on antihypertensive drugs. The results are similar for the full sample of valdecoxib users (N=8,934, delta = -1.2), where baseline SBP is not restricted to ≥ 140 mm Hg. Valdecoxib users with a mean SBP ≥ 140 mm Hg the year before taking valdecoxib who are not on antihypertensive medications show similar results (N=485, delta = -8.1). Overall, valdecoxib users in this real-world clinical practice database did not experience increases in SBP. Results are consistent for patients with baseline SBP ≥ 140 on antihypertensive medications as well as those who are not on antihypertensive medications.