Under Pressure: PRECISION Substudy Shows Adverse BP Effects of Ibuprofen
Authors of the study say, in light of the new findings, guidelines supporting the safety of ibuprofen in arthritis sufferers need changing.
Millions of people with arthritis take prescription-strength ibuprofen for pain relief, but a new study urges caution about this practice in light of data showing significant increases in blood pressure compared with two other common nonsteroidal anti-inflammatory drugs (NSAIDs).
“Ibuprofen puts you under pressure,” said the study’s lead author Frank Ruschitzka, MD (University Hospital in Zürich, Switzerland), in a press conference. “Through the course of the day, day and night, blood pressure goes up.” In comparison, blood pressure with either naproxen or the COX-2 inhibitor celecoxib was shown to be relatively stable.
“If you want to take something to take [away] your pain, don’t take ibuprofen,” Ruschitzka advised. The study, a prespecified substudy of the PRECISION trial, was presented Monday in a Hot Line session at the ESC Congress in Barcelona, Spain, and simultaneously published in the European Heart Journal.
An Added Strain on the Heart
As previously reported by TCTMD, PRECISION enrolled 24,081 adults requiring daily NSAID treatment for osteo- or rheumatoid arthritis symptoms that could not be managed with acetaminophen. Patients also had established cardiovascular disease or were deemed to be at increased cardiovascular risk. They were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day.
By 20 months, a primary outcome event—cardiovascular death (including hemorrhagic death), nonfatal MI, or nonfatal stroke—had occurred at similar rates in all three groups in the intention-to-treat analysis. No statistically significant differences were seen, meeting the definition of noninferiority for celecoxib. Compared with ibuprofen—but not naproxen—renal events and hospitalizations for hypertension were lower for celecoxib-treated patients.
If you want to take something to take [away] your pain, don’t take ibuprofen. Frank Ruschitzka
For the prespecified blood pressure study, known as PRECISION-ABPM, Ruschitzka and colleagues looked at 444 patients who had ambulatory blood pressure measurements at baseline and at 4 months postrandomization. Approximately 85% of patients were taking concomitant medications, primarily ACE inhibitors, beta-blockers, calcium-channel blockers, and diuretics.
While patients in the celecoxib group saw a decrease in average systolic blood pressure of -0.3 mm Hg, those in the ibuprofen and naproxen groups had increases of 3.7 mm Hg and 1.6 mm Hg, respectively. The changes resulted in a significant difference of -3.9 mm Hg between celecoxib and ibuprofen (P = 0.009). Additionally, significantly more patients in the ibuprofen group developed new hypertension by 4 months compared with the naproxen and celecoxib groups (23.2% vs 19.0% and 10.3%, respectively).
While the blood pressure difference is not enormous, Ruschitzka said for an elderly patient with multiple health problems, the added strain on the heart on a daily basis is indeed significant.
He suggested that the findings may be reassuring to those who have considered celecoxib “worrisome,” and added that current guidelines suggesting that ibuprofen is safe need to be changed.
In the paper, Ruschitzka and colleagues say the findings add support for the main PRECISION data and “provide evidence that elevated cardiovascular risk with NSAIDs may not only depend on effects on the vascular endothelium but also agent-specific increases in BP.”
Ruschitzka F, Borer JS, Krum H, et al. Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) trial. Eur Heart J. 2017;Epub ahead of print.
- The study was funded by Pfizer.
- Ruschitzka reports personal fees from Amgen, AstraZeneca, Bristol-Myers Squibb, Cardiorentis, HeartWare, Novartis, Sanofi, Servier, St. Jude Medical, and ZOLL Medical; and grant support from St. Jude Medical.