PRECISION-ABPM: Ibuprofen increases systolic BP, hypertension risk in arthritis
Patients with osteoarthritis or rheumatoid arthritis and elevated risk for CVD who were treated with ibuprofen had increased systolic BP in addition to the risk for hypertension vs. those treated with celecoxib, according to the PRECISION-ABPM study.
The findings were presented at the European Society of Cardiology Congress and published in the European Heart Journal.
“The current findings suggest that the elevated [CV] risk with [nonsteroidal anti-inflammatory drugs] may be partly due to drug-specific increases in [BP],” Frank Ruschitzka, MD, FESC, FHFA, FRCP (Edin.), professor of cardiology and co-head of the department of cardiology at University Heart Centre in Zurich and president of the Heart Failure Association of the European Society of Cardiology, said in a press release. “This challenges the widely advocated belief that conventional NSAIDs, like naproxen and ibuprofen, with their higher COX-1 and thromboxane reducing effects, would provide greater [CV] safety than other more COX-2 selective agents, particularly celecoxib.”
Researchers randomly assigned 444 patients who had osteoarthritis or rheumatoid arthritis with an elevated CV risk or established CVD and required treatment with NSAIDs for 6 months or longer for pain.
Patients were assigned 100 mg of celecoxib twice per day (n = 146; mean age, 62 years; 70 men), 600 mg of ibuprofen three times per day (n = 151; mean age, 62 years; 72 men) or 375 mg of naproxen twice a day (n = 147; mean age, 61 years; 63 men) with matching placebos. Dosages for each NSAID could be increased to the maximum recommended dose for patients with unrelieved symptoms. Daytime and nighttime ambulatory BP measurements were obtained throughout the study.
The primary endpoint was a change in 24-hour mean systolic BP from baseline to 4 months.
At 4 months, ambulatory 24-hour systolic BP decreased by 0.3 mm Hg in the celecoxib group (95% CI, –2.25 to 1.74), increased by 3.7 mm Hg in the ibuprofen group (95% CI, 1.72-5.58) and rose by 1.6 mm Hg in the naproxen group (95% CI, –0.4 to 3.57), Ruschitzka and colleagues found.
The difference between celecoxib and ibuprofen was –3.9 mm Hg (95% CI, –6.19 to –1.61; P ≤ .001), –1.8 mm Hg between celecoxib and naproxen (95% CI, –4.15 to 0.47; P = .12) and –2.1 mm Hg between naproxen and ibuprofen (95% CI, –4.36 to 0.23; P = .08).
During follow-up, among those with normal BP at baseline, hypertension was diagnosed in 35% of patients assigned ibuprofen, 28% of those assigned naproxen and 15% of patients assigned celecoxib (P for all groups = .0349; P for ibuprofen vs. celecoxib = .0038), Ruschitzka said during a press conference.
Those assigned celecoxib had shorter time to first hospitalization for hypertension than those assigned ibuprofen (HR = 0.59; 95% CI, 0.36-0.99), according to the researchers.
“You have to always weigh the pros and cons and look at the worsening of [BP] control and its clinical consequences against the arthritis mitigating the effects,” Ruschitzka said in the presentation. “PRECISION-ABPM clearly demonstrates that some NSAIDs, particularly prescription-strength ibuprofen, may not be as safe as previously thought. Patients should continue to consult their doctor before taking NSAIDs or coxibs, and clinicians need to weigh the potential hazards of worsening [BP] control when considering the use of these agents.” – by Darlene Dobkowski
Ruschitzka F. Late Breaking Clinical Trials 3. Presented at: European Society of Cardiology Congress; August 26-30, 2017; Barcelona, Spain.
Disclosure: The study was funded by Pfizer. Ruschitzka reports serving on a steering committee or speaker bureau for Abbott, Bayer, Biotronik, Cardiorentis, Fresenius, Merck, Novartis, Servier and Zoll.