Ibuprofen was found to be inferior to pivmecillinam for the treatment of uncomplicated urinary tract infections (UTI) in women, according to a randomized, controlled, double-blind, noninferiority trial published in PLoS Medicine.
Nonpregnant women aged 16 to 60 years and presenting with UTI symptoms were recruited from 16 general practice sites across Norway, Sweden, and Denmark from April 2013 to April 2016. Patients were randomly assigned 1:1 to ibuprofen 600 mg or pivmecillinam 200 mg, both administered 3 times per day for 3 days (ClinicalTrials.gov Identifier: NCT01849926).
The primary trial outcome was patient self-reporting on day 4 as to whether they felt cured or not, and secondary outcomes were the percentage of patients in need of secondary treatment with antibiotics and cases of pyelonephritis.
Data from 181 patients in the ibuprofen group and 178 patients in the pivmecillinam group were analyzed. The results showed that on day 4 only 38.7% of patients in the ibuprofen group felt cured compared with 73.6% of patients receiving pivmecillinam. The adjusted risk difference was 35% (90% CI, 27% to 43%) in favor of pivmecillinam, which crossed the prespecified noninferiority margin.
Pyelonephritis was reported in 7 patients in the ibuprofen group and in no patients in the pivmecillinam group. After 4 weeks, UTI resolved without antibiotics in 53% of the patients receiving ibuprofen.
The study design included a long list of exclusion criteria that eliminated close to half of patients presenting with symptoms. Some eligible participants were also not enrolled due to nurse workloads at the study sites, and in some cases nurses did not have the proper training to enroll patients. Symptom burden was not included in the inclusion questionnaire; therefore, the degree of symptoms for patients who did not participate is unknown and may make the results less generalizable. It is also possible that patients in the ibuprofen group who may have taken paracetamol for pain may have had symptoms of upper UTI masked by this medication combination.
The results did show that more than half of women with uncomplicated UTI recovered using ibuprofen alone, suggesting that initial treatment with ibuprofen alone may reduce unnecessary antibiotic use. However, the investigators caution that “until we can identify those women in need of antibiotic treatment to prevent complications, we cannot recommend ibuprofen alone to women with uncomplicated UTIs.”
Vik I, Bollestad M, Grude N, et al. Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women—a double-blind, randomized non-inferiority trial. PLoS Med. 2018;15(5): e1002569.