7 research outputs found
RF04 Oral spironolactone for adult female acne (SAFA): a multicentre, double-blind, randomized trial
Acne is common and results in significant burden and patients with acne frequently receive prolonged oral antibiotics leading to antimicrobial resistance. Oral spironolactone is prescribed for acne, although there is a paucity of evidence on its effectiveness. The aim of this pragmatic parallel, double-blind, superiority trial was to assess the effectiveness of systemic spironolactone for acne in adult women. Participants were identified through primary and secondary health care and through community and social media advertising. Women aged ≥ 18 years with facial acne for at least 6 months, judged to warrant oral antibiotics, were invited to participate. Consented recruits were randomized 1 : 1 to either 50 mg daily spironolactone or matched placebo until week 6, increasing to 100 mg daily spironolactone or placebo until week 24. Topical treatment could be continued. The primary outcome was Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12. Secondary outcomes included Acne-QoL at week 24, participant self-assessed improvement, Investigator’s Global Assessment (IGA) and adverse effects. Of 1267 women assessed, 410 were randomized (201 intervention, 209 control) and 342 were included in the primary analysis. Baseline mean (SD) age was 29.2 (7.2) years, 7.9% (n = 28/356) were of a non-White background, 46% had mild acne, 40% moderate acne and 13% severe acne (IGA classified). Eighty-three per cent used topical treatments. Over 95% of patients in both groups tolerated treatment and increased dosage. Mean (SD) Acne-QoL symptom scores at baseline and week 12 were 13.2 (4.9) and 19.2 (6.1) for spironolactone and 12.9 (4.5) and 17.8 (5.6) for placebo, respectively {difference favouring spironolactone 1.27 [95% confidence interval (CI) 0.07–2.46]}. Scores at week 24 were 21.2 (5.9) for spironolactone and 17.4 (5.8) for placebo [difference 3.45 (95% CI 2.16–4.75)]. Secondary outcomes also favoured spironolactone at week 12, with greater differences at week 24. More participants on spironolactone reported acne improvement than those on placebo. At week 12, this difference was not statistically significant [72.2% vs. 67.9%; odds ratio (OR) 1.16, 95% CI 0.70–1.91], but at week 24, it was significant (81.9% vs. 63.3%; OR 2.72, 95% CI 1.50–4.93). Treatment success (IGA classified) at week 12 was 31/201 on spironolactone and 9/209 on placebo (OR 5.18, 95% CI 2.18–12.28). Adverse reactions were not serious and were similar between groups, although more headaches were reported by those on spironolactone (20.4% vs. 12.0%; P = 0.02). Spironolactone improved outcomes vs. placebo, with greater differences at week 24 than at week 12. This study supports spironolactone as a potential alternative to oral antibiotics for acne in adult women
Recommended from our members
Older Blood Is Associated With Increased Mortality and Adverse Events in Massively Transfused Trauma Patients: Secondary Analysis of the PROPPR Trial
Study objectiveThe transfusion of older packed RBCs may be harmful in critically ill patients. We seek to determine the association between packed RBC age and mortality among trauma patients requiring massive packed RBC transfusion.MethodsWe analyzed data from the Pragmatic, Randomized Optimal Platelet and Plasma Ratios trial. Subjects in the parent trial included critically injured adult patients admitted to 1 of 12 North American Level I trauma centers who received at least 1 unit of packed RBCs and were predicted to require massive blood transfusion. The primary exposure was volume of packed RBC units transfused during the first 24 hours of hospitalization, stratified by packed RBC age category: 0 to 7 days, 8 to 14 days, 15 to 21 days, and greater than or equal to 22 days. The primary outcome was 24-hour mortality. We evaluated the association between transfused volume of each packed RBC age category and 24-hour survival, using random-effects logistic regression, adjusting for total packed RBC volume, patient age, sex, race, mechanism of injury, Injury Severity Score, Revised Trauma Score, clinical site, and trial treatment group.ResultsThe 678 patients included in the analysis received a total of 8,830 packed RBC units. One hundred patients (14.8%) died within the first 24 hours. On multivariable analysis, the number of packed RBCs greater than or equal to 22 days old was independently associated with increased 24-hour mortality (adjusted odds ratio [OR] 1.05 per packed RBC unit; 95% confidence interval [CI] 1.01 to 1.08): OR 0.97 for 0 to 7 days old (95% CI 0.88 to 1.08), OR 1.04 for 8 to 14 days old (95% CI 0.99 to 1.09), and OR 1.02 for 15 to 21 days old (95% CI 0.98 to 1.06). Results of sensitivity analyses were similar only among patients who received greater than or equal to 10 packed RBC units.ConclusionIncreasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusion (≥10 units), but not in those who receive fewer than 10 units
Recommended from our members
Onset of Coagulation Function Recovery Is Delayed in Severely Injured Trauma Patients with Venous Thromboembolism
BackgroundAltered coagulation function after trauma can contribute to development of venous thromboembolism (VTE). Severe trauma impairs coagulation function, but the trajectory for recovery is not known. We hypothesized that enhanced, early recovery of coagulation function increases VTE risk in severely injured trauma patients.Study designSecondary analysis was performed on data from the Pragmatic Randomized Optimal Platelet and Plasma Ratio (PROPPR) trial, excluding patients who died within 24 hours or were on pre-injury anticoagulants. Patient characteristics, adverse outcomes, and parameters of platelet function and coagulation (thromboelastography) were compared from admission to 72 hours between VTE (n = 83) and non-VTE (n = 475) patients. A p value < 0.05 indicates significance.ResultsDespite similar patient demographics, VTE patients exhibited hypercoagulable thromboelastography parameters and enhanced platelet function at admission (p < 0.05). Both groups exhibited hypocoagulable thromboelastography parameters, platelet dysfunction, and suppressed clot lysis (low clot lysis at 30 minutes) 2 hours after admission (p < 0.05). The VTE patients exhibited delayed coagulation recovery (a significant change compared with 2 hours) of K-value (48 vs 24 hours), α-angle (no recovery), maximum amplitude (24 vs 12 hours), and clot lysis at 30 minutes (48 vs 12 hours). Platelet function recovery mediated by arachidonic acid (72 vs 4 hours), ADP (72 vs 12 hours), and collagen (48 vs 12 hours) was delayed in VTE patients. The VTE patients had lower mortality (4% vs 13%; p < 0.05), but fewer hospital-free days (0 days [interquartile range 0 to 8 days] vs 10 days [interquartile range 0 to 20 days]; p < 0.05) and higher complication rates (p < 0.05).ConclusionsRecovery from platelet dysfunction and coagulopathy after severe trauma were delayed in VTE patients. Suppressed clot lysis and compensatory mechanisms associated with altered coagulation that can potentiate VTE formation require additional investigation