Effects of sertraline in the prevention of low blood pressure in patients undergoing hemodialysis

Abstract

Introduction: Intradialytic hypotension (IDH) is a major complication of hemodialysis, with a prevalence of about 25% during hemodialysis sessions, causing increased morbidity and mortality. Objective: To study the effects of sertraline to prevent IDH in hemodialysis patients. Methods: This was a double-blind, crossover clinical trial comparing the use of sertraline versus placebo to reduce intradialytic hypotension. Results: Sixteen patients completed the two phases of the study during a 12-week period. The IDH prevalence was 32%. A comparison between intradialytic interventions, intradialytic symptoms, and IDH episodes revealed no statistical difference in the reduction of IDH episodes (p = 0.207) between the two intervention groups. However, the risk of IDH interventions was 60% higher in the placebo group compared to the sertraline group, and the risk of IDH symptoms was 40% higher in the placebo group compared to the sertraline group. Survival analysis using Kaplan-Meier estimator supported the results of this study. Sertraline presented a number needed to treat (NNT) of 16.3 patients to prevent an episode from IDH intervention and 14.2 patients to prevent an episode from intradialytic symptoms. Conclusion: This study suggests that the use of sertraline may be beneficial to reduce the number of symptoms and ID interventions, although there was no statistically significant difference in the blood pressure levels.

Prevention of intradialytic hypotensive episodes: is setraline an effective pharmacological approach?

“…The main mechanism through which this agent exerts a favorable hemodynamic action is the amelioration of the paradoxical sympathetic withdrawal induced by a sudden surge of serotonin in the central nervous system. In accordance with the above results of the Molin study, 7 earlier interventional studies enrolling hemodialysis patients with IDH failed to show improvement in the incidence of IDH or cardiac output, central blood volume, and peripheral vascular resistance in response to therapy with sertraline. 8 Other studies have associated sertraline administration with improvement in nadir intradialytic SBP or with fewer nursing interventions required for IDH.…”

“…7 This effect was accompanied by 59% higher likelihood for nursing intradialytic interventions during the placebo phase (HR: 1.59; 95% CI: 1.03-2.48). 7 Although interventional studies are important and the efforts of Molin et al are worthy of appreciation, a number of lessons can be taken from this report. This study is not double-blind because the investigators were aware of the drug assignment, therefore it has a single-blind, placebo run-in design.…”

“…In this issue of the Brazilian Journal of Nephrology, Molin C. et al 7 report a "double-blind, placebo-controlled, crossover" study testing the efficacy of the selective serotonin reuptake inhibitor sertraline in preventing IDH. According to the inclusion/exclusion criteria, participants had IDH complication (defined as a drop of ≥ 30 mmHg in SBP within dialysis or predialysis SBP ≤ 100 mmHg accompanied by symptoms requiring nursing interventions) in at least 50% of dialysis sessions over a 3-month period prior to study enrollment.…”

“…Participants entered an initial 6-week placebo phase and then were switched to active-treatment with sertraline for another 6 weeks. 7 Among 55 patients screened, 18 (32%) met the prespecified inclusion/exclusion criteria and 16 patients completed the trial. The occurrence of IDH episodes did not significantly differ between the sertraline and placebo phases.…”

“…However, the risk of reporting adverse intradialytic symptoms was 42% higher with placebo [hazard ratio (HR): 1.42; 95% confidence interval (CI): 1.02-2.02]. 7 This effect was accompanied by 59% higher likelihood for nursing intradialytic interventions during the placebo phase (HR: 1.59; 95% CI: 1.03-2.48). 7 Although interventional studies are important and the efforts of Molin et al are worthy of appreciation, a number of lessons can be taken from this report.…”