What is the safety and dosing of sertraline (Selective Serotonin Reuptake Inhibitor) in patients with End-Stage Renal Disease (ESRD) undergoing Peritoneal Dialysis (PD)?

From the Guidelines

Sertraline should be used with caution in patients with end-stage kidney disease on peritoneal dialysis, with careful consideration of its adverse-effect profile and the need for close monitoring of efficacy and safety. When prescribing sertraline to these patients, it is essential to follow the principles of psychotropic medication prescription in medically fragile patients, including uptitration of subtherapeutic doses with care, keeping efficacy and safety as a top priority 1. The lack of randomized controlled clinical trials addressing SSRI use in peritoneal dialysis and the documented increased adverse effects in patients on hemodialysis warrant a cautious approach 1. Key considerations include:

• Potential for increased adverse effects, such as gastrointestinal issues, QT prolongation, and altered pharmacokinetics in the setting of kidney failure 1
• The need for careful monitoring of patients due to their increased sensitivity to medication side effects
• Starting at a low dose, such as 25 mg daily, and titrating gradually based on clinical response and side effects
• Regular assessment of efficacy and tolerability, as well as monitoring for potential drug interactions with other medications commonly used in ESKD patients.

From the FDA Drug Label

Sertraline is extensively metabolized and excretion of unchanged drug in urine is a minor route of elimination In volunteers with mild to moderate (CLcr=30 to 60 mL/min), moderate to severe (CLcr=10 to 29 mL/min) or severe (receiving hemodialysis) renal impairment (N=10 each group), the pharmacokinetics and protein binding of 200 mg sertraline per day maintained for 21 days were not altered compared to age-matched volunteers (N=12) with no renal impairment

The FDA drug label does not provide specific information on the safety and dose of sertraline in patients with end-stage kidney disease on peritoneal dialysis. However, it does mention that sertraline pharmacokinetics appear to be unaffected by renal impairment, including severe renal impairment in patients receiving hemodialysis. No dose adjustment is explicitly recommended for patients with renal impairment. Nevertheless, given the lack of specific information on peritoneal dialysis, caution should be exercised when administering sertraline to these patients 2.

From the Research

Safety and Dose of Sertraline in End-Stage Kidney Disease

There are no research papers provided that directly address the safety and dose of sertraline in end-stage kidney disease patients on peritoneal dialysis.

Peritoneal Dialysis in End-Stage Kidney Disease

• Peritoneal dialysis (PD) is a replacement therapy for patients with stage 5 chronic kidney disease (CKD5) 3.
• PD can be a safe, efficient, and cost-effective alternative to haemodialysis in late-presenting end-stage renal disease with comparable outcomes 4.
• Incremental PD is a safe approach to initiate dialysis and offers satisfactory outcomes 5.
• Peritoneal dialysis removes uremic toxins and fluid through the peritoneum by instillation and drainage of a special fluid via a PD catheter in and out of the abdominal cavity a number of times a day 6.

Considerations for Peritoneal Dialysis

• Peritoneal dialysis has its own specific complications, including the occurrence of peritonitis and membrane failure 6.
• Automated peritoneal dialysis (APD) is now regarded as at least as efficient as continuous ambulatory peritoneal dialysis (CAPD) with regard to major biomedical outcomes 7.