Clinico-biochemical Study of the Safety and Tolerability of Selective Serotonin Reuptake Inhibitors (SSRI) with Special Reference to SSRI Induced Hyponatremia in Humans and Animals
Introduction: Selective Serotonin Reuptake Inhibitors (SSRIs) are recommended as first-line anti-depressants in Major Depressive Disorder (MDD) because of their relatively benign safety profile. Hyponatremia is under reported and notorious adverse effect of SSRIs shown by few Randomised Clinical...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JCDR Research and Publications Private Limited
2021-03-01
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| Series: | Journal of Clinical and Diagnostic Research |
| Subjects: | |
| Online Access: | https://www.jcdr.net/articles/PDF/14641/48204_CE[Ra1]_F[SK]_PF1(AKA_SHU)_PN(KM).pdf |
| Summary: | Introduction: Selective Serotonin Reuptake Inhibitors (SSRIs)
are recommended as first-line anti-depressants in Major
Depressive Disorder (MDD) because of their relatively benign
safety profile. Hyponatremia is under reported and notorious
adverse effect of SSRIs shown by few Randomised Clinical
Trials (RCTs). There are only few published studies of SSRIs on
serum sodium level in human and animal model.
Aim: To determine SSRI induced hyponatremia in human and its
correlation with age.
Materials and Methods: The clinical part is a prospective
cohort study whereas second part is experimental study
involving animals. In clinical part-Patients of either sex, aged
above 18 years, attending the Out-Patient Department (OPD)
of Psychiatry of a tertiary hospital and diagnosed as MDD
Diagnostic and Statistical Manual (DSM) V with the help of a
senior psychiatrist, were screened and recruited in the study after
satisfying the inclusion and exclusion criteria by consecutive
sampling. Patients were prescribed fluoxetine (n=90), sertraline
(n=55), paroxetine (n=30) and escitalopram (n=25). Parameters
recorded (serum sodium) at baseline, 4th week, 8th week and
12th week. Symptoms due to hyponatremia and Adverse Drug
Reactions (ADR) were also checked. Multiple group comparison
at different visits for sodium level was done using one-way
ANOVA and repeated measures ANOVA test and relationship
of blood sodium level with age were estimated with bivariate
correlation. Animal experiment was done in Pharmacology
Department, animals were randomised into 5 groups control,
fluoxetine, sertraline, paroxetine and escitalopram (n=6). Blood
sodium checked at baseline, 2nd week and 4th week. Kruskal
Wallis test and Friedman’s test done to detect changes in
sodium level in follow-up period.
Results: Mean age ranged between 40-50 years with equal
gender distribution. Both within group and between group
analysis revealed significant difference in blood sodium level
(p-value <0.0001). Hyponatremia was strongly correlated
with age (correlation coefficient >-0.783). Most participants
(184 out of 200) developed asymptomatic hyponatremia. Two
among sertraline developed seizure leading to discontinuation
to therapy. About 72 (38.09%) ADRs belonged to probable,
mostly belonging to fluoxetine and sertraline group,
developement of hyponatremia was 9 days (median) from
starting SSRI. In animal part within group analysis revealed
significant change of sodium from baseline in all drug treated
animals (p-value<0.0001).
Conclusion: SSRI is associated with hyponatremia and is
common in elderly patients. Monitoring of serum sodium is
necessary for patients on SSRI. |
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| ISSN: | 2249-782X 0973-709X |