Table 6.

Adverse events reported in observational studies of adults with ESKD and depression

Author (Reference); N; Years; SourceTreatment versus ComparatorOutcomes of InterestFindings
Assimon et al. (57); N=65,654; 2007–2014; Medicare Recipients in the US Renal Data System DatabaseSSRIs with higher QT-prolonging potentiala versus SSRIs with lower QT-prolonging potentialb1-yr sudden cardiac deathCompared to SSRIs with lower QT-prolonging potential, those with higher QT-prolonging potential were associated with higher risk of sudden cardiac death (AHR, 1.18; 95% CI, 1.05 to 1.31);
this association was more pronounced among older adults (AHR, 1.19; 95% CI, 1.05 to 1.35), women (AHR, 1.23; 95% CI, 1.06 to 1.44), patients with conduction disorders (AHR, 1.47; 95% CI, 1.05 to 2.06), and those treated with other non-SSRI QT-prolonging medications (AHR, 1.29; 95% CI, 1.10 to 1.50)
Guirguis et al. (56); N=41; 2013–2015; ASSertID StudyAntidepressants (no comparator)Antidepressant-management practices related to NICE guidelinesAt baseline, 30 patients had BDI‐II scores ≥16, and 22 remained high at follow‐up;
At baseline, 11 patients had BDI‐II scores <16; five of 11 were ≥16 on follow‐up;
27 of the 41 patients (66%) either deteriorated or failed to improve;
16 patients (39%) had no review of antidepressant medication;
a significant proportion of patients were taking agents cautioned against, or with no available prescribing information in, for patients on HD, or they were taking doses that might be considered subtherapeutic;
15% had no evidence of ever having had MDD over their lifetime according to the MINI, in spite of their being on antidepressants
Vangala et al. (58); N=54,032; 2009–2015; Medicare Recipients in the US Renal Data System DatabaseSSRI versus no SSRIHip fractureAny SSRI use was associated with increased hip fracture risk (AOR, 1.25; 95% CI, 1.17 to 1.35); risk for fracture was estimated for low (AOR, 1.20; 95% CI, 1.08 to 1.32), moderate (AOR, 1.31; 95% CI, 1.18 to 1.43), and high SSRI use (AOR, 1.26; 95% CI, 1.12 to 1.41);
the relationship between hip fracture events and SSRI use was also seen in the examination of new short-term use (AOR, 1.43; 95% CI, 1.23 to 1.67);
no significant interaction with age, sex, BMI, race, or ethnicity was discovered in the short-term analysis
  • SSRIs, selective serotonin reuptake inhibitors; AHR, adjusted hazard ratio; ASSertID, A Study of Sertraline in Dialysis; NICE, National Institute for Health and Care Excellence; BDI-II, Beck Depression Inventory-II; HD, hemodialysis; MDD, major depressive disorder; MINI, Mini International Neuropsychiatric Interview; AOR, adjusted odds ratio; BMI, body mass index.

  • a Citalopram and escitalopram.

  • b Fluoxetine, fluvoxamine, paroxetine, and sertraline.