Impact of Adverse Drug Reactions in Patients with End Stage Renal Disease in Greece

Abstract

Background: Patients with end-stage renal disease (ESRD) require specialized therapeutic interventions. The decreased renal function that modulates the physiology and presence of comorbidities is often associated with variations in the pharmacological response, thus increasing the risk of adverse drug events or reactions (ADE/ADRs) from co-administered drugs.

Methods: A cross-sectional study to record comorbidities, drug-drug interactions (DDIs), ADE/ADRs in patients with chronic kidney disease of stage five in Greece. The study enrolled 60 patients of mean age 64.8 ± 12.9 years, undergoing hemodialysis three times a week. Demographic and social factors, comorbidities, laboratory test data, medication regimens, DDIs and the reporting of ADE/ADRs were analyzed.

Results: Cardiovascular diseases and diabetes were the main comorbidities. In total, 50 different DDIs of various clinical significance were identified. CNS, GI-track, and musculoskeletal-system-related ADE/ADRs were most often reported by patients. ADE/ADRs as clinical outcome from DDIs were associated in 64% of the total identified DDIs. There was a positive trend between number of medications, ADE/ADRs report and DDIs.

Conclusions: The impact of ADE/ADRs in ESRD patients should be always considered. Guidelines as well as continuous training in the context of evidence-based clinical practice by healthcare personnel on therapy administration and prevention of adverse events are important.

Keywords: adverse drug reactions; chronic disease; chronic kidney disease; drug–drug interactions; end-stage renal disease; quality of life.

Figure 1

Comorbidities recorded among the ESRD patients of the study (ESRD: End Stage Renal Disease; SLE: Systemic Lupus Erythematous).

Figure 2

Distributions of medications administered among the ESRD patients. Bar graphs: drug categories among patients; chart pies: pharmacological compounds from each category (Thyroid drugs refer to levothyroxine (100%) alone and not included as pie) (ESRD: End-stage Renal Diseasel CVD: Cardio-Vascular Disease; GI: gastro-intestinal).

Figure 3

Identified DDIs and (A) Clinical significance; (B) pharmacological process involved; (C) Clinical significance and underlying pharmacological mechanism (D) Trends in number of DDIs over number of medications (dashed line) and the clinical significance distribution per average number of identified interactions (bars) (E) Impact of comorbidities and medication number on identified DDIs and ADE/ADRs occurrence (DDIs: Drug-Drug Interactions; ADE/ADRs: Adverse Drug Events/Adverse Drug Reactions).

Figure 4

Naranjo scale results for different drug categories prescribed in ESRD patients of the study (CNS: central nervous system drugs including antiepileptics, antipsychotics, antidepressants, anti-parkinson; CVD: cardiovascular disease drugs, including antiplatelet–anticoagulant).

Figure 5

Distribution and frequency of reported ADE/ADRs in ESRD study group in relevance with related organ systems (GI: gastro-intestinal; CNS: Central Nervous System).