الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
Chronic kidney disease patients are particularly vulnerable to drug-related problems and
ADEs because they have impaired renal function and altered drug clearance, along with multiple
comorbidities and frequent hospitalizations. The convergence of these factors increases CKD
patients’ susceptibility to adverse safety events.
Non-steroidal anti-inflammatory drugs are the most common therapeutic products used
for the management of inflammation and pain. However, NSAIDs have several adverse effects
including nephrotoxicity, resulting in changes in the haemodynamics of the kidney. This could
lead to renal impairment and worsen the degree of renal dysfunction in CKD patients and
consequently lead to the development of ESRD.
The aim of the present study was to investigate the use of NSAIDs among CKD patients
diagnosed in pre-ESRD (i.e. before dialysis or transplantations) and with the following specific
objectives:
1. To estimate the prevalence of NSAIDs use among the study pre-ESRD patients.
2. To identify the pattern of NSAIDs use among pre-ESRD patients.
3. To assess the knowledge of pre-ESRD patients about the adverse effects of NSAIDs.
A cross sectional study was conducted among adult CKD patients (18 years and above)
diagnosed in pre-ESRD. The study included 350 pre-ESRD patients attending the outpatient and
the inpatient wards of Internal Medicine Department of Alexandria Main University Hospital.
Data collection was done using a predesigned interview questionnaire including personal
data, history of comorbid diseases, history of selected drugs interacting with NSAIDs, NSAIDs
use (prevalence, type, purpose, pattern, source of advice, and adverse effects of NSAIDs), and
data about the knowledge of adverse effects of NSAIDs. Measurements (blood pressure, weight,
and height) and laboratory investigations (standardized serum creatinine from patients’ data
with calculation of the eGFR) were done.
Data entry and statistical analysis were done using the software Statistical Package for
Social Science (SPSS) version 23. Statistical analysis was performed in both descriptive and
inferential forms.
The study revealed the following main results:
A. characteristics of CKD patients:
The age of patients ranged between 18 and 93 years with a mean age of 55±13 years.
The percentage of males was slightly higher than females (51.4 % versus 48.6%,
respectively).
Almost three quarters (74.5%) of the study patients were married, while only 4.9%
were single. Widowed patients constituted 16.3% of the study patients.
More than one third (38.6%) of the patients were illiterate. More than one fourth of
the patients were either with preparatory education or read and write (25.4% and
25.1%, respectively). Only 3.2% of the participants were university graduates.
More than two fifths (43.1%) of the study patients were housewives, 20.9% were
retired, 15.7% were non-working and only 8.3% were employees.
More than the half (59.2%) of study patients were non-smokers and about one fifth
(19.1%) were currently smoking.
The percentage of overweight and obese patients were nearly equal (42.6% and 42%,
respectively).
More than the half of study patients were hypertensive, 46% were diabetics, 28%
were suffering from osteoarthritis, and 18.3% had CVDs.
The median (Inter-quartile range) eGFR was 27(18-37) ml/min/1.73m2 among the
study patients. More than half (56%) of study patients were in stage 4 while 40.3%
were in stage 3 (12.6% in stage 3a and 27.7% in stage 3b). Only 3.7% were in stage
2. None of the patients were in stage 1.
The percentage of patients who gave history of using RAAS inhibitors (ACEI/ARBs)
and diuretics were 20% and 9.7% respectively. Only 6.3% of patients gave history of
using both.
B. The prevalence of NSAIDs use among the pre-ESRD patients was 65.7%.
C. NSAIDs use among CKD patients:
Ketoprofen was the most commonly used NSAID (50.3%), followed by diclofenac
(33.7%), ibuprofen (23.1%), ketorolac (2.6%) and meloxicam (2.3%).
More than two thirds (68.7%) of CKD patients mentioned headache as the main
reason for NSAIDs use, followed by generalized pain (49.6%) and joint pain
(43.9%).
Two fifths of CKD patients took NSAIDs twice a week, while more than one fifth
took them every day or three times a week (22.2% and 20.4% respectively) within
the last month.
More than two fifths (46.1%) of study CKD patients used NSAIDs for a period
exceeding three years, 41.7% for 1-3 years and 12.2% less than one year.
More than three quarters (82.6%) of study patients gave history of regular use in the
form of at least twice a week for more than two months.
The percentage of patients using one type of NSAIDs was 44.8%. Those using two
and three types constituted 40% and 13.5% respectively during the last month.
About three quarters (74.3%) of the patients used NSAIDs by oral route while
almost one fourth (24.8%) used both oral and injection route.
About one third (31.3%) of CKD patients with a history of NSAIDs use mentioned
having adverse effects and 90.3% of them reported GIT effects, while 20.8%
reported kidney problems.
The majority of patients (76.5%) used NSAIDs by self-decision, while 25.2% used
them after the advice of physicians. Those who mentioned relatives and friends
constituted 13.5%. Pharmacists and previous prescription constituted 10.4% and
9.1% respectively.
There was a significant inverse/negative correlation between the eGFR and the
duration of NSAIDs use (r = -0.25, p< 0.001).
D. Factors associated with NSAIDs use among CKD patients:
In univariate analysis: gender, occupation, smoking status, hypertension,
osteoarthritis, hepatitis C, and eGFR were significantly associated with NSAIDs
use.
In logistic regression analysis: age, occupation, hypertension, osteoarthritis,
hepatitis C, and eGFR were significantly associated with NSAIDs use.
E. Knowledge of CKD patients about the adverse effect of NSAIDs:
More than the half (53.2%) of the patients did not know whether NSAIDs have
adverse effects or not. Those who mentioned that NSAIDs have adverse effects
constituted 37.1%, and only 9.7% said that NSAIDs have no adverse effects.
Among CKD patients who mentioned that NSAIDs have adverse effects, 55.4% of
them thought that NSAIDs cause kidney problems. The percentage of patients who
thought that NSAIDs lead to gastrointestinal tract, liver and heart problems were
45.4%, 19.2% and 2.3%, respectively.
Based on the results of the current study, the following can be concluded:
The use of NSAIDs is widely prevalent among pre-ESRD patients. About two thirds
(65.7%) of the patients enrolled in this study were NSAIDs users.
The NSAIDs use was associated with a decline of eGFR in CKD patients in a timedependent
manner.
The use of NSAIDs is related to certain comorbid diseases as osteoarthritis and
hypertension.
Improper use of NSAIDs with interacting drugs as RAAS inhibitors (ACEI/ARBS) and/
or diuretics at the same time was reported by more than one third (37.4%) of the study
patients.
The majority NSAIDs users were using them by self-decision.
Age, occupation, hypertension, osteoarthritis, hepatitis C, and eGFR were significantly
associated with NSAIDs use.
More than the half (53.2%) of study patients did not know whether NSAIDs have
adverse effects or not.
The main recommendations of the study are:
A. Recommendations to the Ministry of Health and Population:
Implementing the pharmacovigilance system and helping health care professionals
(HCPs) managing patients with CKD to understand the role of pharmacovigilance in
ensuring patient safety through continuous health education and clinical training in
pharmacovigilance.
Communicating the effects of NSAIDs use especially their nephrotoxicity and potential
interactions with RAAS inhibitors and diuretics to physicians, other prescribers of
medication and the community through training courses and workshops.
Educating pharmacists about the basic principles of rational use of NSAIDs, with
special stress on adverse effects and possible drug-drug interactions.
Improving patient understanding and awareness of CKD and risks of use NSAIDs to
prevent further kidney damage and progression of the disease through the mass media
and public health programs.
Banning self-medication with NSAIDs through enforcing strict regulations.
B. Recommendations to physicians:
Considering doing renal function tests to all patients when prescribing NSAIDs and
doing a risk benefits analysis for NSAIDs use.
Prescribing the lowest effective NSAID, for the shortest possible time, and
discouraging its chronic use.
C. Recommendations to pharmacists:
Pharmacists should spend more time with NSAIDs purchasers explaining the rational
use, the adverse effects of NSAIDs and their interactions with other drugs such as
RAAS inhibitors and diuretics.
D. Recommendations to researchers:
Further researches are required to detect the effect of continuous use of NSAIDs on the
renal function in order to create more awareness among the prescribers.
Additional studies are required to estimate the burden of other nephrotoxic drugs in
patients with CKD, with the aim of reducing the poor outcomes of CKD including
progression to ESRD.