Adverse drug events and the associated factors in patients with chronic Chagas disease

Lopes, Luiza Braz da Cunha; Pereira, Raquel Rodrigues; Andrade, Patricia Mello; Carneiro, Fernanda Martins; Mediano, Mauro Felippe Felix; Kilgore, Sophia Isabel Linnemann; Hasslocher-Moreno, Alejandro Marcel; Sousa, Andréa Silvestre de; Oliveira, Manoel Marques Evangelista; Saraiva, Roberto Magalhães; Holanda, Marcelo Teixeira de; Silva, Gilberto Marcelo Sperandio da

doi:10.1590/0037-8682-0443-2019

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Short Communication • Rev. Soc. Bras. Med. Trop. 53 • 2020 • https://doi.org/10.1590/0037-8682-0443-2019 copy

Adverse drug events and the associated factors in patients with chronic Chagas disease

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

INTRODUCTION:

Herein, we aimed to identify the factors associated with adverse drug events (ADEs) in chronic Chagas disease (CD) patients.

METHODS:

We analyzed 320 medical notes from 295 patients. The Naranjo algorithm was applied to determine the cause of ADEs. Mixed effects logistic regression was performed to evaluate the factors associated with ADEs.

RESULTS:

ADEs were described in 102 medical notes (31.9%). Captopril was most frequently associated with ADEs. Age (RR 0.96; 95%CI 0.94-0.99) and cardiac C/D stages (RR 3.24; 95%CI 1.30-4.58) were the most important clinical factors associated with ADEs.

CONCLUSIONS:

Close follow-up is warranted for CD patients.

Keywords:
Chagas disease; Adverse drug event; Cardiomyopathy

Variable	n (320)	%	Univariate RR	Multivariate RR
			(95%CI)*	(95%CI)*
Age
Mean(SD)	57.4	---	0.96	0.96
	(11.2)		(0.94-0.99)	(0.94-0.99)
Sex
Men	131	40.9	Reference	---
Women	189	59.1	0.99	1.23
			(0.50-1.66)	(0.64-1.94)
Schooling
Illiterate	48	15	Reference	---
Primary	219	68.4	1.14	---
			(0.42-2.19)
Secondary	47	14.7	0.73	---
			(0.15-2.09)
Tertiary	6	1.9	0.57	---
			(0.01-3.06)
Race
White	143	44.7	Reference	---
Mulatto	127	39.7	1.01	---
			(0.48-1.77)
Black	50	15.6	1.11	---
			(0.40-2.15)
Marital status
Single	111	34.7	Reference	---
Married	186	58.1	1.21	---
			(0.62-1.97)
Widowed	23	7.2	0.29	---
			(0.03-1.56)
Alcohol Consumption
No	133	66.8	Reference	---
Yes	66	33.2	0.98	---
			(0.45-1.76)
Stages of Chagas disease
Indeterminate	51	15.9	Reference	Reference
A	128	40.0	1.43	1.56
			(0.45-3.11)	(0.49-3.28)
B1	67	20.9	1.87	2.00
			(0.57-3.71)	(0.61-3.84)
B2	22	6.9	3.36	3.27
			(1.08-4.75)	(0.96-4.75)
C	48	15.0	3.11	3.24
			(1.24-4.51)	(1.30-4.58)
D	4	1.2	(1.24-4.51)	(1.30-4.58)
Number of drugs per prescription
0-1	9	2.8	Reference	---
2-4	103	32.2	1.55	1.35
			(0.14-4.01)	(0.12-3.88)
5-12	208	65.0	1.20	1.01
			(0.10-3.79)	(0.08-3.64)
Causality
Definite	41	12.8	(< 0.001)**	---
Probable	24	7.5		---
Possible	37	11.6		---
Doubtful/no event	218	68.1		---
Severity
Mild	59	18.4	(< 0.001)***	---
Moderate	38	11.9		---
Severe	5	1.6		---
No event	218	68.1		---

Drug name	n (%)
ACE inhibitors*	34 (33.3)
Amiodarone	13 (12.7)
Acetylsalicylic acid	9 (8.8)
Hydrochlorothiazide	7 (6.9)
Spironolactone	6 (5.9)
Warfarin	5 (4.9)
Digoxin	4 (3.9)
Propranolol	4 (3.9)
Isosorbide	4 (3.9)
Amlodipine	3 (2.9)
Benznidazole	3 (2.9)
Carvedilol	2 (2.0)
Furosemide	2 (2.0)
Diazepam	1 (1.0)
Losartan	1 (1.0)
Methyldopa	1 (1.0)
Nifedipine	1 (1.0)
Sotalol	1 (1.0)
Ferrous sulfate	1 (1.0)
Total number of drugs (n=19)	Total events (n=102)

Drug	ADRs	Frequency, n (%)	Total, n (%)
ACE inhibitor (Captopril + enalapril)	Cough	28 (8.8)	34 (10.6)
	Nausea /Gastric intolerance	1 (0.3)
	Hypotension	1 (0.3)
	Hyperkalemia	2 (0.6)
	Presyncope	1 (0.3)
	Dizziness	1 (0.3)
Amiodarone	Endocrine disorders	4 (1.3)	13 (4.1)
	Dizziness	1 (0.3)
	Cerebellar syndrome	1 (0.3)
	Drowsiness and hypotension	1 (0.3)
	Ophthalmic disorders	2 (0.6)
	Hepatitis	1 (0.3)
	Respiratory disorders	3 (0.9)
Acetylsalicylic acid	Bleeding	4 (1.3)	9 (2.8)
	Epigastralgia	3 (0.9)
	Urticaria	2 (0.6)
Hydrochlorothiazide	Nausea and epigastric pain	1 (0.3)	7 (2.2)
	Hypokalemia	1 (0.3)
	Hyponatremia	1 (0.3)
	Renal disorders	1 (0.3)
	Hypotension	2 (0.6)
	Orthostatic hypotension	1 (0.3)
Spironolactone	Hyperkalemia	3 (0.9)	6 (1.9)
	Gynecomastia	2 (0.6)
	Hypotension	1 (0.3)
Warfarin	Increased INR	1 (0.3)	5 (1.6)
	Bleeding	1 (0.3)
	Hematuria	1 (0.3)
	Dermatitis	2 (0.6)
Digoxin	Gynecomastia	1 (0.3)	4 (1.3)
	Bradycardia	1 (0.3)
	Weakness	1 (0.3)
	Bigeminy	1 (0.3)
Propranolol	Hypotension	1 (0.3)	4 (1.3)
	Intense bradycardia	1 (0.3)
	Bronchospasm	1 (0.3)
	Dizziness	1 (0.3)
Isosorbide	Hypotension	1 (0.3)	4 (1.3)
	Severe headache	1 (0.3)
	Headache with nitrate	1 (0.3)
	Dysphagia and dizziness	1 (0.3)
Amlodipine	MMII Edema	1 (0.3)	3 (0.9)
	Edema	1 (0.3)
	Lower limb edema	1 (0.3)
Benznidazole	Leukopenia	1 (0.3)	3 (0.9)
	Memory deficit	1 (0.3)
	Amnesia and mental confusion	1 (0.3)
Carvedilol	Bronchospasm	1 (0.3)	2 (0.6)
	Erectile dysfunction	1 (0.3)
Furosemide	Paresthesia	1 (0.3)	2 (0.6)
	Hypotension	1 (0.3)
Diazepam	Discouragement and daytime prostatitis	1 (0.3)	1 (0.3)
Losartan	Dizziness and drowsiness	1 (0.3)	1 (0.3)
Methyldopa	Postural hypotension	1 (0.3)	1 (0.3)
Nifedipine	Hypotension and redness on face	1 (0.3)	1 (0.3)
Sotalol	Bradycardia, dizziness, and sweating	1 (0.3)	1 (0.3)
Ferrous sulfate	Dizziness	1 (0.3)	1 (0.3)

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[1] Corresponding Author: Dr. Gilberto Marcelo Sperandio da Silva e-mail: gilbertomarcelo@gmail.com