Active Pharmacovigilance in Peruvian Population: Surveillance of a Timolol/Brimonidine/Dorzolamide Ophthalmic Fixed Combination

Figures & data

Table 1 Characteristics of the Patients

Age Groups	n (%)
Children	1 (0.4)
Adolescent	0 (0)
Adult	96 (39.0)
Geriatric	149 (60.5)
Sex	n (%)
Female	132 (53.7)
Male	114 (46.3)
ADRs	n (%)
Yes	94 (38.2)
No	152 (61.8)
Medical Prescription	n (%)
Glaucoma	185 (75.2)
Ocular Hypertension	45 (18.3)
Post-Surgical	14 (5.7)
Other	2 (0.8)
Comorbidity	n (%)
Yes	166 (67.5)
No	80 (32.5)
Concomitant Therapy	n (%)
Yes	125 (50.8)
No	121 (49.2)

Figure 1 Adverse drugs reactions of different age groups of TBD treatment.

Table 2 Causality Assessment of the ADRs

ADRs	Definite	Probable	Possible	Doubtful	Total
Blood pressure decreased	–	–	1 (1%)	–	1 (1%)
Nasopharyngitis	–	–	1 (1%)	1 (1%)	2 (2.1%)
Somnolence	–	1 (1%)	–	–	1 (1%)
Headache	–	1 (1%)	–	–	1 (1%)
Dysgeusia	–	–	1 (1%)	1 (1%)	2 (2.1%)
Dry mouth	–	–	1 (1%)	–	1 (1%)
Eye irritation	2 (2.1%)	70 (75%)	4 (4.3%)	–	76 (80.9%)
Eye pruritus	–	3 (3.2%)	–	–	3 (3.2%)
Vision blurred	–	4 (4.3%)	1 (1%)	–	5 (5.3)
Ocular hyperemia	–	1 (1%)	–	–	1 (1%)
Eye pain	–	1 (1%)	–	–	1 (1%)
Total	2 (2.1%)	81 (86.2%)	9 (9.6%)	2 (2.1%)	94 (100%)

Table 3 ADRs of TBD vs Reported by Individual Active Ingredient

SOC	PT	TBD	B	p	T	p	D	p
Eye disorders	Eye irritation	30.9%	9%
	<0.0001^c***^a	12%	<0.0001^c***^a	32%	0.7709^c
	Eye pruritus	1.2%	20%	<0.0001^d***^b	5%	0.0183^d*^b	1%	>0.9999^d
	Vision blurred	2%	4%	0.1898^c	5%	0.0840^c	5%	0.0840^c
	Ocular hyperemia	0.4%	20%	<0.0001^d***^b	5%	0.0020^d**^b	5%	0.0020^d**^b
Eye pain	0.4%	4%	0.0061^d**^b	5%	0.0020^d**^b	–	––
Gastrointestinal disorders	Dry mouth	0.4%	9%	<0.0001^d***^b	5%	0.0020^d**^b	–	–
Nervous system disorders	Dysgeusia	0.8%	4%	0.0194^d*^b	–	–	25%	<0.0001^d***^b
	Headache	0.4%	4%	0.0061^d**^b	5%	0.0020^d**^b	–	–
	Somnolence	0.4%	4%	0.0061^d**^b	–	–	5%	0.0020^d**^b
Investigations	Blood pressure decreased	0.4%	4%	0.0061^d**^b	1%	0.3153^d	–	–
Infections and infestations	Nasopharyngitis	0.8%	–	–	–	–	–	–

Notes: Significance, *p<0.05, **p<0.01, ***p<0.001. ^aThe statistical significance is above expected to TBD. ^bThe statistical significance is below expected to TBD. ^cPearson Chi-square test. ^dFisher’s exact test.

Abbreviations: SOC, System Organ Class; PT, preferred term; TBD, timolol/brimonidine/dorzolamide fixed combination; T, timolol; B, brimonidine; D, dorzolamide.

Figure 2 Drugs used concomitantly with TBD and their relative risk (RR) of adverse drug reactions (ADRs).

Note: *Relative risk > 1. Abbreviations: Oph, ophthalmic; CMC, carboxymethylcellulose; PEG, polyethylene glycol..