A Prospective Research Study of Anti-Glaucoma Drugs Prescribing, Utilization Pattern and Adverse Drug Reaction Recording in a University Hospital

Alaei, Mastaneh; Najmi, Abul Kalam; Kausar, Hina; Akhtar, Mohd

doi:10.1055/s-0034-1376964

Cited by 7 publications

(4 citation statements)

References 13 publications

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“…This was followed by Timolol, Brimonidine and Prostaglandin analogues. This observation was different from other studies in which ADR related to Dorzolamide was less frequent while Brimonidine (Bhatt et al) 12 and Latanoprost (M Alaei et al) 11 were found to be the most frequent offending medications. Since the ADR could also be related to preservatives (Used in the topical drug preparations), it is difficult to make a definite conclusion regarding this observation.…”

Section: Resultscontrasting

confidence: 98%

Impact of Adverse Drug Reactions of Topical Anti-Glaucoma Medications on the Vision-Related Quality of Life in Primary Open Angle Glaucoma

Sidhan¹,

Thankappan²,

C³

et al. 2017

jemds

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BACKGROUNDAdverse drug reactions (ADR) to topical medications form an important cause for noncompliance in the long term management of glaucoma. This study was aimed to determine the different types of adverse drug reactions associated with glaucoma medications and their impact on the vision-related Quality of Life (vQOL) in patients with Primary Open Angle Glaucoma. MATERIALS AND METHODSPatients with Primary Open Angle Glaucoma, fulfilling the inclusion criteria were interviewed and data collected. Adverse drug reactions to topical anti-glaucoma medications were evaluated using the 'Comparison of Ophthalmic Medications for Tolerability Questionnaire' and quality of life related to vision was evaluated using the 'National Eye Institute Visual Function-25 Questionnaire'. Statistical analysis was performed using the SPSS version 22. The effect of ADR on the vQOL was analysed both by a univariate and multivariate analysis using a linear regression model. RESULTSThe study population included 115 patients (28% females) with mean age of 53.22 ± 11.46 years. At least one adverse drug reaction was reported in 71.2% of cases. Adverse drug reaction (ADR) was reported in nearly all patients on dorzolamide eye drops followed by timolol (74.1%), brimonidine (50%), bimatoprost (31.8%), latanoprost (39.3%) and travoprost (15%). The three most common adverse drug reactions reported were burning (60.75%), blurred vision (45.56%) and bitter taste (44.3%). The vision-related Quality scores in all subset domains were well above 50, the lowest being the general health and near activities domain. Significant association was noted between patients with ADR and low vQOL scores (P = 0.03) on multivariate analysis. CONCLUSIONAdverse drug reactions to topical anti-glaucoma medications were found to have a negative impact on the vision-related quality of life in glaucoma patients, emphasising the integration of proper patient education and counselling in the long-term management.

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Section: Resultscontrasting

confidence: 98%

Impact of Adverse Drug Reactions of Topical Anti-Glaucoma Medications on the Vision-Related Quality of Life in Primary Open Angle Glaucoma

Sidhan¹,

Thankappan²,

C³

et al. 2017

jemds

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“…One SAE (atrial fibrillation) occurred, which is an unknown side effect, but was judged as having a possible relationship with acetazolamide intake. The relevant differences of AE patterns between treatment arms regarding nervous system, gastrointestinal cardiac and general disorders are consistent with the side effect profile of acetazolamide [ 18 – 21 ]. Quality of life was assessed using the NEI VFQ-25 questionnaire.…”

Section: Discussionmentioning

confidence: 56%

Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide/timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma

et al. 2017

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IntroductionTo demonstrate that preoperative treatment for 28 days with topical dorzolamide/timolol is non-inferior (Δ = 4 mm Hg) to oral acetazolamide and topical dexamethasone (standard therapy) in terms of intraocular pressure (IOP) reduction 3 and 6 months after trabeculectomy in glaucoma patients.Materials and methodsSixty-two eyes undergoing trabeculectomy with mitomycin C were included in this monocentric prospective randomized controlled study. IOP change between baseline and 3 months post-op was defined as the primary efficacy variable. Secondary efficacy variables included the number of 5-fluorouracil (5-FU) injections, needlings, suture lyses, preoperative IOP change, hypertension rate and change of conjunctival redness 3 and 6 months post-op. Safety was assessed based on the documentation of adverse events.ResultsPreoperative treatment with topical dorzolamide/timolol was non-inferior to oral acetazolamide and topical dexamethasone in terms of IOP reduction 3 months after trabeculectomy (adjusted means -8.12 mmHg versus -8.30 mmHg; Difference: 0.18; 95% CI -1.91 to 2.26, p = 0.8662). Similar results were found 6 months after trabeculectomy (-9.13 mmHg versus -9.06 mmHg; p = 0.9401). Comparable results were also shown for both groups concerning the classification of the filtering bleb, corneal staining, and numbers of treatments with 5-FU, needlings and suture lyses. More patients reported AEs in the acetazolamide/dexamethasone group than in the dorzolamide/timolol group.DiscussionPreoperative, preservative-free, fixed-dose dorzolamide/timolol seems to be equally effective as preoperative acetazolamide and dexamethasone and has a favourable safety profile.

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“…We excluded 1,293 citations as they did not meet the inclusion criteria, and the remaining 107 were screened full text. Twenty-one citations were further excluded (33–52) and 86 papers were included, corresponding to 69 different studies (53–138).…”

Section: Resultsmentioning

confidence: 99%

Intensive Monitoring Studies for Assessing Medicines: A Systematic Review

et al. 2019

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Introduction: Intensive monitoring (IM) is one of the methods of post-marketing active surveillance based upon event monitoring, which has received interest in the current medicines regulatory landscape. For a specific period of time, IM involves primary data collection and is actively focused on gathering longitudinal information, mainly safety, since the first day of drug use. Objectives: To describe IM systems and studies' data published over 11-years period (2006–2016). Specifically, we reviewed study population/event surveillance, methodological approaches, limitations, and its applications in the real-world evidence generation data. Methods: We completed a systematic search of MEDLINE and EMBASE to identify studies published from 2006 to 2016, that used IM methodology. We extracted data using a standardized form and results were analyzed descriptively. The methodological quality of selected studies was assessed using the modified Downs and Black checklist. Results: From 1,400 screened citations, we identified 86 papers, corresponding to 69 different studies. Seventy percent of reviewed studies corresponded to established IM systems, of which, more than half were prescription event monitoring (PEM) and modified-PEM. Among non-established IM systems, vaccines were the most common studied drugs ( n = 14). The median cohort size ranged from 488 (hospitals) to 10,479 (PEM) patients. Patients and caregivers were the event data source in 39.1% of studies. The mean overall quality score was similar between established and non-established IM. Conclusions: Over the study period, IM studies were implemented in 26 countries with different maturity levels of post-marketing surveillance systems. We identified two major limitations: only 20% of studies were conducted at hospital-level, which is a matter of concern, insofar as healthcare systems are facing a lack of access to new medicines at ambulatory care level. Additionally, IM access to data of drug exposure cohorts, either at identification or at follow-up stages, could somehow constitute a barrier, given the complexity of managerial, linkable, and privacy data issues.

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A Prospective Research Study of Anti-Glaucoma Drugs Prescribing, Utilization Pattern and Adverse Drug Reaction Recording in a University Hospital

Abstract: In the present study, the maximum patients were in the age group of 41-50 years. The most commonly prescribed drugs were timolol followed by dorzolamide, acetazolamide. Latanoprost was associated with maximum number of ADRs.

Cited by 7 publications

References 13 publications

Impact of Adverse Drug Reactions of Topical Anti-Glaucoma Medications on the Vision-Related Quality of Life in Primary Open Angle Glaucoma

Impact of Adverse Drug Reactions of Topical Anti-Glaucoma Medications on the Vision-Related Quality of Life in Primary Open Angle Glaucoma

Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide/timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma

Intensive Monitoring Studies for Assessing Medicines: A Systematic Review

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