VALSARTAN: EXPLORING KNOWLEDGE AND PERCEPTIONS OF ITS OFF-LABEL USE FOR COGNITIVE IMPAIRMENT AMONG PHARMACY STUDENTS

Background: Dementia and cognitive dysregulation are significantly prevalent in patients with hypertension, identified as a major modifiable risk factor. Angiotensin receptor blocker (ARBs) is one of the first line agents for managing hypertension and heart failure, this study focuses on one of the agents such as Valsartan, explored for its potential neuroprotective effect. However, their use in cognitive impairment remains an off-label use and lacks robust clinical evidence. Objective: The objectives of this study are two folds. First, to review the literature on the effect of valsartan on cognitive impairment. Second, to evaluate first-year pharmacy (P1) students’ knowledge of valsartan and its non–FDA-approved use in cognitive impairment, and to assess their perceptions regarding its appropriateness, safety, and evidence base. Methods: A comprehensive literature search was conducted using the Google Scholar, PubMed, Ovid, CINAHL, and Cochrane databases to identify peer-reviewed studies on the off-label use of ARBs in cognitive impairment, using relevant keywords and Medical Subject Headings (MeSH) terms such as neuroprotective mechanism of ARBs, survey on students’ knowledge on off label use, generalizability of off label use findings. For the second objective, a cross-sectional, survey-based study was conducted among P1 pharmacy students at a single institution. A structured questionnaire utilizing a 4-point Likert scale assessed knowledge and opinions related to valsartan and cognitive impairment. Demographic data were collected, and descriptive statistics were calculated. Given the ordinal nature of the data, Mann–Whitney U tests were used to evaluate differences between groups, with statistical significance defined as p < 0.05. Results: Although ARBs have been explored as a potential off-label therapy for cognitive impairment due to their neurovascular and anti-inflammatory effects, current evidence remains insufficient to support their use as a primary treatment. Observational studies and small randomized trials suggest a possible association with reduced cognitive decline. To further explore perceptions and knowledge regarding this potential off-label use, a survey-based assessment was conducted among pharmacy (P1) students. A total of 40 participants were included in the analysis. In the opinion domain, responses largely aligned with evidence-based perspectives discouraging the off-label use of valsartan for cognitive impairment. Agreement rates ranged from 34.2% to 78.9%, with the highest agreement observed for the statement supporting the need for increased FDA-encouraged clinical trials for off-label use (78.9%), followed by reluctance to use valsartan for cognitive impairment without an approved indication (71.1%). Additionally, 63.2% agreed that using valsartan in this context may provide false hope, reflecting awareness of the ethical implications of unsupported therapies. However, variability was noted in responses related to avoiding valsartan due to potential adverse effects (50.0% agreement) and prior exposure to the medication (34.2% agreement), suggesting some inconsistency in perceptions influenced by safety concerns and personal experience. In the knowledge domain, participants demonstrated generally strong performance in core pharmacotherapy areas. High correct response rates were observed for valsartan’s approved indication for hypertension (73.7%), maximum dosing knowledge (76.3%), and understanding of contributors to cognitive decline (78.9%). Recognition of the lack of evidence supporting valsartan use in cognitive impairment was moderate (44.7%), indicating some residual uncertainty. Knowledge regarding the absence of FDA-approved treatments for mild cognitive impairment was lower (36.8%), representing a relative gap in disease-state–specific understanding. Overall, the findings suggest solid foundational knowledge with targeted deficiencies in applied and emerging clinical domains. Overall, the findings indicate gaps in applied pharmacotherapy knowledge, particularly in off-label use, despite some recognition of evidence limitations. Lower knowledge scores were associated with inaccurate beliefs regarding efficacy, suggesting a disconnect between foundational knowledge and clinical application. These findings are consistent with existing literature demonstrating insufficient evidence for ARB use in cognitive impairment and highlight the need for enhanced emphasis on applied therapeutics in early pharmacy education. Conclusions: Literature findings are inconsistent and limited by methodological constraints. Consequently, ARBs should not be initiated solely for cognitive impairment but may be appropriately utilized in patients with concurrent cardiovascular indications, where potential cognitive benefits may be realized. Despite demonstrating appropriate evidence-based attitudes, P1 pharmacy students showed gaps in applied pharmacotherapy knowledge, particularly in off-label indications. These findings highlight the importance of preparing pharmacists to critically evaluate and apply evidence for both approved and non-approved uses of medications in clinical practice.

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Publication Details

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Zenodo (CERN European Organization for Nuclear Research)
Published
2026-04-24
DOI
https://doi.org/10.5281/zenodo.19739851
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Pharmaceutical studies and practices
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article
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article

VALSARTAN: EXPLORING KNOWLEDGE AND PERCEPTIONS OF ITS OFF-LABEL USE FOR COGNITIVE IMPAIRMENT AMONG PHARMACY STUDENTS

Earnestrad Porselvame, Bisrat* Hailemeskel, Tamunodiepinye Bamson
Zenodo (CERN European Organization for Nuclear Research)
Pharmaceutical studies and practices
article

VALSARTAN: EXPLORING KNOWLEDGE AND PERCEPTIONS OF ITS OFF-LABEL USE FOR COGNITIVE IMPAIRMENT AMONG PHARMACY STUDENTS

Earnestrad Porselvame, Bisrat* Hailemeskel, Tamunodiepinye Bamson
article en

Abstract

Background: Dementia and cognitive dysregulation are significantly prevalent in patients with hypertension, identified as a major modifiable risk factor. Angiotensin receptor blocker (ARBs) is one of the first line agents for managing hypertension and heart failure, this study focuses on one of the agents such as Valsartan, explored for its potential neuroprotective effect. However, their use in cognitive impairment remains an off-label use and lacks robust clinical evidence. Objective: The objectives of this study are two folds. First, to review the literature on the effect of valsartan on cognitive impairment. Second, to evaluate first-year pharmacy (P1) students’ knowledge of valsartan and its non–FDA-approved use in cognitive impairment, and to assess their perceptions regarding its appropriateness, safety, and evidence base. Methods: A comprehensive literature search was conducted using the Google Scholar, PubMed, Ovid, CINAHL, and Cochrane databases to identify peer-reviewed studies on the off-label use of ARBs in cognitive impairment, using relevant keywords and Medical Subject Headings (MeSH) terms such as neuroprotective mechanism of ARBs, survey on students’ knowledge on off label use, generalizability of off label use findings. For the second objective, a cross-sectional, survey-based study was conducted among P1 pharmacy students at a single institution. A structured questionnaire utilizing a 4-point Likert scale assessed knowledge and opinions related to valsartan and cognitive impairment. Demographic data were collected, and descriptive statistics were calculated. Given the ordinal nature of the data, Mann–Whitney U tests were used to evaluate differences between groups, with statistical significance defined as p < 0.05. Results: Although ARBs have been explored as a potential off-label therapy for cognitive impairment due to their neurovascular and anti-inflammatory effects, current evidence remains insufficient to support their use as a primary treatment. Observational studies and small randomized trials suggest a possible association with reduced cognitive decline. To further explore perceptions and knowledge regarding this potential off-label use, a survey-based assessment was conducted among pharmacy (P1) students. A total of 40 participants were included in the analysis. In the opinion domain, responses largely aligned with evidence-based perspectives discouraging the off-label use of valsartan for cognitive impairment. Agreement rates ranged from 34.2% to 78.9%, with the highest agreement observed for the statement supporting the need for increased FDA-encouraged clinical trials for off-label use (78.9%), followed by reluctance to use valsartan for cognitive impairment without an approved indication (71.1%). Additionally, 63.2% agreed that using valsartan in this context may provide false hope, reflecting awareness of the ethical implications of unsupported therapies. However, variability was noted in responses related to avoiding valsartan due to potential adverse effects (50.0% agreement) and prior exposure to the medication (34.2% agreement), suggesting some inconsistency in perceptions influenced by safety concerns and personal experience. In the knowledge domain, participants demonstrated generally strong performance in core pharmacotherapy areas. High correct response rates were observed for valsartan’s approved indication for hypertension (73.7%), maximum dosing knowledge (76.3%), and understanding of contributors to cognitive decline (78.9%). Recognition of the lack of evidence supporting valsartan use in cognitive impairment was moderate (44.7%), indicating some residual uncertainty. Knowledge regarding the absence of FDA-approved treatments for mild cognitive impairment was lower (36.8%), representing a relative gap in disease-state–specific understanding. Overall, the findings suggest solid foundational knowledge with targeted deficiencies in applied and emerging clinical domains. Overall, the findings indicate gaps in applied pharmacotherapy knowledge, particularly in off-label use, despite some recognition of evidence limitations. Lower knowledge scores were associated with inaccurate beliefs regarding efficacy, suggesting a disconnect between foundational knowledge and clinical application. These findings are consistent with existing literature demonstrating insufficient evidence for ARB use in cognitive impairment and highlight the need for enhanced emphasis on applied therapeutics in early pharmacy education. Conclusions: Literature findings are inconsistent and limited by methodological constraints. Consequently, ARBs should not be initiated solely for cognitive impairment but may be appropriately utilized in patients with concurrent cardiovascular indications, where potential cognitive benefits may be realized. Despite demonstrating appropriate evidence-based attitudes, P1 pharmacy students showed gaps in applied pharmacotherapy knowledge, particularly in off-label indications. These findings highlight the importance of preparing pharmacists to critically evaluate and apply evidence for both approved and non-approved uses of medications in clinical practice.

Zenodo (CERN European Organization for Nuclear Research)
Quality Education
Openalex Percentile: Top 4%
Pharmaceutical studies and practices
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