Prevalence and Extent of Adverse Drug Reactions in Sudanese Patients in Highly Active Anti-retroviral Therapy Regimens

Elnagar, Bushra Mohamed Ibrahim

doi:10.15226/2476-2431/2/2/00118

Cited by 3 publications

(9 citation statements)

References 34 publications

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“…This is agreed with the author of the Sudanese report-based study in his belief in the inaccuracy of data regarding severity and patients’ dependence on their perceptions. 11 However, in another study, more than 40% of the adverse cases were in WHO grade 1. 10 Another study supporting this finding indicated that most ART-related ADEs are mild in general, not serious, and resolved over time.…”

Section: Discussionmentioning

confidence: 91%

“…The study showed a high rate of recovery among all adverse events except anemia and peripheral neuropathy, where the percentages of “not recovered” exceeded “recovered”, coming in line with the Sudanese report-based study where the outcome of ADRs was mostly “recovered”. 11 …”

Section: Discussionmentioning

confidence: 99%

“…Intervention to ADEs should be considered, ART-related ADE events accounted as a main cause of patients’ non-adherence to their medicines, 10 and they also stand beyond changing or modifying patients’ initial therapy, 14 besides affecting their quality of life and hindering them achieving the therapeutic goals. 10 , 11 A substantial portion of the studied population who experienced ADEs received no intervention. In our study, only three types of intervention were detected: switch therapy, pharmacologic treatment, and patient counselling, where pre-treatment counselling was the most followed intervention.…”

Section: Discussionmentioning

confidence: 99%

“… 15 , 16 According to the Sudanese study of Elnagar, 2017, the most reported adverse drug reactions were gastro-intestinal and dermatological reactions. 11 In Nigeria, nausea was the most common adverse event, followed by abdominal discomfort then insomnia. 12 While in Italy, the gastro-intestinal, blood or metabolic, and allergic symptoms were mentioned as the most common adverse events that caused drug discontinuation, with the gastro-intestinal ranked first representing about a quarter of the cases.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of Adverse Drug Events in Patients on Anti-Retroviral Therapy Regimen at Omdurman Voluntary Counselling and Testing and Anti-Retroviral Therapy Center in Sudan – A Cross-Sectional Study

Ibrahim,

Badi,

Yousef

et al. 2024

HIV

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Background Anti-retroviral therapy-related adverse drug events are accounted as a main cause of anti-retroviral therapy non-adherence. In Sudan, pharmacovigilance studies are relatively rare and obstructed by the problem of under-reporting. It is a well-defined issue worldwide and is highly reported in developing countries. This study aimed to evaluate the prevalence of adverse events associated with anti-retroviral therapy among adult patients with immunodeficiency virus at Omdurman Voluntary Counselling and Testing and Anti-retroviral Therapy Center. Methods The study was a descriptive cross-sectional study conducted through direct interviews with 429 patients at the selected center using the Adverse Drug Events (ADEs) reporting form. The collected data were analyzed by The Statistical Package for Social Sciences. Results More than half (55.5%) of the participants experienced adverse events, with 48.7% having experienced them at the beginning of treatment. Central nervous system manifestations were the most common adverse events. By using the Naranjo scale, most adverse events showed a “probable” relationship to anti-retroviral medicines. Based on the chi-square test, medication regimen was significantly associated with the presence of ADEs (namely abdominal pain and jaundice) (p values = 0.03 and 0.001), respectively. Conclusion This study clearly stated that ART-related ADEs are common among Sudanese PLHIV and with central nervous system being the main adverse events. More pharmacovigilance studies and efforts by healthcare providers should be applied targeting ART-related ADEs under-reporting in Sudanese healthcare facilities.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluation of Adverse Drug Events in Patients on Anti-Retroviral Therapy Regimen at Omdurman Voluntary Counselling and Testing and Anti-Retroviral Therapy Center in Sudan – A Cross-Sectional Study

Ibrahim,

Badi,

Yousef

et al. 2024

HIV

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“…Unfortunately, up to 28.9% of patients on HAART are noncompliant to their medications, with 25% dropping off their initial regimens within the first eight months due to ADEs [9]. This has far reaching implications including; treatment failure, necessitating change to more expensive therapy, development of drug resistance and ultimately increased mortality [10]. Great effort has been put into development of new antiretroviral drugs with better tolerability and consequently, it is crucial to constantly monitor for new developing adverse drug events [11].…”

Section: Introductionmentioning

confidence: 99%

Prevalence and Factors Associated With Adverse Drug Events Among Patients On Dolutegravir-Based Regimen At The Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: A Retrospective Cross-Sectional Study.

Namulindwa

Wasswa²,

Muyindike³

et al. 2021

Preprint

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Background: Highly Active Antiretroviral Therapy is efficacious in suppression of Human Immunodeficiency Virus (HIV) however, it is associated with numerous toxicities hence great effort has been put into development of antiretrovirals with better tolerability. The World Health Organization recommended dolutegravir as first-line antiretroviral therapy however, recent studies have raised concerns regarding its safety in real-clinical settings due to adverse drug reactions (ADEs). Hence the purpose of this study was to establish the prevalence and factors associated with adverse drug events among patients on dolutegravir-based regimen at the Immune Suppression Syndrome (ISS) Clinic- Mbarara Regional Referral Hospital (MRRH).Methods: A retrospective cross-sectional study was conducted at ISS Clinic-MRRH among 375 randomly selected patients who had been exposed to DTG-based regimen for at least 12 weeks. The patients were interviewed to obtain data on sociodemographics, dietary habits and thereafter their files reviewed to obtain data on ADEs. Data entry was done using Epi-data 3.0 and exported to SPSS version 25.0 for analysis. The prevalence of ADEs was determined as a percentage, and ADE associated factors were assessed using bivariate analysis, those found significant were further subjected to multivariate logistic regression model and were considered significant at P<0.05.Results: The prevalence of adverse drug events among patients on DTG-based regimen was found to be 33.1% (124/375) with 5.6% (7/124) participants discontinued from treatment due ADEs, 4 of which were due to hyperglycemia and 3 due to liver toxicity. The commonly experienced ADEs included abdominal pain, hyperglycemia and liver toxicity each at 7.3%, headache at 11.3%, and allergy at 36.3%. Male sex (AOR 1.571, 95% CI 1.433- 1.984), WHO stage one at entry to care (AOR 4.586, 95% CI 1.649-12.754), stage two (AOR 4.536, 95% CI 1.611-12.776), stage three (AOR 3.638, 95% CI 1.262-10.488), were significantly associated with ADEs. Patients with undetectable viral load at initiation of DTG-based regimen were less likely to experience ADEs (AOR = .324, 95% CI .1167-.629).Conclusions: Up to a third of patients on DTG-based regimen experienced ADEs. Male sex, WHO HIV disease stage and a detectable viral load at initiation of DTG-based regimen were significantly associated with ADEs. It is crucial to actively monitor patients with these characteristics for ADEs.

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Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

Raksha,

Rakhi,

Deepak

et al. 2024

RJST

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With the establishment of 12 regional centers, India implemented a comprehensive system for monitoring drug reactions in 1986. In 1997, India became a member of the Uppsala Monitoring Centre in Sweden, which oversees the World Health Organization's Programme for International Drug Surveillance. Beginning at the outset, six regional centers were created in Chandigarh, New Delhi, Mumbai, Kolkata, Lucknow, and Pondicherry. ADR is being watched throughout the nation. Advocating for safe drug use may become a top focus for the Indian Pharmacopoeia Commission, which also functions as the National Coordination Centre for India's Pharmacovigilance Program. We currently have 179 adverse drug reactions under observation. At the moment, the National Coordination Centre receives adverse event reports from centers in India.Reporting Form; Phocomelia; Vigiflow; UMC; Death; Thalidomide

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Prevalence and Extent of Adverse Drug Reactions in Sudanese Patients in Highly Active Anti-retroviral Therapy Regimens

Cited by 3 publications

References 34 publications

Evaluation of Adverse Drug Events in Patients on Anti-Retroviral Therapy Regimen at Omdurman Voluntary Counselling and Testing and Anti-Retroviral Therapy Center in Sudan – A Cross-Sectional Study

Evaluation of Adverse Drug Events in Patients on Anti-Retroviral Therapy Regimen at Omdurman Voluntary Counselling and Testing and Anti-Retroviral Therapy Center in Sudan – A Cross-Sectional Study

Prevalence and Factors Associated With Adverse Drug Events Among Patients On Dolutegravir-Based Regimen At The Immune Suppression Syndrome Clinic of Mbarara Regional Referral Hospital, Uganda: A Retrospective Cross-Sectional Study.

Ensuring Medication Safety in India: The Crucial Role of the Pharmacovigilance Programme of India (PvPI) in Adverse Drug Event Monitoring

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