Adverse drug reactions – examples of detection of rare events using databases

Chan, Esther W.; Liu, Kirin Q.L.; Chui, Celine S L; Sing, Chor‐Wing; Wong, Lo; Wong, Ian C K

doi:10.1111/bcp.12474

Cited by 28 publications

(32 citation statements)

References 35 publications

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“…Observational studies have demonstrated a higher incidence of cardiovascular events such as arrhythmia and sudden death in patients treated with methylphenidate or other stimulants, as compared to controls. Yet, this finding has not been confirmed in other studies . However, there is sufficient evidence suggesting a potential relationship between stimulants and cardiovascular risk.…”

Section: Discussionmentioning

confidence: 57%

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Use of methylphenidate and risk for valvular heart disease: A case‐control study nested in the BIFAP cohort

Saiz

Gil

Alonso

et al. 2020

Pharmacoepidemiology and Drug

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Purpose To examine the association between use of methylphenidate and the risk for valvular heart disease (VHD) in the Spanish primary care database BIFAP. Methods Case‐control study nested in a cohort of patients aged 5 to 25 years between 2002 and 2014, based in a general practice research database. Cases were people with a validated diagnosis of VHD. Ten controls per case were matched on age, sex, and calendar year. Multivariable conditional logistic regression was used to estimate odds ratios (ORs) of VHD comparing patients ever treated with methylphenidate vs never users, as well as by time since last use, treatment duration, and variations in case inclusion criteria. Results From a cohort of 1 596 284 patients, we identified 262 valid cases of VHD. No difference in the incidence of VHD was observed when comparing “ever users” of methylphenidate with “never users” (adjusted OR 0.52, 95%CI 0.16‐1.69). A similar result was found comparing current, recent, or past users of methylphenidate. Differences were not significant when both valid and probable cases were included as events of interest (adjusted OR 0.59, 95%CI 0.22‐1.63). Conclusions In this first‐ever population‐based study on this issue, association between methylphenidate and the incidence of VHD among persons in the 5 to 25 years age range was neither confirmed nor excluded. Additional studies may be required to clarify the presence or absence of this relationship.

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Section: Discussionmentioning

confidence: 57%

“…Yet, this finding has not been confirmed in other studies. 15,21 However, there is sufficient evidence suggesting a potential relationship between stimulants and cardiovascular risk.…”

Section: Background Of Published Studiesmentioning

confidence: 99%

Use of methylphenidate and risk for valvular heart disease: A case‐control study nested in the BIFAP cohort

Saiz

Gil

Alonso

et al. 2020

Pharmacoepidemiology and Drug

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“…Another issue might be reporting bias [93] and attitudes of clinicians may unconsciously influence the reporting of adverse events. Rigorous research methodologies using large population-based health databases should help do address some of these limitations [94]. Data linkage of medication data and the onset of specific predefined clinical events supported by large integrate electronic medical records [95] should enable clinicians and regulators to identify potential adverse events without clinical reporting bias.…”

Section: Discussionmentioning

confidence: 99%

Use of Evidence-Based Herbal Medicines for Patients with Functional Gastrointestinal Disorders: A Conceptional Framework for Risk-Benefit Assessment and Regulatory Approaches

Holtmann

Schrenk

Madisch

et al. 2019

Dig Dis

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Background: Herbal or complementary medicines are frequently used for the treatment of patients with functional gastrointestinal disorders (FGID). Regulatory requirements for herbal therapies are inconsistent and, in many jurisdictions, herbal therapies are either self-, minimally-or unregulated. Aim: To provide guidance for the appropriate and safe use of herbal medicines in patients with FGID patients with special consideration of the regulatory frameworks. Methods: A PubMed search of the literature was performed; relevant articles were included. Results: Similar to chemically defined therapies herbal medicines can cause adverse events. Thus, a risk-benefit appraisal should be undertaken for these therapies. While there is no disease specific mortality in FGID public and policy makers. However, the frequently chronic or relapsing nature of FGIDs cause disabilities in predominately young people and are a considerable burden to society even though life expectancy is not affected.

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“…adverse event reporting systems) and are occasionally mandated by regulators if there is an inconclusive safety signal in pre‐licensing RCTs . Observational studies can facilitate the detection of rare (<1/1000) and very rare (<1/10 000) adverse events (see Table ) and are also able to provide long‐term data on tolerability …”

Section: Observational Pharmacoepidemiologymentioning

confidence: 99%

“…88 Observational studies can facilitate the detection of rare (<1/1000) and very rare (<1/10 000) adverse events (see Table 3) and are also able to provide long-term data on tolerability. 83,89 Since observational studies frequently run in parallel with routine clinical care, they often cost less than RCTs. 90…”

Section: Op Studies Can Be Carried Out Over a Long Period Of Time mentioning

confidence: 99%

Pharmacoepidemiology: Using randomised control trials and observational studies in clinical decision‐making

Caparrotta

Dear

Colhoun

et al. 2019

Brit J Clinical Pharma

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Weighing up sources of evidence is a key skill for clinical decision‐makers. Randomised controlled trials (RCTs) and observational studies each have advantages and disadvantages, and in both cases perceived weaknesses can be improved through modifications of design and analysis. In the field of pharmacoepidemiology, RCTs are the best way to determine whether an intervention modifies an outcome being studied, largely because randomisation reduces bias and confounding. Observational studies are useful to investigate whether benefits/harms of a treatment are seen in day‐to‐day clinical practice in a wider group of patients. Although observational studies, even in a small cohort, can provide very useful clinical evidence, they may also be misleading (as shown by subsequent RCTs), in part because of allocation bias. There is an unmet need for clinicians to become well versed in appraising the study design and statistical analysis of observational pharmacoepidemiology (OP) studies, rather like the medical training already offered for RCT evaluation. This is because OP studies are likely to become more common with the computerisation of healthcare records and increasingly contribute to the evidence base available for clinical decision‐making. However, when the results of an RCT conflict with the results of an OP study, the findings of the RCT should be preferred, especially if its findings have been repeated elsewhere. Conversely, OP studies that align with the findings of RCTs can provide rich and useful information to complement that generated by RCTs.

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Adverse drug reactions – examples of detection of rare events using databases

Cited by 28 publications

References 35 publications

Use of methylphenidate and risk for valvular heart disease: A case‐control study nested in the BIFAP cohort

Use of methylphenidate and risk for valvular heart disease: A case‐control study nested in the BIFAP cohort

Use of Evidence-Based Herbal Medicines for Patients with Functional Gastrointestinal Disorders: A Conceptional Framework for Risk-Benefit Assessment and Regulatory Approaches

Pharmacoepidemiology: Using randomised control trials and observational studies in clinical decision‐making

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