Experiences with the Use of Varenicline in Daily Practice in the Netherlands: A Prospective, Observational Cohort Study

Oosterhuis, Ingrid; Härmark, Linda; Puijenbroek, Eugène van

doi:10.1007/s40264-014-0166-7

Cited by 10 publications

(15 citation statements)

References 9 publications

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“…Prospective monitoring studies in patients starting new drugs have shown that patients may continue to use a drug despite perceiving a possible ADE and without taking further action . Our study adds to this knowledge that patients on chronic medication may experience persisting ADEs over periods of at least 13 weeks, whereas other ADEs may come and go during considerable periods of drug use.…”

Section: Discussionmentioning

confidence: 99%

“…We previously found that 27% of diabetes patients experienced at least one ADE in the past 4 weeks at a random moment of treatment stage . ADEs are most likely to occur at treatment start, that is, within days or weeks after treatment initiation . However, ADEs can also emerge during chronic treatment because of changes in the patient's susceptibility or situation, such as a decrease in kidney function or a drug–drug interaction …”

Section: Introductionmentioning

confidence: 99%

“…Occasionally, information is provided on the expected duration, for example, when reactions are usually transient and expected to resolve within a short period of time. Postmarketing studies have illustrated that some ADEs are experienced by patients for a short time whereas others can persist during treatment …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care

Denig

Puijenbroek

Soliman

et al. 2019

Pharmacoepidemiology and Drug

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Purpose Little is known about adverse drug events (ADEs) experienced over time during chronic drug use. The purpose of this study was to assess ADE patterns experienced by patients with diabetes. Methods Patients who received an oral glucose‐lowering drug completed a daily diary for 13 weeks. The diary asked for experienced symptoms and whether patients related these symptoms to any drug they used. Summaries of Product Characteristics were used to check whether the ADEs were known adverse drug reactions (ADRs) of the drugs used. Patterns of weekly occurring ADEs were assessed with descriptive statistics. Results We included 78 patients. Almost half of them reported at least one ADE (N = 36; 46%). In total, 80 ADEs were reported. Of these ADEs, 71 (90%) were known ADRs. ADEs lasted less than 1 week in 27 cases (34%) and between 2 and 12 weeks in 15 cases (19%). The remaining ADEs fluctuated (16 cases; 20%) or persisted (22 cases; 28%) during the entire study period. Conclusions ADEs experienced by patients with diabetes can fluctuate or persist over long periods of drug use.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care

Denig

Puijenbroek

Soliman

et al. 2019

Pharmacoepidemiology and Drug

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“…One way of coming to terms with this is to actively approach patients; for example, collecting data directly from patients as is done in Lareb Intensive Monitoring (LIM) [41][42][43][44][45][46][47]. Cohorts of consecutive exposed patients can be identified in various ways (e.g.…”

Section: New Ways Of Collecting Safety Information From Patientsmentioning

confidence: 99%

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Härmark

Raine²,

Leufkens

et al. 2016

Drug Saf

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The role of patients as key contributors in pharmacovigilance was acknowledged in the new EU pharmacovigilance legislation. This contains several efforts to increase the involvement of the general public, including making patient adverse drug reaction (ADR) reporting systems mandatory. Three years have passed since the legislation was introduced and the key question is: does pharmacovigilance yet make optimal use of patient-reported safety information? Independent research has shown beyond doubt that patients make an important contribution to pharmacovigilance signal detection. Patient reports provide first-hand information about the suspected ADR and the circumstances under which it occurred, including medication errors, quality failures, and 'near misses'. Patient-reported safety information leads to a better understanding of the patient's experiences of the ADR. Patients are better at explaining the nature, personal significance and consequences of ADRs than healthcare professionals' reports on similar associations and they give more detailed information regarding quality of life including psychological effects and effects on everyday tasks. Current methods used in pharmacovigilance need to optimise use of the information reported from patients. To make the most of information from patients, the systems we use for collecting, coding and recording patient-reported information and the methodologies applied for signal detection and assessment need to be further developed, such as a patient-specific form, development of a severity grading and evolution of the database structure and the signal detection methods applied. It is time for a renaissance of pharmacovigilance.

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“…However, depending on the drug, the type of ADR and the underlying mechanism of toxicity, the TTO can vary considerably in length. For instance, visual field defects due to vigabatrin use can manifest years after the start of the treatment [8], whereas varenicline-induced nausea usually occurs within several days [9]. During the period of drug use, the risk of developing the ADR is not necessarily a constant but can be seen as a function that changes over time.…”

Section: What Is New?mentioning

confidence: 99%

Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs

Scholl

Ven

Puijenbroek

2015

Journal of Clinical Epidemiology

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Experiences with the Use of Varenicline in Daily Practice in the Netherlands: A Prospective, Observational Cohort Study

Abstract: This prospective cohort study has given insight into latency time and action taken with varenicline when ADRs occur during treatment with varenicline in daily practice. It confirms the ADR pattern detected prior to marketing of the drug.

Cited by 10 publications

References 9 publications

Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care

Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care

Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?

Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs

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