November 16, 2020AddictionOpen Access

Risk of neuropsychiatric and cardiovascular adverse events following treatment with varenicline and nicotine replacement therapy in the UK Clinical Practice Research Datalink: a case–cross‐over study

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Why the study?

Given the widespread use of varenicline and nicotine replacement therapy as the most common smoking cessation medications, monitoring their adverse risks remains important.

Does varenicline or nicotine replacement therapy increase the risk of neuropsychiatric and cardiovascular adverse events in adult smokers?

Population

282,429 adult smokers in UK electronic primary care records from 2006 to 2015

Comparison

Exposure during a 90-day risk period prior to the event vs earlier reference periods

Design

Case-cross-over study

Authors

KTKyla H Thomas NDNeil M Davies ATAmy E. Taylor

Discussion

Member takes

Overview

No causal risks confirmed for varenicline or NRT; leaves open neuropsychiatric signals for prospective trials.

Structured PICO

Does varenicline or nicotine replacement therapy increase the risk of neuropsychiatric and cardiovascular adverse events in adult smokers?

Population

282,429 adult smokers from UK-based electronic primary care records (Clinical Practice Research Datalink) from 2006 to 2015.

Intervention

Varenicline or nicotine replacement therapy (NRT) exposure during the 90-day risk period prior to an event.

Comparator

Non-exposure during an earlier single reference period (91-180 days prior to the event) or multiple 90-day reference periods within the same individuals (case-crossover design).

Outcome

Suicide, self-harm, myocardial infarction (MI), all-cause death, and cause-specific death (MI, chronic obstructive pulmonary disease).safety

While varenicline and NRT are associated with certain neuropsychiatric and cardiovascular events in routine care, these findings are likely confounded by underlying health changes and behaviors during smoking cessation.

Limitations

Associations may not be causal
Confounding by health changes at the time of smoking cessation (e.g., NRT prescribed for people with cardiac problems)
Confounding by quit attempts (exposure to both medicines was associated with self-harm)

Cite This Study

Thomas et al. (2020) studied this question.

synapsesocial.com/papers/6a72b6038031ec7bb1dd73fa https://doi.org/10.1111/add.15338

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November 16, 2020AddictionOpen Access

Risk of neuropsychiatric and cardiovascular adverse events following treatment with varenicline and nicotine replacement therapy in the UK Clinical Practice Research Datalink: a case–cross‐over study

View Full Paper

Ask AI

Bookmark

Why the study?

Given the widespread use of varenicline and nicotine replacement therapy as the most common smoking cessation medications, monitoring their adverse risks remains important.

Does varenicline or nicotine replacement therapy increase the risk of neuropsychiatric and cardiovascular adverse events in adult smokers?

Population

282,429 adult smokers in UK electronic primary care records from 2006 to 2015

Comparison

Exposure during a 90-day risk period prior to the event vs earlier reference periods

Design

Case-cross-over study

Authors

KTKyla H Thomas NDNeil M Davies ATAmy E. Taylor

Discussion

Member takes

Overview

No causal risks confirmed for varenicline or NRT; leaves open neuropsychiatric signals for prospective trials.

Structured PICO

Does varenicline or nicotine replacement therapy increase the risk of neuropsychiatric and cardiovascular adverse events in adult smokers?

Population

282,429 adult smokers from UK-based electronic primary care records (Clinical Practice Research Datalink) from 2006 to 2015.

Intervention

Varenicline or nicotine replacement therapy (NRT) exposure during the 90-day risk period prior to an event.

Comparator

Non-exposure during an earlier single reference period (91-180 days prior to the event) or multiple 90-day reference periods within the same individuals (case-crossover design).

Outcome

Suicide, self-harm, myocardial infarction (MI), all-cause death, and cause-specific death (MI, chronic obstructive pulmonary disease).safety

Limitations

Associations may not be causal
Confounding by health changes at the time of smoking cessation (e.g., NRT prescribed for people with cardiac problems)
Confounding by quit attempts (exposure to both medicines was associated with self-harm)

Cite This Study

Thomas et al. (2020) studied this question.

synapsesocial.com/papers/6a72b6038031ec7bb1dd73fa https://doi.org/10.1111/add.15338

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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