scholarly journals 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

Addiction ◽  
2020 ◽  
Author(s):  
Kyla H. Thomas ◽  
Neil M. Davies ◽  
Amy E. Taylor ◽  
Gemma M. J. Taylor ◽  
David Gunnell ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Nicotine Replacement ◽  
The Uk

scholarly journals Varenicline versus nicotine replacement therapy for long-term smoking cessation: an observational study using the Clinical Practice Research Datalink

2020 ◽  
Vol 24 (9) ◽  
pp. 1-46
Author(s):  
Neil M Davies ◽  
Amy E Taylor ◽  
Gemma MJ Taylor ◽  
Taha Itani ◽  
Tim Jones ◽  
...  
Keyword(s):  
Primary Care ◽  
Smoking Cessation ◽  
Clinical Practice ◽  
Confidence Interval ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Instrumental Variable ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Nicotine Replacement

Background Smoking is the leading avoidable cause of illness and premature mortality. The first-line treatments for smoking cessation are nicotine replacement therapy and varenicline. Meta-analyses of experimental studies have shown that participants allocated to the varenicline group were 1.57 times (95% confidence interval 1.29 to 1.91 times) as likely to be abstinent 6 months after treatment as those allocated to the nicotine replacement therapy group. However, there is limited evidence about the effectiveness of varenicline when prescribed in primary care. We investigated the effectiveness and rate of adverse events of these medicines in the general population. Objective To estimate the effect of prescribing varenicline on smoking cessation rates and health outcomes. Data sources Clinical Practice Research Datalink. Methods We conducted an observational cohort study using electronic medical records from the Clinical Practice Research Datalink. We extracted data on all patients who were prescribed varenicline or nicotine replacement therapy after 1 September 2006 who were aged ≥ 18 years. We investigated the effects of varenicline on smoking cessation, all-cause mortality and cause-specific mortality and hospitalisation for: (1) chronic lung disease, (2) lung cancer, (3) coronary heart disease, (4) pneumonia, (5) cerebrovascular disease, (6) diabetes, and (7) external causes; primary care diagnosis of myocardial infarction, chronic obstructive pulmonary disease, depression, or prescription for anxiety; weight in kg; general practitioner and hospital attendance. Our primary outcome was smoking cessation 2 years after the first prescription. We investigated the baseline differences between patients prescribed varenicline and patients prescribed nicotine replacement therapy. We report results using multivariable-adjusted, propensity score and instrumental variable regression. Finally, we developed methods to assess the relative bias of the different statistical methods we used. Results People prescribed varenicline were healthier at baseline than those prescribed nicotine replacement therapy in almost all characteristics, which highlighted the potential for residual confounding. Our instrumental variable analysis results found little evidence that patients prescribed varenicline had lower mortality 2 years after their first prescription (risk difference 0.67, 95% confidence interval –0.11 to 1.46) than those prescribed nicotine replacement therapy. They had similar rates of all-cause hospitalisation, incident primary care diagnoses of myocardial infarction and chronic obstructive pulmonary disease. People prescribed varenicline subsequently attended primary care less frequently. Patients prescribed varenicline were more likely (odds ratio 1.46, 95% confidence interval 1.42 to 1.50) to be abstinent 6 months after treatment than those prescribed nicotine replacement therapy when estimated using multivariable-adjusted for baseline covariates. Patients from more deprived areas were less likely to be prescribed varenicline. However, varenicline had similar effectiveness for these groups. Conclusion Patients prescribed varenicline in primary care were more likely to quit smoking than those prescribed nicotine replacement therapy, but there was little evidence that they had lower rates of mortality or morbidity in the 4 years following the first prescription. There was little evidence of heterogeneity in effectiveness across the population. Future work Future research should investigate the decline in prescribing of smoking cessation products; develop an optimal treatment algorithm for smoking cessation; use methods for using instruments with survival outcomes; and develop methods for comparing multivariable-adjusted and instrumental variable estimates. Limitations Not all of our code lists were validated, body mass index and Index of Multiple Deprivation had missing values, our results may suffer from residual confounding, and we had no information on treatment adherence. Trial registration This trial is registered as NCT02681848. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 9. See the NIHR Journals Library website for further project information.

scholarly journals Smoking cessation medicines and e-cigarettes: a systematic review, network meta-analysis and cost-effectiveness analysis

2021 ◽  
Vol 25 (59) ◽  
pp. 1-224
Author(s):  
Kyla H Thomas ◽  
Michael N Dalili ◽  
José A López-López ◽  
Edna Keeney ◽  
David Phillippo ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cost Effectiveness ◽  
Adverse Events ◽  
Replacement Therapy ◽  
Nicotine Replacement Therapy ◽  
Odds Ratio ◽  
Cost Effective ◽  
Credible Interval ◽  
Nicotine Replacement ◽  
The Uk

Background Cigarette smoking is one of the leading causes of early death. Varenicline [Champix (UK), Pfizer Europe MA EEIG, Brussels, Belgium; or Chantix (USA), Pfizer Inc., Mission, KS, USA], bupropion (Zyban; GlaxoSmithKline, Brentford, UK) and nicotine replacement therapy are licensed aids for quitting smoking in the UK. Although not licensed, e-cigarettes may also be used in English smoking cessation services. Concerns have been raised about the safety of these medicines and e-cigarettes. Objectives To determine the clinical effectiveness, safety and cost-effectiveness of smoking cessation medicines and e-cigarettes. Design Systematic reviews, network meta-analyses and cost-effectiveness analysis informed by the network meta-analysis results. Setting Primary care practices, hospitals, clinics, universities, workplaces, nursing or residential homes. Participants Smokers aged ≥ 18 years of all ethnicities using UK-licensed smoking cessation therapies and/or e-cigarettes. Interventions Varenicline, bupropion and nicotine replacement therapy as monotherapies and in combination treatments at standard, low or high dose, combination nicotine replacement therapy and e-cigarette monotherapies. Main outcome measures Effectiveness – continuous or sustained abstinence. Safety – serious adverse events, major adverse cardiovascular events and major adverse neuropsychiatric events. Data sources Ten databases, reference lists of relevant research articles and previous reviews. Searches were performed from inception until 16 March 2017 and updated on 19 February 2019. Review methods Three reviewers screened the search results. Data were extracted and risk of bias was assessed by one reviewer and checked by the other reviewers. Network meta-analyses were conducted for effectiveness and safety outcomes. Cost-effectiveness was evaluated using an amended version of the Benefits of Smoking Cessation on Outcomes model. Results Most monotherapies and combination treatments were more effective than placebo at achieving sustained abstinence. Varenicline standard plus nicotine replacement therapy standard (odds ratio 5.75, 95% credible interval 2.27 to 14.90) was ranked first for sustained abstinence, followed by e-cigarette low (odds ratio 3.22, 95% credible interval 0.97 to 12.60), although these estimates have high uncertainty. We found effect modification for counselling and dependence, with a higher proportion of smokers who received counselling achieving sustained abstinence than those who did not receive counselling, and higher odds of sustained abstinence among participants with higher average dependence scores. We found that bupropion standard increased odds of serious adverse events compared with placebo (odds ratio 1.27, 95% credible interval 1.04 to 1.58). There were no differences between interventions in terms of major adverse cardiovascular events. There was evidence of increased odds of major adverse neuropsychiatric events for smokers randomised to varenicline standard compared with those randomised to bupropion standard (odds ratio 1.43, 95% credible interval 1.02 to 2.09). There was a high level of uncertainty about the most cost-effective intervention, although all were cost-effective compared with nicotine replacement therapy low at the £20,000 per quality-adjusted life-year threshold. E-cigarette low appeared to be most cost-effective in the base case, followed by varenicline standard plus nicotine replacement therapy standard. When the impact of major adverse neuropsychiatric events was excluded, varenicline standard plus nicotine replacement therapy standard was most cost-effective, followed by varenicline low plus nicotine replacement therapy standard. When limited to licensed interventions in the UK, nicotine replacement therapy standard was most cost-effective, followed by varenicline standard. Limitations Comparisons between active interventions were informed almost exclusively by indirect evidence. Findings were imprecise because of the small numbers of adverse events identified. Conclusions Combined therapies of medicines are among the most clinically effective, safe and cost-effective treatment options for smokers. Although the combined therapy of nicotine replacement therapy and varenicline at standard doses was the most effective treatment, this is currently unlicensed for use in the UK. Future work Researchers should examine the use of these treatments alongside counselling and continue investigating the long-term effectiveness and safety of e-cigarettes for smoking cessation compared with active interventions such as nicotine replacement therapy. Study registration This study is registered as PROSPERO CRD42016041302. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 59. See the NIHR Journals Library website for further project information.

scholarly journals Risk of adverse events in patients prescribed long‐term opioids: A cohort study in the UK Clinical Practice Research Datalink

2019 ◽  
Vol 23 (5) ◽  
pp. 908-922 ◽  
Author(s):  
John Bedson ◽  
Ying Chen ◽  
Julie Ashworth ◽  
Richard A. Hayward ◽  
Kate M. Dunn ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Adverse Events ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
The Uk

scholarly journals Calcium channel blockers and cancer: a risk analysis using the UK Clinical Practice Research Datalink (CPRD)

BMJ Open ◽  
2016 ◽  
Vol 6 (1) ◽  
pp. e009147 ◽  
Author(s):  
Lamiae Grimaldi-Bensouda ◽  
Olaf Klungel ◽  
Xavier Kurz ◽  
Mark C H de Groot ◽  
Ana S Maciel Afonso ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Risk Analysis ◽  
Calcium Channel ◽  
Calcium Channel Blockers ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Channel Blockers ◽  
The Uk

scholarly journals Development and validation of prediction models to estimate risk of primary total hip and knee replacements using data from the UK: two prospective open cohorts using the UK Clinical Practice Research Datalink

2018 ◽  
Vol 78 (1) ◽  
pp. 91-99 ◽  
Author(s):  
Dahai Yu ◽  
Kelvin P Jordan ◽  
Kym I E Snell ◽  
Richard D Riley ◽  
John Bedson ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Large Scale ◽  
Prediction Models ◽  
Cox Proportional Hazards ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Total Hip ◽  
Risk Of Death ◽  
Geographical Regions ◽  
The Uk

ObjectivesThe ability to efficiently and accurately predict future risk of primary total hip and knee replacement (THR/TKR) in earlier stages of osteoarthritis (OA) has potentially important applications. We aimed to develop and validate two models to estimate an individual’s risk of primary THR and TKR in patients newly presenting to primary care.MethodsWe identified two cohorts of patients aged ≥40 years newly consulting hip pain/OA and knee pain/OA in the Clinical Practice Research Datalink. Candidate predictors were identified by systematic review, novel hypothesis-free ‘Record-Wide Association Study’ with replication, and panel consensus. Cox proportional hazards models accounting for competing risk of death were applied to derive risk algorithms for THR and TKR. Internal–external cross-validation (IECV) was then applied over geographical regions to validate two models.Results45 predictors for THR and 53 for TKR were identified, reviewed and selected by the panel. 301 052 and 416 030 patients newly consulting between 1992 and 2015 were identified in the hip and knee cohorts, respectively (median follow-up 6 years). The resultant model C-statistics is 0.73 (0.72, 0.73) and 0.79 (0.78, 0.79) for THR (with 20 predictors) and TKR model (with 24 predictors), respectively. The IECV C-statistics ranged between 0.70–0.74 (THR model) and 0.76–0.82 (TKR model); the IECV calibration slope ranged between 0.93–1.07 (THR model) and 0.92–1.12 (TKR model).ConclusionsTwo prediction models with good discrimination and calibration that estimate individuals’ risk of THR and TKR have been developed and validated in large-scale, nationally representative data, and are readily automated in electronic patient records.

scholarly journals Statin use and reduced risk of biliary tract cancers in the UK Clinical Practice Research Datalink

Gut ◽  
2018 ◽  
Vol 68 (8) ◽  
pp. 1458-1464 ◽  
Author(s):  
Zhiwei Liu ◽  
Rotana Alsaggaf ◽  
Katherine A McGlynn ◽  
Lesley A Anderson ◽  
Huei-Ting Tsai ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Biliary Tract ◽  
Conditional Logistic Regression ◽  
Incidence Density ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Biliary Tract Cancers ◽  
The Uk ◽  
Reduced Risk ◽  
Statin Use

ObjectiveTo evaluate the association between statin use and risk of biliary tract cancers (BTC).DesignThis is a nested case–control study conducted in the UK Clinical Practice Research Datalink. We included cases diagnosed with incident primary BTCs, including cancers of the gall bladder, bile duct (ie, both intrahepatic and extrahepatic cholangiocarcinoma), ampulla of Vater and mixed type, between 1990 and 2017. For each case, we selected five controls who did not develop BTCs at the time of case diagnosis, matched by sex, year of birth, calendar time and years of enrolment in the general practice using incidence density sampling. Exposures were defined as two or more prescription records of statins 1 year prior to BTC diagnosis or control selection. ORs and 95% CIs for associations between statins and BTC overall and by subtypes were estimated using conditional logistic regression, adjusted for relevant confounders.ResultsWe included 3118 BTC cases and 15 519 cancer-free controls. Current statin use versus non-use was associated with a reduced risk of all BTCs combined (adjusted OR=0.88, 95% CI 0.79 to 0.98). The reduced risks were most pronounced among long-term users, as indicated by increasing number of prescriptions (ptrend=0.016) and cumulative dose of statins (ptrend=0.008). The magnitude of association was similar for statin use and risk of individual types of BTCs. The reduced risk of BTCs associated with a record of current statin use versus non-use was more pronounced among persons with diabetes (adjusted OR=0.72, 95% CI 0.57 to 0.91). Among non-diabetics, the adjusted OR for current statin use versus non-use was 0.91 (95% CI 0.81 to 1.03, pheterogeneity=0.007).ConclusionCompared with non-use of statins, current statin use is associated with 12% lower risk of BTCs; no association found with former statin use. If replicated, particularly in countries with a high incidence of BTCs, our findings could pave the way for evaluating the value of statins for BTC chemoprevention.

scholarly journals Validation of hip osteoarthritis diagnosis recording in the UK Clinical Practice Research Datalink

2018 ◽  
Vol 28 (2) ◽  
pp. 187-193 ◽  
Author(s):  
Rory J. Ferguson ◽  
Daniel Prieto‐Alhambra ◽  
Christine Walker ◽  
Dahai Yu ◽  
Jose M. Valderas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Hip Osteoarthritis ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
The Uk

scholarly journals The incidence, prevalence, and survival of systemic sclerosis in the UK Clinical Practice Research Datalink

2018 ◽  
Vol 37 (8) ◽  
pp. 2103-2111 ◽  
Author(s):  
Jeremy G. Royle ◽  
Peter C. Lanyon ◽  
Matthew J. Grainge ◽  
Abhishek Abhishek ◽  
Fiona A. Pearce
Keyword(s):  
Clinical Practice ◽  
Systemic Sclerosis ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
The Uk ◽  
Incidence Prevalence
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