ResearchPad - pharmacoepidemiology-and-prescription https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Risk factors for severe bleeding events during warfarin treatment: the influence of sex, age, comorbidity and co-medication]]> https://www.researchpad.co/article/elastic_article_9978 To investigate risk factors for severe bleeding during warfarin treatment, including the influence of sex, age, comorbidity and co-medication on bleeding risk.MethodsPatients initiating warfarin treatment between 2007 and 2011 were identified in the nationwide Swedish Prescribed Drug Register, and diagnoses of severe bleeding were retrieved from the National Patient Register. Hazard ratios (HR) with 95% confidence intervals (CI) for severe bleeding were estimated using multiple Cox regression adjusting for indications and including covariates age, sex, comorbidities and co-medications. Interactions between sex and other covariates were investigated.ResultsThe study cohort included 232,624 patients ≥ 18 years (101,011 women and 131,613 men). The incidence rate of severe bleeding was 37 per 1000 person-years, lower among women than men with an adjusted HR (95% CI) of 0.84 (0.80–0.88). Incidence of bleeding increased with age, HR 2.88 (2.37–3.50) comparing age ≥ 80 to < 40 years, and comorbidities associated with the highest risk of severe bleeding were prior bleeding, HR 1.85 (1.74–1.97); renal failure, HR 1.82 (1.66–2.00); and alcohol dependency diagnosis, HR 1.79 (1.57–2.05). Other comorbidities significantly associated with bleeding events were hypertension, diabetes, peripheral vascular disease, congestive heart failure, liver failure, stroke/TIA, COPD and cancer.ConclusionMost of the well-established risk factors were found to be significantly associated with bleeding events in our study. We additionally found that women had a lower incidence of bleeding. Potential biases are selection effects, residual confounding and unmeasured frailty.Electronic supplementary materialThe online version of this article (10.1007/s00228-020-02856-6) contains supplementary material, which is available to authorized users. ]]> <![CDATA[Prescribing medications of questionable benefit prior to death: a retrospective study on older nursing home residents with and without dementia in Germany]]> https://www.researchpad.co/article/elastic_article_9939 We studied the prevalence of medications of questionable benefit in the last 6 months of life among older nursing home residents with and without dementia in Germany.MethodsA retrospective cohort study was conducted on claims data from 67,328 deceased nursing home residents aged 65+ years who were admitted between 2010 and 2014. We analyzed prescription regimens of medications of questionable benefit in the 180–91-day period and the 90-day period prior to death for residents with dementia (n = 29,052) and without dementia (n = 38,276). Factors associated with new prescriptions of medications of questionable benefit prior to death were analyzed using logistic regression models among all nursing home residents and stratified by dementia.ResultsA higher proportion of nursing home residents with dementia were prescribed at least one medication of questionable benefit in the 180–91-day (29.6%) and 90-day (26.8%) periods prior to death, compared with residents without dementia (180–91 days, 22.8%; 90 days, 20.1%). Lipid-lowering agents were the most commonly prescribed medications. New prescriptions of medications of questionable benefit were more common among residents with dementia (9.8% vs. 8.7%). When excluding anti-dementia medication, new prescriptions of these medications were more common among residents without dementia (6.4% vs. 8.0%). The presence of dementia (odds ratio [OR] 1.40, 95% confidence interval [95%CI] 1.32–1.48) and excessive polypharmacy were associated with new prescriptions of medications of questionable benefit prior to death (OR 4.74, 95%CI 4.15–5.42).ConclusionEven when accounting for anti-dementia prescriptions, the prevalence of nursing home residents with dementia receiving medications of questionable benefit is considerable and may require further attention.Electronic supplementary materialThe online version of this article (10.1007/s00228-020-02859-3) contains supplementary material, which is available to authorized users. ]]> <![CDATA[Trends and variations in the prescribing of secondary preventative cardiovascular therapies for non-ST elevation myocardial infarction (NSTEMI) in Malaysia]]> https://www.researchpad.co/article/5c043be1d5eed0c4846a8380

Purpose

Information is lacking on prescribing of preventative cardiovascular pharmacotherapies for patients with non-ST elevation myocardial infarction (NSTEMI) in the Asian region. This study examined the prescribing rate of these pharmacotherapies, comparing NSTEMI to STEMI, and variations across demographics and clinical factors within the NSTEMI group in the multi-ethnic Malaysian population.

Methods

This is a retrospective analysis of the Malaysian National Cardiovascular Disease Database-Acute Coronary Syndrome registry from year 2006 to 2013 (n = 30,873). On-discharge pharmacotherapies examined were aspirin, ADP-antagonists, statins, ACE-inhibitors, angiotensin-II-receptor blockers, and beta-blockers. Multivariate logistic regression was used to calculate adjusted odds ratio of receiving individual pharmacotherapies according to patients’ characteristics in NSTEMI patients (n = 11,390).

Results

Prescribing rates for cardiovascular pharmacotherapies had significantly increased especially for ADP-antagonists (76%) in NSTEMI patients. More than 85% were prescribed statins and antiplatelets but rates remained significantly lower compared to STEMI. Women and those over 65 years old were less likely to be prescribed these pharmacotherapies compared to men and younger NSTEMI patients. Chinese and Indians were more likely to receive selected pharmacotherapies compared to Malays (main ethnicity). Geographical variations were observed; East Malaysian (Malaysian Borneo) patients were less likely to receive these compared to Western region of Malaysian Peninsular. Underprescribing in patients with risk factors such as diabetes were observed with other co-morbidities influencing prescribing selectively.

Conclusion

This study uncovers demographic and clinical variations in cardiovascular pharmacotherapies prescribing for NSTEMI. Concerted efforts by policy makers, specialty societies, and physicians are required focusing on elderly, women, Malays, East Malaysians, and high-risk patients.

Electronic supplementary material

The online version of this article (10.1007/s00228-018-2451-3) contains supplementary material, which is available to authorized users.

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<![CDATA[The interplay of context factors in hypnotic and sedative prescription in primary and secondary care—a qualitative study]]> https://www.researchpad.co/article/5c59e16bd5eed0c484111d24

Purpose

Non-medical or contextual factors strongly influence physicians’ prescribing behavior and may explain why drugs, such as benzodiazepines and Z-drugs, are still frequently prescribed in spite of well-known adverse effects. This study aimed to explore which contextual factors influence the prescription of hypnotics and sedatives and to compare their role in primary and secondary care.

Methods

Understanding medical practices as games with specific rules and strategies and performed in a largely habitual, not fully conscious manner, we asked a maximum variation sample of 12 hospital doctors and 12 general practitioners (GPs) about their use of hypnotics and sedatives. The interviews were analyzed by qualitative content analysis.

Results

Hospital doctors’ and GPs’ use of hypnotics and sedatives was influenced by a variety of contextual factors, such as the demand of different patient groups, aims of management, time resources, or the role of nurses and peers. Negotiating patient demands, complying with administrative regulations, and finding acceptable solutions for patients were the main challenges, which characterized the game of drug use in primary care. Maintaining the workflow in the hospital and finding a way to satisfy both nurses and patients were the main challenges in secondary care.

Conclusions

Even if doctors try to act rationally, they cannot escape the interplay of contextual factors such as handling patient needs, complying with administrative regulations, and managing time resources. Doctors should balance these factors as if they were challenges in a complex game and reflect upon their own practices.

Electronic supplementary material

The online version of this article (10.1007/s00228-018-2555-9) contains supplementary material, which is available to authorized users.

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<![CDATA[Baclofen in gamma-hydroxybutyrate withdrawal: patterns of use and online availability]]> https://www.researchpad.co/article/5b4b0b97463d7e71b50cd7d8

Purpose

Gamma-hydroxybutyrate (GHB) withdrawal is a life-threatening condition that does not always respond to standard treatment with benzodiazepines. Baclofen has potential utility as a pharmacological adjunct and anecdotal reports suggest that it is being used by drug users to self-manage GHB withdrawal symptoms. Here, we investigate current patterns of use and the online availably of baclofen.

Methods

Data triangulation techniques were applied to published scientific literature and publicly accessible Internet resources (grey literature) to assess the use of baclofen in GHB withdrawal. An Internet snapshot survey was performed to identify the availability of baclofen for online purchase and the compliance of retailers with the UK regulations. Data were collected according to pre-defined criteria.

Results

A total of 37 cases of baclofen use in GHB withdrawal were identified in the scientific literature, as well as 51 relevant discussion threads across eight Internet forums in the grey literature. Baclofen was available to purchase from 38 online pharmacies, of which only one conformed to the UK regulations.

Conclusions

There is limited published evidence on the use of baclofen in GHB withdrawal, but both scientific and grey literature suggests clinical utility. Online pharmacies are readily offering prescription-only-medication without prescription and due to inadequate regulation, pose a danger to the public.

Electronic supplementary material

The online version of this article (10.1007/s00228-017-2387-z) contains supplementary material, which is available to authorized users.

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<![CDATA[The nocebo effect challenges the non-medical infliximab switch in practice]]> https://www.researchpad.co/article/5b588f6c463d7e4bbcb756dd

Background

In clinical practice, non-medical switching of biological medication may provoke nocebo effects due to unexplained deterioration of therapeutic benefits. Indication extrapolation, idiosyncratic reactions, and interchangeability remain challenged in clinical practice after biosimilar approval by the European Medicines Agency. The principle of “first do no harm” may be challenged in a patient when switching from originator to biosimilar biological.

Aim

To describe the 1-year results of a pragmatic study on infliximab biosimilar implementation in immune-mediated inflammatory disease patients on the basis of shared decision-making under effectiveness and safety monitoring.

Methods

Inflammatory bowel disease and rheumatology patients on infliximab originator were converted to infliximab biosimilar after providing informed consent. Nocebo response patients were monitored after switch back to originator. Linear mixed models were used to analyze continuous endpoints on effectiveness and laboratory outcomes to determine significance (P ≤ 0.05) of change over time after switching.

Results

After inviting 146 patients, a group of 125 patients enrolled in the project over time, respectively, 73 Crohn’s disease, 28 ulcerative colitis, nine rheumatoid arthritis, ten psoriatic arthritis, and five ankylosing spondylitis patients. No statistically significant changes in effectiveness and safety were observed in any of the indications after a median of 4 infusions in 9 months of study. An overall nocebo response of 12.8% was found among the patients during a minimal observation period of 6 months after the transition to biosimilar infliximab. The overall nocebo response rate did not differ between the studied indications.

Conclusions

In inflammatory bowel disease and rheumatological patients, similar effectiveness and safety were demonstrated on the transition into infliximab biosimilar. In our series, patient empowerment and registration of treatment outcomes delineated biosimilar transition, an approach that hypothetically could reduce nocebo response rates which are relevant to account for regarding biosimilar implementation.

Electronic supplementary material

The online version of this article (10.1007/s00228-018-2418-4) contains supplementary material, which is available to authorized users.

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