Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial.

UnlabelledChinese translationBackgroundDepression is overrepresented in smokers.ObjectiveTo evaluate smoking abstinence and changes in mood and anxiety levels in smokers with depression treated with varenicline versus placebo.DesignPhase 4, multicenter, parallel, 1:1 allocation, double-blind, randomization trial. Randomization, stratified by antidepressant use and depression score at baseline, was blocked in sizes of 4. (ClinicalTrials.gov: NCT01078298).Setting38 centers in 8 countries.Participants525 adult smokers with stably treated current or past major depression and no recent cardiovascular events.InterventionVarenicline, 1 mg twice daily, or placebo for 12 weeks, with 40-week nontreatment follow-up.MeasurementsPrimary outcome was carbon monoxide-confirmed continuous abstinence rate (CAR) for weeks 9 to 12. Other outcomes included CARs assessed during nontreatment follow-up and ratings of mood, anxiety, and suicidal ideation or behavior.Results68.4% versus 66.5% of the varenicline and placebo groups, respectively, completed the study. Varenicline-treated participants had higher CARs versus placebo at weeks 9 to 12 (35.9% vs. 15.6%; odds ratio [OR], 3.35 [95% CI, 2.16 to 5.21]; P < 0.001), 9 to 24 (25.0% vs. 12.3%; OR, 2.53 [CI, 1.56 to 4.10]; P < 0.001), and 9 to 52 (20.3% vs. 10.4%; OR, 2.36 [CI, 1.40 to 3.98]; P = 0.001). There were no clinically relevant differences between groups in suicidal ideation or behavior and no overall worsening of depression or anxiety in either group. The most frequent adverse event was nausea (varenicline, 27.0%; placebo, 10.4%). Two varenicline-group participants died during the nontreatment phase.LimitationsSome data were missing, and power to detect differences between groups was low in rare events. Smokers with untreated depression, with co-occurring psychiatric conditions, or receiving mood stabilizers and antipsychotics were not included.ConclusionVarenicline increased smoking cessation in smokers with stably treated current or past depression without exacerbating depression or anxiety.Primary funding sourcePfizer

Status and trends in the structure of Arctic benthic food webs

On-going climate warming is causing a dramatic loss of sea-ice in the Arctic Ocean and it is projected that the Arctic Ocean will become seasonally ice-free by 2040. Many studies of local Arctic food webs now exist and with this review paper we aim to synthesize these into a large-scale assessment of the current status of knowledge on the structure of various Arctic marine food webs, and their response to climate change, and to sea-ice retreat in particular. Key drivers of ecosystem change and potential consequences for ecosystem functioning and Arctic marine food webs are identified along the sea-ice gradient with special emphasis on the following regions: seasonally ice free Barents and Chukchi Seas, loose ice pack zone of the Polar Front (PF) and Marginal Ice Zone (MIZ), and permanently sea-ice covered high Arctic. Finally, we identify gaps existing in the knowledge of different Arctic marine food webs and provide recommendations for future studies

Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial.

UnlabelledChinese translationBackgroundDepression is overrepresented in smokers.ObjectiveTo evaluate smoking abstinence and changes in mood and anxiety levels in smokers with depression treated with varenicline versus placebo.DesignPhase 4, multicenter, parallel, 1:1 allocation, double-blind, randomization trial. Randomization, stratified by antidepressant use and depression score at baseline, was blocked in sizes of 4. (ClinicalTrials.gov: NCT01078298).Setting38 centers in 8 countries.Participants525 adult smokers with stably treated current or past major depression and no recent cardiovascular events.InterventionVarenicline, 1 mg twice daily, or placebo for 12 weeks, with 40-week nontreatment follow-up.MeasurementsPrimary outcome was carbon monoxide-confirmed continuous abstinence rate (CAR) for weeks 9 to 12. Other outcomes included CARs assessed during nontreatment follow-up and ratings of mood, anxiety, and suicidal ideation or behavior.Results68.4% versus 66.5% of the varenicline and placebo groups, respectively, completed the study. Varenicline-treated participants had higher CARs versus placebo at weeks 9 to 12 (35.9% vs. 15.6%; odds ratio [OR], 3.35 [95% CI, 2.16 to 5.21]; P < 0.001), 9 to 24 (25.0% vs. 12.3%; OR, 2.53 [CI, 1.56 to 4.10]; P < 0.001), and 9 to 52 (20.3% vs. 10.4%; OR, 2.36 [CI, 1.40 to 3.98]; P = 0.001). There were no clinically relevant differences between groups in suicidal ideation or behavior and no overall worsening of depression or anxiety in either group. The most frequent adverse event was nausea (varenicline, 27.0%; placebo, 10.4%). Two varenicline-group participants died during the nontreatment phase.LimitationsSome data were missing, and power to detect differences between groups was low in rare events. Smokers with untreated depression, with co-occurring psychiatric conditions, or receiving mood stabilizers and antipsychotics were not included.ConclusionVarenicline increased smoking cessation in smokers with stably treated current or past depression without exacerbating depression or anxiety.Primary funding sourcePfizer

Psychiatric co-morbidity and multi-morbidity in the EAGLES trial: Descriptive correlates and associations with neuropsychiatric adverse events, treatment adherence, and smoking cessation

IntroductionPsychiatric and substance use disorders represent barriers to smoking cessation. We sought to identify correlates of psychiatric comorbidity (CM; 2 diagnoses) and multimorbidity (MM; 3+ diagnoses) among smokers attempting to quit and to evaluate whether these conditions predicted neuropsychiatric adverse events (NPSAEs), treatment adherence, or cessation efficacy (CE).Aims and methodsData were collected from November 2011 to January 2015 across sixteen countries and reflect the psychiatric cohort of the EAGLES trial. Participants were randomly assigned to receive varenicline, bupropion, nicotine replacement therapy, or placebo for 12 weeks and were followed for an additional 12 weeks posttreatment. NPSAE outcomes reflected 16 moderate-to-severe neuropsychiatric symptom categories, and CE outcomes included continuous abstinence at weeks 9-12 and 9-24.ResultsOf the 4103 participants included, 36.2% were diagnosed with multiple psychiatric conditions (20.9% CM, 15.3% MM). Psychiatric CM and MM were associated with several baseline factors, including male gender, nonwhite race or ethnicity, more previous quit attempts, and more severe mental health symptoms. The incidence of moderate-to-severe NPSAEs was significantly higher (p < .01) in participants with MM (11.9%) than those with CM (5.1%) or primary diagnosis only (4.6%). There were no significant (ps > .05) main effects or interactions with treatment condition for diagnostic grouping on treatment adherence or CE outcomes.ConclusionsWhile having multiple psychiatric diagnoses increased risk of developing moderate-to-severe NPSAEs during a quit attempt, neither CM nor MM were associated with treatment adherence or odds of quitting. These findings reassure providers to advise smokers with multiple stable psychiatric conditions to consider using Food and Drug Administration (FDA)-approved medications when trying to quit.ImplicationsPsychiatric MM may be associated with development of NPSAEs when smokers make a medication-assisted quit attempt, but it does not appear to be differentially associated with medication compliance or efficacy. Prescribing healthcare professionals are encouraged to not only promote use of FDA-approved pharmacotherapies by smokers with complex psychiatric presentations, but also to closely monitor such smokers for neuropsychiatric side effects that may be related to their mental health conditions.Nct #NCT01456936

Considerations for the assessment of suicidal ideation and behavior in older adults with cognitive decline and dementia.

INTRODUCTION:Better understanding of suicide risk and its management in older adults with cognitive impairment and/or dementia remain significant unmet public health needs. Urgency to address them derives from concern that CNS treatments for dementia may impact suicide risk. Regulatory guidances requiring assessment of emergent suicidal ideation and behavior (SI/SB) at every clinical trial visit emphasize the need for understanding their prevalence. METHODS:The literature regarding SI/SB in older persons with cognitive impairment or dementia was reviewed by an Alzheimer's Association Taskforce with emphasis on epidemiology, classification, assessment, and regulatory requirements. RESULTS:Gaps in our knowledge were identified, challenges discussed and recommendations for future work provided. DISCUSSION:Currently available SI/SB data from geriatric persons with dementia do not provide adequate understanding of its epidemiology, identification, assessment, or management. The growing public health burden of this population requires greater attention from clinicians and researchers on tactics and assessment tools to meet these needs

2018 ESC Guidelines for the management of cardiovascular diseases during pregnancy

Guidelines summarize and evaluate available evidence with the aim of assisting health professionals in selecting the best management strategies for an individual patient with a given condition. Guidelines and their recommendations should facilitate decision making of health professionals in their daily practice. However, the final decisions concerning an individual patient must be made by the responsible health professional(s) in consultation with the patient and caregiver as appropriate