A multi-component intervention increased access to smoking cessation treatment after hospitalization for atherosclerotic cardiovascular disease: a randomized trial.

Aims: To evaluate the effects of a multi-component intervention for smokers hospitalized for atherosclerotic cardiovascular disease (ASCVD) on the participation rate in community-based cessation programmes and the use of cessation drugs. Additionally, to explore the impact on the cessation rates at 6 months. Methods and results: A randomized parallel-group study was conducted at a Norwegian secondary care hospital in 2021. The intervention group was: (i) counselled using motivational interviewing techniques during hospitalization; (ii) given an information leaflet, detailing the cessation programme; and (iii) referred to the community-based smoking cessation treatment including a post-discharge pro-active telephone invitation. The control group received usual care and the same information leaflet containing clear contact details for initiating participation. Data were collected at baseline, 1, 3, and 6 months. Among 99 smokers hospitalized with ASCVD, 40 were excluded. Of 59 randomized patients, 4 were lost to follow-up and 55 completed the study. The mean age was 65.1 (standard deviation 9.3) years, 35% were female, and 88% had smoked >20 years. Co-morbidity was prevalent (mean Charlson score 4.8). The intervention group was more likely to participate in the smoking cessation treatment {48 vs. 7%, difference: 41% [95% confidence interval (CI): 14%, 63%]} and used cessation drugs more frequently [59 vs. 21%, difference: 38% (95% CI: 17%, 59%)]. At the 6 months point prevalence, we observed notable between-group differences in self-reported cessation rate (48 vs. 25%). Conclusion: The intervention significantly increased the participation rate at community-based smoking cessation programmes and the use of cessation drugs among multi-morbid smokers hospitalized for ASCVD.

Does deep TMS really works for smoking cessation? A prospective, double blind, randomized, sham controlled study.

INTRODUCTION: A substantial proportion of smokers wishing to quit do not stop smoking when using current therapies to aid cessation. Magnetic pulses to specific brain areas designated as transcranial magnetic stimulation may modulate brain activity and thereby change chemical dependencies. Deep transcranial magnetic stimulation (dTMS) with the H4 coil stimulates neuronal pathways in the lateral prefrontal cortex and insula bilaterally, areas involved in tobacco addiction. OBJECTIVE: To evaluate the efficacy and safety of dTMS with T4 coil in smoking cessation. METHODS: In a double blind, controlled clinical trial, adult smokers of at least 10 cigarettes/day were randomized to active (n = 50) versus sham dTMS (n = 50). The protocol involved up to 21 sessions administered over up to 12 weeks. Tobacco use was monitored by self-report and confirmed by expired air monoximetry (at each dTMS visit) and blood cotinine (at the screening visit and at the end of sessions). Participants completed abstinence, mood and cognition scales at determined timepoints during follow-up. RESULTS: In the intention to-treat-analysis, the cessation rate of the intervention and control groups was 14.0%. The reported side effects were as expected for this procedure. Although there were no serious adverse events, three participants were withdrawn according to safety criteria. CONCLUSION: Active treatment with dTMS H4 coil was safe but not effective for smoking cessation.

Validation and Reproducibility of Total Plaque Thickness in Carotid and Femoral Arteries Using Ultrasound.

OBJECTIVE: Plaque burden quantification by ultrasound improves cardiovascular (CV) risk prediction. However, measuring total plaque volume (TPV) with 3-D ultrasound, the current gold standard, is time consuming. In the present study we investigated the reproducibility of weighted total plaque thickness (wTPT) measured by 2-D ultrasound and its correlation with TPV. METHODS: Participants in an ongoing study of subclinical atherosclerosis and CV risk with no known atherosclerotic CV disease but who were found to have one or more plaques in carotid or femoral arteries by 2-D ultrasound were included. A total of 34 women and 26 men (mean age: 59.4 y, standard deviation: 8.7) underwent primary 2-D and 3-D ultrasound examinations. Participants then underwent a 2-D ultrasound examination by another radiologist blinded to the first radiologist's findings. Finally, all participants underwent a follow-up 2-D ultrasound by the first radiologist. RESULTS: Comparison of wTPT measurements between the 2-D studies revealed no significant difference (mean difference: 0.29 mm, 95% confidence interval [CI]: -0.48 to 1.17). Inter-observer and intra-observer analyses revealed intraclass correlation coefficients of 0.97 (95% CI: 0.96-0.98) and 1.0 (95% CI: 0.99-1.00), respectively. wTPT correlated with TPV (Spearman's ρ = 0.98, 95% CI: 0.96-0.99). Elapsed time for assessing wTPT was less than that for TPV (mean difference: 36.1 min, 95% CI: 26.0-46.3). CONCLUSION: wTPT had high reproducibility and correlation with TPV while requiring substantially less time. Future studies addressing the role of wTPT in predicting CV disease are needed.

Protocol for a 20-year follow-up after a randomized controlled trial of a Mediterranean diet in pregnancy: maternal and offspring risk factors for cardiovascular disease.

Background: An inadequate maternal diet during pregnancy can impair offspring health and may increase the risk of cardiovascular disease later in life. The purpose of the proposed study is to assess the risk factors associated with cardiovascular disease in both mothers and their offspring 20 years following their participation in a Mediterranean diet intervention trial during pregnancy. Methods: The "Cardiovascular Risk Reduction Diet In Pregnancy" (CARRDIP) study was a randomized controlled trial performed between 1999 and 2001. The participants were randomized to adhere to either a Mediterranean diet or their regular diet during pregnancy. An extensive amount of data such as diet information, ultrasound measurements, anthropometry, and biomarkers from these mothers during pregnancy and their offspring in the neonatal period were collected. The mother-offspring pairs (n = 269) from the CARRDIP study will be invited to participate in a clinical examination and blood sample collection. This follow-up study, conducted 20 years after the original CARRDIP study, will investigate cardiovascular risk factors in mothers and offspring. The primary outcome will be the blood pressure of the offspring. In addition, the study will explore various aspects of cardiovascular health, including metabolic and inflammatory status, clinical history, and body composition of the participants. Discussion: Previous studies investigating the effects of nutrition during pregnancy on maternal and offspring health have been either observational studies, animal studies, or randomized controlled trials with a follow-up period of less than 5 years. This project aims to study the long-term effects of dietary intervention during pregnancy on maternal and offspring cardiovascular risk markers. Clinical Trial Registration: Clinicaltrials.gov, identifier (NCT05030922).

Sex differences in secondary preventive follow-up after coronary heart events.

BACKGROUND AND AIMS: Some studies point to sex differences in cardiovascular preventive practices. The aim of this study was to investigate differences in achievement of secondary preventive targets and long-term outcome in men and women after a coronary heart event. METHODS: This study was a subanalysis from a randomized controlled trial of hospital-based versus primary care-based secondary preventive follow-up at Sorlandet Hospital, Norway, 2007-2022 and included both groups. The main outcome was achievement of treatment targets two years after the index event. Event-free survival was calculated based on the composite of mortality, coronary intervention, stroke, or myocardial infarction during follow-up. Participants were followed-up for up to 10 years after the index event through out-patient consultations. RESULTS: In total, 337 women and 1203 men were eligible for the study. Due to loss of follow-up during the first two years after the index coronary event 106 (7%) participants were excluded from further analysis (53% withdrawal of consent, 12% death, and 35% other causes) leaving 307 (21%) women and 1127 (79%) men. After two years of follow-up we found no differences between women and men in achievement of blood pressure targets (61% vs. 59%; p = 0.57), LDL-cholesterol goals (64% vs. 69%; p = 0.15), HbA1c-goal in patients with diabetes (49% vs. 45%; p = 0.57), non-smoking (79% vs. 81%; p = 0.34), healthy diets (14% vs. 13%, p = 0.89), physical activity (55% vs. 58%; p = 0.38), use of acetylsalicylic acid (93% vs. 94%; p = 0.39), and use of lipid lowering therapy (92% vs. 94%; p = 0.15). After a median follow-up time of 5.0 [SD 3.2] years there were no differences between women and men regarding composite endpoint (89 [30.0%] vs. 345 [30.6]; p = 0.58), and composite endpoint-free survival did not differ between women and men (hospital-based follow-up HR for women versus men, 0.87, 95% CI 0.62-1.23; p = 0.44 and primary care service HR for women versus men 0.95, 95% CI 0.69-1.31; p = 0.78). CONCLUSIONS: The study show no sex differences in achievement of secondary preventive targets or composite endpoint after coronary heart events. However, many women and men did not achieve treatment goals, and further improvement in secondary prevention is needed. TRIAL REGISTRATION: The study is registered in ClinicalTrials.gov (NCT00679237).

Association of Troponin T measurements with long-term outcomes in patients with coronary artery disease participating in a secondary prevention trial.

BACKGROUND AND AIMS: Identification of high-risk patients in secondary cardiovascular prevention may be challenging, although risk stratification tools are available. Cardiac troponins might have predictive value in identification of high-risk patients. The aim of this study was to investigate the association between cardiac Troponin T (cTnT) levels following a coronary event and long-term outcomes. METHODS: This study was carried out as a subanalysis from a randomized controlled trial conducted at Sørlandet Hospital, Norway, where patients hospitalized with myocardial infarction (MI) or scheduled percutaneous coronary intervention (PCI)/coronary artery bypass grafting (CABG) were included between 2007 and 2017. Participants were followed-up for up to 10 years after the index event through out-patient consultations. cTnT was assessed at each consultation as well as information regarding new cardiovascular events or death. RESULTS: A total of 1278 patients (18-80 years) with complete measurements of cTnT were included. cTnT was elevated (≥ 14 ng/L) one year after the primary event in 241 (19%) of participants. Median follow-up was 5.7 [SD 2.7] years. Cox regression analyses showed reduced survival (adjusted HR 0.37, 95% CI 0.19-0.72; p = 0.003) and composite endpoint-free survival (adjusted HR 0.73, 95% CI 0.55-0.98; p = 0.04) in participants with elevated cTnT versus participants with low cTnT after adjustment for risk factors at inclusion and randomization assignment. CONCLUSIONS: Assessment of cTnT after coronary heart events may help identify patients at high risk of poor outcomes and might contribute to more focused secondary preventive treatment. TRIAL REGISTRATION: The study is registered in ClinicalTrials.gov (NCT00679237).

The Effect of Smoking Cessation on Body Weight and Other Metabolic Parameters with Focus on People with Type 2 Diabetes Mellitus.

Smokers with diabetes mellitus substantially lower their risks of microvascular and macrovascular diabetic complications, in particular cardiovascular disease, by quitting smoking. However, subsequent post-smoking-cessation weight gain may attenuate some of the beneficial effects of smoking cessation and discourage attempts to quit. Weight gain can temporarily exacerbate diabetes and deteriorate glycemic control and metabolic profile. The molecular mechanisms by which quitting smoking leads to weight gain are largely associated with the removal of nicotine's effects on the central nervous system. This review addresses mechanisms of post-smoking-cessation weight gain, by reviewing the effects of nicotine on appetite, food intake, eating behaviour, energy expenditure, fat oxidation and appetite-regulating peptides. We also highlight correlations between post-cessation weight gain and risk of type 2 diabetes, consequences of weight gain in people with type 2 diabetes and the role of pharmacotherapies, which combine treatment of nicotine addiction and promotion of weight control.

Medication-assisted quit rates in participants with smoking-related diseases in EAGLES: Post hoc analyses of a double-blind, randomized, placebo-controlled clinical trial.

INTRODUCTION: Greater understanding is required of how smokers with smoking-related diseases respond to smoking cessation medications. This post hoc analysis of EAGLES data compared continuous abstinence rates (CARs) in smokers with/without smoking-related diseases and assessed participant demographic and baseline characteristics that may serve as predictors of continuous abstinence (CA). METHODS: EAGLES was a 24-week (12-week treatment, 12-week follow-up), double-blind, active- (nicotine replacement therapy; patch) and placebo-controlled study in motivated-to-quit smokers with/without psychiatric disorders. This analysis assessed CARs at weeks 9-12 (CAR9-12) and 9-24 (CAR9-24) in participants with smoking-related diseases [asthma, chronic obstructive pulmonary disease (COPD), diabetes, and/or cardiovascular disease (n=1372)] versus controls without these comorbidities (n=6039). Participants received varenicline 1 mg twice daily, bupropion 150 mg twice daily, nicotine patches 21 mg/day with taper, or placebo for 12 weeks. Stepwise logistic modeling was also performed to analyze odds ratio (OR) for predictors of CA at weeks 9-12 (CA9-12) and 9-24 (CA9-24). RESULTS: Smokers with smoking-related diseases were older, had a longer smoking history, more quit attempts, and were more likely to have a psychiatric disorder and reside in the US versus smokers without comorbidities. Fagerström Test for Cigarette Dependence scores and treatment adherence were comparable between cohorts. Smokers with smoking-related diseases had lower CARs versus controls (CAR9-12: 20.8% vs 24.0%; CAR9-24: 13.0% vs 16.9%). Use of smoking cessation medication was the strongest predictor of CA after control for demographics, smoking characteristics, and psychiatric disorder. By treatment, OR and CI were: varenicline CA9-12 (OR=3.82; 95% CI: 3.21-4.54) and CA9-24 (OR=2.92; 95% CI: 2.40-3.54); bupropion CA9-12 (OR=2.17; 95% CI: 1.81-2.60) and CA9-24 (OR=1.99; 95% CI: 1.63-2.44); nicotine patches CA9-12 (OR=2.23; 95% CI: 1.87-2.67) and CA9-24 (OR=1.86; 95% CI: 1.52-2.28). CONCLUSIONS: Smokers with smoking-related diseases had lower quit rates than controls. Of the active treatments compared, varenicline was most effective in smokers with asthma, COPD, diabetes, or cardiovascular disease. TRIAL REGISTRATION: NCT01456936 (https://clinicaltrials.gov/ct2/show/NCT01456936).

Do we need new lipid-lowering agents in the era of PCSK9 inhibitors? Recent advances.

Atherosclerotic disease remains the leading cause of death worldwide. Much of atherosclerotic disease initiation and progression is driven by dyslipidemia. With the advent of statins, ezetimibe, and more recently the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, physicians across all specialties have access to an armamentarium to address this major pathophysiological driver. Nevertheless, there is still a large unmet need in terms of optimizing pharmacotherapeutic lipid lowering strategies. This article will review the evidence pertaining to the major lipid-lowering agents that have been introduced lately, or still are under development, after the advent of statins, ezetimibe and PCSK9 inhibitors. There is cumulating evidence suggesting that there soon will be a broad specter of differential therapies across a variety of mechanistic pathways that will enter clinical medicine. Knowledge about these potential recent advances and various upcoming therapeutic options will make choice easier for physicians, and will lead to more personalized selections of available treatments.

Tobacco and nicotine use.

Tobacco smoking is a major determinant of preventable morbidity and mortality worldwide. More than a billion people smoke, and without major increases in cessation, at least half will die prematurely from tobacco-related complications. In addition, people who smoke have a significant reduction in their quality of life. Neurobiological findings have identified the mechanisms by which nicotine in tobacco affects the brain reward system and causes addiction. These brain changes contribute to the maintenance of nicotine or tobacco use despite knowledge of its negative consequences, a hallmark of addiction. Effective approaches to screen, prevent and treat tobacco use can be widely implemented to limit tobacco's effect on individuals and society. The effectiveness of psychosocial and pharmacological interventions in helping people quit smoking has been demonstrated. As the majority of people who smoke ultimately relapse, it is important to enhance the reach of available interventions and to continue to develop novel interventions. These efforts associated with innovative policy regulations (aimed at reducing nicotine content or eliminating tobacco products) have the potential to reduce the prevalence of tobacco and nicotine use and their enormous adverse impact on population health.

Quality of clinical management of cardiometabolic risk factors in patients with severe mental illness in a specialist mental health care setting.

PURPOSE: Cardiometabolic disease in patients with severe mental illness is a major cause of shortened life expectancy. There is sparse evidence of real-world clinical risk prevention practice. We investigated levels of assessments of cardiometabolic risk factors and risk management interventions in patients with severe mental illness in the Norwegian mental health service according to an acknowledged international standard. METHODS: We collected data from 264 patients residing in six country-wide health trusts for: (a) assessments of cardiometabolic risk and (b) assessments of levels of risk reducing interventions. Logistic regressions were employed to investigate associations between risk and interventions. RESULTS: Complete assessments of all cardiometabolic risk variables were performed in 50% of the participants and 88% thereof had risk levels requiring intervention according to the standard. Smoking cessation advice was provided to 45% of daily smokers and 4% were referred to an intervention program. Obesity was identified in 62% and was associated with lifestyle interventions. Reassessment of psychotropic medication was done in 28% of the obese patients. Women with obesity were less likely to receive dietary advice, and use of clozapine or olanzapine reduced the chances for patients with obesity of getting weight reducing interventions. CONCLUSIONS: Nearly nine out of the ten participants were identified as being at cardiometabolic high risk and only half of the participants were adequately screened. Women with obesity and patients using antipsychotics with higher levels of cardiometabolic side effects had fewer adequate interventions. The findings underscore the need for standardized recommendations for identification and provision of cardiometabolic risk reducing interventions in all patients with severe mental illness.

Statins seldom cause adverse reactions. / Statiner gir sjelden bivirkninger.

Statins seldom cause muscle side effects and are tolerated by the great majority of people. It is important to spend time, build trust, manage negative expectations and identify other causes of muscle problems than the use of statins.

Effect of smoking cessation on cardiac troponin I concentrations.

Chronic elevation of cardiac troponin I (cTnI) is associated with heart failure and cardiovascular death. Paradoxically, observational studies have indicated that current smokers have lower cTnI concentrations than non-smokers. We examined determinants of cTnI in smokers and the effect of smoking cessation on cTnI. Overweight or obese smokers received motivational support and varenicline to aid cessation and dietary advice to limit weight gain. Quitters were defined according to the Russell standard (≤5 cigarettes after the quit date) and validated with expired breath CO <10 ppm. Of the total 122 participants, 108 completed assessments at 12 weeks and 78 were classified as quitters versus 30 who continued smoking. cTnI was measured with a high-sensitivity assay with a limit of detection of 1.2 ng/L (Abbott Diagnostics), and concentrations (log-transformed) were compared between quitters and continuing smokers. cTnI concentrations were significantly higher in men than women and correlated with age, but not with number of cigarettes/day. Quitters had median baseline and 12-week levels of 1.4 ng/L (interquartile range [IQR] 1.2-2.5) and 1.4 ng/L (IQR 1.2-2.4), respectively, while nonquitters had baseline and 12-week levels of 1.5 ng/L (IQR 1.2-2.9) and 1.8 ng/L (IQR 1.3-3.4), respectively. The change in cTnI concentrations from baseline to 12 weeks did not differ between quitters and continuous smokers (p = .7). The results suggest that smoking cessation does not affect levels of cTnI, a marker of chronic subclinical myocardial injury, in contrast to prior observational data suggesting that tobacco smoking is associated with lower cTn concentrations.

A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial.

BACKGROUND AND AIMS: Obesity with type-2 diabetes is a global challenge. Lifestyle interventions have limited effect for most patients. Bariatric surgery is highly effective, but resource-demanding, invasive and associated with serious complications. Recently, a new intragastric balloon was introduced, not requiring endoscopy for placement or removal (Elipse™, Allurion Inc., Natick, MA). The balloon is swallowed in a capsule and filled with water once in the stomach. The balloon self-deflates after 4 months and is naturally excreted. The present trial investigated balloon feasibility, safety and efficacy in patients with obesity and type-2 diabetes. PATIENTS AND METHODS: We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0-39.9 kg/m2 at two Norwegian centers with the Elipse balloon. Patient follow-up during balloon treatment mimicked real-world clinical practice, including dietary plan and outpatient visits. The primary efficacy endpoints were total body weight loss (TBWL) and HbA1c at weeks 16 and 52. RESULTS: All patients underwent balloon insertion uneventfully as out-patients. Mean TBWL and HbA1c reduction after 16 and 52 weeks of balloon insertion was 3.9% (95%CI 2.1-5.7) and 0.8% (95%CI 1.9-3.5); and 7 (95%CI 4-10), and 1 (95%CI -6 to 9) mmol/mol, respectively. Adverse events occurred in two patients (10.5%): one developed gastric outlet obstruction, managed by endoscopic balloon removal; the other excessive vomiting and dehydration, managed conservatively. CONCLUSIONS: This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.

Long-term hospital-based secondary prevention of coronary artery disease: a randomized controlled trial.

BACKGROUND AND AIMS: Despite established guidelines on secondary prevention of cardiovascular disease, practical implementation of treatment targets is deficient even in high-income countries. This study compared long-term hospital-based treatment with follow-up at primary health care regarding new cardiovascular events and achievement of treatment targets. METHODS: This randomized controlled trial at Sørlandet Hospital, Norway 2007-2021 included patients hospitalized due to myocardial infarction (n = 760) or after scheduled percutaneous coronary intervention (PCI) (n = 677) or coronary artery bypass grafting (n = 103). Patients were randomized to hospital-based secondary preventive care with consultations 2 weeks, 3 months, 6 months and 1 year after the index event and annually for up to 5 years, or follow-up at primary health care. Final data was collected after 10 years and hazard ratios were calculated using Cox regression analyses. RESULTS: Composite endpoint-free survival due to a lower rate of PCI improved in patients with hospital-based follow-up (n = 788) compared to patients followed-up at primary health care (n = 752) (HR 0.80, 95% CI 0.66-0.96; p = 0.02) but all-cause mortality was not reduced (HR 0.96, 95% CI 0.59-1.56; p = 0.86). At 1 year, LDL-cholesterol (2.1 [SD 0.7] versus 2.3 [SD 0.8] mmol/l; p < 0.001) and systolic blood pressure (132 [SD 16] versus 142 [SD 20] mm/Hg; p < 0.001) were lower in the hospital-based group, and the differences remained significant during the first 5 years. Other secondary preventive measures (smoking cessation, physical activity, body weight, glucose control, drug adherence) did not differ. CONCLUSIONS: Long-term hospital-based secondary preventive follow-up improved composite endpoint-free survival, but not mortality. Substantial risk factors remained unaddressed. The beneficial effects on blood pressure and LDL-cholesterol disappeared after annual consultations ceased. TRIAL REGISTRATION: The study is registered in ClinicalTrials.gov (NCT00679237) May 16, 2008.