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Article: Interpretation of cardiovascular outcome trials in type 2 diabetes needs a multiaxial approach.

Johansen, Odd Erik

2015 Volume 6, Issue 9, Page(s) 1092–1096

Abstract: In cardiovascular (CV) diabetology a "one-size fits-all" approach needs caution as vasculopathy and CV manifestations in patients with type 2 diabetes (T2D) with short disease duration are different as compared to those with longer duration. This is of ... ...

Abstract	In cardiovascular (CV) diabetology a "one-size fits-all" approach needs caution as vasculopathy and CV manifestations in patients with type 2 diabetes (T2D) with short disease duration are different as compared to those with longer duration. This is of relevance when interpreting results of CV outcome trials as responses to any intervention aimed to reduce CV risk might be different in patients with established vasculopathy as compared to those without, where also the duration of the intervention may play a role. Additionally, the mode-of-action of the intervention and its assumed time to peak CV risk modulation need to be taken into account: an intervention with possibly immediate effects, like on blood pressure or other direct functional dynamic parameters such as endothelial function or renal hemodynamics, could likely provide a meaningful impact on CV outcomes over a shorter time span than interventions that primarily target pathways that work on atherosclerotic processes, organ-remodelling, or vessel integrity. We are now faced with CV outcome results to interpret from a plethora of outcomes trials in T2D, some of which are testing the CV risk modulation predominantly beyond glucose lowering, e.g., as is the case for several trials testing the newer therapy classes di-peptidyl peptidase-4 inhibitors, glucagon-like protein-1 receptor analogues and sodium glucose co-transporter-2 inhibitors, and this paper reviews the data that support a call for a multiaxial approach to interpret these results.
Language	English
Publishing date	2015-07-21
Publishing country	United States
Document type	Journal Article
ZDB-ID	2583471-X
ISSN	1948-9358
ISSN	1948-9358
DOI	10.4239/wjd.v6.i9.1092
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Article ; Online: Development of a tool to predict the risk of incident heart failure in a general population: the HUNT for HF risk score.

Ofstad, Anne Pernille / Brunborg, Cathrine / Johansen, Odd Erik / Mørkedal, Bjørn / Fagerland, Morten W / Laugsand, Lars Erik / Gullestad, Lars L / Dalen, Håvard

ESC heart failure

2023 Volume 10, Issue 5, Page(s) 2807–2815

Abstract: Aims: Currently, no incident heart failure (HF) risk score that is in regular use in a general population is available. We aimed to develop this and compare with existing HF risk scores.: Methods and results: Participants in the third wave (2006-08) ... ...

Abstract	Aims: Currently, no incident heart failure (HF) risk score that is in regular use in a general population is available. We aimed to develop this and compare with existing HF risk scores. Methods and results: Participants in the third wave (2006-08) of the population-based Trøndelag Health Study 3 (HUNT3) were included if they reported no previous HF. Any hospital diagnoses captured during follow-up (until the end of 2018) of HF, cardiomyopathy, or hypertensive heart disease were assessed by an experienced cardiologist. Valid HF events were defined as symptoms/signs of HF and objective evidence of structural/functional abnormality of the heart at rest. The model was compared with slightly modified HF risk scores (the Health Aging and Body Composition HF risk score, the Framingham HF risk score, the Pooled Cohort equations to Prevent HF risk score, and NORRISK 2). Among 36 511 participants (mean ± SD age of 57.9 ± 13.3 years, 55.4% female), with a mean follow-up of 10.2 ± 1.3 years, 1366 developed HF (incidence rate of 3.66 per 1000 participant years). Out of the 38 relevant clinical variables assessed, we identified 12 (atrial fibrillation being the strongest) that independently predicted an HF event. The final model demonstrated good discrimination (C statistics = 0.904) and calibration, was stable in internal validation, and performed well compared with existing risk scores. The model identified that, at enrolment, 31 391 (86%), 2386 (7%), 1246 (3%), and 1488 (4%) had low, low-intermediate, high-intermediate, and high 10-year HF risk, respectively. Conclusions: Twelve clinical variables independently predicted 10-year HF risk. The model may serve well as the foundation of a practical, online risk score for HF in general practice. Trial registration: ClinicalTrials.gov Identifier: NCT04648852.
Language	English
Publishing date	2023-05-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2814355-3
ISSN	2055-5822 ; 2055-5822
ISSN (online)	2055-5822
ISSN	2055-5822
DOI	10.1002/ehf2.14390
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Article: Oral enzyme combination with bromelain, trypsin and the flavonoid rutoside reduces systemic inflammation and pain when used pre- and post-operatively in elective total hip replacement: a randomized exploratory placebo-controlled trial.

Vosáhlo, Jiří / Salus, Adam / Smolko, Michael / Němcová, Barbora / Nordmeyer, Veit / Mikles, Milos / Rau, Stefanie M / Erik Johansen, Odd

Therapeutic advances in musculoskeletal disease

2023 Volume 15, Page(s) 1759720X231186875

Abstract: Background: Early mobilization after total hip replacement (THR) is key for fast recovery but is often limited by pain. Oral enzyme combinations (OECs) have demonstrated anti-inflammatory and pain-relieving effects.: Objectives and design: This ... ...

Abstract	Background: Early mobilization after total hip replacement (THR) is key for fast recovery but is often limited by pain. Oral enzyme combinations (OECs) have demonstrated anti-inflammatory and pain-relieving effects. Objectives and design: This prospective, randomized, double-blind, placebo-controlled exploratory trial evaluated the effects of pre- and post-operative use of OEC (90 mg bromelain, 48 mg trypsin, 100 mg rutoside) following elective THR, on post-operative recovery. Methods: Candidates for primary elective cementless THR owing to osteoarthritis were eligible for participation [age ⩾50 years, body mass index 25-35 kg/m Results: Patients ( Conclusions: Pre- and post-operative use of OEC significantly reduced CRP levels and patient self-reported pain. OEC may be an efficacious and safe treatment option to facilitate post-operative recovery following THR. Trial registration: EudraCT number 2016-003078-41.
Language	English
Publishing date	2023-07-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2516075-8
ISSN	1759-7218 ; 1759-720X
ISSN (online)	1759-7218
ISSN	1759-720X
DOI	10.1177/1759720X231186875
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Article ; Online: The OPTIFAST total and partial meal replacement programme reduces cardiometabolic risk in adults with obesity: Secondary and exploratory analysis of the OPTIWIN study.

Ard, Jamy D / Neeland, Ian J / Rothberg, Amy E / Chilton, Robert J / de Luis, Daniel / Cohen, Sarah S / Johansen, Odd Erik

Diabetes, obesity & metabolism

2023 Volume 26, Issue 3, Page(s) 950–960

Abstract: Aim: The effects of weight loss with a partial or total meal replacement programme (MRP) on atherosclerotic cardiovascular disease (ASCVD) risk factors are not fully understood, in particular in people at higher CV risk. In the 52-week randomized ... ...

Abstract	Aim: The effects of weight loss with a partial or total meal replacement programme (MRP) on atherosclerotic cardiovascular disease (ASCVD) risk factors are not fully understood, in particular in people at higher CV risk. In the 52-week randomized controlled OPTIWIN study in men and women with obesity, meal replacement programme (total for first 26 weeks, partial for the ensuing 26 weeks) with OPTIFAST (OP) resulted in significantly greater weight loss compared with a low-calorie food-based (FB) dietary plan, both as part of a comprehensive lifestyle intervention [OP (n = 135)/FB (n = 138) week 26: -12.4%/-6.0%, p < .001; week 52: -10.5%/-5.5%, p < .001]. Here, we examined effects on ASCVD risk factors and 10-year ASCVD risk. Materials and methods: Participants with body mass index 30-55 kg/m Results: Baseline characteristics were well balanced (OP/FB females 86%/79%, mean age 47/47 years, body mass index 38.4/39.2 kg/m Conclusions: In people with obesity at low ASCVD risk, OP significantly reduced cardiovascular risk factors and 10-year predicted risk for ASCVD.
MeSH term(s)	Adult ; Male ; Humans ; Female ; Middle Aged ; Adolescent ; Young Adult ; Aged ; Obesity/complications ; Obesity/epidemiology ; Blood Pressure ; Risk Factors ; Weight Loss ; Atherosclerosis ; Lipids ; Hypertension/drug therapy
Chemical Substances	Lipids
Language	English
Publishing date	2023-12-11
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	1454944-x
ISSN	1463-1326 ; 1462-8902
ISSN (online)	1463-1326
ISSN	1462-8902
DOI	10.1111/dom.15392
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Article: Females with type 2 diabetes are at higher risk for accelerated cognitive decline than males: CAROLINA-COGNITION study

Verhagen, Chloë / Janssen, Jolien / Biessels, Geert Jan / Johansen, Odd Erik / Exalto, Lieza G.

Nutrition, metabolism, and cardiovascular diseases. 2022 Feb., v. 32, no. 2

2022

Abstract: Cognitive dysfunction is increasingly recognized as an important comorbidity of type 2 diabetes (T2D). We aimed to establish if the risk of accelerated cognitive decline (ACD) is higher in females with T2D than males.3163 participants (38% female) with ... ...

Abstract	Cognitive dysfunction is increasingly recognized as an important comorbidity of type 2 diabetes (T2D). We aimed to establish if the risk of accelerated cognitive decline (ACD) is higher in females with T2D than males.3163 participants (38% female) with T2D from the cognition substudy of CAROLINA® (NCT01243424) were included (mean age 64.4 ± 9.2 years; T2D duration 7.6 ± 6.1 years). The cognitive outcome was occurrence of ACD at end of follow-up, defined as a regression based index score ≤16th percentile on either the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning (Trail Making and Verbal Fluency Test). Potential confounders, were taken into account at an individual patient level. Logistic regression analysis was used to investigate ACD risk by sex. We assessed potential mediators for sex differences in ACD using Causal Mediation Analysis (CMA). After a median follow-up duration of 6.1 ± 0.7 years, 361 (30.0%) females compared to 494 (25.2%) males exhibited ACD (OR 1.27 [95%CI 1.08–1.49], p = .003). Depressive symptoms, which were more common in females (24.3% vs 12.5%), mediated between sex and ACD (mediation effect 20.3%, p = 0.03). There were no other significant mediators.Females with T2D had a higher risk of ACD compared to males. This was partly explained by depressive symptoms. After evaluation of vascular and diabetes-related risk factors, complications and treatment, a major share of the higher risk of ACD in females remained unexplained. Our results highlight the need for further research on causes of sex-specific ACD in T2D.
Keywords	cognition ; cognitive disorders ; comorbidity ; females ; metabolism ; noninsulin-dependent diabetes mellitus ; nutrition ; patients ; regression analysis
Language	English
Dates of publication	2022-02
Size	p. 355-364.
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	1067704-5
ISSN	0939-4753
ISSN	0939-4753
DOI	10.1016/j.numecd.2021.10.013
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Chronic kidney disease and cognitive decline in patients with type 2 diabetes at elevated cardiovascular risk.

Verhagen, Chloë / Janssen, Jolien / Minderhoud, Crista A / van den Berg, Esther / Wanner, Christoph / Passera, Anna / Johansen, Odd Erik / Biessels, Geert Jan

Journal of diabetes and its complications

2022 Volume 36, Issue 10, Page(s) 108303

MeSH term(s)	Aged ; Albumins ; Albuminuria/complications ; Albuminuria/epidemiology ; Cardiovascular Diseases/complications ; Cardiovascular Diseases/epidemiology ; Cognitive Dysfunction/complications ; Cognitive Dysfunction/epidemiology ; Creatinine/urine ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/epidemiology ; Diabetes Mellitus, Type 2/psychology ; Glomerular Filtration Rate ; Heart Disease Risk Factors ; Humans ; Middle Aged ; Renal Insufficiency, Chronic/complications ; Renal Insufficiency, Chronic/diagnosis ; Renal Insufficiency, Chronic/epidemiology ; Risk Factors
Chemical Substances	Albumins ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2022-08-31
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1105840-7
ISSN	1873-460X ; 1056-8727
ISSN (online)	1873-460X
ISSN	1056-8727
DOI	10.1016/j.jdiacomp.2022.108303
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Article ; Online: Females with type 2 diabetes are at higher risk for accelerated cognitive decline than males: CAROLINA-COGNITION study.

Verhagen, Chloë / Janssen, Jolien / Biessels, Geert Jan / Johansen, Odd Erik / Exalto, Lieza G

Nutrition, metabolism, and cardiovascular diseases : NMCD

2021 Volume 32, Issue 2, Page(s) 355–364

Abstract: Background and aim: Cognitive dysfunction is increasingly recognized as an important comorbidity of type 2 diabetes (T2D). We aimed to establish if the risk of accelerated cognitive decline (ACD) is higher in females with T2D than males.: Methods and ... ...

Abstract	Background and aim: Cognitive dysfunction is increasingly recognized as an important comorbidity of type 2 diabetes (T2D). We aimed to establish if the risk of accelerated cognitive decline (ACD) is higher in females with T2D than males. Methods and results: 3163 participants (38% female) with T2D from the cognition substudy of CAROLINA® (NCT01243424) were included (mean age 64.4 ± 9.2 years; T2D duration 7.6 ± 6.1 years). The cognitive outcome was occurrence of ACD at end of follow-up, defined as a regression based index score ≤16th percentile on either the Mini-Mental State Examination (MMSE) or a composite measure of attention and executive functioning (Trail Making and Verbal Fluency Test). Potential confounders, were taken into account at an individual patient level. Logistic regression analysis was used to investigate ACD risk by sex. We assessed potential mediators for sex differences in ACD using Causal Mediation Analysis (CMA). After a median follow-up duration of 6.1 ± 0.7 years, 361 (30.0%) females compared to 494 (25.2%) males exhibited ACD (OR 1.27 [95%CI 1.08-1.49], p = .003). Depressive symptoms, which were more common in females (24.3% vs 12.5%), mediated between sex and ACD (mediation effect 20.3%, p = 0.03). There were no other significant mediators. Conclusion: Females with T2D had a higher risk of ACD compared to males. This was partly explained by depressive symptoms. After evaluation of vascular and diabetes-related risk factors, complications and treatment, a major share of the higher risk of ACD in females remained unexplained. Our results highlight the need for further research on causes of sex-specific ACD in T2D.
MeSH term(s)	Aged ; Cognition ; Cognitive Dysfunction/diagnosis ; Cognitive Dysfunction/epidemiology ; Comorbidity ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/epidemiology ; Female ; Humans ; Male ; Middle Aged ; Risk Factors
Language	English
Publishing date	2021-10-27
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1067704-5
ISSN	1590-3729 ; 0939-4753
ISSN (online)	1590-3729
ISSN	0939-4753
DOI	10.1016/j.numecd.2021.10.013
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Article ; Online: Oligomalt, a New Slowly Digestible Carbohydrate, Is Well Tolerated in Healthy Young Men and Women at Intakes Up to 180 Gram per Day: A Randomized, Double-Blind, Crossover Trial.

Johansen, Odd Erik / Curti, Delphine / von Eynatten, Maximilian / Rytz, Andreas / Lahiry, Anirban / Delodder, Frederik / Ufheil, Gerhard / D'Urzo, Carmine / Orengo, Audrey / Thorne, Kate / Lerea-Antes, Jaclyn S

Nutrients

2023 Volume 15, Issue 12

Abstract: In this randomized, double-blind triple-crossover study (NCT05142137), the digestive tolerance and safety of a novel, slowly digestible carbohydrate (SDC), oligomalt, an α-1,3/α-1,6-glucan α-glucose-based polymer, was assessed in healthy adults over ... ...

Abstract	In this randomized, double-blind triple-crossover study (NCT05142137), the digestive tolerance and safety of a novel, slowly digestible carbohydrate (SDC), oligomalt, an α-1,3/α-1,6-glucan α-glucose-based polymer, was assessed in healthy adults over three separate 7-day periods, comparing a high dose of oligomalt (180 g/day) or a moderate dose of oligomalt (80 g/day in combination with 100 g maltodextrin/day) with maltodextrin (180 g/day), provided as four daily servings in 300 mL of water with a meal. Each period was followed by a one-week washout. A total of 24 subjects (15 females, age 34 years, BMI 22.2 kg/m
MeSH term(s)	Male ; Young Adult ; Humans ; Female ; Adult ; Cross-Over Studies ; Gastrointestinal Diseases ; Glucans ; Abdominal Pain ; Double-Blind Method
Chemical Substances	Glucans
Language	English
Publishing date	2023-06-15
Publishing country	Switzerland
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2518386-2
ISSN	2072-6643 ; 2072-6643
ISSN (online)	2072-6643
ISSN	2072-6643
DOI	10.3390/nu15122752
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Article ; Online: Hypoglycemia and Cardiovascular Outcomes in the CARMELINA and CAROLINA Trials of Linagliptin: A Secondary Analysis of Randomized Clinical Trials.

Marx, Nikolaus / Kolkailah, Ahmed A / Rosenstock, Julio / Johansen, Odd Erik / Cooper, Mark E / Alexander, John H / Toto, Robert D / Wanner, Christoph / Espeland, Mark A / Mattheus, Michaela / Schnaidt, Sven / Perkovic, Vlado / Gollop, Nicholas D / McGuire, Darren K

JAMA cardiology

2024 Volume 9, Issue 2, Page(s) 134–143

Abstract: Importance: Previous studies have reported an association between hypoglycemia and cardiovascular (CV) events in people with type 2 diabetes (T2D), but it is unclear if this association is causal or identifies a high-risk patient phenotype.: Objective! ...

Abstract	Importance: Previous studies have reported an association between hypoglycemia and cardiovascular (CV) events in people with type 2 diabetes (T2D), but it is unclear if this association is causal or identifies a high-risk patient phenotype. Objective: To evaluate the associations between hypoglycemia and CV outcomes. Design, setting, and participants: This secondary analysis was a post hoc assessment of the multinational, double-blind CARMELINA (Cardiovascular and Renal Microvascular Outcome Study With Linagliptin; 2013-2016) and CAROLINA (Cardiovascular Outcome Trial of Linagliptin vs Glimepiride in Type 2 Diabetes; 2010-2018) randomized clinical trials of the antihyperglycemic drug, linagliptin, a dipeptidyl peptidase 4 inhibitor. Participants were adults with T2D at high CV risk with or without high kidney risk. By design, participants in the CARMELINA trial had longer duration of T2D and had a higher CV risk than participants in the CAROLINA trial. Data analyses were conducted between June 2021 and June 2023. Intervention: Linagliptin or placebo in the CARMELINA trial, and linagliptin or glimepiride in the CAROLINA trial. Main outcomes and measures: The primary outcome for both trials was CV death, myocardial infarction (MI), or stroke (3-point major adverse CV events [3P-MACE]). For the present analyses, hospitalization for heart failure (HF) was added. Hypoglycemia was defined as plasma glucose less than 54 mg/dL or severe hypoglycemia (episodes requiring the assistance of another person). Associations between the first hypoglycemic episode and subsequent CV events and between nonfatal CV events (MI, stroke, hospitalization for HF) and subsequent hypoglycemic episodes were assessed using multivariable Cox proportional hazards regression models. Sensitivity analyses explored the risk of CV events within 60 days after each hypoglycemic episode. Results: In the CARMELINA trial (6979 patients; 4390 males [62.9%]; mean [SD] age, 65.9 [9.1] years), there was an association between hypoglycemia and subsequent 3P-MACE plus hospitalization for HF (hazard ratio [HR], 1.23; 95% CI, 1.04-1.46) as well as between nonfatal CV events and subsequent hypoglycemia (HR, 1.39; 95% CI, 1.06-1.83). In the CAROLINA trial (6033 patients; 3619 males (60.0%); mean [SD] age, 64.0 [9.5] years), there was no association between hypoglycemia and subsequent 3P-MACE plus hospitalization for HF (HR, 1.00; 95% CI, 0.76-1.32) and between nonfatal CV events and subsequent hypoglycemia (HR, 1.44; 95% CI, 0.96-2.16). In analyses of CV events occurring within 60 days after hypoglycemia, there was either no association or too few events to analyze. Conclusions and relevance: This study found bidirectional associations between hypoglycemia and CV outcomes in the CARMELINA trial but no associations in either direction in the CAROLINA trial, challenging the notion that hypoglycemia causes adverse CV events. The findings from the CARMELINA trial suggest that both hypoglycemia and CV events more likely identify patients at high risk for both. Trial registration: ClinicalTrials.gov Identifier: NCT01897532 (CARMELINA) and NCT01243424 (CAROLINA).
MeSH term(s)	Male ; Humans ; Aged ; Middle Aged ; Linagliptin/therapeutic use ; Diabetes Mellitus, Type 2/complications ; Diabetes Mellitus, Type 2/drug therapy ; Risk Factors ; Randomized Controlled Trials as Topic ; Hypoglycemic Agents/therapeutic use ; Hypoglycemia/chemically induced ; Hypoglycemia/epidemiology ; Hypoglycemia/complications ; Heart Failure/complications ; Myocardial Infarction/drug therapy ; Stroke/chemically induced ; Sulfonylurea Compounds
Chemical Substances	Linagliptin (3X29ZEJ4R2) ; glimepiride (6KY687524K) ; Hypoglycemic Agents ; Sulfonylurea Compounds
Language	English
Publishing date	2024-01-03
Publishing country	United States
Document type	Journal Article
ISSN	2380-6591
ISSN (online)	2380-6591
DOI	10.1001/jamacardio.2023.4602
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Article ; Online: Effects of an oral biodegradable device used for 12 weeks on weight reduction, cardiovascular risk factors, satiety, snacking, and meal size.

Shirin, Haim / Neeland, Ian J / Ryan, Donna H / de Luis, Daniel / Lecube, Albert / Magos, Zoltan / Kenan, Yael / Amir, Ruthie / Cohen, Daniel L / Johansen, Odd Erik

Obesity Pillars (Online)

2023 Volume 8, Page(s) 100094

Abstract: Background: The Epitomee Capsule (EC) is an, oral, self-use, bio-degradable device for weight management, composed of absorbent polymers that self-expands in the stomach (pH-sensitive) and creates a triangular shape, space-occupying super-absorbent gel ... ...

Abstract	Background: The Epitomee Capsule (EC) is an, oral, self-use, bio-degradable device for weight management, composed of absorbent polymers that self-expands in the stomach (pH-sensitive) and creates a triangular shape, space-occupying super-absorbent gel structure. A recent study reported that 42 % of study completers obtained >5 % weight reduction at 12 weeks. We performed exploratory analyses of this study to evaluate its effect on cardiovascular risk factors and on self-reported satiety, between-meal snacking and meal-size. Methods: This single-center observational study (Israel) enrolled 78 volunteers, with mean age 41 years, BMI 32.5 kg/m Result: Compared to baseline, at 12 weeks, SBP/DBP were reduced (ΔSBP: -5.5 mmHg, p = 0.0003/ΔDBP: -1.9 mmHg, p = 0.1341), with a larger effect in people with hypertension at baseline (ΔSBP: -13.2 mmHg, p < 0.00001/ΔDBP: -6.1, p = 0.008). Triglyceride-level was also significantly reduced, but not other lipids. Mean scores to Q1-3 were high throughout, with slight decreases (Q1 at W2 3.9 ± 1.1/W12 3.0 ± 1.6; Q2 at W2 3.7 ± 1.1/W12 3.1 ± 1.6; Q3 at W2 3.8 ± 1.2/W12 2.9 ± 1.6). There was a moderate correlation between PROs and weight reduction, although significance was not observed for all weeks. Conclusions: Exploratory analyses of 12 weeks treatment with EC demonstrated significant reductions in SBP, DBP, and triglycerides. The weight reduction correlated with satiety, less snacking, and reduced meal size.
Language	English
Publishing date	2023-11-13
Publishing country	United States
Document type	Journal Article
ISSN	2667-3681
ISSN (online)	2667-3681
DOI	10.1016/j.obpill.2023.100094
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