Metabolic syndrome cluster does not provide incremental prognostic information in patients with stable cardiovascular disease: A post hoc analysis of the AIM-HIGH trial

Background Beyond antihyperglycemic effects, metformin may improve cardiovascular outcomes. Patients with type 2 diabetes often have an elevated plasma level of N-terminal pro B-type as a marker of (sub) clinical cardiovascular disease. We studied whether metformin was associated with a reduction in the serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP) in these patients. Methods In the HOME trial 390 insulin-treated patients with type 2 diabetes were randomized to 850 mg metformin or placebo three times daily. Plasma samples were drawn at baseline, 4, 17, 30, 43 and 52 months. In a post-hoc analysis we analyzed the change in NT-proBNP in both groups. We used a longitudinal mixed model analysis adjusting for age, sex and prior cardiovascular disease. In a secondary analysis we assessed a possible immediate treatment effect post baseline. Results Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]). In the secondary analysis there was also no sustained time independent immediate treatment effect (initial increase of 17% [95%CI 4;30, p = 0.006] followed by yearly decrease of -4% [95%CI -7;0, p = 0.07]). Conclusions Metformin as compared to placebo did not affect NT-proBNP plasma levels in this 4.3-year placebo-controlled trial. Potential cardioprotective effects of metformin cannot be explained by changes in cardiac pressures or volumes to the extent reflected by NT-proBNP.

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Effects of Low-Volume, High-Intensity Interval Training Compared with Continuous Training on Regional and Global Body Composition in Adults with Metabolic Syndrome: A post hoc Analysis of a Randomized Clinical Trial

Annals of Nutrition and Metabolism ◽

10.1159/000518909 ◽

2021 ◽

pp. 1-10

Author(s):

Juan Carlos Aristizabal ◽

Esperanza Montoya ◽

Yeliana L. Sánchez ◽

Manuela Yepes-Calderón ◽

Raul Narvaez-Sanchez ◽

...

Keyword(s):

Metabolic Syndrome ◽

Clinical Trial ◽

Body Composition ◽

Interval Training ◽

High Intensity Interval Training ◽

Continuous Training ◽

Post Hoc Analysis ◽

Low Volume ◽

High Intensity Interval ◽

Post Hoc

Objective: The aim of this study was to compare the effects of low-volume, high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT) on body composition in adults with metabolic syndrome (MS). Methods: This is a post hoc analysis of the randomized clinical trial Intraining-MET. Sixty adults (40–60 years old) were randomized to an MICT (n = 31) or HIIT (n = 29) supervised programme 3 days/week for 12 weeks. MICT sessions were conducted for 36 min at 60% of peak oxygen consumption (VO2peak). HIIT sessions included 6 intervals at 90% VO2peak for 1 min, followed by 2 min at 50% VO2peak. Body composition was assessed with dual energy X-ray absorptiometry. Results: Body weight did not change from pre- to post-training in either MICT (78.9 ± 15.6 kg; 77.7 ± 16.5 kg, p = 0.280) or HIIT groups (76.3 ± 13.4 kg; 76.3 ± 13.7 kg, p = 0.964). Body fat percentage and fat mass (FM) decreased post-training in the MICT (−0.9%; 95% confidence interval [CI]: −0.27 to −1.47 and −0.7 kg; 95% CI: −0.12 to −1.30) and HIIT groups (−1.0%; 95% CI: −0.32 to −1.68 and −0.8 kg; 95% CI: −0.17 to −1.47). Compared to the HIIT programme, MICT significantly reduced android FM (−0.14 kg; 95% CI: −0.02 to −0.26). Lean mass (LM) increased post-training in MICT (+0.7 kg; 95% CI: 0.01–1.41) and HIIT groups (+0.9 kg; 95% CI: 0.12–1.64), but only HIIT increased the trunk LM (+0.6 kg; 95% CI: 0.06–1.20). Conclusions: Both MICT and HIIT reduced FM without changing body weight in adults with MS. MICT had additional benefits by reducing the android FM, whereas HIIT seemed to increase LM. Given the characteristics of the post hoc analysis, further research is required to confirm these results.

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RVX-208 a selective bromodomain extra-terminal protein inhibitor reduces mace in patients with high residual risks of cardiovascular disease, a post-hoc analysis

Atherosclerosis ◽

10.1016/j.atherosclerosis.2015.04.045 ◽

2015 ◽

Vol 241 (1) ◽

pp. e8

Author(s):

N.C.W. Wong ◽

J.O. Johansson ◽

K. Lebioda ◽

C. Halliday ◽

E. Kulikowski

Keyword(s):

Cardiovascular Disease ◽

Protein Inhibitor ◽

Terminal Protein ◽

Post Hoc Analysis ◽

Post Hoc

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Reaching blood pressure guideline targets with the CNIC polypill in patients with a previous cardiovascular event in Mexico: a post hoc analysis of the SORS study

Future Cardiology ◽

10.2217/fca-2019-0075 ◽

2020 ◽

Vol 16 (1) ◽

pp. 53-60

Author(s):

Enrique Gómez-Álvarez ◽

Juan Verdejo ◽

Salvador Ocampo ◽

Emilio Ruiz ◽

Marco A Martinez-Rios

Keyword(s):

Blood Pressure ◽

Cardiovascular Disease ◽

Prospective Study ◽

Calcium Antagonists ◽

Renin Angiotensin System ◽

Routine Practice ◽

Angiotensin System ◽

Post Hoc Analysis ◽

Β Blockers ◽

Post Hoc

Aim: To determine the effectiveness of Centro Nacional de Investigaciones Cardiovasculares (CNIC)-polypill (acetylsalicylic acid 100 mg, ramipril 5/10 mg, simvastatin 40 mg) in achieving blood pressure (BP) goals. Patients & methods: A multicenter, observational, one cohort, prospective study. BP targets were analyzed in patients with cardiovascular disease after 12-months treatment with the CNIC polypill. Results: A total of 572 patients (59.4 ± 13.9 years, 57.3% men) were analyzed. At baseline, BP was 147.1 ± 18.1/88.3 ± 10.6 mmHg, 97.1% of patients were taken renin-angiotensin system inhibitors, 5.4% calcium antagonists, 1.9% diuretics and 13.1% β-blockers. The proportion of patients who achieved BP targets increased from 20.1 to 55.4% (p < 0.001). Conclusion: In routine practice, switching from usual care to the CNIC-polypill in patients with cardiovascular disease could facilitate achieving BP goals.

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160 Lurasidone and Metabolic Syndrome: Results from Short- and Long-Term Clinical Studies in Patients with Bipolar Depression

CNS Spectrums ◽

10.1017/s1092852920000760 ◽

2020 ◽

Vol 25 (2) ◽

pp. 302-303

Author(s):

Michael Tocco ◽

John W. Newcomer ◽

Yongcai Mao ◽

Andrei Pikalov

Keyword(s):

Metabolic Syndrome ◽

Adjunctive Therapy ◽

Bipolar Depression ◽

Prevention Study ◽

Short Term ◽

Post Hoc Analysis ◽

Short And Long Term ◽

Post Hoc ◽

Therapy Studies

Abstract:Background:Among patients with depressive disorders, the prevalence of metabolic syndrome (MetS) is estimated to range from 35-40% and has been associated with increased mortality rates. The aim of this post-hoc analysis was to assess the effect of treatment with lurasidone on the prevalence of MetS in patients with bipolar depression.Method:Lurasidone data (dose range, 20-120 mg/d) used in the current analyses consisted of 3 double-blind (DB), placebo-controlled, 6-week studies in adults with bipolar I depression (total N=1,192), consisting of 1 monotherapy, and 2 adjunctive therapy trials with lithium or valproate. Patients who completed the short-term trials continued into a 6-month open-label (OL) extension study, with 6-month (LOCF-endpoint) data available on 274 patients treated with lurasidone monotherapy, and 436 patients treated with lurasidone adjunctive therapy. Also analyzed was a recurrence prevention study in stabilized bipolar patients who completed up to 20 weeks of OL adjunctive treatment with lurasidone, and then were randomized to 28 weeks of DB adjunctive therapy with lurasidone or placebo (N=497). MetS was defined based on NCEP ATP III criteria (2005 revision).Results:In the short-term monotherapy and adjunctive therapy studies, the proportion of patients at baseline meeting NCEP III criteria for MetS were 27.6% and 23.6%, respectively, for lurasidone, and 23.8% and 25.1%, respectively, for placebo; and at week 6 (LOCF) the proportion with MetS was 27.5% and 26.6%, respectively, for lurasidone and 29.9% and 20.2%, respectively, for placebo. The proportion of patients who did not meet MetS criteria at baseline but developed MetS at week 6 (LOCF) was similar for lurasidone vs. placebo in the monotherapy study (9.9% vs. 11.6%); and in the two adjunctive therapy studies (10.3% vs. 8.3%). During the 6-month OL extension study, the proportion of patients treated with lurasidone monotherapy and adjunctive therapy who did not meet MetS criteria at OL baseline but developed MetS at month 6 (LOCF) was 11.7% and 11.9%, respectively. Conversely, the proportion of patients who met MetS criteria at OL baseline, but no longer met criteria at month 6 (LOCF) was 9.5% and 7.7%, respectively. In the 20-week, OL phase of the recurrence prevention study, the proportion of patients treated with adjunctive lurasidone who did not meet MetS criteria at OL baseline but developed MetS at endpoint was 11.5% (LOCF). After up to 28 weeks of DB treatment, the proportion of patients who did not meet MetS criteria at DB baseline but developed MetS at endpoint was 9.0% in the adjunctive lurasidone group, and 10.5% in the adjunctive placebo group (LOCF).Conclusion:This post-hoc analysis found that short- and long-term treatment with lurasidone was associated with a relatively low risk for the development of metabolic syndrome in patients with bipolar I disorder. These findings are consistent with similar analyses in patients with schizophrenia.Funding Acknowledgements:Supported by funding from Sunovion Pharmaceuticals Inc.

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