P6271The effect of semaglutide once weekly on MACE and blood pressure by race and ethnicity: SUSTAIN 6 post hoc analysis

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Desouza ◽  
S C Bain ◽  
T Gondolf ◽  
T Hansen ◽  
I Holst ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Blood Pressure ◽  
African American ◽  
Race And Ethnicity ◽  
P Value ◽  
Black African ◽  
Treatment Difference ◽  
Post Hoc Analysis ◽  
Fatal Stroke ◽  
Post Hoc

Abstract Background In SUSTAIN 6, subcutaneous semaglutide once weekly added to standard of care significantly reduced major adverse cardiovascular events (MACE: non-fatal myocardial infarction, non-fatal stroke or death) vs placebo over 2 years in T2D subjects. Purpose Assess the effect of semaglutide vs placebo on MACE and blood pressure (BP) by race and ethnicity in a post hoc analysis of SUSTAIN 6. Methods Subjects were randomised to semaglutide 0.5 mg, 1.0 mg or volume-matched placebo. Data for the two semaglutide-dose groups were pooled and compared to the pooled placebo groups. Time-to-event data were analysed with a Cox proportional hazards model. Changes from baseline to week 104 were analysed using analysis of covariance. The interaction between treatment and subgroup was added to the models. Results Overall, 3,297 patients received treatment. Subgroups included Caucasian, Asian, Black/African American, Other (race), and Hispanic, non-Hispanic (ethnicity). Mean baseline characteristics were similar across subgroups (age 64.7 years, HbA1c 8.7%, diabetes duration 14.2 years). Time to composite MACE and individual components were improved with semaglutide across all subgroups. Semaglutide affected BP similarly across race and ethnicity, except for systolic BP in Black/African American subjects (Table). Race Ethnicity Caucasian Asian Black/African American Other Interaction p-value Hispanic Non-Hispanic Interaction p-value Semaglutide (n) 1,384 121 108 35 256 1,392 Placebo (n) 1,352 152 113 32 254 1,395 MACE and individual outcomes   MACE HR [95% CI] 0.76 [0.58; 1.00] 0.58 [0.25; 1.34] 0.72 [0.23; 2.28] 0.46 [0.08; 2.50] 0.8793 0.67 [0.33; 1.36] 0.74 [0.57; 0.96] 0.7978   CV death HR [95% CI] 0.98 [0.63; 1.50] 0.32 [0.04; 2.85] 1.01 [0.06; 16.20] n/a† 0.8089 0.79 [0.31; 2.00] 1.00 [0.63; 1.59] 0.6521   Non-fatal MI HR [95% CI] 0.69 [0.45; 1.07] 0.97 [0.36; 2.60] 1.37 [0.31; 6.12] 0.31 [0.03; 3.00] 0.6637 0.65 [0.18; 2.31] 0.74 [0.50; 1.10] 0.8562   Non-fatal stroke HR [95% CI] 0.70 [0.42; 1.16] 0.31 [0.04; 2.77] n/a‡ n/a‡ 0.9176 0.73 [0.16; 3.27] 0.60 [0.36; 0.99] 0.7995 Blood pressure at week 104   Systolic BP* ETD (mmHg) [95% CI] −1.92 [−3.09; −0.74] −4.98 [−8.61; 1.35] 4.47 [0.15; 8.79] −11.02 [−18.45; −3.60] 0.0008 −3.22 [−5.93; −0.51] −1.81 [−2.98; −0.64] 0.3489   Diastolic BP* ETD (mmHg) [95% CI] 0.36 [−0.32; 1.04] −1.31 [−3.43; 0.80] −0.07 [−2.56; 2.43] −3.41 [−7.73; 0.92] 0.1871 −0.18 [−1.75; 1.39] 0.16 [−0.52; 0.83] 0.6981 *Treatment difference between semaglutide and placebo (pooled 0.5 and 1.0 mg values for each treatment group) at week 104. †No events in the placebo group; ‡No events in the semaglutide group. BP, blood pressure; CI, confidence interval; ETD, estimated treatment difference; HR, hazard ratio; MACE, major adverse cardiovascular event; MI, myocardial infarction. Conclusion Overall there was no evidence of a differential effect of semaglutide on risk reduction in MACE and its components and on BP across race and ethnicity subgroups in this post hoc analysis. Acknowledgement/Funding Novo Nordisk A/S

scholarly journals 563 The Effect of Once-Weekly Semaglutide on MACE and Blood Pressure by Race and Ethnicity: SUSTAIN 6 Post Hoc Analysis

2020 ◽  
Vol 29 ◽  
pp. S291
Author(s):  
T. Davis ◽  
C. Desouza ◽  
S. Bain ◽  
T. Gondolf ◽  
T. Hansen ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Race And Ethnicity ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Treatment effect of oil-based contrast is related to experienced pain at HSG: a post-hoc analysis of the randomised H2Oil study

2019 ◽  
Vol 34 (12) ◽  
pp. 2391-2398 ◽  
Author(s):  
N van Welie ◽  
K Dreyer ◽  
J van Rijswijk ◽  
H R Verhoeve ◽  
M Goddijn ◽  
...  
Keyword(s):  
Underlying Mechanism ◽  
Pregnancy Rates ◽  
P Value ◽  
Ongoing Pregnancy ◽  
Research Grants ◽  
Enhancing Effect ◽  
Post Hoc Analysis ◽  
Infertile Women ◽  
Water Based ◽  
Post Hoc

Abstract STUDY QUESTION Does pain or volume of used contrast medium impact the effectiveness of oil-based contrast during hysterosalpingography (HSG)? SUMMARY ANSWER In women who report moderate to severe pain during HSG, the use of oil-based contrast resulted in more ongoing pregnancies compared to the use of water-based contrast, whereas in women who reported mild or no pain, no difference in ongoing pregnancies was found. WHAT IS KNOWN ALREADY We recently showed that in infertile women undergoing HSG, the use of oil-based contrast results in more ongoing pregnancies within 6 months as compared to the use of water-based contrast. However, the underlying mechanism of this fertility-enhancing effect remains unclear. STUDY DESIGN, SIZE, DURATION We performed a post-hoc analysis of the H2Oil study, a multicentre randomised controlled trial (RCT) evaluating the therapeutic effect of oil- and water-based contrast at HSG. Here, we evaluated the impact of pain experienced at HSG and volume of used contrast media during HSG on ongoing pregnancy. PARTICIPANTS/MATERIALS, SETTING, METHODS In a subset of 400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0–10.0 cm) was reported, while in 512 women, we registered the volume of used contrast (in millilitres). We used logistic regression analyses to assess whether pain and volume of used contrast media modified the effect of oil-based contrast on ongoing pregnancy rates. Data were analysed according to intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE In 400 women in whom pain scores were reported, the overall median pain score was 5.0 (Interquartile range (IQR) 3.0–6.8) (oil group (n = 199) 4.8 (IQR 3.0–6.4); water group (n = 201) 5.0 (IQR 3.0–6.7); P-value 0.28). There was a significant interaction between pain (VAS ≤5 versus VAS ≥6) and the primary outcome ongoing pregnancy (P-value 0.047). In women experiencing pain (VAS ≥6), HSG with oil-based contrast resulted in better 6-month ongoing pregnancy rates compared to HSG with water-based contrast (49.4% versus 29.6%; RR 1.7; 95% CI, 1.1–2.5), while in women with a pain score ≤5, 6-month ongoing pregnancy rates were not significantly different between the use of oil- (28.8%) versus water-based contrast (29.2%) (RR 0.99; 95% CI, 0.66–1.5). In the 512 women in whom we recorded contrast, median volume was 9.0 ml (IQR 5.7–15.0) in the oil group versus 8.0 ml (IQR 5.9–13.0) in the water group, respectively (P-value 0.72). Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23). LIMITATIONS, REASONS FOR CAUTION This was a post-hoc analysis that should be considered as hypothesis generating. The RCT was restricted to infertile ovulatory women, younger than 39 years of age and with a low risk for tubal pathology. Therefore, our results should not be generalised to infertile women who do not share these features. WIDER IMPLICATIONS OF THE FINDINGS The underlying mechanism of the fertility-enhancing effect induced by HSG with the use of oil-based contrast remains unclear. However, these findings suggest a possible mechanistic pathway, that is increasing intrauterine pressure occurring prior to dislodging pregnancy hindering debris or mucus plugs from the proximal part of otherwise normal fallopian tubes. This information might help in the search of the underlying fertility-enhancing mechanism found by using oil-based contrast during HSG. STUDY FUNDING/COMPETING INTEREST(S) The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports consultancy for Guerbet. H.V. reports consultancy fees from Ferring. C.B.L. reports speakers’ fees from Ferring and research grants from Ferring, Merck and Guerbet. V.M. reports receiving travel and speakers fees as well as research grants from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflict of interests. TRIAL REGISTRATION NUMBER The H2Oil study was registered at the Netherlands Trial Registry (NTR 3270). TRIAL REGISTRATION DATE 1 February 2012. DATE OF FIRST PATIENT’S ENROLMENT 3 February 2012.

scholarly journals Relative hyperglycemia is associated with complications following an acute myocardial infarction: a post-hoc analysis of HI-5 data

2017 ◽  
Vol 16 (1) ◽  
Author(s):  
Tien F. Lee ◽  
Morton G. Burt ◽  
Leonie K. Heilbronn ◽  
Arduino A. Mangoni ◽  
Vincent W. Wong ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract P181: Cardiac Structure is Associated with Obesity and Blood Pressure But Not Inflammation

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Robert A Palermo ◽  
Samuel S Gidding ◽  
Stehpanie S DeLoach ◽  
Scott W Keith ◽  
Bonita Falkner
Keyword(s):  
Blood Pressure ◽  
African American ◽  
Left Ventricular Mass Index ◽  
African American Adolescents ◽  
Female Gender ◽  
Left Ventricular ◽  
P Value ◽  
Cardiac Structure ◽  
Z Score ◽  
Pai 1

Purpose: The aim of this study was to identify risk factors associated with cardiac structure in a cohort of African American adolescents oversampled for obesity and high blood pressure (BP). Additional associations of cardiac structure with a pro-inflammatory adipokine profile (low adiponectin, elevated IL6, PAI-1 and CRP) were sought. Methods: A cross-sectional study was conducted using a two-by-two factorial design with four groups of African American adolescents based on BP (prehypertension or stage 1 hypertension=high BP) and body mass index (BMI > 95% =obese) designation. Measurements included: echocardiogram, anthropomorphics, BP (on 3 separate occasions), high sensitivity CRP and plasma adipokines (adiponectin, IL6, PAI-1). Standardized echocardiogram measurements were used to obtain left ventricular mass index (LVMI, g/m 2.7 ) and left atrial diameter index (LADI, mm/m 2 ). Ordinary least-squares regression with model selection by Mallow's Cp was used to determine if pro-inflammatory adipokine profile predicted LV mass and LA diameter in models including age, gender, BMI z-score, and systolic BP. Results: Data on 251 African American adolescents, ages 13-19, were analyzed. BMI-z score was strongly associated with a pro-inflammatory adipokine profile whereas high BP was not. Variation in LADI was significantly associated with BMI (β=0.12, p<0.01) and female gender (β=0.08, p=0.04). LVMI variation was significantly associated with BMI (β=3.53, p<0.01), age (β=0.71, p<0.01), female gender (β=-4.32, p<0.01), and systolic BP (β=0.10, p=0.03). Though significant in univariate models, inflammatory markers were not significantly associated with LADI or LVMI after BMI adjustment. Conclusions: In African American adolescents, BMI is an important determinant of LADI and LVMI. Obesity is associated with a pro-inflammatory adipokine profile but LADI and LVMI are not. Table. Regression modeling results after variable selection by Mallow C p : Left Atrium Diameter Index and Left Ventricular Mass Index (N = 251) LADI LVMI Estimate (95% CL) p-value Estimate (95% CL) p-value Age (yr) 0.00063 (-0.021, 0.023) 0.955 0.71 ( 0.18, 1.24) 0.009 Gender (F) 0.08 ( 0.01, 0.16) 0.036 −4.32 (-6.13,-2.51) <.001 BMI z-score 0.12 ( 0.08, 0.16) <.001 3.53 ( 2.66, 4.40) <.001 Systolic BP 0.0019 (-0.0017, 0.0055) 0.306 0.0952 ( 0.0085, 0.1819) 0.032

scholarly journals Additive beneficial effects of beta blockers in the prevention of symptomatic heart failure

2016 ◽  
Vol 72 (1) ◽  
Author(s):  
Alberto Genovesi Ebert ◽  
Furio Colivicchi ◽  
Marco Malvezzi Caracciolo ◽  
Carmine Riccio
Keyword(s):  
Myocardial Infarction ◽  
Heart Failure ◽  
Heart Disease ◽  
Beta Blockers ◽  
Structural Heart Disease ◽  
Symptomatic Heart Failure ◽  
Post Hoc Analysis ◽  
Lv Dysfunction ◽  
History Of ◽  
Post Hoc

The prevention of symptomatic heart failure represents the treatment of patients in the A and B stages of AHA/ACC heart failure classification. Stage A refers to patients without structural heart disease but at risk to develop chronic heart failure. The major risk factors in stage A are hypertension, diabetes, atherosclerosis, family history of coronary artery disease and history of cardiotoxic drug use. In this stage, blockers hypertension is the primary area in which beta blockers may be useful. Beta blockers seem not to be superior to other medication in reducing the development of heart failure due to hypertension. Stage B heart failure refers to structural heart disease but without symptoms of heart failure. This includes patients with asymptomatic valvular disease, asymptomatic left ventricular (LV) dysfunction, previous myocardial infarction with or without LV dysfunction. In asymptomatic valvular disease no data are available on the efficacy of beta blockers to prevent heart failure. In asymptomatic LV dysfunction only few asymptomatic patients have been enrolled in the trials which tested beta blockers. NYHA I patients were barely 228 in the MDC, MERIT and ANZ trials altogether. The REVERT trial was the only trial focusing on NYHA I patients with LV ejection fraction less than 40%. Metoprolol extended release on top of ACE inhibitors ameliorated LV systolic volume and ejection fraction. A post hoc analysis of the SOLVD Prevention trial demonstrated that beta blockers reduced death and development of heart failure. Similar results were reported in post MI patients in a post hoc analysis of the SAVE trial (Asymptomatic LV failure post myocardial infarction). In the CAPRICORN trial about 65% of the patients were not taking diuretics and then could be considered asymptomatic. The study revealed a reduction in mortality and a non-significant trend toward reduction of death and hospital admission for heart failure. Conclusions: beta blockers are not specifically indicated in stage A heart failure. On the contrary, in most of the stage B patients, and particularly after MI, beta blockers are indicated to reduce mortality and, probably, also the progression toward symptomatic heart failure.

scholarly journals 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

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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