scholarly journals Gender Differences in Self-Reported Symptoms of Depression among Patients with Acute Coronary Syndrome

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Lorraine Frazier ◽  
Erica Yu ◽  
Jennifer Sanner ◽  
Fang Liu ◽  
Malini Udtha ◽  
...  
Keyword(s):  
Gender Differences ◽  
Acute Coronary Syndrome ◽  
Depressive Symptoms ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Chi Square ◽  
Convenience Sample ◽  
Coronary Syndrome ◽  
Symptoms Of Depression ◽  
The Impact

This study examined the prevalence of self-reported depressive symptoms and the self reported somatic depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) among patients hospitalized for acute coronary syndrome (ACS), and explored the impact of gender on both. A convenience sample of 789 adults (248 women and 541 men) was recruited for the study during hospital admission for ACS and participants were screened for self-reported depressive symptoms. BDI-II scores of ≥14 indicate a moderate level of depressive symptoms and this cut-off score was used to categorize patients into depressed and non-depressed groups. Pearson chi-square tests for independence (categorical variables) andttests for independent samples (continuous variables) were used for gender comparisons. Results showed that depressive symptoms during ACS episodes were different between women and men. Women reported greater overall depressive symptoms (BDI-II mean = 11.89, S.D. = 9.68) than men (BDI-II mean = 9.00, S.D. = 7.93) (P<0.000). Significantly more women (7.66%) were identified positive for somatic depressive symptoms (sleep and appetite disturbances and fatigue) than men (2.22%) (P=0.0003). Findings support that there are gender differences in depressive symptoms experienced by patients hospitalized for ACS. Somatic symptoms of depression may be important indicators of depression especially among female ACS patients.

scholarly journals 350. Neurocysticercosis – Gender Differences in Clinical Presentations

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S244-S244
Author(s):  
Bharath Pendyala ◽  
Prasanth Lingamaneni ◽  
Patricia DeMarais ◽  
Lakshmi Warrior ◽  
Gregory Huhn
Keyword(s):  
Gender Differences ◽  
Categorical Variables ◽  
Public Health Issue ◽  
Diagnostic Code ◽  
Continuous Variables ◽  
Chi Square ◽  
Generalized Seizures ◽  
Icd 10 ◽  
Chi Square Test ◽  
Reported Data

Abstract Background Neurocysticercosis is a Neglected Tropical Disease and an important public health issue. Our goal was to collect and analyze data regarding clinically significant gender differences among our Neurocysticercosis patients. Methods A retrospective chart search with ICD 9/ ICD 10 diagnostic code for Neurocysticercosis and neuroimaging suggestive of Neurocysticercosis was performed for clinical encounters in the hospital or affiliated clinics between years 2013–2018. After a careful chart review, patients who were clinically diagnosed with Neurocysticercosis were included in the study. T-test was used to compare means of continuous variables and chi-square test to compare proportions of categorical variables. Results Among 90 total patients included, male (49.4%) and female (50.6%) distribution were nearly identical. The mean age in females was found to be higher than males (52.5 vs 42.0, P &lt; 0.0001). Almost an equal number of males and females presented with either seizures (63.6% vs 57.8%, P= 0.85), headaches (25.0% vs 28.9%, p= 0.85), or other symptoms (11.4% vs 13.3%, p= 0.85). Males had more generalized seizures compared to females (60% vs 38%, P= 0.37), although this result was not statistically significant. Females were more likely to present with &gt; 1 lesion (82.2% vs 56.8%, P= 0.01). Males were more likely to have cystic lesions (64.7% vs 27.9%, P &lt; 0.001) compared to females who had more calcified lesions on presentation (65.1% vs 20.6%, P &lt; 0.001). Male patients were more likely to have contrast enhancement or edema surrounding the lesions (61.4% vs 33.3%, P= 0.01) and were more likely to require treatment with Albendazole/Praziquantel (75.8% vs 31.7%, P &lt; 0.001). Conclusion Although previously reported data is limited, there is a suggestion that there are gender differences in host immune response and that inflammation surrounding parenchymal lesions is more intense in females. This study suggests that men either present early in the disease phase or have different immune responses than women and require anti-parasitic therapy more frequently. More research in this aspect is needed. Disclosures All Authors: No reported disclosures

Anticoagulation in cancer patients in hospice

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20509-e20509
Author(s):  
H. M. Holmes ◽  
K. T. Bain ◽  
R. Luo ◽  
A. Zalpour ◽  
E. Bruera ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Patient Characteristics ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Length Of Service ◽  
Chi Square ◽  
Patients With Cancer ◽  
Hospice Patients ◽  
The Mean ◽  
The Impact

e20509 Background: Low-molecular weight heparin (LMWH) is preferred over warfarin in patients with thromboembolic disease and active cancer, but no guidelines exist in hospice. Although warfarin may be less safe in hospice patients, hospices may prefer to provide warfarin due to lower cost and less invasiveness compared to LMWHs. We sought to identify disparities in the use of warfarin vs. LMWHs in cancer patients enrolled in hospice. Methods: We analyzed a dataset from a national pharmacy provider for more than 800 hospices. We identified patients with a terminal diagnosis of cancer who were enrolled and died in hospice in 2006 and who were prescribed warfarin or LMWH. Patient characteristics included age, gender, race, cancer diagnosis, length of hospice service, and number of comorbidities. For descriptive comparisons, the Kruskal-Wallis test was used for continuous variables, and the Chi-square test was used for categorical variables. Results: Of 54,764 patients with cancer admitted and deceased in 2006, 3874 (7.1%) were prescribed warfarin, and 1137 (2.1%) were prescribed LMWH. Patients prescribed warfarin (n=576) or enoxaparin (n=5) for treatment of atrial arrhythmias were excluded. The mean age was 70.6 years for warfarin and 64.8 years for LMWH (p<0.0001). The mean and median lengths of service, respectively, were 43.6 days and 23.0 days for warfarin and 35.0 and 18.0 days for LMWH, (p<0.0001). There were no differences for gender, and a higher proportion of white patients were prescribed warfarin. Patients prescribed warfarin had an average of 2.1 comorbid conditions, versus 1.6 conditions for LMWH (p<0.0001). Cancer diagnoses were significantly different between the two groups, with a higher proportion of patients with lung and prostate cancer taking warfarin. Conclusions: Patients prescribed warfarin were older, had more comorbidities, and a longer length of service than patients prescribed LMWHs. Further research is needed to determine the impact of anticoagulation on outcomes, especially cost and quality of life, for cancer patients in hospice. This study raises the need to establish guidelines for the appropriateness of anticoagulation in hospice patients with cancer. No significant financial relationships to disclose.

MO513CLINICAL AND ECONOMIC BURDEN OF FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) IN THE UNITED STATES: A RETROSPECTIVE, OBSERVATIONAL COHORT STUDY

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Kam Kalantar-Zadeh ◽  
Christine Baker ◽  
J Brian Copley ◽  
Daniel Levy ◽  
Stephen Berasi ◽  
...  
Keyword(s):  
Economic Burden ◽  
Medical Costs ◽  
The United States ◽  
Treatment Modalities ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Chi Square ◽  
Prescription Costs ◽  
The Impact ◽  
Nephrotic Range Proteinuria

Abstract Background and Aims The burden of disease associated with FSGS has not been well characterized, especially with regard to health care resource utilization (HCRU) and related costs. The aim of this study was to evaluate all-cause HCRU and estimate associated costs in patients with FSGS compared with a matched non-FSGS cohort; a secondary aim was to evaluate the impact of nephrotic range proteinuria on these outcomes. Method Data were from the Optum Clinformatics® Data Mart Database. Patients with ≥ 1 claim (1st claim = index event) for FSGS between April 2016 and December 2018 were identified based on ICD-10-CM codes and matched 1:2 (FSGS:controls) on index date, age, sex, and race to non-FSGS controls; continuous enrollment 6 months pre- and 12 months post-index was required. FSGS nephrotic range (either UPCR &gt;3000 mg/g or ACR &gt;2000 mg/g) and non-nephrotic subpopulations were also identified. Quan-Charlson Comorbidity Index (CCI) and individual comorbidities at baseline, and 12-month post-index all-cause HCRU and associated costs (per patient per year [PPPY]) as well as medication prescriptions related to FSGS treatment were compared between the matched cohorts and between the FSGS subpopulations; t-tests were used for continuous variables and chi-square tests for categorical variables. Results 844 patients with FSGS were matched with 1688 non-FSGS controls; 57.4% male, 56.9% white, mean (SD) age 54.7 (18.4) years. Mean (SD) CCI was higher in the FSGS cohort relative to matched controls (2.72 [2.12] vs 0.55 [1.29]; P &lt; .0001), with prevalence of most individual comorbidities higher in the FSGS cohort. Only 308 FSGS patients (36.5%) had UPCR or ACR tests with available results during the review period; 112 (36.4%) were in the nephrotic range and 196 were non- nephrotic (63.6%). The FSGS cohort was characterized by higher rates of all-cause HCRU across resource categories (all P &lt; .0001) (Table 1); outpatient visits was the most frequently used category (99.1% vs 69.0%), followed by prescription medications. Among patients who used these resources, units of use were significantly higher in FSGS vs matched controls except for length of stay (Table 1). Readmission rates following 1st post-index hospitalization were higher in the FSGS cohort vs matched controls at 30 days (16.1% vs 6.0%; P &lt; .05) and 365 days (39.1% vs 22.9%; P &lt; .05). Glucocorticoids were the most frequently prescribed FSGS-related medication in both cohorts, with a higher rate in FSGS vs matched controls (50.6% vs 23.3%; P &lt; .0001); other FSGS-related medications were infrequently prescribed (&lt; 14%). Inpatient, outpatient, and prescription costs were higher in the FSGS cohort vs matched controls (all P &lt; .0001) resulting in mean total annual medical costs of $59,753 vs $8,431 PPPY (P &lt; .0001) that were driven by outpatient costs (Fig. 1A). Nephrotic range proteinuria was associated with higher all-cause inpatient, outpatient, and prescription costs vs non-nephrotic patients (all P &lt; .0001; Fig. 1B), resulting in higher total costs ($70,481 vs $36,099 PPPY; P &lt; .0001). A higher proportion of nephrotic range patients were prescribed FSGS-modifying medications (73.2% vs 54.1%; P = 0.001), with glucocorticoids the most frequent medication. However, 26.8% of nephrotic range patients were not prescribed any FSGS-related medications. Conclusion FSGS is associated with significant clinical and economic burdens with total annual medical costs &gt; 7-fold higher than matched controls that were driven by outpatient costs. The presence of nephrotic range proteinuria substantially and significantly increased the economic burden. New treatment modalities leading to lower rates of proteinuria may help improve patient outcomes while reducing HCRU and their associated costs.

scholarly journals Identification of warning signs for prevention of in-hospital cardiorespiratory arrest

2019 ◽  
Vol 27 ◽  
Author(s):  
Beatriz Tessorolo Souza ◽  
Maria Carolina Barbosa Teixeira Lopes ◽  
Meiry Fernanda Pinto Okuno ◽  
Ruth Ester Assayag Batista ◽  
Aécio Flávio Teixeira de Góis ◽  
...  
Keyword(s):  
Heart Rate ◽  
Acute Coronary Syndrome ◽  
Respiratory Rate ◽  
Vital Signs ◽  
Warning Signs ◽  
Categorical Variables ◽  
P Value ◽  
Continuous Variables ◽  
Cardiorespiratory Arrest ◽  
Coronary Syndrome

ABSTRACT Objective: to identify the occurrence of warning signs and changes in vital signs in individuals who experienced in-hospital cardiorespiratory arrest and correlate them with the occurrence of this event. Method: this is a retrospective, analytical and quantitative study that included 218 medical records of patients who suffered in-hospital cardiorespiratory arrest and identified warning signs and alterations in vital signs. Mean, standard deviation, median, minimum and maximum values were calculated for the continuous variables, and frequency and percentage for the categorical variables. We compared the age and occurrence of cardiorespiratory arrest with the occurrence of warning signs using the Chi-Square Test and the Mann Whitney non-parametric test (p-value < 0.05). Results: 62.1% of the patients presented signs and symptoms of shock, 44.9% of neurological alteration, 40.4% of malaise, 15.2% presented signs suggestive of acute coronary syndrome, and 25.9% presented mental confusion. In the last measurement of vital signs before cardiorespiratory arrest, the majority of patients had altered abnormal (32.6%) and severely abnormal (23.9%) heart rate, and abnormal (37.1%) and severely abnormal (27.0%) respiratory rate. Conclusion: the warning signs identified were: shock, neurological signs, malaise and acute coronary syndrome. The prevalent changes in vital signs were: heart rate, respiratory rate and O2 saturation. Patients with severely abnormal systolic blood pressure were not discharged and those with abnormal respiratory rate did not survive 6 months after cardiorespiratory arrest.

65 Clinical depression among post- acute coronary syndrome patients: A prospective single tertiary centre analysis

2020 ◽  
Vol 41 (Supplement_1) ◽  
Author(s):  
L Leong ◽  
A S Mahmood Zuhdi ◽  
M I Abdul Hafidz
Keyword(s):  
Acute Coronary Syndrome ◽  
Associated Factors ◽  
Severe Depression ◽  
Clinical Depression ◽  
Phone Call ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Dialysis Patients ◽  
Post Discharge ◽  
Coronary Syndrome

Abstract Background Clinical depression is a known consequence of acute coronary syndrome (ACS). It is also known to carry an adverse outcome among these patients. Despite the availability of validated tools for screening of depression in acute coronary syndrome patients, depression is still significantly under-recognized and undertreated in patients with acute coronary syndrome. Purpose To investigate the prevalence of depression in post-ACS patients and the factors associated with it. Methods Prospective cohort study conducted on 95 ACS patients (26 female, 69 male) admitted to our cardiology ward University. Data collected with consent from patients through electronic medical record and Patient Health Questionnaire (PHQ-9), Medical Adherence Questionnaire(MAQ). Depression outcome at 30-day was obtained from hospital records and via phone call to the patient. Data analyzed using SPSS 24.0. Chi-square test was used for comparison of categorical variables and independent t-test and Mann-Whitney U tests were used for comparison of continuous variables. Binary logistic regression was used to determine the independent associated factors for depression after adjusted with significant demographic variables and clinical characteristics. The strength of this association was presented in odds ratio (OR) and 95% confidence interval (CI). The significance level adopted was 0.05. Results Mean age of the study population is 60 years old. 72.6% were male and 27.4% female. Symptoms of depression (mild to severe) were present in 88.4% of patients at baseline. Among the depressed patients, 22.6% of the cases were found to have for severe depression, 14.3% moderately-severe depressed, 15.5% moderately depressed, 27.4% for mildly depressed and 20.2% for minimally depressed. Depression at 30-day post discharge is more likely in women, diabetics and dialysis patients (p= 0.024, p &lt; 0.001, p= 0.008 respectively). There was no difference in depression among ethnicity. Patients with baseline moderate to severe depression are more likely to have moderate to severe depression at 30 days (p &lt; 0.001). Patients with low adherence to medications at 30 days reported moderate to severe depression at 30 days (p = 0.007). Baseline depression is the strongest predictor of 30-days depression. An increase in one unit of PHQ-9 baseline score increases the risk of developing severe depression after 30 days by 29%. There is no difference in terms of mortality between patients with significant depression and those without. Conclusions Clinical depression is prevalent in our post-ACS patients. Associated factors are female gender, diabetics and dialysis patients. Depression at baseline predicts clinical depression at 30-days post discharge and is associated with low adherence to their medications. Thus we should actively screen for depression among ACS patients in order to administer appropriate treatment.

scholarly journals 49 A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
S Sadiq ◽  
M Tahir ◽  
I Nur ◽  
S Elerian ◽  
A Malik
Keyword(s):  
Categorical Variables ◽  
Next Of Kin ◽  
Chi Square ◽  
Neck Of Femur ◽  
Improvement Project ◽  
Handover Process ◽  
Neck Of Femur Fracture ◽  
The Impact ◽  
Standard Operating Protocol

Abstract Introduction Poor handover between shifts can result in patient harm. This study was designed to evaluate the impact of implementing a handover protocol on the quality of information exchanged in the trauma handover meetings in a UK hospital. Method A prospective single-centre observational study was performed at an NHS Trust. Ten consecutive weekday trauma meetings, involving 43 patients, were observed to identify poor practices in handover. This data was used in conjunction with the Royal College of Surgeons’ recommendations for effective handover (2007) to create and implement a standard operating protocol (SOP). Following its implementation, a further 8 consecutive meetings, involving a further 47 patients, were observed. The data was analysed using t-test for quantitative variables and chi-square or Fisher’s exact tests for categorical variables. Results An improvement was demonstrated in multiple aspects of trauma handover including past medical history, injury date, results, diagnosis, consent, mark, and starvation status (all p &lt; 0.001). Subgroup analyses showed that handover of neck-of-femur fracture patients including information on baseline mobility (p = 0.04), Nottingham-Hip-Fracture Score (p = 0.01), next-of-kin discussion (p = 0.075) and resuscitation status (p = 0.001) all improved following the intervention. Conclusions These results demonstrate that the implementation of a well-structured handover protocol can improve the transmission of critical information in trauma meetings.

scholarly journals Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

2021 ◽  
Vol 8 (1) ◽  
pp. e000840
Author(s):  
Lianne Parkin ◽  
Sheila Williams ◽  
David Barson ◽  
Katrina Sharples ◽  
Simon Horsburgh ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Clinical Practice ◽  
Real World ◽  
Chronic Obstructive ◽  
Treatment Intensification ◽  
Cardiovascular Comorbidity ◽  
Coronary Syndrome ◽  
Long Acting ◽  
The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

scholarly journals Relationship of Hydroxychloroquine and Ophthalmic Complications in Patients with Type 2 Diabetes in Taiwan

2021 ◽  
Vol 18 (15) ◽  
pp. 8154
Author(s):  
Hung-Chih Chen ◽  
Hung-Yu Lin ◽  
Michael Chia-Yen Chou ◽  
Yu-Hsun Wang ◽  
Pui-Ying Leong ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Conditional Logistic Regression ◽  
Categorical Variables ◽  
Control Group ◽  
Case Group ◽  
Research Database ◽  
Continuous Variables ◽  
Chi Square ◽  
Increased Risk

The purpose of this study is to evaluate the relationship between hydroxychloroquine (HCQ) and diabetic retinopathy (DR) via the national health insurance research database (NHIRD) of Taiwan. All patients with newly diagnosed type 2 diabetes (n = 47,353) in the NHIRD (2000–2012) were enrolled in the study. The case group consists of participants with diabetic ophthalmic complications; 1:1 matching by age (±1 year old), sex, and diagnosis year of diabetes was used to provide an index date for the control group that corresponded to the case group (n = 5550). Chi-square test for categorical variables and Student’s t-test for continuous variables were used. Conditional logistic regression was performed to estimate the adjusted odds ratio (aOR) of DR. The total number of HCQ user was 99 patients (1.8%) in the case group and 93 patients (1.7%) in the control group. Patients with hypertension (aOR = 1.21, 95% CI = 1.11–1.31) and hyperlipidemia (aOR = 1.65, 95% CI = 1.52–1.79) significantly increased the risk of diabetic ophthalmic complications (p < 0.001). Conversely, the use of HCQ and the presence of rheumatoid diseases did not show any significance in increased risk of DR. HCQ prescription can improve systemic glycemic profile, but it does not decrease the risk of diabetic ophthalmic complications.

scholarly journals Immediate versus staged revascularisation in multivessel coronary disease: an updated meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Von Renteln ◽  
S Hassan ◽  
K Szummer ◽  
R Edfors ◽  
D Venetsanos ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Coronary Disease ◽  
Controlled Trial ◽  
Interventional Treatment ◽  
Index Hospitalisation ◽  
Coronary Syndrome ◽  
Coronary Interventions ◽  
Baseline Characteristics ◽  
Meta Regression ◽  
The Impact

Abstract Background Percutaneous coronary interventions (PCIs) are often aimed at the culprit vessel in acute coronary syndromes (ACSs) followed by revascularisation of other stenoses later in the index hospitalisation or shortly after discharge. PCI delay of non-culprit coronary vessels stenoses is supported by lower contrast fluid use and thrombocyte aggregation. Distinct coronary interventions increase the risk of both non- and coronary artery complications, e.g. acute abdominal and periphery artery bleeding, suggesting undertaking all PCIs at the same time. Purpose To assess the effect on mortality and re-myocardial infarction (MI) of immediate versus staged revascularisation in multivessel coronary disease, with the latter constrained to initial PCI of the culprit coronary vessel. Methods The syntax of “randomised controlled trial (RCT) & acute coronary syndrome & complete revascularisation” was undertaken in PubMed. Clinical characteristics were gathered at the index hospitalisation. The intervention scenario was acute coronary syndrome or not. Meta-analyses calculated relative risk (RR) reductions on outcomes of 1) mortality and 2) re-MI. Meta-regression assessed linear difference between interventional treatment benefits and baseline characteristics. Results A total of 148 studies was found. Of those, 8 was found eligible for further analyses and their baseline characteristics are shown in Table 1. Comparison of immediate versus staged revascularisation on mortality was nonsignificant (RR, 1.19; 95% CI: 0.78–1.81, p=0.43) (Figure 1). The impact of Immediate vs staged revascularisation on re-MI was also nonsignificant (RR, 0.83; 95% CI: 0.44–1.55, p=0.56). Meta-regression found no associations between the outcomes and study characteristics (not shown). Conclusion The intervention of immediate compared to staged revascularisation assessed on outcomes of all-cause mortality and re-MI were nonsignificant. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Impact of timing of randomization after an acute coronary syndrome and subsequent events in patients with type 2 diabetes mellitus: an analysis of the EXAMINE trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Elharram ◽  
A Sharma ◽  
W White ◽  
G Bakris ◽  
P Rossignol ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Type 2 Diabetes Mellitus ◽  
Acute Coronary Syndrome ◽  
Primary Outcome ◽  
Funding Source ◽  
Coronary Syndrome ◽  
The Impact

Abstract Background The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes. Methods EXAMINE was a randomized trial of alogliptin versus placebo in 5380 patients with T2DM and a recent ACS. The primary outcome was a composite of CV death, non-fatal myocardial infarction [MI], or non-fatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8–34, 35–56, and 57–141 days. Results Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs. 33.0%), prior coronary artery bypass graft (9.6% vs. 15.9%), or atrial fibrillation (5.9% vs. 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio [aHR] 1.47; 95% CI 1.21–1.74) (Figure 1). Similarly, patients randomized early had an increased risk of recurrent MI (aHR 1.51; 95% CI 1.17–1.96) and HF hospitalization (1.49; 95% CI 1.05–2.10). Conclusion In a contemporary cohort of T2DM with a recent ACS, early randomization following the ACS increases the risk of CV events including recurrent MI and HF hospitalization. This should be taken into account when designing future clinical trials. Figure 1 Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Takeda Pharmaceutical

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