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Cardiovascular Disease, Hypogonadism and Erectile Dysfunction: Early Detection, Prevention and the Positive Effects of Long-Term Testosterone Treatment: Prospective Observational, Real-Life Data.
Alwani, M, Yassin, A, Talib, R, Al-Qudimat, A, Aboumarzouk, O, Al-Zoubi, RM, Saad, F, Haider, KS, Al Ansari, A
Vascular health and risk management. 2021;:497-508
Abstract
PURPOSE Erectile dysfunction (ED) is associated with testosterone deficiency and is a symptom of functional hypogonadism. A correlation between ED and cardiovascular disease (CVD) has been recognized, and ED has been proposed as an early marker of CVD. However, the relationship between ED and CVD risk in hypogonadism requires clarification and whether testosterone therapy (TTh) can be a beneficial treatment strategy, but long-term data are limited. This study investigates long-term TTh in men with hypogonadism and ED with a history of CVD. METHODS Seventy-seven patients with a history of CVD and diagnosed with functional hypogonadism and erectile dysfunction (erectile function domain score <21 on the International Index of Erectile Function questionnaire (IIEF questions 1-5)) were enrolled and TTh effects on anthropometric and metabolic parameters investigated for a maximum duration of 12 years. All men received long-acting injections of testosterone undecanoate at 3-monthly intervals. Eight-year data were analysed. Data collection registry started in November 2004 till January 2015. RESULTS In hypogonadal men receiving TTh, IIEF increased by 5.4 (p<0.001). Total weight loss was 23.6 ± 0.6 kg after 8 years. HbA1c had declined by an average of 2.0% (P<0.0001). Total cholesterol levels significantly declined following TTh after only 1 year (P<0.0001), and HDL increased from 1.6±0.5 at baseline to 2±0.5 mmol/L following 8 years of TTh (P<0.0001). SBP decreased from 164±14 at baseline to 133±9 mmHg, signifying a reduction of 33±1 mmHg (P<0.0001). CONCLUSION In hypogonadal men with a history of CVD, TTh improves and preserves erectile function over prolonged periods with concurrent sustained improvements in cardiometabolic risk factors. Measuring ED and testosterone status may serve as an important male health indicator predicting subsequent CVD-related events and mortality and TTh may be an effective add-on treatment in secondary prevention of cardiovascular events in hypogonadal men with a history of CVD.
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Oral Anticoagulants in Atrial Fibrillation Patients With Recent Stroke Who Are Dependent on the Daily Help of Others.
Meya, L, Polymeris, AA, Schaedelin, S, Schaub, F, Altersberger, VL, Traenka, C, Thilemann, S, Wagner, B, Fladt, J, Hert, L, et al
Stroke. 2021;(11):3472-3481
Abstract
BACKGROUND AND PURPOSE Data on the effectiveness and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with stroke attributable to atrial fibrillation (AF) who were dependent on the daily help of others at hospital discharge are scarce. METHODS Based on prospectively obtained data from the observational Novel-Oral-Anticoagulants-in-Ischemic-Stroke-Patients-longterm registry from Basel, Switzerland, we compared the occurrence of the primary outcome—the composite of recurrent ischemic stroke, major bleeding, and all-cause death—among consecutive patients with AF-stroke treated with either VKAs or DOACs between patients dependent (defined as modified Rankin Scale score, 3–5) and patients independent at discharge. We used simple, adjusted, and weighted Cox proportional hazards regression to account for potential confounders. RESULTS We analyzed 801 patients (median age 80 years, 46% female), of whom 391 (49%) were dependent at discharge and 680 (85%) received DOACs. Over a total follow-up of 1216 patient-years, DOAC- compared to VKA-treated patients had a lower hazard for the composite outcome (hazard ratio [HR], 0.58 [95% CI, 0.42–0.81]), as did independent compared to dependent patients (HR, 0.54 [95% CI, 0.40–0.71]). There was no evidence that the effect of anticoagulant type (DOAC versus VKA) on the hazard for the composite outcome differed between dependent (HRdependent, 0.68 [95% CI, 0.45–1.01]) and independent patients (HRindependent, 0.44 [95% CI, 0.26–0.75]) in the simple model (Pinteraction=0.212). Adjusted (HRdependent, 0.74 [95% CI, 0.49–1.11] and HRindependent, 0.51 [95% CI, 0.30–0.87]; Pinteraction=0.284) and weighted models (HRdependent, 0.79 [95% CI, 0.48–1.31] and HRindependent, 0.46 [95% CI, 0.26–0.81]; Pinteraction=0.163) yielded concordant results. Secondary analyses focusing on the individual components of the composite outcome were consistent to the primary analyses. CONCLUSIONS The benefits of DOACs in patients with atrial fibrillation with a recent stroke were maintained among patients who were dependent on the help of others at discharge. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT03826927.
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Elevated Serum Non-HDL (High-Density Lipoprotein) Cholesterol and Triglyceride Levels as Residual Risks for Myocardial Infarction Recurrence Under Statin Treatment.
Suzuki, K, Oikawa, T, Nochioka, K, Miura, M, Kasahara, S, Sato, M, Aoyanagi, H, Shiroto, T, Takahashi, J, Miyata, S, et al
Arteriosclerosis, thrombosis, and vascular biology. 2019;(5):934-944
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Abstract
Objective- Secondary prevention for recurrent myocardial infarction (MI) is one of the most important therapeutic goals in patients with old MI (OMI). Although statins are widely used for this purpose, there remains considerable residual risk even after LDL (low-density lipoprotein cholesterol) is well controlled by statins. Approach and Results- We examined clinical impacts of nHDL (nonhigh-density lipoprotein cholesterol) and its major components triglyceride and LDL as residual risks for acute MI recurrence, using the database of our CHART (Chronic Heart Failure Analysis and Registry in the Tohoku District)-2 Study, the largest-scale cohort study of cardiovascular patients in Japan. We enrolled 1843 consecutive old MI patients treated with statins (mean age 67.3 years, male 19.2%) in the CHART-2 Study. The incidence of recurrent acute MI during the median 8.6-year follow-up was compared among the groups divided by the levels of nHDL (<100, 100-129, and ≥130 mg/dL), LDL (<70, 70-99, and ≥100 mg/dL), triglyceride (<84, 84-149, and ≥150 mg/dL), and combination of LDL and triglyceride. Kaplan-Meier curves and multiple Cox proportional hazards models showed that higher levels of nHDL, but not LDL or triglyceride alone, were associated with higher incidence of recurrent acute MI. Furthermore, higher triglyceride levels were associated with higher incidence of recurrent MI in patients with LDL <100 mg/dL but not in those with LDL ≥100 mg/dL. Conclusions- These results indicate that management of residual risks for acute MI recurrence should include nHDL management considering both LDL and triglyceride in old MI patients under statin treatment. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00418041.
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Secondary prevention of coronary heart disease in elderly population of Turkey: A subgroup analysis of ELDERTURK study.
Kilic, S, Sümerkan, MÇ, Emren, V, Bekar, L, Cersit, S, Tunc, E, Gök, G, Altuntas, E, Canpolat, U, Sinan, UY, et al
Cardiology journal. 2019;(1):13-19
Abstract
BACKGROUND Secondary prevention plays an important role after acute coronary event due to high risk of adverse events in elderly. In present study we aimed to evaluate the lifestyle, management of risk factors and medical treatment for secondary protection in elderly patients with known coronary heart disease (CHD). METHODS ELDERTURK is a non-interventional, multi-centered, observational study, which included total of 5694 elderly patients ( > 65 years) from 50 centers in Turkey. In this study elderly patients from the ELDERTURK population with known CHD were evaluated for cardiovascular risk factors, comor- bidities and medication usage. RESULTS A total of 2976 (52.3% of study) out of 5694 patients included in the ELDERTURK study were evaluated. All had known CHD with a mean age of 73.4 ± 6.2 years and 60.3% were male. 13.0% of patients were smokers, 42.4% were overweight and 21.1% were obese. Only 23.6% of patients reported to do regular exercise, 73.4% had history of hypertension, 47.4% had dyslipidemia and 33.9% had diabetes mellitus. The rate of patients with systolic blood pressure > 140 mmHg were 31.1% and only 13.9% of patients had a recommended ≤ 70 mg/dL level of low-density lipoprotein cholesterol. Anti- platelet, statin, beta-blocker and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker usage was limited to 27.3%. CONCLUSIONS The ELDERTURK study shows that many patients with CHD have a high prevalence of modifiable risk factors and unhealthy lifestyle. Apart from this, many patients are not receiving thera- peutic intervention and as a consequence most were not achieving the recommended goals.
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Effectiveness of single- vs dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study.
Neuzner, J, Hohnloser, SH, Kutyifa, V, Glikson, M, Dietze, T, Mabo, P, Vinolas, X, Kautzner, J, O'Hara, G, Lawo, T, et al
Journal of cardiovascular electrophysiology. 2019;(7):1078-1085
Abstract
INTRODUCTION Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates. METHODS AND RESULTS In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SC-coil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates. CONCLUSION In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients. Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients.
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Risk Factors Associated with Failure to Achieve the Low Density Lipoprotein Cholesterol Therapeutic Target in Patients with Acute Coronary Syndrome: A Longitudinal, Single Centre Investigation.
Hajahmadi Pourrafsanjani, M, Khayati Shal, E, Khezrpour, S
High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension. 2019;(1):37-43
Abstract
INTRODUCTION Reducing low-density lipoprotein cholesterol (LDL-C) to target < 100 mg/dL is considered as a critical therapeutic goal after acute coronary syndrome (ACS). AIM: To evaluate the factors associated with reaching or not this LDL-C target after 6 months of statin therapy. METHODS Demographic features and other clinically relevant information from a cohort of patients enrolled from April 3, 2016 through March 20, 2017 were analyzed in the current investigation. All included cases had baseline LDL-C levels ≥ 100 mg/dL. LDL-C levels were determined once again after 6-month of statin therapy for each patient. RESULTS Two hundred and thirty two participants were included in the final analysis. One third of patients (33.2%) with ACS with initially elevated LDL-C failed to attain LDL-C goal at 6 months. Spearman correlation test showed that the age, diabetes mellitus, lipid lowering therapy and statin daily dose were among the influential factors associated with LDL-C goal achievement. Furthermore, multiple logistic regression analysis revealed that diabetes mellitus and statin treatment before admission were the only independent predictors of achieving LDL-C goal. CONCLUSIONS According to our findings, the drug adherence and use of higher intensity as recommended in secondary prevention are needed to increase the achievement of LDL-C treatment targets.
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Secondary prevention of minor trauma fractures: the effects of a tailored intervention-an observational study.
van der Vet, PCR, Kusen, JQ, Rohner-Spengler, M, Link, BC, Houwert, RM, Babst, R, Henzen, C, Schmid, L, Beeres, FJP
Archives of osteoporosis. 2019;(1):44
Abstract
INTRODUCTION Minor trauma fractures (MTF) in the elderly are associated with an increase in mortality, morbidity, and the risk of subsequent fractures. Often, these patients who sustain MTF have an underlying bone disease, such as osteopenia or osteoporosis. Osteoporosis is known to be underdiagnosed and undertreated, and adequate treatment is essential to reduce the occurrence of MTFs. At our hospital, this has led to the implementation of Osteofit, a patient-education-based intervention targeted at improving screening and prevention of osteoporosis, with the goal to reduce the rate of subsequent MTF. OBJECTIVE The aim of this study was to assess the efficacy of Osteofit in improving osteoporosis screening and treatment in patients after an initial MTF episode. METHODS The study is a prospective, single-center, cohort study of MTF patients aged 50 years or older. A standardized questionnaire and telephone interview were used to collect 1-year follow-up data. The primary outcome was the rate of patients undergoing Dual X-ray Absorptiometry (DXA) scanning. Secondary outcomes were the rate of patients with a diagnosis of osteoporosis or osteopenia, the rate of patients treated with anti-osteoporotic medication, and the rate of patients with a subsequent fracture. DXA scanning rate, the prevalence of a diagnosis (osteoporosis/osteopenia), and data on medical treatment for osteoporosis were compared to the results of a previous study in the same hospital, published in 2004. RESULTS Between 2012 and 2015, 411 of 823 eligible patients consented to participate and were included in this study. The mean age was 72 ± 9.3 years. Sixty-three percent (63.3%, n = 252) of the patients received a DXA scan, compared to 12.6% reported in our previous study. Of all patients who received a DXA scan, 199 (82.9%) were diagnosed with osteoporosis or osteopenia. A total of 95 patients (23.1%) received specific medical treatment for osteoporosis and 59.8% reported the intake of any unspecific medication (vitamin D, calcium, or both). Fifteen patients (3.9%) had a subsequent fracture as a result of a minor trauma fall. CONCLUSION The implementation of a MTF secondary prevention program with dedicated health professionals improved the rate of patients who underwent DXA screening by fivefold. Despite this improvement, DXA screening was missed in over a third of patients, with only 23% of eligible patients receiving specific medical treatment for osteoporosis at 1-year follow-up. Consequently, this tailored intervention is a promising first step in improving geriatric fracture care. However, further work to improve the rate of osteoporosis screening and medical treatment initiation for the long-term prevention of subsequent MTF is recommended. We believe osteoporosis screening and adequate osteoporosis medication should be integrated as standard procedure in the aftercare of MTF. LEVEL OF EVIDENCE II.
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Lipid Testing and Statin Dosing After Acute Myocardial Infarction.
Wang, WT, Hellkamp, A, Doll, JA, Thomas, L, Navar, AM, Fonarow, GC, Julien, HM, Peterson, ED, Wang, TY
Journal of the American Heart Association. 2018;(3)
Abstract
BACKGROUND The 2013 American College of Cardiology/American Heart Association cholesterol guidelines recommend high-intensity statins for patients after myocardial infarction (MI) rather than treating to a low-density lipoprotein cholesterol goal, as the previous ATP III (Adult Treatment Panel third report) guidelines had advised. METHODS AND RESULTS To evaluate the frequency of postdischarge lipid testing and high-intensity statin use among MI patients discharged on a statin during the ATP III guidelines era, we linked ACTION (Acute Coronary Treatment and Intervention Outcomes Network) Registry data to Medicare claims for 11 046 MI patients aged ≥65 years who were discharged alive on a statin from 347 hospitals (2007-2009). Multivariable regression was used to evaluate the association between lipid testing and 1-year high-intensity statin use. Only 21% of MI patients were discharged on a high-intensity statin. By 90 days after MI, 44% of patients discharged on a statin underwent lipid testing (43% on low- or moderate-intensity statins and 49% on high-intensity statins; P=0.001). Follow-up lipid testing rates were 47% among patients with in-hospital low-density lipoprotein cholesterol ≥100 mg/dL and 47% among newly prescribed statin recipients. By 1 year, only 14% of patients were on high-intensity statins. Only 4% of patients discharged on low- or moderate-dose statin were uptitrated to high intensity; postdischarge lipid testing was associated with a slightly higher likelihood of high-intensity statin use by 1 year (5.4% versus 2.9%, adjusted odds ratio: 1.92; 95% confidence interval, 1.52-2.41). CONCLUSIONS Previous guidelines recommended low-density lipoprotein cholesterol goal-directed statin therapy, but lipid testing and high-intensity statin use were infrequent after MI. The American College of Cardiology/American Heart Association guidelines may promote more intensive cardiovascular risk reduction by eliminating treatment dependence on lipid testing.
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Safety and Effectiveness of Direct Oral Anticoagulants Versus Vitamin K Antagonists: Pilot Implementation of a Near-Real-Time Monitoring Program in Italy.
Mayer, F, Kirchmayer, U, Coletta, P, Agabiti, N, Belleudi, V, Cappai, G, Di Martino, M, Schneeweiss, S, Davoli, M, Patorno, E
Journal of the American Heart Association. 2018;(6)
Abstract
BACKGROUND Real-time monitoring is used to the ends of postmarketing observational research on newly marketed drugs. We implemented a pilot near-real-time monitoring program on the test case of oral anticoagulants. Specifically, we evaluated the safety and effectiveness of direct oral anticoagulants compared to vitamin K antagonists in nonvalvular atrial fibrillation secondary prevention during 2013-2015 in the Lazio Region, Italy. METHODS AND RESULTS A cohort study was conducted using a sequential propensity-score-matched new user parallel-cohort design. Sequential analyses were performed using Cox models. Overall, 10 742 patients contributed to the analyses. Compared with vitamin K antagonists, direct oral anticoagulant use was associated with a reduction of all-cause mortality (0.81; 95% confidence interval [CI] 0.66-0.99), cardiovascular mortality (0.71; 95% CI 0.54-0.93), myocardial infarction (0.67; 95% CI 0.43-1.04), ischemic stroke (0.87; 95% CI 0.52-1.45), hemorrhagic stroke (0.25; 95% CI 0.07-0.88), and with a nonsignificant increase of gastrointestinal bleeding (1.26; 95% CI 0.69-2.30). CONCLUSIONS The present pilot study is a cornerstone to develop real-time monitoring for new drugs in our region.
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Early occurrence of drug intolerance as risk factor during follow-up in patients with acute coronary syndrome or coronary revascularization.
Albani, S, Fabris, E, Doimo, S, Barbati, G, Perkan, A, Merlo, M, Gatti, G, Di Lenarda, A, Van't Hof, AWJ, Maras, P, et al
European heart journal. Cardiovascular pharmacotherapy. 2018;(4):195-201
Abstract
AIMS: The occurrence of drug intolerance (DI) after an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) is an important reason for quitting treatment. Nevertheless, the association between DI and major cardiac and cerebrovascular events (MACCE) is poorly reported in the literature, therefore, we analysed potential relationship between DI and MACCE (a composite of ACS, PCI, heart failure, and stroke) during follow-up. METHODS AND RESULTS From 1 January 2014 to 31 December 2015, 891 consecutive patients after ACS or coronary revascularization were referred to cardiac rehabilitation (CR) programme and included in a dedicated registry where DI was analysed and treatment appropriately tailored. Three hundred and nine patients (34.7%) developed DI, 26.9% of them were female. Angiotensin-converting enzyme (ACE) inhibitors and statins were the most frequent drugs which caused DI, followed by beta-blockers and calcium channel blockers, in 13.1%, 12.8%, 7.5%, and 5.5% of patients, respectively. During a median follow-up of 18 (interquartile range 11-24) months after CR, MACCE occurred in 14.1% of patients with DI and 8.1% without DI (P = 0.007). At multivariable model, DI to 1 drug [odds ratio (OR) 1.8, 95% confidence interval (CI) 1.01-3.18; P = 0.043] or to 2 drugs (OR 2.56, 95% CI 1.27-5.17; P = 0.008) were independently associated to MACCE. Regarding the association of specific class of prognostic drugs to MACCE, only DI to ACE-inhibitors was independently associated with MACCE (OR 2.31, 95% CI 1.14-4.65; P = 0.019). CONCLUSION DI was frequently encountered in real-world clinical practice and was significantly associated with MACCE during follow-up. This study suggests that early occurrence of DI could be considered to be an adjunctive cardiovascular risk factor during secondary prevention.