| 1. |
- Alehagen, Urban, et al.
(författare)
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Natriuretic Peptide Biomarkers as Information Indicators in Elderly Patients With Possible Heart Failure Followed Over Six Years : A Head-to-Head Comparison of Four Cardiac Natriuretic Peptides
- 2007
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Ingår i: Journal of Cardiac Failure. - : Elsevier BV. - 1071-9164 .- 1532-8414. ; 13:6, s. 452-461
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Tidskriftsartikel (refereegranskat)abstract
- Background: Little is known about the differences between natriuretic peptides used to evaluate elderly patients with heart failure. The aim of the study was to evaluate the information and the power to predict cardiovascular mortality derived from an analysis of cardiac natriuretic peptides from the same study population and at the same time. Methods and Results: In all, 415 elderly patients (age 65-82 years) in primary health care were evaluated and followed for 6 years. All patients had symptoms of heart failure and were examined by a cardiologist. An electrocardiogram and chest x-rays were taken, and the systolic and diastolic functions were assessed using Doppler echocardiography. Brain natriuretic peptide (BNP), N-terminal proBNP, atrial natriuretic peptide (ANP), and N-terminal proANP were analyzed. All 4 peptides were associated with age, and only 1 of them showed any gender difference. Three of the 4 peptides (not ANP) provided important information for identifying patients with impaired systolic function and diastolic dysfunction (pseudonormal or restrictive filling pattern), and for assessing the risk of cardiovascular death. Conclusions: Cardiac natriuretic peptides are useful tools for evaluating elderly patients with heart failure. Three of the 4 peptides were very similar. ANP exhibits inferior properties and cannot be recommended in clinical practice. © 2007 Elsevier Inc. All rights reserved.
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| 2. |
- Ghali, Jalal K, et al.
(författare)
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The influence of renal function on clinical outcome and response to beta-blockade in systolic heart failure: insights from Metoprolol CR/XL Randomized Intervention Trial in Chronic HF (MERIT-HF).
- 2009
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Ingår i: Journal of cardiac failure. - : Elsevier BV. - 1532-8414 .- 1071-9164. ; 15:4, s. 310-8
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Limited information is available on the risk and impact of renal dysfunction on the response to beta-blockade and mode of death in systolic heart failure (HF). METHODS AND RESULTS: Renal function was estimated with glomerular filtration rate (eGFR) using the simplified Modification of Diet in Renal Disease (MDRD) equation. Patients from the Metoprolol CR/XL Controlled Randomized Intervention Trial in Chronic HF (MERIT-HF) were divided into 3 renal function subgroups (MDRD formula): eGFR(MDRD) > 60 (n = 2496), eGFR(MDRD) 45 to 60 (n = 976), and eGFR(MDRD) < 45 mL/min per 1.73 m(2) body surface area (n = 493). Hazard ratio (HR) was estimated with Cox proportional hazards models adjusted for prespecified risk factors. Placebo patients with eGFR < 45 had significantly higher risk than those with eGFR > 60: HR for all-cause mortality, 1.90 (95% confidence interval [CI], 1.28 to 2.81) comparing placebo patients with eGFR < 45 and eGFR > 60, and for the combined end point of all-cause mortality/hospitalization for worsening HF (time to first event): HR, 1.91 (95% CI, 1.44 to 2.53). No significant increase in risk with deceased renal function was observed for those randomized to metoprolol controlled release (CR)/extended release (XL) due to a highly significant decrease in risk on metoprolol CR/XL in those with eGFR < 45. For total mortality, metoprolol CR/XL vs placebo: HR, 0.41 (95% CI. 0.25 to 0.68; P < .001) in those with eGFR < 45 compared with HR, 0.71 (95% CI, 0.54 to 0.95; P < .021) for those with eGFR > 60; corresponding data for the combined end point was HR, 0.44 (95% CI, 0.31 to 0.63; P < .0001) and HR, 0.75 (0.62 to 0.92; P = .005, respectively; P = .095 for interaction by treatment for total mortality; P = .011 for combined end point). Metoprolol CR/XL was well tolerated in all 3 renal function subgroups. CONCLUSIONS: Renal function as estimated by eGFR was a powerful predictor of death and hospitalizations from worsening HF. Metoprolol CR/XL was at least as effective in reducing death and hospitalizations for worsening HF in patients with eGFR < 45 as in those with eGFR > 60.
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| 3. |
- Ingelsson, Erik, et al.
(författare)
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Socioeconomic factors as predictors of incident heart failure
- 2006
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Ingår i: Journal of Cardiac Failure. - : Elsevier BV. - 1071-9164 .- 1532-8414. ; 12:7, s. 540-545
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Studies of socioeconomic factors as predictors of heart failure (HF) are few and have given opposing results. Further, it is unknown if these factors predict incident HF independently of myocardial infarction and other established risk factors for HF. METHODS AND RESULTS: In a community-based cohort of 2314 middle-age men free from HF, valvular disease, and previous myocardial infarction at baseline, socioeconomic factors were examined as predictors for HF using Cox proportional hazards analyses. In multivariable Cox proportional hazards models adjusted for established risk factors for HF (hypertension, diabetes, electrocardiographic left ventricular hypertrophy, smoking, serum cholesterol, and interim myocardial infarction), low occupational classification (hazard ratio [HR] 1.55, 95% confidence interval [CI] 1.03-2.35 for low vs. high occupational classification), low education level (HR 1.98, 95% CI 1.07-3.68 for elementary school vs. college exam) and being unmarried (HR 1.44, 95% CI 0.99-2.10 for being unmarried vs. being married) increased the risk of HF. CONCLUSION: High occupational classification and high education level decreased, and being unmarried increased, the risk of subsequent HF in middle-age men, via mechanisms largely independent of established risk factors for HF, including an interim myocardial infarction. Further studies are needed to understand the mechanisms behind these associations.
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| 4. |
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| 5. |
- Kato, Naoko, et al.
(författare)
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Relationship of depressive symptoms with hospitalization and death in Japanese patients with heart failure
- 2009
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Ingår i: Journal of Cardiac Failure. - : Elsevier. - 1071-9164 .- 1532-8414. ; 15:10, s. 912-919
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND:Depressive symptoms are risk factors for poor outcomes and are positively associated with disease severity in patients with heart failure (HF). However, little is known about this association in the Japanese population. Therefore, we evaluated the prevalence of depressive symptoms and whether depressive symptoms predicted hospitalization for HF and death independent of disease severity and other factors in HF patients.METHODS AND RESULTS:A 2-year prospective cohort study was conducted on 115 outpatients with HF (73.9% males; mean age 64.7 years) in Tokyo. Of these, 27 patients (23.5%) were classified as having depressive symptoms (Center for Epidemiologic Studies Depression Scale score >or=16). Patients with depressive symptoms had higher rates of 2-year cardiac death or HF hospitalization (34.0% vs. 10.3%; P < .01), HF hospitalization (27.4% vs. 9.2%; P = .01), and all-cause death (27.4% vs. 7.2%; P < .01). Multivariate Cox regression analyses indicated that depressive symptoms were predictors of cardiac death or HF hospitalization (hazard ratio [HR], 3.29; P = .02), HF hospitalization (HR, 3.36; P = .04), and all-cause death (HR, 5.52; P = .01), independent of age and brain natriuretic peptide.CONCLUSIONS:Depressive symptoms were common and independent predictors of poor outcomes in Japanese patients with HF.
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| 6. |
- Lesman-Leegte, Ivonne, et al.
(författare)
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Quality of life and depressive symptoms in the elderly : a comparison between patients with heart failure and age- and gender-matched community controls.
- 2009
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Ingår i: Journal of Cardiac Failure. - : Elsevier BV. - 1071-9164 .- 1532-8414. ; 15:1, s. 17-23
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Comparisons of heart failure (HF) patients with an unselected healthy sample in terms of quality of life (QoL) and depressive symptoms might prove misleading. We compared QoL and depressive symptoms of a HF population with an age- and gender-matched sample of community dwelling elderly. METHODS AND RESULTS: Data were collected from 781 HF patients (36% female; age 72 +/- 9; New York Heart Association II-IV) and 781 age- and gender-matched community-dwelling elderly. Participants completed the Medical Outcome Study 36-item General Health Survey, the Cantril's Ladder of life, and the Center for Epidemiological Studies-Depression scale (CES-D). Analysis of variance techniques with Welch F test and chi-square tests were used to describe differences in QoL and depressive symptoms between different groups. For both men and women with HF, QoL was reduced and depressive symptoms were elevated when compared with their elderly counterparts (CES-D >or=16: 39% vs. 21%, P < .001). HF patients had more chronic conditions-specifically diabetes and asthma/chronic obstructive pulmonary disease. Impaired QoL and depressive symptoms were most prevalent among HF patients with comorbidities. Prevalence was also higher in HF patients in the absence of these conditions. CONCLUSIONS: HF has a large impact on QoL and depressive symptoms, especially in women with HF. Differences persist, even in the absence of common comorbidities. Results demonstrate the need for studies of representative HF patients with direct comparisons to age- and gender-matched controls.
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| 7. |
- Luttik, Marie Louise, et al.
(författare)
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Quality of life and depressive symptoms in heart failure patients and their partners : the impact of role and gender.
- 2009
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Ingår i: Journal of Cardiac Failure. - : Elsevier BV. - 1071-9164 .- 1532-8414. ; 15:7, s. 580-5
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Partners of heart failure (HF) patients are important in the course and management of the disease. It is unclear whether HF affects the quality of life (QoL) of partners as much as it affects the QoL of patients. METHODS AND RESULTS: The study aims to determine the influence of role (patient or partner) and gender on quality of life (QoL) and depressive symptoms in HF patients and their partners. Using a cross-sectional design, data on demographics, QoL, and depressive symptoms were collected from 393 HF patients (age, 68+/-11; 76% male) and their partners (age, 67+/-12; 24% male) using questionnaires (Medical Outcome Study 36-item General Health Survey [RAND-36], Cantril Ladder of Life, and Center for Epidemiologic Studies Depression Scale) that were send at home. At a group level HF, patients reported a significantly worse QoL and more depressive symptoms compared with their partners. When examining the influence of role and gender a significant interaction between role and gender was found. QoL in terms of general well-being of female HF partners and female HF patients did not differ (7.0 vs. 6.9), whereas male partners had a significantly higher well-being compared to male HF patients (7.6 vs. 6.8). Most of the RAND-36 domains were explained by role (either being a patient or a partner) with patients having lower scores compared with their partners. However, the RAND-36 domain mental health was mainly explained by gender, with women reporting worse mental health compared with men, independent of their role as a patient or a partner. The same trend was found for the presence of depressive symptoms. CONCLUSIONS: Females, either as patients or as partners are vulnerable in their response to HF in terms of their QoL. The QoL of male partners does not seem to be negatively affected. Supporting couples who are dealing with HF requires different interventions for male and female patients and their partners.
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| 8. |
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| 9. |
- Alehagen, Urban, et al.
(författare)
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Are There Any Significant Differences Between Females and Males in the Management of Heart Failure? Gender Aspects of an Elderly Population With Symptoms Associated With Heart Failure
- 2009
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Ingår i: JOURNAL OF CARDIAC FAILURE. - : Elsevier BV. - 1071-9164. ; 15:6, s. 501-507
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Tidskriftsartikel (refereegranskat)abstract
- Background: An increasing interest has been shown in potential l., 11 With heart failure (HF), a serious condition for the individual. To evaluate whether there are any differences ill the prevalence of HF, cardiac function, biomarkers. and the treatment of HF with respect to gender. Methods and Results: All persons ages 70 to 80 in a rural municipality were invited to participate ill the project 876 persons accepted. Three cardiologists evaluated the patients including a new history, clinical examination. electrocardiogram, chest x-ray. blood samples. and Doppler echocardiography to assess both Systolic and diastolic function. The patients were followed during a mean period of 8 years. Conclusion: Females hypertension more frequently and included fewer smokers than their male Counterparts. A Female preponderance was seen in those with preserved systolic function. whereas males predominated among those with systolic dysfunction. During the follow-up period, 20% of the males and 14% of the females died of cardiovascular diseases. The results did not show any inferior treatment of females with HF. but it clearly was more difficult to correctly classify female patients presenting with symptoms of HE
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| 10. |
- Alm, Torbjörn, et al.
(författare)
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The Value of Spatial Cues in 3D Air Traffic Displays
- 2007
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Ingår i: The International journal of aviation psychology. - : Informa UK Limited. - 1050-8414 .- 1532-7108. ; 17:2, s. 109-129
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Tidskriftsartikel (refereegranskat)abstract
- Interest in implementing 3D pictorial displays for traffic information in aircraft has been prevalent for decades without any obvious implementation in the cockpit. Our research is focused on design issues for these displays. The purpose of the experiments discussed here was to investigate where and when additional spatial cues, e.g., drop-lines, could contribute to better performance and whether such additions could replace shifts between 2D and 3D presentation for different tasks. Our results show that drop-lines are beneficial in focused attention tasks but are not necessarily beneficial in more integrated tasks. This speaks to the need for an adaptive approach to the presentation of flight situation displays.
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| 11. |
- Björklund, Caroline M., et al.
(författare)
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Mode monitoring and call-outs : An eye-tracking study of 2-crew automated flight deck operations
- 2006
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Ingår i: The International journal of aviation psychology. - : Taylor & Francis. - 1050-8414 .- 1532-7108. ; 16:3, s. 263-275
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Tidskriftsartikel (refereegranskat)abstract
- Mode awareness has been suggested as a critical factor in safe operations of automated aircraft. This study investigated mode awareness by measuring eye point of gaze of both pilots during simulated commercial flights, while recording call-outs and tracking aircraft performance. The results of this study show that the compliance to manufacturer or air carrier procedures regarding mode monitoring and call-outs was very low. However, this did not seem to have a negative effect on the flight path or safety during our observations. Crews exhibited a proliferation of strategies to keep track of status and behavior of the automation, often with little reliance on the flight mode annunciations of the primary flight display. The data confirm the limitations of current flight mode annunciator designs, and suggest that mode awareness is a more complex phenomenon than what can be captured by measuring eye point of gaze and communication alone.
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| 12. |
- Caro, J. J., et al.
(författare)
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Economic implications of extended-release metoprolol succinate for heart failure in the MERIT-HF trial: a US perspective of the MERIT-HF trial
- 2005
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Ingår i: J Card Fail. - 1071-9164. ; 11:9, s. 647-56
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The MERIT-HF trial demonstrated improved survival and fewer hospitalizations for worsening heart failure with extended-release (ER) metoprolol succinate in patients with heart failure. This study sought to estimate the economic implications of this trial from a US perspective. METHODS AND RESULTS: A discrete event simulation was developed to examine the course of patients with heart failure. Characteristics of the population modeled, probabilities of hospitalization and death with standard therapy, and risk reductions with ER metoprolol succinate were obtained from Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure (MERIT-HF) and evaluated in weekly cycles. Direct medical costs were estimated from US databases in 2001 US dollars. Uncertainty in inputs was incorporated and analyses were carried out to estimate events prevented total and net costs. The model predicts that ER metoprolol succinate will prevent approximately 7 deaths and 15 hospitalizations from heart failure per 100 patients over 2 years. Compared with standard therapy alone, this translates to a cost reduction between $395 and $1112 per patient, depending on whether the costs of hospitalizations for other causes are included. Savings were maintained in 90% of the simulations. CONCLUSION: This analysis predicts that the positive effect of ER metoprolol succinate on mortality and morbidity demonstrated in MERIT-HF leads to substantial savings.
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| 13. |
- Dahlström, Nicklas, et al.
(författare)
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Mental Workload in Aircraft and Simulator during Basic Civil Aviation Training
- 2009
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Ingår i: The International journal of aviation psychology. - : Taylor & Francis. - 1050-8414 .- 1532-7108. ; 19:4, s. 309-325
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- This study investigated mental workload in basic civil aviation training. Heart rate, eye movement and subjective ratings from eleven students were collected during simulator and aircraft sessions. Results show high correspondence in psychophysiological reactions between the sessions. For some flight segments heart rate was consistently lower in the simulator, suggesting higher mental workload in the aircraft. Differences in heart rate during rejected take-off and engine failure indicate that the increase of workload starts in advance of an “unexpected“ event in the simulator and seem to be of preparatory nature, while more connected to management of the situation in the aircraft. Descriptors: psychophysiology, mental workload, aviation training, flight simulation, learning transfer
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| 14. |
- Ekman, Inger, 1952, et al.
(författare)
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Symptoms in patients with heart failure are prognostic predictors. Insights from COMET
- 2005
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Ingår i: Journal of Cardiac Failure. - : Elsevier BV. - 1071-9164. ; 11:4, s. 288-92
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Although functional status, as assessed by the New York Heart Association classification, is known to be a powerful prognostic marker in chronic heart failure (CHF), the significance of individual symptoms such as breathlessness and fatigue are unknown. OBJECTIVE: To assess the relative importance of self-reported severity of symptoms as predictors of outcomes in CHF. METHODS AND RESULTS: All 3029 patients randomized in the Carvedilol or Metoprolol European Trial (ie, COMET) study were included in the analysis. Mean follow-up was 58 months. Symptoms were assessed by 5-point scales. In a univariate analysis, worse scores for breathlessness, orthopnea and fatigue were all significantly related to increased mortality (all P < .0001) and development of worsening heart failure. In a multivariate Cox regression analysis including 16 baseline covariates, only the symptom of breathlessness remained significantly related to mortality (risk ratio [RR] 1.14 per unit: 95% CI 1.04-1.26; P = .01). Fatigue, but not breathlessness, remained a significant predictor for developing worsening heart failure (RR 1.09 per unit; 95% CI 1.02-1.18; P = .02). CONCLUSIONS: Fatigue and breathlessness, common symptoms in CHF, have important and independent long-term prognostic implications. Accordingly, symptoms need to be effectively evaluated not only because symptom alleviation is a target for treatment, but also because they guide prognosis in patients with CHF.
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| 15. |
- Gheorghiade, M., et al.
(författare)
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Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the Efficacy of Vasopressin antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST)
- 2005
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Ingår i: Journal of cardiac failure. - 1071-9164. ; 11:4, s. 260-9
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Hospitalizations for worsening heart failure due to fluid overload (congestion) are common. Agents that treat congestion without causing electrolyte abnormalities or worsening renal function are needed. Tolvaptan is an oral vasopressin (V 2 ) antagonist that decreases body weight and increases urine volume without inducing renal dysfunction or hypokalemia. The Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial is evaluating mortality, morbidity, and patient-assessed global clinical status in patients treated with tolvaptan compared with standard care. METHODS AND RESULTS: Patients are eligible for inclusion if they have a reduced left ventricular ejection fraction and are hospitalized for worsening heart failure with evidence of systemic congestion. Patients are randomized 1:1 to tolvaptan 30 mg/day or matching placebo for a minimum of 60 days. Time to all-cause mortality and time to cardiovascular mortality or heart failure hospitalization are the coprimary end points. Patient-assessed global clinical status and quality of life are also evaluated. EVEREST will be continued until 1065 deaths occur. As of April 18, 2005, 2260 patients have been enrolled. CONCLUSION: Tolvaptan has been shown to reduce body weight in patients with worsening heart failure without inducing renal dysfunction or causing hypokalemia. The results of EVEREST will determine whether these effects translate into improved clinical outcomes.
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| 16. |
- Goteman, O., et al.
(författare)
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HUD with a velocity (flight-path) vector reduces lateral error during landing in restricted visibility
- 2007
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Ingår i: The International journal of aviation psychology. - 1050-8414 .- 1532-7108. ; 17:1, s. 91-108
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Tidskriftsartikel (refereegranskat)abstract
- The operational community has assumed that using a head-up display (HUD) instead of conventional head-down displays will increase accuracy and safety during approach and landing. The putative mechanism for this increase in safety is that previously demonstrated improvements in lateral and vertical control of the aircraft in flight should carry over to the landing situation. Alternatively, it is possible that, during approach and landing, the HUD might affect the pilot's ability to assimilate outside cues at the decision height, thereby reducing the success ratio for landings using an HUD. This article reports a pair of experiments that test these competing hypotheses. Taking advantage of the opportunity when an air transport operator introduced HUD in an existing aircraft fleet, we were able to use a Boeing 737-700 full-motion simulator flown by commercial airline pilots. We explored the effects of (a) HUD use, (b) ambient visibility, and (c) length of approach lighting on the size and location of the touchdown footprint. We also explored the effects of HUD use on approach success ratio. HUD use reduced the width of the touchdown footprint in all tested visibility and lighting conditions, including visibility below the minimum allowed. HUD use had no effect on the length of the touchdown footprint. We could not detect any decrease in approach success rate for HUD approaches. Based on these empirical data, the minimum visibility for approaches using HUDs could be set lower than for approaches without an HUD. Copyright © 2007, Lawrence Erlbaum Associates, Inc.
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| 17. |
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| 18. |
- Lorentzon, Malin, 1976, et al.
(författare)
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In vivo effects of myocardial creatine depletion on left ventricular function, morphology, and energy metabolism--consequences in acute myocardial infarction
- 2007
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Ingår i: Journal of cardiac failure. - 1532-8414. ; 13:3, s. 230-7
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The failing heart is characterized by disturbed myocardial energy metabolism and creatine (Cr) depletion. The aims of this study were to in vivo evaluate the effects of Cr depletion on: a) left ventricular (LV) function and morphology during rest and stress, b) LV energy metabolism, c) catecholamine in LV and plasma content, and d) incidence of malignant ventricular arrhythmias (MVA) during acute myocardial infarction (MI). METHODS AND RESULTS: Male rats weighing approximately 200 g were used. Two groups were studied: the rats treated with Cr analogue beta-guanidinopropionic acid (BGP) (n = 25) and controls (n = 23). BGP (1 M) was administered by subcutaneously implanted osmotic minipumps over 4 weeks. The rats (BGP n = 9, control n = 12) were than examined with transthoracic echocardiography at basal and at stress conditions induced by transesophageal pacing. In vivo (31)P magnetic resonance spectroscopy (MRS) was used for evaluation of myocardial energy status (BGP n = 7, control n = 12). (31)P MRS, echocardiography and high-performance liquid chromatography analysis of myocardial Cr, total adenine nucleotides and catecholamines in myocardium and plasma were performed on noninfarcted hearts. Myocardial infarction was induced in a subgroup of animals (BGP n = 15, control n = 15) by ligation of the left coronary artery resulting in a large ( approximately 50%) anterolateral MI and acute HF. A computerized electrocardiogram tracing was obtained continuously before induction of MI and up to 60 minutes postinfarction. Qualitative and quantitative variables of ventricular arrhythmias were analyzed using arrhythmia score. Body weight (BW) was lower (P < .01), whereas LV/BW was higher (P < .01) in the BGP group. Total myocardial Cr pool was decreased for at least 50% (P < .01) compared with the controls. There was no difference in total nucleotide pool. Phosphocreatine/adenosine-3-phosphate ratio was lower in the BGP group (P < .01). LV systolic function was disturbed during rest and stress (P < .05). Similarly, LV dimensions were increased in the BGP group (P < .05). Induction of acute MI resulted in markedly increased incidence of MVA and higher mortality in the BGP group (P < .01). CONCLUSIONS: Myocardial Cr depletion results in functional and structural LV alterations associated with lower myocardial energy reserve. Intact myocardial Cr metabolism is important for normal LV function during basal and stress conditions. Acute MI in the setting of myocardial Cr depletion leads to excessive mortality from ventricular arrhythmias and progressive heart failure.
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| 19. |
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| 20. |
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| 21. |
- Packer, M., et al.
(författare)
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Clinical effects of endothelin receptor antagonism with bosentan in patients with severe chronic heart failure: results of a pilot study
- 2005
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Ingår i: Journal of cardiac failure. - : Elsevier BV. - 1071-9164. ; 11:1, s. 12-20
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Endothelin receptor antagonism produces favorable short-term hemodynamic effects in heart failure, but the clinical effects of longer term therapy have not been evaluated. METHODS AND RESULTS: Three hundred and seventy patients with symptoms of heart failure at rest or on minimal exertion and a left ventricular ejection fraction <35% were randomly assigned (double-blind) to placebo (n = 126) or the endothelin receptor antagonist bosentan, titrated slowly (n = 121) or rapidly (n = 123) to a target dose of 500 mg twice daily. Treatment with the study drug was to be maintained for 26 weeks, whereas background medications for heart failure were kept constant. Safety concerns led to early termination of the trial when only 174 patients had had an opportunity to complete 26 weeks of therapy. Bosentan exerted no apparent benefit when all randomized patients were analyzed (P = .709). However, in the first 174 patients who were recruited at least 26 weeks before study termination and who could therefore be followed for the planned duration of the trial, patients in the bosentan groups were more likely to be improved (26% versus 19%) and were less likely to be worse (28% versus 43%), P = .045. When compared with placebo-treated patients, bosentan-treated patients had a increased risk of heart failure during the first month of treatment but a decreased risk of heart failure during the fourth, fifth, and sixth months of therapy. The major noncardiac adverse effects of bosentan included an increase in hepatic transaminases (in 15.6% of patients) and a decrease in hemoglobin (of about 1 g/L). CONCLUSION: Although bosentan exerted no favorable effects in the overall study, our findings suggest that the clinical responses to endothelin antagonism with bosentan in patients with severe chronic heart failure may be dependent on the duration of treatment.
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| 22. |
- Torp-Pedersen, C., et al.
(författare)
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The safety of amiodarone in patients with heart failure
- 2007
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Ingår i: J Card Fail. - 1532-8414. ; 13:5, s. 340-5
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Uncertainty persists about the safety and efficacy of amiodarone for the management of heart failure. METHODS AND RESULTS: We randomized 3029 patients with chronic heart failure to receive carvedilol or metoprolol and followed patients for a median of 58 months. One hundred fifty-five of 1466 patients in New York Heart Association (NYHA) Class II and 209 of 1563 in Class III or IV received amiodarone at baseline. Persistence with amiodarone treatment was high and 66% received amiodarone after 4 years. During follow-up, 38.7% and 58.9% of patients receiving amiodarone in NYHA Classes II and III + IV died versus 26.2% and 43.3% not receiving amiodarone (P < .001). This difference was maintained in multivariable analysis (hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.2-1.7, P < .001). The difference was explained by an increased risk of death due to circulatory failure (HR 2.4, CI 1.9-3.1, P < .001) in patients receiving amiodarone. Sudden death was not different (HR 1.07, CI 0.8-1.4, P = .7). The increased risk was similar across NYHA classes with HR of 1.60 (CI 1.2-2.1, P < .001) in NYHA Class II versus 1.58 (CI 1.3-1.9, P < .001) in Classes III + IV. CONCLUSIONS: Treatment with amiodarone was associated with an increased risk of death from circulatory failure independent of functional class.
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