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1.
  • Flook, N. W., et al. (author)
  • Acid-Suppressive Therapy With Esomeprazole for Relief of Unexplained Chest Pain in Primary Care: A Randomized, Double-Blind, Placebo-Controlled Trial
  • 2013
  • In: American Journal of Gastroenterology. - : Ovid Technologies (Wolters Kluwer Health). - 0002-9270. ; 108:1, s. 56-64
  • Journal article (peer-reviewed)abstract
    • OBJECTIVES: High-quality data regarding the efficacy of acid-suppressive treatment for unexplained chest pain are lacking. The aim of this study was to evaluate the efficacy of esomeprazole in primary-care treatment of patients with unexplained chest pain stratified for frequency of reflux/regurgitation symptoms. METHODS: Patients with a ≥2-week history of unexplained chest pain (unrelated to gastroesophageal reflux) who had at least moderate pain on ≥2 of the last 7 days were stratified by heartburn/regurgitation frequency (≤1 day/week (stratum 1) vs. ≥2 days/week (stratum 2)) and randomized to 4 weeks of double-blind treatment with twice-daily esomeprazole 40mg or placebo. Chest pain relief during the last 7 days of treatment (≤1 day with minimal symptoms assessed daily using a 7-point scale) was analyzed by stratum in keeping with the predetermined analysis plan. RESULTS: Overall, 599 patients (esomeprazole: 297, placebo: 302) were randomized. In stratum 1, more esomeprazole than placebo recipients achieved chest pain relief (38.7% vs. 25.5%; P=0.018); no between-treatment difference was observed in stratum 2 (27.2% vs. 24.2%; P=0.54). However, esomeprazole was superior to placebo in a post-hoc analysis of the whole study population (combined strata; 33.1% vs. 24.9%; P=0.035). CONCLUSIONS: A 4-week course of high-dose esomeprazole provided statistically significant relief of unexplained chest pain in primary-care patients who experienced infrequent or no heartburn/regurgitation, but there was no such significant reduction in patients with more frequent reflux symptoms.
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3.
  • Alsén, Pia, 1956-, et al. (author)
  • Fatigue after myocardial infarction : Relationships with indices of emotional distress, and sociodemographic and clinical variables
  • 2010
  • In: International Journal of Nursing Practice. - 1322-7114 .- 1440-172X. ; 16:4, s. 326-334
  • Journal article (peer-reviewed)abstract
    • Fatigue and depressive symptoms are relatively common among patients recovering from myocardial infarction (MI). The symptoms of depression and fatigue overlap. The present study aimed at identifying patient fatigue and at examining the incidence of fatigue, particularly without coexisting depression, after MI. The sample comprised 204 consecutive patients who had completed the questionnaires Hospital Anxiety and Depression Scale and the Multidimensional Fatigue Inventory–20 after MI (1 week and 4 months). The results showed that fatigue had decreased after 4 months compared with the time of MI onset. Compared with the general population, patients reported significantly higher levels of fatigue. Furthermore, fatigue was associated with depression, but 33% of the sample reported fatigue without coexisting depression after 4 months. In order to prevent or treat patients' symptoms of fatigue after MI, the concepts of fatigue and depression should be assessed separately so as to exclude overlapping effects.
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4.
  • Ballantyne, C. M., et al. (author)
  • Efficacy, safety and effect on biomarkers related to cholesterol and lipoprotein metabolism of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg vs. simvastatin 40 or 80 mg plus ezetimibe 10 mg in high-risk patients: Results of the GRAVITY randomized study
  • 2014
  • In: Atherosclerosis. - : Elsevier BV. - 0021-9150. ; 232:1, s. 86-93
  • Journal article (peer-reviewed)abstract
    • Objectives: Combination therapy may help high-risk patients achieve low-density lipoprotein cholesterol (LDL-C) goals. Impact of rosuvastatin 10 or 20 mg plus ezetimibe 10 mg (RSV10/EZE10 and RSV20/EZE10) has not been fully characterized previously. GRAVITY (NCT00525824) compared efficacy, safety and effect on biomarkers of RSV10/EZE10 and RSV20/EZE10 vs. simvastatin 40 mg and 80 mg plus EZE10 (SIM40/EZE10 and SIM80/EZE10) in patients with coronary heart disease (CHD) or CHD risk equivalent. Methods: Adult patients (n = 833) were randomized to RSV10/EZE10, RSV20/EZE10, SIM40/EZE10 or SIM80/EZE10. Following a 6-week dietary lead-in, patients received 6 weeks' statin monotherapy followed by same statin dose plus ezetimibe for 6 more weeks. Primary endpoint was LDL-C change from baseline to 12 weeks. Results: Significantly greater (p < 0.05) reductions in LDL-C and other atherogenic lipids were observed with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10. A significantly greater proportion of patients achieved LDL-C goals of < 100 mg/dl and < 70 mg/dl with RSV20/EZE10 vs. SIM40/EZE10 and SIM80/EZE10 and with RSV10/EZE10 vs. SIM40/EZE10. LDL-C was reduced w10-14% further with combination therapy vs. monotherapy. Statin monotherapy reduced cholesterol and bile acid synthesis biomarkers, ezetimibe reduced beta-sitosterol (sterol absorption marker), and combination therapy achieved additive reductions in lipoprotein-associated phospholipase A(2) mass and activity, free cholesterol and 7-ketocholesterol. Safety profiles of rosuvastatin/ezetimibe and simvastatin/ezetimibe combinations were comparable. Conclusion: Co-administration of rosuvastatin 10 or 20 mg plus ezetimibe achieved significant improvements in lipid profiles in high-risk patients vs. simvastatin 40 or 80 mg plus ezetimibe. (C) 2013 Elsevier Ireland Ltd. All rights reserved.
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5.
  • Herlitz, Johan, 1949, et al. (author)
  • Symptoms of chest pain and dyspnoea during a period of 15 years after coronary artery bypass grafting.
  • 2010
  • In: European journal of cardio-thoracic surgery. - : Elsevier. - 1873-734X .- 1010-7940. ; 37:1, s. 112-118
  • Journal article (peer-reviewed)abstract
    • AIM: To describe changes in chest pain and dyspnoea during a period of 15 years after coronary artery bypass grafting (CABG) and to define factors at the time of operation that were associated with the occurrence of these symptoms after 15 years. DESIGN: Prospective observational study in western Sweden. SUBJECTS: All patients who underwent first-time CABG, without simultaneous valve surgery, between 1 June 1988 and 1 June 1991. There were no exclusion criteria. FOLLOW-UP: All patients were followed up prospectively for 15 years. The evaluation of symptoms took place through postal questionnaires prior to and 5, 10 and 15 years after the operation. RESULTS: Totally, 2000 patients were included in the survey and 904 (45%) of them survived to 15 years. Among these 904 survivors, the percentage of patients with chest pain increased from 44% to 50% between the 5- and 15-year follow-up (p=0.004). The percentage of patients who reported symptoms of dyspnoea increased from 60% after 5 years to 74% after 15 years (p<0.001). Factors at the time of surgery that independently tended to predict chest pain after 15 years were higher age (p=0.04) and prolonged duration of symptoms prior to surgery (p=0.04). Predictors of dyspnoea after 15 years were higher age (p<0.0001), the use of inotropic drugs at the time of surgery (p=0.001), a history of diabetes (p=0.01) and obesity (p=0.01). CONCLUSION: After CABG, relief from chest pain and dyspnoea is generally maintained over a long period of time. Eventually, however, functional-limiting symptoms tend to recur and about half the patients report symptoms of chest pain, while three-quarters report dyspnoea after 15 years. Even if no clear predictor of chest pain was found at the time of surgery, age, the use of inotropic drugs, diabetes and obesity predicted dyspnoea.
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6.
  • Johansson, Ingvor, et al. (author)
  • Disturbed sleep, fatigue, anxiety and depression in myocardial infarction patients
  • 2010
  • In: European Journal of Cardiovascular Nursing. - : Oxford University Press (OUP). - 1474-5151 .- 1873-1953. ; 9:3, s. 175-180
  • Journal article (peer-reviewed)abstract
    • Background: Disturbed sleep has been linked to increased morbidity, mortality and depression and worsened health-related quality of life in patients with chronic illness. Few studies of readjustment after coronary artery disease have explicitly focused on sleep disturbance. Aim: To explore associations between disturbed sleep, fatigue, anxiety and depression, and to assess to what extent fatigue four months post-MI could be explained. Method: The sample included 204 consecutive patients, ≤ 80 years of age who answered questionnaires about disturbed sleep, fatigue, anxiety and depression four months after MI. Results: The variables anxiety, depression and disturbed sleep were all associated with fatigue. The regression model accounted for 46% of the variance in fatigue with depression and disturbed sleep as predictors. Infarct size measured by conventional biochemical markers, left ventricle ejection fraction and history of previous MI were not correlated with disturbed sleep, fatigue, anxiety or depression. Conclusions: From knowledge about associations between disturbed sleep, fatigue, anxiety and depression after MI, cardiac nurses could be trained to observe such symptoms. Optimal care for sleep disturbance may include actions to reduce anxiety and depression as well as self-care advices about sleep hygiene in order to improve sleep quality and reduce fatigue. © 2009 European Society of Cardiology.
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7.
  • Karlson, Björn W., 1953, et al. (author)
  • A Pharmacokinetic and Pharmacodynamic Comparison of Immediate-Release Metoprolol and Extended-Release Metoprolol CR/XL in Patients with Suspected Acute Myocardial Infarction : A Randomized, Open-Label Study
  • 2014
  • In: Cardiology. - : S. Karger AG. - 0008-6312 .- 1421-9751. ; 127:2, s. 73-82
  • Journal article (peer-reviewed)abstract
    • Background: Previous metoprolol studies in myocardial infarction patients were performed with immediate-release (IR) metoprolol. This study aims to evaluate if extended-release metoprolol CR/XL once daily gives a similar β-blockade over 24 h compared to multiple dosing of metoprolol IR. Methods: After 2 days of routine metoprolol treatment, 27 patients with suspected acute myocardial infarction were randomized to open-label treatment with metoprolol IR (50 mg four times daily or 100 mg twice daily) or metoprolol CR/XL 200 mg once daily for 3 days. Results: Metoprolol CR/XL 200 mg once daily gave more pronounced suppression of peak heart rate, with lower peak and less variation in peak to trough plasma levels. There were no differences in AUC between the CR/XL and IR formulations, although the trough plasma metoprolol levels were comparable for metoprolol CR/XL 200 mg once daily and metoprolol IR 50 mg four times daily, but lower for metoprolol IR 100 mg twice daily. Both treatments were well tolerated. Conclusions: Metoprolol CR/XL 200 mg once daily showed lower peak and less variation in peak to trough plasma levels compared to multiple dosing of metoprolol IR with the same AUC. This was accompanied by a more uniform β-blockade over time, which was reflected by heart rate, and a more pronounced suppression of peak heart rate with similar tolerability. This suggests metoprolol CR/XL may be used as an alternative to metoprolol IR in patients with myocardial infarction.
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8.
  • Karlson, Björn W., 1953, et al. (author)
  • Achievement of 2011 European low-density lipoprotein cholesterol (LDL-C) goals of either < 70 mg/dl or >= 50% reduction in high-risk patients: Results from VOYAGER
  • 2013
  • In: Atherosclerosis. - : Elsevier BV. - 0021-9150 .- 1879-1484. ; 228:1, s. 265-269
  • Journal article (peer-reviewed)abstract
    • Objective Guidelines published in 2011 by the European Atherosclerosis Society and the European Society of Cardiology recommend a goal of either low-density lipoprotein cholesterol (LDL-C) <70 mg/dl (∼1.8 mmol/l) or ≥50% reduction in LDL-C for patients at very high cardiovascular risk. The aim of this study was to determine the percentage of high-risk patients from the VOYAGER individual patient data meta-analysis treated with rosuvastatin 10–40 mg, atorvastatin 10–80 mg or simvastatin 10–80 mg who achieved this goal. Methods We analysed 25,075 patient exposures from high-risk patients. Paired comparisons were made between each rosuvastatin dose and an equal or higher dose of either atorvastatin or simvastatin, with a series of meta-analyses that included only randomised studies that directly compared rosuvastatin and its comparator treatments. Results As statin dose increased, higher percentages of patients achieved LDL-C <70 mg/dl or ≥50% LDL-C reduction. A greater percentage achieved this goal with rosuvastatin 10–40 mg (43.8–79.0%) than with equal or double milligram doses of atorvastatin (16.1–65.2%) or simvastatin (0–39.7%). Paired comparisons showed statistically significant differences for: rosuvastatin 10 mg vs. atorvastatin 10–20 mg and simvastatin 10–20 mg; rosuvastatin 20 mg vs. atorvastatin 20–40 mg and simvastatin 20–80 mg; and rosuvastatin 40 mg vs. atorvastatin 40–80 mg and simvastatin 40–80 mg (all p < 0.001). Conclusion These data from VOYAGER highlight the importance of an effective statin at an appropriate dose to achieve treatment goals for LDL-C in patients with very high cardiovascular risk.
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9.
  • Karlson, Björn W., 1953, et al. (author)
  • Achievement of combined goals of low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol with three different statins: Results from VOYAGER
  • 2014
  • In: IJC Metabolic and Endocrine. - : Elsevier Ireland Ltd. - 2214-7624. ; 5, s. 61-66
  • Journal article (peer-reviewed)abstract
    • Background: Guidelines suggest that the combination of low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) is the most clinically relevant goal for lipid-lowering treatments. Methods: Data from VOYAGER, an individual patient data meta-analysis including 32,258 patients from 37 clinical trials, was used to determine the percentage of patients reaching combined goals of LDL-C and non-HDL-C following treatment with simvastatin, atorvastatin, or rosuvastatin. Paired comparisons were made between each dose of rosuvastatin and the same or higher doses of simvastatin and atorvastatin. Results: Each dose of rosuvastatin brought significantly more patients to the combined goal of LDL-C <. 100. mg/dL and non-HDL-C <. 130. mg/dL than the same or double dose of atorvastatin; atorvastatin 80. mg was significantly superior to rosuvastatin 10. mg (all p. <. 0.001). Each dose of rosuvastatin helped significantly more patients reach the combined goal than any dose of simvastatin (all p. <. 0.001), except for rosuvastatin 10. mg versus simvastatin 80. mg (non-significant). Also, each dose of rosuvastatin helped significantly more patients to reach the combined goal of LDL-C <. 70. mg/dL and non-HDL-C <. 100. mg/dL than the same or double dose of atorvastatin (all p. <. 0.001). Every dose of rosuvastatin was significantly superior to all doses of simvastatin (all p. ≤. 0.020), except for rosuvastatin 10. mg versus simvastatin 40. mg and 80. mg (non-significant). Conclusions: Physicians' choice of statin and dose is important in helping patients achieve the combined LDL-C and non-HDL-C goals recommended in established guidelines.
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10.
  • Karlson, Björn W., 1953, et al. (author)
  • Comparison of the effects of different statins and doses on lipid levels in patients with diabetes: Results from VOYAGER
  • 2012
  • In: Nutrition Metabolism and Cardiovascular Diseases. - : Elsevier BV. - 0939-4753 .- 1590-3729. ; 22:9, s. 697-703
  • Journal article (peer-reviewed)abstract
    • Background and aims: Diabetes mellitus is a well-known risk factor for cardiovascular disease, and brings an increased risk of vascular events and a higher mortality rate. Treatment guidelines recommend statins in patients with diabetes, with low-density lipoprotein cholesterol (LDL-C) targets of 100 mg dl(-1) (similar to 2.5 mmol l(-1)), and 80 (similar to 2.0 mmol l(-1)) or 70 mg dl(-1) (similar to 1.8 mmol l(-1)) in especially high-risk patients. The current study used the VOYAGER (an indiVidual patient data-meta-analysis Of statin therapY in At risk Groups: Effects of Rosuvastatin, atorvastatin, and simvastatin) database to characterise effects of rosuvastatin, atorvastatin and simvastatin in different doses on lipid levels in diabetes patients. Methods and results: The VOYAGER database included individual patient data from 37 studies involving comparisons of rosuvastatin with either atorvastatin or simvastatin. Of the 32 258 patients included, 8859 (27.5%) had diabetes. Rosuvastatin appeared to be the most efficacious of the three statins, both for lowering LDL-C and for reaching a target level of <70 mg dl(-1) for LDL-C. It was also more effective than atorvastatin at raising high-density lipoprotein cholesterol in the diabetes population. These results are consistent with the overall VOYAGER results. Conclusions: This meta-analysis of 8859 patients with diabetes mellitus shows favourable effects on lipids with the three statins studied, in line with results for the overall VOYAGER population. The importance of using an effective statin at an effective dose to reach treatment goals for such high-risk patients is evident. (c) 2012 Elsevier B.V. All rights reserved.
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