Spontaneous reports of adverse drug reactions related to oral anticoagulants in the Czech Republic

International Journal of Clinical Pharmacy - Background Oral anticoagulants are established drugs of choice for the prevention and treatment of thromboembolic events. However, monitoring their...     

Oxygen uptake efficiency slope, a new submaximal parameter in evaluating exercise capacity in chronic heart failure patients

Background

The oxygen uptake efficiency slope (OUES) is a new submaximal parameter which objectively predicts the maximal exercise capacity in children and healthy subjects. However, the usefulness of OUES in adult patients with and without advanced heart failure remains undetermined. The present study investigates the stability and the usefulness of OUES in adult cardiac patients with and without heart failure.

Methods

Forty-five patients with advanced heart failure (group A) and 35 patients with ischemic heart disease but normal left ventricular ejection fraction (group B) performed a maximal exercise test. PeakVO₂ and percentage of predicted peakVO₂ were markers of maximal exercise capacity, whereas OUES, ventilatory anaerobic threshold (VAT), and slope VE/VCO₂ were calculated as parameters of submaximal exercise.

Results

Group A patients had lower peakVO₂ (P < .001), lower percentage of predicted peakVO₂ (P = .001), lower VAT (P < .05), steeper slope VE/VCO₂ (P < .001), and lower OUES (P < .02). Within group A, significant differences were found for VAT, slope VE/VCO₂, and OUES (all P < .01) between patients with peakVO₂ above and below 14 mL O₂/kg/min. Of all the submaximal parameters, VAT correlated best with peakVO₂ (r =.814, P < .01) followed by OUES/kg (r = .781, P < .01), and slope VE/VCO₂ (r = −.492, P < .001). However, VAT could not be determined in 18 (23%) patients.

Conclusions

OUES remains stable over the entire exercise duration and is significantly correlated with peakVO₂ in adult cardiac patients with and without impaired LVEF. Therefore, OUES could be helpful to assess exercise performance in advanced heart failure patients unable to perform a maximal exercise test. Further studies are needed to confirm our hypothesis.     

Importance of measurements at or after the J-point for evaluation of ST-segment deviation and resolution during treatment for acute myocardial infarction

BACKGROUND: Determination of ST-segment deviation (STdev) and its resolution (STR) by reperfusion strategies have become important tools in the assessment of patients with acute myocardial infarction (AMI). STdev has been measured at different time-points, i.e. at 20-80 ms after the J-point. There are no data comparing STR at different time-points. METHODS AND RESULTS: STdev was measured using a new computer-assisted workflow. The intraclass correlation coefficients (ICC) for validity and agreement vs. classical manual measurements (n=1020) were both 0.996 (p<0.0001). The reliability indices were 0.991 (95% CI 0.990-0.992) for the manual vs. 0.995 (95% CI 0.995-0.996) for the computer-assisted method, indicating superiority of the latter. 12-lead STdev were determined on ECGs before (baseline) and 180 min after start of thrombolytic therapy, measured both at the J-point (STdev(J)) and 20 ms after the J-point (STdev(J20); n=2400). STdev(J20) was on average 0.01+/-0.03 mV higher than STdev(J) (p<0.0001) with a tendency towards larger differences for higher ST-elevations (p<0.001). Although the average STR calculated from STdev(J20) and STdev(J) was not statistically different in any infarct location group, in 26% of the patients the difference was >10%, and 11% of the patients were classified into another ST-resolution group. Analysing STdev only in the single lead with the highest ST-elevation at baseline (a simplified measurement which may eliminate the confounding effect of ST-depressions) showed an even higher classification discordance (14% of the patients). CONCLUSIONS: The time-point of STdev measurement is an important variable to be accounted for when evaluating ST resolution data. Uncontrolled extrapolation of classification schemes based on STdev(J20) to other time-points cannot be justified.     

Acetylsalicylic acid (ASA) use among Polish adults with diabetes mellitus

People with diabetes mellitus have higher risk of cardiovascular morbidity and mortality from thrombo-vascular complications than non-diabetics and it is recommended that they should use acetylsalicylic acid (ASA) as anitiplatelet agent regularly. The aim of this study was to examine current physician counseling about ASA therapy and the use of ASA by Polish patients with diabetes. The study involved 464 randomly selected Caucasian diabetic individuals, mainly with type 2 (>98%), who were asked to complete a questionnaire consisting of 16 questions while visiting out-patient medical centres for periodical examination or during hospitalization. We collected data on the prevalence of cardiovascular disease (CVD), frequency of risk factors among diabetic patients and on ASA physician counseling, and on the rate of regular ASA users among the patients. The most self-reported conditions were angina pectoris or prior myocardial infarction (63,6%). Current cigarette smoking was declared by 7,1% of the patients, elevated serum cholesterol levels by 58%, and hypertension by 62,9%. Majority of the patients were overweight, and family history of coronary artery disease (CAD) was reported by 30,2% of the patients. ASA was taken by 67,2% of all the patients and 72,1% of them had taken ASA regularly. The highest percentage (>80%) of regular ASA users was found among diabetic patients with CAD. A minority of the patients who reported stroke (43,9%) or claudication (15,8%) were taking ASA regularly. Number of the patients (32,8%) with CVD risk factor(s) but without diagnosed CVD did not use ASA at all. The majority of the patients (78%) were counseled by their physicians why they should use ASA regularly. In conclusion: the number of regular users of ASA among diabetic patients in Poland with CVD others than CAD or among patients with at least two CAD risk factors is still unsatisfactory. Therefore, while it seems that there is a remarkable growing of ASA therapy world-wide more effort is needed to make this practice a standard of multifactorial, intensive diabetes treatment. Our results also suggest the need for more aggressive education of both doctors and patients.     

Accuracy and cost-effectiveness of [18F]-2-fluoro-deoxy-D-glucose-positron emission tomography scan in potentially resectable non-small cell lung cancer

STUDY OBJECTIVES: This retrospective study of patients who were referred for surgical resection of non-small cell lung cancer (NSCLC) assessed the accuracy and cost-effectiveness of positron emission tomography (PET) with radiolabeled [18F]-2-fluoro-deoxy-D-glucose (FDG) in staging mediastinal lymph nodes (MLNs). DESIGN: From January 2001 to September 2002, 90 patients with suspected or proven NSCLC who had been referred for curative resection were retrospectively reviewed. All patients were without evidence of metastatic disease. Sixty-nine of the 90 patients had undergone thoracic FDG-PET imaging as part of their evaluation and are the focus of this study. Sensitivity, specificity, accuracy, and positive and negative predictive values for metastasis to the MLN were calculated for CT scanning vs FDG-PET scanning. Four algorithms for staging MLN with mediastinoscopy and/or FDG-PET scan were compared. MEASUREMENTS AND RESULTS: Sixty-nine patients underwent preoperative CT and FDG-PET scans, and 32 of 69 patients underwent mediastinoscopy. Fifty-seven patients underwent thoracotomy with complete mediastinal lymphadenectomy. Sensitivity, specificity, accuracy, and positive and negative predictive values for CT scans and FDG-PET scans were 46%, 86%, 78%, 43%, and 87%, and 62%, 98%, 91%, 89% and 92%, respectively. Mediastinoscopy was accurate in 32 of 32 patients (100%). Routine mediastinoscopy remains the most economically reasonable strategy with excellent sensitivity. Selective FDG-PET imaging improved the sensitivity of noninvasive staging for patients with normal MLNs on CT scans. CONCLUSIONS: Selective use of FDG-PET imaging improves staging accuracy compared to CT scanning alone and makes it a cost-effective adjunct to the preoperative staging of NSCLC. However, in patients with adenocarcinoma and MLNs of < 1 cm, FDG-PET scanning cannot yet replace mediastinoscopy.     

Endocrine pancreatic function in patients after acute pancreatitis

BACKGROUND/AIMS: The incidence of carbohydrate tolerance disorders in patients after acute pancreatitis has not been clearly established yet. The aim of the study was to estimate the frequency of endocrine pancreatic function impairment in patients after acute pancreatitis and its correlation with acute pancreatitis etiology and clinical course. METHODOLOGY: 82 patients (27 women and 55 men), aged between 28-65 (mean: 47 +/- 8.3), 1-7 (mean: 4.7 +/- 3.6) years after acute pancreatitis were evaluated. Control group consisted of 15 healthy volunteers. Oral glucose tolerance test with RIA insulin level was performed in all examined patients. Patients with any sign of chronic pancreatitis, based on clinical, functional (stool chymotrypsin test) and imaging (US and CT) findings, were excluded from the study. RESULTS: Impaired glucose tolerance was found in 4 patients (4.9%) and overt diabetes in 13 patients (15.8%) recovered from acute pancreatitis, which was not significantly different from those values in the local general population. Mean insulin values fasting and 30, 60 and 90 min after administration of 75 g glucose were significantly lower in patients after acute pancreatitis than in controls (p < 0.001). Endocrine pancreatic function impairment was found significantly more often in patients after severe acute pancreatitis clinical course (p < 0.0001), than in patients after mild pancreatitis. The frequency of impaired glucose tolerance and diabetes after acute alcoholic pancreatitis was 13 (36%), which was significantly higher (p < 0.05), than in cases of gallstone etiology (14%) and other causes (0%). CONCLUSIONS: Pancreatic endocrine function impairment following acute pancreatitis is associated with the decreased plasma insulin levels fasting and after glucose stimulus. Overall, the incidence of diabetes mellitus in patients after acute pancreatitis is similar to the reported values for the general population in this area. Alcoholic pancreatitis is more often complicated with impaired glucose tolerance and diabetes mellitus as regards to other causes of pancreatitis. Endocrine pancreatic function impairment is significantly more common after severe than after mild acute pancreatitis.     

Breast cancer characteristics—Comparison of preoperative and postoperative values

Breast cancer characteristics obtained at the time of diagnosis are important for setting the basic strategy of the treatment. Reliability of preoperative investigation differs for various features of the disease. The aim of this study was to ascertain the agreements and differences between preoperative and postoperative values.     

Early prediction of major depression in chronic hepatitis C patients during peg-interferon a-2b treatment by assessment of vegetative-depressive symptoms after four weeks

AIM: To study the predictive value of the vegetativedepressive symptoms of the Zung Depression Rating Scale for the occurrence of depression during treatment with peg-interferon α-2b of chronic hepatitis C (CHC)patients.METHODS: The predictive value of vegetativedepressive symptoms at 4 wk of treatment for the occurrence of a subsequent diagnosis of major depressive disorder (MDD) was studied in CHC patients infected after substance use in a prospective, multicenter treatment trial in Belgium. The presence of vegetative-depressive symptoms was assessed using the Zung Scale before and 4 wk after the start of antiviral treatment.RESULTS: Out of 49 eligible patients, 19 (39%)developed MDD. The area under the ROC curve of the vegetative Zung subscale was 0.73, P = 0.004. The sensitivity at a cut-point of ＞ 15/35 was 95% (95% CI:74-100). The positive predictive value equalled 44% (95%CI: 29-60).CONCLUSION: In this group of Belgian CHC patients infected after substance use, antiviral treatment caused a considerable risk of depression. Seven vegetativedepressive symptoms of the Zung scale at wk 4 of treatment predicted 95% of all emerging depressions, at a price of 56% false positive test results.