Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study.

Four methods for measuring volar angulation in 5th metacarpal neck fractures were tested for validity and reliability. Mid-medullary canal measurement in the lateral view (method MC-90) has previously been proven valid in a cadaveric study, hence used as a reference to test validity of the latter three. These three yielded a significant different mean fracture angle compared with MC-90, with only minor enhancement in reliability. Therefore, none of these three methods is recommended as a better standard method than the MC-90, where reliability was found to be substantial (intraclass correlation coefficient 0.53-0.81). Two methods for measuring shortening in 5th metacarpal neck fractures were compared, and stipulation of shortening by drawing a line through the most distal point of the heads of the neighbouring 3rd and 4th metacarpals (method SH-Stip) is a simple method with excellent reliability (intraclass correlation coefficient 0.81-0.96) for estimating shortening, requiring only radiological examination of the injured hand.

A randomized, multicentre, double-blind, parallel-group study to assess the adverse event-related discontinuation rate with celecoxib and diclofenac in elderly patients with osteoarthritis.

OBJECTIVE: To compare the adverse event (AE)-related discontinuation rate with celecoxib vs. diclofenac when given to reduce joint pain associated with knee or hip osteoarthritis (OA) in elderly patients. METHODS: This was a double-blind, randomized, multicentre, parallel-group, 1-year comparison of celecoxib 200 mg once daily and diclofenac 50 mg twice daily in 925 patients with OA aged > or = 60 years. Study visits were at baseline and at 4, 13, 26, 39, and 52 weeks. At each visit, the Patient's and Physician's Global Assessment of Arthritis (PaGAA, PhGAA), the Patient's Assessment of Arthritis Pain--Visual Analogue Scale (PAAP-VAS), and AEs were assessed. A concomitant health economic analysis was conducted throughout. RESULTS: The rate of study discontinuation due to AEs, laboratory abnormalities, and deaths was 27% for celecoxib and 31% for diclofenac (p = 0.22). The results of the arthritis/pain efficacy assessments were similar for celecoxib and diclofenac. Significantly fewer patients in the celecoxib group than the diclofenac group experienced cardiovascular/renal AEs (70/458 vs. 95/458, p = 0.039) or hepatic AEs (10/458 vs. 39/458, p<0.0001). Medication costs were higher for celecoxib than diclofenac but mean total treatment cost was slightly higher in the diclofenac group. CONCLUSION: Treatment with celecoxib 200 mg once daily and diclofenac 50 mg twice daily resulted in similar rates of AE-related study discontinuation in elderly patients with OA. Celecoxib and diclofenac demonstrated comparable efficacy in relieving the signs and symptoms of OA. However, the proportion of patients with cardiorenal and hepatic AEs was significantly lower in the celecoxib group than the diclofenac group.

Prognostic value of two-dimensional echocardiography and N-terminal proatrial natriuretic peptide following an acute myocardial infarction. Assessment of baseline values (2-7 days) and changes at 3 months in patients with a preserved systolic function.

AIMS: The purpose of this prospective, observational study was to evaluate the relationship of left ventricular volumes, systolic function and plasma N-terminal proatrial natriuretic peptide (Nt-proANP) to cardiac morbidity and mortality in post-myocardial infarction patients with left ventricular ejection fraction > or =40%. METHODS AND RESULTS: Two-dimensional echocardiographic recordings and Nt-proANP measurements were obtained in 834 patients who survived acute myocardial infarction. Patients were examined at 2-7 days and 3 months after the index infarction and followed up for 24 months. All measurements of left ventricular volumes, ejection fraction and Nt-proANP were performed in core laboratories. During follow-up 102 patients sustained one or more incidents of the combined primary end-point: cardiac death (n=11), recurrent infarction (n=55) or heart failure requiring hospitalization or treatment with an ACE inhibitor and a diuretic (n=52). Using Cox proportional hazards model, baseline Nt-proANP predicted these events (chi-square 25.3, P<0.0001), while baseline echo volumes and ejection fraction did not. During the subsequent 3-24 month period, 51 patients suffered a primary end-point: cardiac death (n=9), recurrent infarction (n=29), heart failure (n=21). An increase in left ventricular end-systolic volume was the strongest predictor for adverse events (chi-square 19.1, P<0.0001), especially for heart failure. Individual changes in Nt-proANP did not predict cardiac events, whereas both echocardiographic variables and Nt-proANP measured at 3 months had a prognostic impact on subsequent cardiac events (3-24 months). CONCLUSIONS: In post-myocardial infarction patients with preserved left ventricular function (left ventricular ejection fraction > or =40%) baseline Nt-proANP, but not echocardiographic left ventricular volumes predicted adverse cardiac events. Early changes in left ventricular volumes and ejection fraction from baseline to 3 months had a further prognostic impact on subsequent events (3-24 months).

Effects of fluvastatin on cardiac events in renal transplant patients: ALERT (Assessment of Lescol in Renal Transplantation) study design and baseline data.

BACKGROUND: Recent clinical trials of primary and secondary prevention of cardiovascular disease have demonstrated that lowering plasma cholesterol with 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors ('statins') reduces morbidity and mortality from coronary heart disease in diverse patient populations. STUDY AIMS: The aim of the present ALERT (Assessment of Lescol in Renal Transplantation) study is to determine whether renal transplant recipients would also benefit from statin therapy. ALERT is a multicentre, randomized, double-blind, placebo-controlled trial to assess the effect of fluvastatin in renal transplant recipients with mild-to-moderate hypercholesterolaemia. The primary objective is to investigate the effects of fluvastatin on major adverse cardiac events (MACE). In addition, the effects on cardiovascular and all-cause mortality, as well as renal function, will be addressed. STUDY POPULATION: The study population contains patients with functioning renal allografts of more than 6 months' duration, recruited from 75 centres in Northern Europe and Canada. Patients of both sexes, aged 30-75 years, with a total cholesterol level of 4.0-9.0 mmol/l (155-348 mg/dl) were included, except for those with a history of myocardial infarction, where the upper limit for inclusion was 7.0 mmol/l (270 mg/dl). STUDY DESIGN: A total of 2100 patients were recruited by the end of October 1997 and will be followed for up to 6 years. This report presents the design features of the study (recruitment, follow-up, sample size, data analysis and study organization), along with baseline results. ALERT is the first large-scale prospective, randomized, double-blind study to address the prevention of cardiovascular mortality in renal transplant patients receiving an HMGCoA reductase inhibitor.

Reproducibility of quantitative arteriographic assessment of atherosclerosis in the femoral artery.

Results from computer-analysed angiograms in the Probucol Quantitative Regression Swedish Trial (PQRST) were analysed to determine the reproducibility of the method and any drift in the analysing system. The precision index (P(mu)) for 2 angiography series, made at 10 min intervals, of the femoral artery in 276 patients was 10.5 for lumen volume and 21.9 for roughness (edge irregularity). No difference in reproducibility was found between patients with and without symptoms of peripheral atherosclerosis or when looking at the reproducibility over years. A drift of 0.67% per year in the radiographic equipment (but not in the analysis system) was found, confirmed by use of phantoms. Computer-based analysis of femoral atherosclerosis is a reliable method for follow-up trials, giving high reproducibility even if the trial spans over several years and involves different centres. The use of phantoms is essential for checking the method over time.

Socio-economic status as a coronary risk factor: the Oslo study.

The association between socioeconomic status, measured by a combination of income and education, and CHD mortality has been studied in a cohort of 40-49 year old Oslo men. Socio-economic status was significantly associated with CHD mortality. However, the lowest CHD mortality was found in social status Group III (middle class) and this could not be explained by the risk factor gradients seen among those studied. Although the number of fatalities is small (68 CHD deaths during 4.5 years) socio-economic status seems to be independently associated with coronary risk after adjusting for serum cholesterol, systolic blood pressure and cigarette smoking.

Physical activity at work and at leisure in relation to coronary risk factors and social class. A 4-year mortality follow-up. The Oslo study.

The association between physical activity at work and at leisure, coronary risk factors, social class and mortality has been studied in about 15000 Oslo men, aged 40-49, without known cardiovascular disease or diabetes at a screening examination for coronary risk factors. Four-year total and CHD mortality showed a decrease with increasing degree of leisure activity, and an increase with increasing work activity. The three conventional coronary risk factors--serum cholesterol, systolic blood pressure (SBP) and number of cigarettes--associated negatively with physical leisure activity, whereas they all associated positively with physical activity at work. Men in lower social classes were less active at leisure but more active at work than men in the higher classes. In a multivariate analysis of variance with coronary risk score (based on SBP, serum total cholesterol and number of cigarettes), social class and physical activity, the predictive power of physical leisure activity for future death was almost as good as the coronary risk score. Physical activity at work, on the other hand, was not an independent risk factor either for total or for CHD mortality.

Four-year mortality by some socioeconomic indicators: the Oslo study.

The association between four-year mortality and some socioeconomic indicators has been studied in al Oslo men aged 40--49, invited to a screening programme for cardiovascular disease, and in a 'healthy' subgroup of participating men free of cardiovascular disease and diabetes at screening. The lowest social class exhibited a much higher total mortality than the other classes. This was pronounced for a variety of causes of death, such as cancer of the lung, accidents and homicide, and coronary heart disease. The negative mortality gradient by increasing socioeconomic status can to a certain degree be 'explained' by the coronary risk factor pattern.