- Email: [email protected]
1.P.159 Assessment of liver function monitoring in the West of Scotland Coronary Prevention Study (WOSCOPS)
Monday 6 October 1997: Posters Clinical trials (prevention, regression)
50
diet, weight correction in patients with obesity, modification of other risk factors (arterial hypertension, smoking), exercise trainings. Hypolipidemic drugs were prescribed through 3-4 months after MI in case of inadequate decreasing of LDL ch. During hypolipidemic diet total ch, trig&rides and LDL ch was decreased by 12-15% in compare with initial levels (p < 0.01). More expressed changes of atherogenic lipids were revealed in patients who decreased body mass - significant reduction of total ch triglicerides, LDL ch (p < 0.01). Physical trainings were accompanied by HDL ch increasing (p < 0.05). In 45% of patients target level of LDL ch was not achieved without drugs to the end of 4-m month. In this cases statins were prescribed. Average lovastatin dose was 54 f 12 mg in a day, simvastatin average dose consisted 16f4mginaday.
1 1 .P. 158 ] Identilbtion of the most appropriate recipients of pravastatin therapy iu the West of Scotland Coronary Prevention Study (WOSCOPS) cohort J. Shepherd. For the WOSCOPS Glasgow, Scotland
Study Group;
Glasgow
Royal Injirmary,
WOSCOPS was a placebo-controlled trial that assessed the benefits of pravastatin (40 mg/day) in preventing coronary heart disease (CHD) events in 6595 men aged 45 to 64 years (y) with no history of myocardial infarction (MI) and plasma total cholesterol (TC) concentrations ~252 mg/dl at initial screening. Patients were followed for a mean of 4.9 y. The primary endpoint was definite CHD death or nonfatal MI. Multivariate analysis determined that independent predictors of the primary endpoint were treatment allocation, current smoking, diabetes mellitus, nitrate consumption, angina pectoris, family history, being a widower, increased age, diastolic blood pressure, and totaliHDL cholesterol ratio. Risk scores were calculated from results of the multivariate analysis and plotted to illustrate the relationship between risk and the probability of having an endpoint during the trial. Patients in the highest risk quartile, with a risk score ~6.2, had 45% of all coronary events and 59% of all cardiovascular deaths. Overall, 44%-&l% of all endpoints occurred in the top quartile of the respective risk distributions. Limiting treatment to patients in the highest risk quartile would affect many, but not a majority of coronary events, which occur in the greater number of patients at moderate risk. Since it may not be economically feasible to treat patients in lower risk groups prior to aggressive lifestyle intervention, the best approach to cholesterol screening and treatment targets moderateto high-risk persons. This approach is exemplified by the reports of the Adult Treatment Panel of the National Cholesterol Education Program (NCEP), European Task Force, and American College of Physicians. Retrospective analysis reveals that 77% of WOSCOPS patients fell within the categories for which the NCEP recommends drug treatment. In these patients, pravastatin therapy can be recommended as a safe and effective means of reducing tbe risk of major coronary events if lifestyle intervention has been unsuccessful.
LIzI159 1 P
Assessment of liver function monitoring in the West of Scotland Coronary Prevention Study (WOSCOPS)
J. Shepherd. For the WOSCOPS Glasgow, Scotland
Study Group:
Glasgow
Royal Injirmary,
The liver is the primary target organ for the cholesterol-lowering effects of pravastatin (PR). WOSCOPS allowed for the evaluation of liver function (LF) changes during PR treatment for a mean of 4.9 years. Since LF tests were performed sequentially, it was also possible to evaluate the effective-ness of liver enzyme (LE) monitoring as currently recommended. That recommendation is that LF tests be performed before starting treatment, at 6 and 12 weeks after initiating therapy or dose elevation, and then periodically (e.g., semiannually). During the trial, clinical laboratory profiles were obtained every 3 months in year 1 and then every 6 months. There were no differences between the PR and placebo (PL) groups in the percentage of patients with adverse events @Es) or serious treatment-emergent AEs of the hepatobiliary system (HBS) or in those discontinuing study drug for such AEs. The incidence of marked abnormalities of ALT or AST (3 x the upper limit of normal [ULN]) at any time during the trial was the same in both groups. Of 5794 patients with normal LF at Week 12 (Visit 1). 195 later had elevations zULN on 2 consecutive visits. No patient had consecutive ALT elevations >3 x ULN. For AST, 2 PR- and 1 PL-treated patient had elevations >3 x ULN. Compared to patients with normal LF at Week 12, the 131 patients with elevated ALT ZIZ AST at Week 12 were more likely to develop subsequent consecutive transaminase elevations. Elevated LEs found on routine monitoring were not associated with a clinical course leading to discontinuation of study medication due to HBS 11th International
Symposium
AEs. Periodic monitoring in asymptomatic patients does not identify those at risk for developing HBS-related AEs. Thus, after initiating treatment with PR or increasing the dosage, LEs should only be checked at the first follow-up visit. Beyond that visit, no other regularly scheduled LF monitoring appears to be required in asymptomatic patients with normal LF.
1 .P. 180
Serum lipid profile in patients with diierent clinical stages of squamous cell and small cell lung cancer
K. Siemianowicz, J. Gmidski, A. Telega, M. Stajszczyk, W. Wojakowski, M. Machalski, M. Goss. Department of Biochemistry and Chemistry, First Clinic of Internal Medicine, Silesian Medical Academy, Katowice, Poland Lipid disorders are one of the most common metabolic disfunctions. The positive correlation between high total cholesterol serum level and an increased morbidity is well documented. There are many studies indicating that the dependence between total serum cholesterol and morbidity is “U’‘-shaped curve and a low cholesterol level may increase the risk of death caused by cancer. Lung cancer is often indicated as a neoplasm reported among People with low cholesterol level. The serum lipid parameters in patients with lung cancer have been studied mainly in an aspect of comparing them with healthy people. Squamous cell lung cancer and small cell lung cancer differ not only in their histological type, but also in the intensity of neoplasm cells’ growth, the ability to metastase and the prognosis of treatment. These differences cause that these two histological types of lung cancer are regarded as two various diseases. The aim of our work was to evaluate serum lipid profile in patients with diierent clinical stages of squamous cell and small cell lung cancer. 135 patients with these histological types of lung cancer were qualified into the study. All of them have taken neither chemotherapy, radiotherapy nor surgical treatment before blood samples collection. Serum levels of total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and phospholipids were determined. Lipoprotein electrophoresis was performed. Cholesterol esters composition was analyzed by thin-layer chromatography. The obtained results were statistically analysed using the ANOVA test. In all evaluated serum lipid parameters there were no statistically significant differences between patients with squamous cell and small cell lung cancer, neither between different clinical stages of each neoplasm. The obtained results indicate that the decrease in serum lipid parameters in patients with squamous cell and small cell lung cancer is not correlated with the clinical.
rll
1 P 181
The effect of statin therapy on common carotid artery intimal thickness in patients with familial hyperlipidemia
J. Soaccil, R. CeSka, J. PetrBek, J. Sobra. IHrd Dep. of Internal Charles University Hospital, Prague 2, Czech Rep
Medicine,
Using sonography, the common carotid artery (ACC) diameter, peak velocity and intimal thickness (IT) was examined in patients with familial hyperlipidemias before and after 47 months of treatment. In 25 patients with familial hypercholesterolemia (FH) without coronary heart disease and stroke or TIA, total cholesterol (TC) decreased from 9.3 to 7.7 mmohl, ACC diameter didn’t change, velocity decreased from 94 to 78 cm/s and ACC IT decreased from 0.78 f. 0.22 to 0.69 f 0.17 mm (p = 0.004). In 27 patients with combined hyperlipidemia TC and triglycerides (TG) decreased from 8.5 to 7.0 mmol/l and from 4.1. to 3.0 mmolll respectively, ACC IT decreased from 0.72 f 0.22 to 0.67 * 0.15 mm (p = 0.044). In the treatment of FH we used statins, in combined hyperlipidemia we used fibrate (mostly micronised fenofibrate) frequently Combined drug therapy has been used as well in several cases. In 31 patients treated with statins TC and TG decreased from 9.5 to 7.3 and 2.6 to 2.3 mmol/l respectively, peak velocity decreased from 93 to 73 cm/s, ACC diameter increased from 0.6 to 0.65 cm (p = 0.001) and ACC IT decreased from 0.84 f 0.26 to 0.75 f 0.2 mm (p = 0.006). These findings indicate a beneficial effect of hypolipidemic drugs (particularly statins) on development of atherosclerosis in patients with familial hyperlipidemia.
I
1 P. 162
Follow-up of hypercholesterolaemic participating in a clinical trial
A. Svilaas, 0. Kolbjiimsen, E. Strom, Rikshospitalet, Oslo, Norway For five years
on Atherosclerosis,
107 patients
Paris, October
with 1997
patients after
P. Bye, S. Tonstad,
primary
hyperlipidaemia
L. Ose. Lipid Clinic, participated
in a
50
diet, weight correction in patients with obesity, modification of other risk factors (arterial hypertension, smoking), exercise trainings. Hypolipidemic drugs were prescribed through 3-4 months after MI in case of inadequate decreasing of LDL ch. During hypolipidemic diet total ch, trig&rides and LDL ch was decreased by 12-15% in compare with initial levels (p < 0.01). More expressed changes of atherogenic lipids were revealed in patients who decreased body mass - significant reduction of total ch triglicerides, LDL ch (p < 0.01). Physical trainings were accompanied by HDL ch increasing (p < 0.05). In 45% of patients target level of LDL ch was not achieved without drugs to the end of 4-m month. In this cases statins were prescribed. Average lovastatin dose was 54 f 12 mg in a day, simvastatin average dose consisted 16f4mginaday.
1 1 .P. 158 ] Identilbtion of the most appropriate recipients of pravastatin therapy iu the West of Scotland Coronary Prevention Study (WOSCOPS) cohort J. Shepherd. For the WOSCOPS Glasgow, Scotland
Study Group;
Glasgow
Royal Injirmary,
WOSCOPS was a placebo-controlled trial that assessed the benefits of pravastatin (40 mg/day) in preventing coronary heart disease (CHD) events in 6595 men aged 45 to 64 years (y) with no history of myocardial infarction (MI) and plasma total cholesterol (TC) concentrations ~252 mg/dl at initial screening. Patients were followed for a mean of 4.9 y. The primary endpoint was definite CHD death or nonfatal MI. Multivariate analysis determined that independent predictors of the primary endpoint were treatment allocation, current smoking, diabetes mellitus, nitrate consumption, angina pectoris, family history, being a widower, increased age, diastolic blood pressure, and totaliHDL cholesterol ratio. Risk scores were calculated from results of the multivariate analysis and plotted to illustrate the relationship between risk and the probability of having an endpoint during the trial. Patients in the highest risk quartile, with a risk score ~6.2, had 45% of all coronary events and 59% of all cardiovascular deaths. Overall, 44%-&l% of all endpoints occurred in the top quartile of the respective risk distributions. Limiting treatment to patients in the highest risk quartile would affect many, but not a majority of coronary events, which occur in the greater number of patients at moderate risk. Since it may not be economically feasible to treat patients in lower risk groups prior to aggressive lifestyle intervention, the best approach to cholesterol screening and treatment targets moderateto high-risk persons. This approach is exemplified by the reports of the Adult Treatment Panel of the National Cholesterol Education Program (NCEP), European Task Force, and American College of Physicians. Retrospective analysis reveals that 77% of WOSCOPS patients fell within the categories for which the NCEP recommends drug treatment. In these patients, pravastatin therapy can be recommended as a safe and effective means of reducing tbe risk of major coronary events if lifestyle intervention has been unsuccessful.
LIzI159 1 P
Assessment of liver function monitoring in the West of Scotland Coronary Prevention Study (WOSCOPS)
J. Shepherd. For the WOSCOPS Glasgow, Scotland
Study Group:
Glasgow
Royal Injirmary,
The liver is the primary target organ for the cholesterol-lowering effects of pravastatin (PR). WOSCOPS allowed for the evaluation of liver function (LF) changes during PR treatment for a mean of 4.9 years. Since LF tests were performed sequentially, it was also possible to evaluate the effective-ness of liver enzyme (LE) monitoring as currently recommended. That recommendation is that LF tests be performed before starting treatment, at 6 and 12 weeks after initiating therapy or dose elevation, and then periodically (e.g., semiannually). During the trial, clinical laboratory profiles were obtained every 3 months in year 1 and then every 6 months. There were no differences between the PR and placebo (PL) groups in the percentage of patients with adverse events @Es) or serious treatment-emergent AEs of the hepatobiliary system (HBS) or in those discontinuing study drug for such AEs. The incidence of marked abnormalities of ALT or AST (3 x the upper limit of normal [ULN]) at any time during the trial was the same in both groups. Of 5794 patients with normal LF at Week 12 (Visit 1). 195 later had elevations zULN on 2 consecutive visits. No patient had consecutive ALT elevations >3 x ULN. For AST, 2 PR- and 1 PL-treated patient had elevations >3 x ULN. Compared to patients with normal LF at Week 12, the 131 patients with elevated ALT ZIZ AST at Week 12 were more likely to develop subsequent consecutive transaminase elevations. Elevated LEs found on routine monitoring were not associated with a clinical course leading to discontinuation of study medication due to HBS 11th International
Symposium
AEs. Periodic monitoring in asymptomatic patients does not identify those at risk for developing HBS-related AEs. Thus, after initiating treatment with PR or increasing the dosage, LEs should only be checked at the first follow-up visit. Beyond that visit, no other regularly scheduled LF monitoring appears to be required in asymptomatic patients with normal LF.
1 .P. 180
Serum lipid profile in patients with diierent clinical stages of squamous cell and small cell lung cancer
K. Siemianowicz, J. Gmidski, A. Telega, M. Stajszczyk, W. Wojakowski, M. Machalski, M. Goss. Department of Biochemistry and Chemistry, First Clinic of Internal Medicine, Silesian Medical Academy, Katowice, Poland Lipid disorders are one of the most common metabolic disfunctions. The positive correlation between high total cholesterol serum level and an increased morbidity is well documented. There are many studies indicating that the dependence between total serum cholesterol and morbidity is “U’‘-shaped curve and a low cholesterol level may increase the risk of death caused by cancer. Lung cancer is often indicated as a neoplasm reported among People with low cholesterol level. The serum lipid parameters in patients with lung cancer have been studied mainly in an aspect of comparing them with healthy people. Squamous cell lung cancer and small cell lung cancer differ not only in their histological type, but also in the intensity of neoplasm cells’ growth, the ability to metastase and the prognosis of treatment. These differences cause that these two histological types of lung cancer are regarded as two various diseases. The aim of our work was to evaluate serum lipid profile in patients with diierent clinical stages of squamous cell and small cell lung cancer. 135 patients with these histological types of lung cancer were qualified into the study. All of them have taken neither chemotherapy, radiotherapy nor surgical treatment before blood samples collection. Serum levels of total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and phospholipids were determined. Lipoprotein electrophoresis was performed. Cholesterol esters composition was analyzed by thin-layer chromatography. The obtained results were statistically analysed using the ANOVA test. In all evaluated serum lipid parameters there were no statistically significant differences between patients with squamous cell and small cell lung cancer, neither between different clinical stages of each neoplasm. The obtained results indicate that the decrease in serum lipid parameters in patients with squamous cell and small cell lung cancer is not correlated with the clinical.
rll
1 P 181
The effect of statin therapy on common carotid artery intimal thickness in patients with familial hyperlipidemia
J. Soaccil, R. CeSka, J. PetrBek, J. Sobra. IHrd Dep. of Internal Charles University Hospital, Prague 2, Czech Rep
Medicine,
Using sonography, the common carotid artery (ACC) diameter, peak velocity and intimal thickness (IT) was examined in patients with familial hyperlipidemias before and after 47 months of treatment. In 25 patients with familial hypercholesterolemia (FH) without coronary heart disease and stroke or TIA, total cholesterol (TC) decreased from 9.3 to 7.7 mmohl, ACC diameter didn’t change, velocity decreased from 94 to 78 cm/s and ACC IT decreased from 0.78 f. 0.22 to 0.69 f 0.17 mm (p = 0.004). In 27 patients with combined hyperlipidemia TC and triglycerides (TG) decreased from 8.5 to 7.0 mmol/l and from 4.1. to 3.0 mmolll respectively, ACC IT decreased from 0.72 f 0.22 to 0.67 * 0.15 mm (p = 0.044). In the treatment of FH we used statins, in combined hyperlipidemia we used fibrate (mostly micronised fenofibrate) frequently Combined drug therapy has been used as well in several cases. In 31 patients treated with statins TC and TG decreased from 9.5 to 7.3 and 2.6 to 2.3 mmol/l respectively, peak velocity decreased from 93 to 73 cm/s, ACC diameter increased from 0.6 to 0.65 cm (p = 0.001) and ACC IT decreased from 0.84 f 0.26 to 0.75 f 0.2 mm (p = 0.006). These findings indicate a beneficial effect of hypolipidemic drugs (particularly statins) on development of atherosclerosis in patients with familial hyperlipidemia.
I
1 P. 162
Follow-up of hypercholesterolaemic participating in a clinical trial
A. Svilaas, 0. Kolbjiimsen, E. Strom, Rikshospitalet, Oslo, Norway For five years
on Atherosclerosis,
107 patients
Paris, October
with 1997
patients after
P. Bye, S. Tonstad,
primary
hyperlipidaemia
L. Ose. Lipid Clinic, participated
in a