- Email: [email protected]
An epidemiological study in school children
AJH–April 2001–VOL. 14, NO. 4, PART 2
POSTERS: Epidemiology/Special Populations
entered the study after giving their informed consent. All of them were considered valuable for the safety analysis and 4227 for the effectiveness analysis. The follow-up period lasted between 3 and 9 months on treatment with doxazosin standard (Phase 1) and then patients were switched to doxazosin GITS (4 mg o.d.) and followed for 3 additional months (Phase 2). Outcome measures included blood pressure, compliance and incidence of adverse events (AE). Results: Mean age of the patients (50.6% male) was 62.4⫾10.6 years. A total of 343 adverse events (7.2%) were reported in 322 patients, 38 of which were serious (0.9%). AE were observed in 264 patients (5.85%) while treated with doxazosin standard, being 28 serious. Most of the AE were mild or moderate. Seventy-seven percent of patients received doxazosin as monotherapy and 29.3% as add-on therapy. Mean SBP and DBP values for the both groups, monotherapy and combination therapy were as follows:
SBP (mmHg)
DBP (mmHg)
Monotherapy Combination Therapy Monotherapy Combination Therapy
Baseline
End Phase 1 (dox. Standard)
End Phase 2 (dox.GITS)
160.6 ⫾ 10.5 161.7 ⫾ 10.9
137.9 ⫾ 11.2 141.4 ⫾ 12.9
134.2 ⫾ 10.1 137.4 ⫾ 12.1
95.6 ⫾ 6.8 94.7 ⫾ 7.9
81.6 ⫾ 7.4 82.7 ⫾ 7.6
79.1 ⫾ 7 79.8 ⫾ 7.5
Significant reductions in the mean values of SBP and DBP were observed in both groups (p⬍0.01). As a conclusion these results showed that switching doxazosin GITS from the standard form is safe and may improve effectiveness in reducing blood pressure. Grant/Research Support: Pfizer Key Words: Effectiveness, Doxazosin GITS, Safety
P-490 PROJECTED RISKS AND COSTS OF CARDIOVASCULAR DISEASE DUE TO INCREASED SYSTOLIC BLOOD PRESSURE ASSOCIATED WITH USE OF ROFECOXIB Mason W. Russell, Jeffrey D. Miller, Douglas C.A. Taylor, Daniel M. Huse. 1ICSL Healthcare Research, Waltham, MA, United States In a recent randomized clinical trial involving hypertensive osteoarthritic subjects, use of rofecoxib 25 mg/day was associated with a 3.07 torr mean increase (95% CI 1.06-5.08) in systolic blood pressure versus celecoxib 200 mg/day. We estimated the potential impact of this increase on coronary heart disease (CHD) and stroke morbidity and mortality among hypertensive U.S. adults with osteoarthritis. Published Framingham Heart Study cardiovascular risk models and costs of CHD and stroke treatment were used in conjunction with risk factor data on hypertensive osteoarthritics obtained from the Third National Health and Nutrition Examination Survey to estimate occurrences and associated costs of CHD (sudden and nonsudden CHD death, acute myocardial infarction, unstable and stable angina) and stroke over 4 years. The effect of the mean increase in systolic blood pressure on event occurrence and costs was then estimated. The sensitivity of findings with respect to variations in the effect of rofecoxib vs. celecoxib on systolic blood pressure over the 95% confidence interval was assessed through Monte Carlo simulation. Among the estimated 10.2 million U.S. osteoarthritics aged 35⫹ years who are hypertensive, a 3.07 torr increase in systolic blood pressure may be associated with 21,800 additional CHD events (95% CI 7,400-35,200; 22% fatal) and 22,100 additional stroke events (95% CI 7,600-36,600; 26% fatal) over 4 years. Associated costs of treating these events are estimated at US$650 million (95% CI US$133 million-$1.06 billion). Findings from this population-based epidemiologic model suggest that the increase in systolic blood pressure associated with use of rofecoxib in the clinical trial may result in significant cardiovascular morbidity and
195A
mortality if left unmanaged, and thus may require more aggressive blood pressure management than otherwise warranted. Affiliation/Financial Interest: Pharmacia Corp. & Pfizer, Inc. Consultant: Pharmacia Corp. & Pfizer, Inc. Key Words: cardiovascular disease, COX-2 inhibitors, hypertension
P-491 AN EPIDEMIOLOGICAL STUDY IN SCHOOL CHILDREN Virgilio Di Legge, Michela Simi, Daniele Faraggiana, Marco Terrazzi, Sergio Spagnolo, Vittorio Taccini, Cataldo Graci. 1ANCE, Pisa, Italy, 2 FMSI, Pisa, Italy Blood pressure (BP) is influenced by genetic factors and some cardiovascular risk factors developed at an early age tend to remain throughout adulthood. On the other hand a regular physical activity (PA) decreases development of cardiovascular disease. This study analyses life-style of 1015 school children (girls:475 boys: 540; 11-12 years) participating in a screening for cardiovascular risk factors that took place in the suburban area of Pisa. During the baseline examination, systolic (SBP) and diastolic (DBP) BP, body mass index (BMI) and skinfold thickness (ST) were taken; the parents were asked to fill in a questionnaire that included demographic data, family history, parent’s weight and height, children’s perinatal measurements (birth weight, birth length and head circumference) and his or her actual involvement in PA. The results showed a positive correlation between parental and children’s BMI (paternal BMI p ⬍0.01 r⫽0,2; maternal BMI p⬍0.001 r⫽0.4), children’s BP and children’s BMI (SBP p⬍0.001 r⫽0.4; DBP p⬍0.001 r⫽0,3); a negative correlation between PA and SBP (p⬍0.001 r⫽0,3), DBP (p⬍0.001 r⫽0,4), children’s BMI (p⬍0.001 r⫽0,4), ST (p⬍0.001 r⫽0,2) and heart rate (0,04 r⫽0,2). Step-wise multiple regression analysis with BP values as dependent variable and children’s, birth’s and parent’s antropometric measurements, familial history of disease and PA as independent variables showed that PA and children’s BMI were the variables carrying the greatest weight on BP values; furthermore step-wise multiple regression analysis with children’s BMI as dependent variable and birth’s and parent’s antropometric measurements, familial history of disease and PA as independent variables showed that PA was the variables carrying the greatest weight on children’s BMI. In conclusion our results shown that BP and BMI are independently related to PA in children; these data suggests that an early intervention with PA might have favourable effects in prevention of hypertension and obesity among adults. Key Words: epidemiology, prevention, physical activity
P-492 PARENTAL SMOKING AND CARDIOVASCULAR RISK FACTORS IN SCHOOL CHILDREN Virgilio Di Legge, Michela Simi, Daniele Faraggiana, Marco Terrazzi, Sergio Spagnolo, Vittorio Taccini, Cataldo Graci. 1ANCE, Pisa, Italy, 2 FMSI, Pisa, Italy Smokers have multiple adverse health-related behaviours and an increased risk of cardiovascular disease. We examined whether health behaviours in parents who smoke may influence children’s health behaviours. This study analyses the life-style habits of 1015 school children (girls:475 boys: 540; 11-12 years) participating in a screening for cardiovascular risk factors that took place in the suburban area of Pisa. During the baseline children’s examination, parents were asked to fill in a questionnaire that included parent’s smoking habits and children’s demographic data including actual involvement in physical activity. Parent’s smoking was additive predictor in children of lower physical activity (p ⬍0.01); furthermore children’s body mass index (p⬍0.001) and blood pressure values (p⬍0.001) were significantly greater if parents smoked. In conclusions these data seem to suggest that health behaviours
POSTERS: Epidemiology/Special Populations
entered the study after giving their informed consent. All of them were considered valuable for the safety analysis and 4227 for the effectiveness analysis. The follow-up period lasted between 3 and 9 months on treatment with doxazosin standard (Phase 1) and then patients were switched to doxazosin GITS (4 mg o.d.) and followed for 3 additional months (Phase 2). Outcome measures included blood pressure, compliance and incidence of adverse events (AE). Results: Mean age of the patients (50.6% male) was 62.4⫾10.6 years. A total of 343 adverse events (7.2%) were reported in 322 patients, 38 of which were serious (0.9%). AE were observed in 264 patients (5.85%) while treated with doxazosin standard, being 28 serious. Most of the AE were mild or moderate. Seventy-seven percent of patients received doxazosin as monotherapy and 29.3% as add-on therapy. Mean SBP and DBP values for the both groups, monotherapy and combination therapy were as follows:
SBP (mmHg)
DBP (mmHg)
Monotherapy Combination Therapy Monotherapy Combination Therapy
Baseline
End Phase 1 (dox. Standard)
End Phase 2 (dox.GITS)
160.6 ⫾ 10.5 161.7 ⫾ 10.9
137.9 ⫾ 11.2 141.4 ⫾ 12.9
134.2 ⫾ 10.1 137.4 ⫾ 12.1
95.6 ⫾ 6.8 94.7 ⫾ 7.9
81.6 ⫾ 7.4 82.7 ⫾ 7.6
79.1 ⫾ 7 79.8 ⫾ 7.5
Significant reductions in the mean values of SBP and DBP were observed in both groups (p⬍0.01). As a conclusion these results showed that switching doxazosin GITS from the standard form is safe and may improve effectiveness in reducing blood pressure. Grant/Research Support: Pfizer Key Words: Effectiveness, Doxazosin GITS, Safety
P-490 PROJECTED RISKS AND COSTS OF CARDIOVASCULAR DISEASE DUE TO INCREASED SYSTOLIC BLOOD PRESSURE ASSOCIATED WITH USE OF ROFECOXIB Mason W. Russell, Jeffrey D. Miller, Douglas C.A. Taylor, Daniel M. Huse. 1ICSL Healthcare Research, Waltham, MA, United States In a recent randomized clinical trial involving hypertensive osteoarthritic subjects, use of rofecoxib 25 mg/day was associated with a 3.07 torr mean increase (95% CI 1.06-5.08) in systolic blood pressure versus celecoxib 200 mg/day. We estimated the potential impact of this increase on coronary heart disease (CHD) and stroke morbidity and mortality among hypertensive U.S. adults with osteoarthritis. Published Framingham Heart Study cardiovascular risk models and costs of CHD and stroke treatment were used in conjunction with risk factor data on hypertensive osteoarthritics obtained from the Third National Health and Nutrition Examination Survey to estimate occurrences and associated costs of CHD (sudden and nonsudden CHD death, acute myocardial infarction, unstable and stable angina) and stroke over 4 years. The effect of the mean increase in systolic blood pressure on event occurrence and costs was then estimated. The sensitivity of findings with respect to variations in the effect of rofecoxib vs. celecoxib on systolic blood pressure over the 95% confidence interval was assessed through Monte Carlo simulation. Among the estimated 10.2 million U.S. osteoarthritics aged 35⫹ years who are hypertensive, a 3.07 torr increase in systolic blood pressure may be associated with 21,800 additional CHD events (95% CI 7,400-35,200; 22% fatal) and 22,100 additional stroke events (95% CI 7,600-36,600; 26% fatal) over 4 years. Associated costs of treating these events are estimated at US$650 million (95% CI US$133 million-$1.06 billion). Findings from this population-based epidemiologic model suggest that the increase in systolic blood pressure associated with use of rofecoxib in the clinical trial may result in significant cardiovascular morbidity and
195A
mortality if left unmanaged, and thus may require more aggressive blood pressure management than otherwise warranted. Affiliation/Financial Interest: Pharmacia Corp. & Pfizer, Inc. Consultant: Pharmacia Corp. & Pfizer, Inc. Key Words: cardiovascular disease, COX-2 inhibitors, hypertension
P-491 AN EPIDEMIOLOGICAL STUDY IN SCHOOL CHILDREN Virgilio Di Legge, Michela Simi, Daniele Faraggiana, Marco Terrazzi, Sergio Spagnolo, Vittorio Taccini, Cataldo Graci. 1ANCE, Pisa, Italy, 2 FMSI, Pisa, Italy Blood pressure (BP) is influenced by genetic factors and some cardiovascular risk factors developed at an early age tend to remain throughout adulthood. On the other hand a regular physical activity (PA) decreases development of cardiovascular disease. This study analyses life-style of 1015 school children (girls:475 boys: 540; 11-12 years) participating in a screening for cardiovascular risk factors that took place in the suburban area of Pisa. During the baseline examination, systolic (SBP) and diastolic (DBP) BP, body mass index (BMI) and skinfold thickness (ST) were taken; the parents were asked to fill in a questionnaire that included demographic data, family history, parent’s weight and height, children’s perinatal measurements (birth weight, birth length and head circumference) and his or her actual involvement in PA. The results showed a positive correlation between parental and children’s BMI (paternal BMI p ⬍0.01 r⫽0,2; maternal BMI p⬍0.001 r⫽0.4), children’s BP and children’s BMI (SBP p⬍0.001 r⫽0.4; DBP p⬍0.001 r⫽0,3); a negative correlation between PA and SBP (p⬍0.001 r⫽0,3), DBP (p⬍0.001 r⫽0,4), children’s BMI (p⬍0.001 r⫽0,4), ST (p⬍0.001 r⫽0,2) and heart rate (0,04 r⫽0,2). Step-wise multiple regression analysis with BP values as dependent variable and children’s, birth’s and parent’s antropometric measurements, familial history of disease and PA as independent variables showed that PA and children’s BMI were the variables carrying the greatest weight on BP values; furthermore step-wise multiple regression analysis with children’s BMI as dependent variable and birth’s and parent’s antropometric measurements, familial history of disease and PA as independent variables showed that PA was the variables carrying the greatest weight on children’s BMI. In conclusion our results shown that BP and BMI are independently related to PA in children; these data suggests that an early intervention with PA might have favourable effects in prevention of hypertension and obesity among adults. Key Words: epidemiology, prevention, physical activity
P-492 PARENTAL SMOKING AND CARDIOVASCULAR RISK FACTORS IN SCHOOL CHILDREN Virgilio Di Legge, Michela Simi, Daniele Faraggiana, Marco Terrazzi, Sergio Spagnolo, Vittorio Taccini, Cataldo Graci. 1ANCE, Pisa, Italy, 2 FMSI, Pisa, Italy Smokers have multiple adverse health-related behaviours and an increased risk of cardiovascular disease. We examined whether health behaviours in parents who smoke may influence children’s health behaviours. This study analyses the life-style habits of 1015 school children (girls:475 boys: 540; 11-12 years) participating in a screening for cardiovascular risk factors that took place in the suburban area of Pisa. During the baseline children’s examination, parents were asked to fill in a questionnaire that included parent’s smoking habits and children’s demographic data including actual involvement in physical activity. Parent’s smoking was additive predictor in children of lower physical activity (p ⬍0.01); furthermore children’s body mass index (p⬍0.001) and blood pressure values (p⬍0.001) were significantly greater if parents smoked. In conclusions these data seem to suggest that health behaviours