- Email: [email protected]
Sirolimus- versus paclitaxel-eluting stents in patients with acute myocardial infarction: A meta-analysis of randomized trials
234
Letters to the Editor
Sirolimus- versus paclitaxel-eluting stents in patients with acute myocardial infarction: A meta-analysis of randomized trials Raffaele Piccolo, Salvatore Cassese, Gennaro Galasso, Roberta De Rosa, Carolina D'Anna, Federico Piscione ⁎ Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via S. Pansini, 5, 80131, Naples, Italy
a r t i c l e
i n f o
Article history: Received 23 July 2010 Accepted 2 October 2010 Available online 9 November 2010 Keywords: Sirolimus-eluting stent Paclitaxel-eluting stent Drug-eluting stent Myocardial infarction PCI Meta-analysis
Primary percutaneous coronary intervention (PCI) is the standard of care in patients with acute ST-segment elevation myocardial infarction (STEMI), since it is associated with a mortality reduction as compared with thrombolytic therapy alone. At this regard, we have previously demonstrated that drugeluting stents are more effective than bare-metal stents in reducing the need for repeat revascularization of target vessel, without safety concerns [1,2]. However, it is unclear whether there are differences in clinical outcomes between sirolimus- (SES) and paclitaxel-eluting stent (PES). Herein, we report a meta-analysis of randomized studies comparing SES versus PES in patients undergoing primary PCI. An electronic search was performed in Medline, EMBASE, scientific session abstracts in Circulation, Journal of the American College of Cardiology, European Heart Journal and The American Journal of Cardiology, and relevant websites, from inception of each database until July 2010. No language restriction was enforced. The key words used were: “myocardial infarction”, “ST-segment elevation”, “percutaneous coronary intervention”, “drug-eluting stent”, “sirolimuseluting stent”, and “paclitaxel-eluting stent”. To be included, the citation had to meet the following criteria: 1) random treatment allocation and 2) availability of complete clinical features. Exclusion criteria were: 1) ongoing studies and 2) irretrievable data. Two investigators independently assessed reports for eligibility, with divergences resolved by consensus. The primary endpoint was target-vessel revascularization (TVR). Secondary endpoints were: cardiac death, recurrent myocardial infarction and stent thrombosis. All clinical endpoints were evaluated at the longest available follow-up. Statistical analysis was performed with Review Manager 5.0.16 (RevMan, The Nordic Cochrane Centre, The Cochrane Collaboration, 2008). The pooled odds ratio (OR) was calculated by using the fixed effects Mantel–Hænzel model. Heterogeneity was appraised by using both Breslow–Day chi-squared test (p < 0.1) and I2 statistic, which
⁎ Corresponding author. Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via S. Pansini, 5. 80131. Naples, Italy. Tel.: + 39 0817462234; fax: + 39 0817462229. E-mail address: [email protected] (F. Piscione).
describes the percentage variation across studies that is due to heterogeneity rather than chance. We screened the title and/or the abstract of 601 potentially eligible publications and included in the meta-analysis a total of 5 randomized trials [3–7], enrolling 1247 patients (625 or 50.1% randomized to SES and 622 or 49.9% randomized to PES). Three trials reported 1-year follow-up [4,6,7], while, for the remaining two trials, follow-up was available at 4.3 [3] and 3 years [5], respectively. Stent thrombosis was defined as an acute coronary syndrome with angiographically documented thrombus within stent in all trials, while we abstracted from 3 trials [3,5,6] possible and/or probable stent thrombosis, according to ARC (Academic Research Consortium) criteria. TVR was needed in a total of 84 patients (6.7%). As reported in Fig. 1A, there was a trend towards lower TVR rates in SES patients (5.4% versus 8%, SES versus PES respectively, OR [95% CI] = 0.66 [0.42– 1.03], p = 0.07). Cardiac death (Fig. 1B) occurred in a total of 51 patients (4.1%), without significant differences between SES and PES (4% versus 4.2%, respectively, OR [95% CI] = 0.95 [0.55–1.67], p = 0.87). Recurrent MI (Fig. 1C) was found in a total of 56 patients (3.9%) without any differences between SES and PES (3.8% versus 5.1%, respectively, OR [95% CI] = 0.73 [0.42–1.25], p = 0.25). A total of 39 patients (2.7%) experienced stent thrombosis (Fig. 1D), with similar rates between SES (3.4%) and PES (2.9%), (OR [95% CI] = 1.16 [0.62–2.19], p = 0.64). For each endpoint there was no significant heterogeneity among included studies. This is the first meta-analysis reporting clinical outcomes of SES versus PES in patients with STEMI undergoing PCI, showing no differences between SES and PES in terms of cardiac death, reinfarction and stent thrombosis. However, there was a trend towards lower TVR rates among patients treated with SES. These results are similar to an adjusted indirect comparison of 12 randomized trials, including 6618 patients, that found significantly lower rates of TVR with SES as compared to PES, without differences in death, reinfarction and stent thrombosis [2]. It is probable that the smaller number of patients included in the present meta-analysis was not sufficient to reach statistical significance. In fact, if we would consider an absolute reduction in TVR of 3% from TVR incidence observed in the PES group (8%), with a statistical power of 80% and a significance level (alpha) of 0.05, a total 1063 patients per group would have been required to detect such a difference. Thus, our study remains underpowered to detect a significant difference in terms of TVR between SES and PES. An additional limitation is that the present meta-analysis is at the study level, and we could not properly assess the role of confounding factors. In conclusion, our findings suggest that both SES and PES are safe in this setting, with a possible greater efficacy of SES as compared to PES. Further randomized studies, with larger population, are warranted to definitively address this important issue. There was no funding source for this study. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. For no Authors there is any condition that may represent a potential conflict of interest.
Letters to the Editor
235
Fig. 1. A. Odds ratio of target-vessel revascularization associated with sirolimus- (SES) versus paclitaxel-eluting stent (PES). B. Odds ratio of death associated with SES versus PES. C. Odds ratio of recurrent myocardial infarction associated with SES versus PES. D. Odds ratio of stent thrombosis associated with SES versus PES.
The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [8]. References [1] Piscione F, Piccolo R, Cassese S, Galasso G, Chiariello M. Clinical impact of sirolimuseluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized clinical trials. Catheter Cardiovasc Interv 2009;74:323–32.
[2] Piscione F, Piccolo R, Cassese S, et al. Effect of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: a meta-analysis of randomised trials and an adjusted indirect comparison. EuroIntervention 2010;5:853–60. [3] Di Lorenzo E, Sauro R, Varricchio A, et al. Long-term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial. Circulation 2009;120:964–72. [4] Juwana YB, Suryapranata H, Ottervanger JP, et al. Comparison of rapamycin- and paclitaxel-eluting stents in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction. Am J Cardiol 2009;104:205–9.
236
Letters to the Editor
[5] Kim HS, Lee JH, Lee SW, et al. Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial. Int J Cardiol doi:10.1016/j.ijcard.2009.09.466. [6] Lee CW, Park DW, Lee SH, et al. Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction. Am J Cardiol 2009;104:1370–6.
[7] Pittl U, Kaiser C, Brunner-La Rocca HP, et al. Safety and efficacy of drug eluting stents versus bare metal stents in primary angioplasty of patients with acute ST-elevation myocardial infarction -a prospective randomized study. Eur Heart J 2006;27:650 (Abstract Suppl). [8] Coats AJ. Ethical authorship and publishing. Int J Cardiol 2009;131:149–50.
0167-5273/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2010.10.008
Overweight, physical activity and atherosclerotic disease risk in Brazilian adolescents Tamara Costábile Sant'Anna, Carolina Martins Vieira Braga, Grasiela Mara Moreira, Lidiane Sousa ⁎ Centro Universitário Newton Paiva, Belo Horizonte, MG, Brazil
a r t i c l e
i n f o
Article history: Received 30 July 2010 Accepted 2 October 2010 Available online 5 November 2010 Keywords: Obesity Adolescent health Motor activity Hypertension Atherosclerosis
Atherosclerotic disease arises when fatty plaques form on the arterial walls. Advanced lesions may obstruct the arterial lumen and cause cardiovascular problems [1]. It strongly correlates with predispositions, such as arterial hypertension (AHT) and obesity, inactivity and others [2]. The literature has shown that changes may even appear in infants and adolescents [1–5]. Therefore, the objective of this study was to analyse possible relationships between indexes of body composition, blood pressure (BP) and level of physical activity in adolescents in a public-sector school in the city of Belo Horizonte, Minas Gerais state, Brazil. It was evaluated 56 students between 12 and 18 years of age of both sexes. They were selected among volunteers after the authorisation of their parents or guardians and signature of an informed consent agreement before data were collected. The study was approved by the Research Ethics Committee of the Centro Universitário Newton Paiva (N. 126). Body mass index (BMI) and waist circumference were used to evaluate body composition. In relation to BMI, the students were classified in accordance with the National Centre for Health Statistics (NCHS) criteria [6]. Waist circumference (WC) measures were taken at the narrowest part of the trunk, at the level of the “natural” belt position [7]. The results were interpreted taking the age and sex of the students into consideration, with a waist circumference in the 90th percentile or above considered to be high risk [8]. BP was determined by the palpation and auscultation methods used jointly. Two measurements were taken with an interval of 1 min ⁎ Corresponding author. Rua Timbiras 63/1102, Funcionários, CEP: 30140060., Belo Horizonte, Minas Gerais, Brazil. E-mail address: [email protected] (L. Sousa).
using standard procedures and a third measurement was taken when necessary [9]. Several sizes of sphygmomanometer were available and the proper size was chosen based on the arm circumference of the subjects. Published normative data on children and adolescents were used to classify the values taken [10]. Finally, the level of physical activity of the participants was evaluated using the Physical Activity Questionnaire for Children (PAQC). This instrument has been translated and modified to exclude physical activities that are not practised in Brazil. The individuals were classified as active or inactive according to the final questionnaire score. Subjects with scores ≥ 3 were considered active, while the inactive had scores < 3 [11]. For statistical analysis, the data normality was first evaluated using the Shapiro–Wilk test. The variables were described by their mean and standard deviation, or their median and Q25–Q75, depending on their distribution. The Chi-square test and Fisher's exact test were used to compare the proportions between the groups. In addition, the t-Student test for independent samples or the Mann–Whitney test was used to provide comparison between the means of the variables analysed in the groups of boys and girls. With regard to relationships between the variables, either the Pearson correlation or Spearman correlation was used, as appropriate to the data distribution. A value of significance p < 0.05 was considered. Table 1 shows the data for the groups. As can be seen, there was no difference in the data distribution between boys and girls, except with regard to two variables: BMI and PAQ-C. Regarding to the correlations analysed, there was significant association between BP, WC and BMI in the group of girls. However, no such correlation was found in the group of boys (Table 2). Table 1 Distribution of clinical, anthropometric, blood pressure and physical activity level data in the groups of boys and girls.
Age (years)# Weight (kg)# Height(m)* BMI (kg/m2)# WC (increased risk/normal) BP (borderline/adequate) PAQ-C (inactive/active)
Boys (23)
Girls(33)
p
12(11.5–14) 46.4(40.3–50.8) 1.59(0.11) 17.5(16.0–21.1) 1/22 3/20 17/6
13(12–16.5) 49.8(42.6–54.5) 1.57(0.06) 20.3(17.6–22.5) 2/31 2/31 31/2
0.70 0.18 0.45 0.02 0.63 0.33 0.04
# median (Q1–Q3). *mean (standard deviation). BMI – body mass index. WC – waist circumference. BP – blood pressure. Statistically significant values are given in bold type.
Letters to the Editor
Sirolimus- versus paclitaxel-eluting stents in patients with acute myocardial infarction: A meta-analysis of randomized trials Raffaele Piccolo, Salvatore Cassese, Gennaro Galasso, Roberta De Rosa, Carolina D'Anna, Federico Piscione ⁎ Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via S. Pansini, 5, 80131, Naples, Italy
a r t i c l e
i n f o
Article history: Received 23 July 2010 Accepted 2 October 2010 Available online 9 November 2010 Keywords: Sirolimus-eluting stent Paclitaxel-eluting stent Drug-eluting stent Myocardial infarction PCI Meta-analysis
Primary percutaneous coronary intervention (PCI) is the standard of care in patients with acute ST-segment elevation myocardial infarction (STEMI), since it is associated with a mortality reduction as compared with thrombolytic therapy alone. At this regard, we have previously demonstrated that drugeluting stents are more effective than bare-metal stents in reducing the need for repeat revascularization of target vessel, without safety concerns [1,2]. However, it is unclear whether there are differences in clinical outcomes between sirolimus- (SES) and paclitaxel-eluting stent (PES). Herein, we report a meta-analysis of randomized studies comparing SES versus PES in patients undergoing primary PCI. An electronic search was performed in Medline, EMBASE, scientific session abstracts in Circulation, Journal of the American College of Cardiology, European Heart Journal and The American Journal of Cardiology, and relevant websites, from inception of each database until July 2010. No language restriction was enforced. The key words used were: “myocardial infarction”, “ST-segment elevation”, “percutaneous coronary intervention”, “drug-eluting stent”, “sirolimuseluting stent”, and “paclitaxel-eluting stent”. To be included, the citation had to meet the following criteria: 1) random treatment allocation and 2) availability of complete clinical features. Exclusion criteria were: 1) ongoing studies and 2) irretrievable data. Two investigators independently assessed reports for eligibility, with divergences resolved by consensus. The primary endpoint was target-vessel revascularization (TVR). Secondary endpoints were: cardiac death, recurrent myocardial infarction and stent thrombosis. All clinical endpoints were evaluated at the longest available follow-up. Statistical analysis was performed with Review Manager 5.0.16 (RevMan, The Nordic Cochrane Centre, The Cochrane Collaboration, 2008). The pooled odds ratio (OR) was calculated by using the fixed effects Mantel–Hænzel model. Heterogeneity was appraised by using both Breslow–Day chi-squared test (p < 0.1) and I2 statistic, which
⁎ Corresponding author. Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Via S. Pansini, 5. 80131. Naples, Italy. Tel.: + 39 0817462234; fax: + 39 0817462229. E-mail address: [email protected] (F. Piscione).
describes the percentage variation across studies that is due to heterogeneity rather than chance. We screened the title and/or the abstract of 601 potentially eligible publications and included in the meta-analysis a total of 5 randomized trials [3–7], enrolling 1247 patients (625 or 50.1% randomized to SES and 622 or 49.9% randomized to PES). Three trials reported 1-year follow-up [4,6,7], while, for the remaining two trials, follow-up was available at 4.3 [3] and 3 years [5], respectively. Stent thrombosis was defined as an acute coronary syndrome with angiographically documented thrombus within stent in all trials, while we abstracted from 3 trials [3,5,6] possible and/or probable stent thrombosis, according to ARC (Academic Research Consortium) criteria. TVR was needed in a total of 84 patients (6.7%). As reported in Fig. 1A, there was a trend towards lower TVR rates in SES patients (5.4% versus 8%, SES versus PES respectively, OR [95% CI] = 0.66 [0.42– 1.03], p = 0.07). Cardiac death (Fig. 1B) occurred in a total of 51 patients (4.1%), without significant differences between SES and PES (4% versus 4.2%, respectively, OR [95% CI] = 0.95 [0.55–1.67], p = 0.87). Recurrent MI (Fig. 1C) was found in a total of 56 patients (3.9%) without any differences between SES and PES (3.8% versus 5.1%, respectively, OR [95% CI] = 0.73 [0.42–1.25], p = 0.25). A total of 39 patients (2.7%) experienced stent thrombosis (Fig. 1D), with similar rates between SES (3.4%) and PES (2.9%), (OR [95% CI] = 1.16 [0.62–2.19], p = 0.64). For each endpoint there was no significant heterogeneity among included studies. This is the first meta-analysis reporting clinical outcomes of SES versus PES in patients with STEMI undergoing PCI, showing no differences between SES and PES in terms of cardiac death, reinfarction and stent thrombosis. However, there was a trend towards lower TVR rates among patients treated with SES. These results are similar to an adjusted indirect comparison of 12 randomized trials, including 6618 patients, that found significantly lower rates of TVR with SES as compared to PES, without differences in death, reinfarction and stent thrombosis [2]. It is probable that the smaller number of patients included in the present meta-analysis was not sufficient to reach statistical significance. In fact, if we would consider an absolute reduction in TVR of 3% from TVR incidence observed in the PES group (8%), with a statistical power of 80% and a significance level (alpha) of 0.05, a total 1063 patients per group would have been required to detect such a difference. Thus, our study remains underpowered to detect a significant difference in terms of TVR between SES and PES. An additional limitation is that the present meta-analysis is at the study level, and we could not properly assess the role of confounding factors. In conclusion, our findings suggest that both SES and PES are safe in this setting, with a possible greater efficacy of SES as compared to PES. Further randomized studies, with larger population, are warranted to definitively address this important issue. There was no funding source for this study. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. For no Authors there is any condition that may represent a potential conflict of interest.
Letters to the Editor
235
Fig. 1. A. Odds ratio of target-vessel revascularization associated with sirolimus- (SES) versus paclitaxel-eluting stent (PES). B. Odds ratio of death associated with SES versus PES. C. Odds ratio of recurrent myocardial infarction associated with SES versus PES. D. Odds ratio of stent thrombosis associated with SES versus PES.
The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [8]. References [1] Piscione F, Piccolo R, Cassese S, Galasso G, Chiariello M. Clinical impact of sirolimuseluting stent in ST-segment elevation myocardial infarction: a meta-analysis of randomized clinical trials. Catheter Cardiovasc Interv 2009;74:323–32.
[2] Piscione F, Piccolo R, Cassese S, et al. Effect of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: a meta-analysis of randomised trials and an adjusted indirect comparison. EuroIntervention 2010;5:853–60. [3] Di Lorenzo E, Sauro R, Varricchio A, et al. Long-term outcome of drug-eluting stents compared with bare metal stents in ST-segment elevation myocardial infarction: results of the paclitaxel- or sirolimus-eluting stent versus bare metal stent in Primary Angioplasty (PASEO) Randomized Trial. Circulation 2009;120:964–72. [4] Juwana YB, Suryapranata H, Ottervanger JP, et al. Comparison of rapamycin- and paclitaxel-eluting stents in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction. Am J Cardiol 2009;104:205–9.
236
Letters to the Editor
[5] Kim HS, Lee JH, Lee SW, et al. Long-term safety and efficacy of sirolimus- vs. paclitaxel-eluting stent implantation for acute ST-elevation myocardial infarction: 3-year follow-up of the PROSIT trial. Int J Cardiol doi:10.1016/j.ijcard.2009.09.466. [6] Lee CW, Park DW, Lee SH, et al. Comparison of the efficacy and safety of zotarolimus-, sirolimus-, and paclitaxel-eluting stents in patients with ST-elevation myocardial infarction. Am J Cardiol 2009;104:1370–6.
[7] Pittl U, Kaiser C, Brunner-La Rocca HP, et al. Safety and efficacy of drug eluting stents versus bare metal stents in primary angioplasty of patients with acute ST-elevation myocardial infarction -a prospective randomized study. Eur Heart J 2006;27:650 (Abstract Suppl). [8] Coats AJ. Ethical authorship and publishing. Int J Cardiol 2009;131:149–50.
0167-5273/$ – see front matter © 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijcard.2010.10.008
Overweight, physical activity and atherosclerotic disease risk in Brazilian adolescents Tamara Costábile Sant'Anna, Carolina Martins Vieira Braga, Grasiela Mara Moreira, Lidiane Sousa ⁎ Centro Universitário Newton Paiva, Belo Horizonte, MG, Brazil
a r t i c l e
i n f o
Article history: Received 30 July 2010 Accepted 2 October 2010 Available online 5 November 2010 Keywords: Obesity Adolescent health Motor activity Hypertension Atherosclerosis
Atherosclerotic disease arises when fatty plaques form on the arterial walls. Advanced lesions may obstruct the arterial lumen and cause cardiovascular problems [1]. It strongly correlates with predispositions, such as arterial hypertension (AHT) and obesity, inactivity and others [2]. The literature has shown that changes may even appear in infants and adolescents [1–5]. Therefore, the objective of this study was to analyse possible relationships between indexes of body composition, blood pressure (BP) and level of physical activity in adolescents in a public-sector school in the city of Belo Horizonte, Minas Gerais state, Brazil. It was evaluated 56 students between 12 and 18 years of age of both sexes. They were selected among volunteers after the authorisation of their parents or guardians and signature of an informed consent agreement before data were collected. The study was approved by the Research Ethics Committee of the Centro Universitário Newton Paiva (N. 126). Body mass index (BMI) and waist circumference were used to evaluate body composition. In relation to BMI, the students were classified in accordance with the National Centre for Health Statistics (NCHS) criteria [6]. Waist circumference (WC) measures were taken at the narrowest part of the trunk, at the level of the “natural” belt position [7]. The results were interpreted taking the age and sex of the students into consideration, with a waist circumference in the 90th percentile or above considered to be high risk [8]. BP was determined by the palpation and auscultation methods used jointly. Two measurements were taken with an interval of 1 min ⁎ Corresponding author. Rua Timbiras 63/1102, Funcionários, CEP: 30140060., Belo Horizonte, Minas Gerais, Brazil. E-mail address: [email protected] (L. Sousa).
using standard procedures and a third measurement was taken when necessary [9]. Several sizes of sphygmomanometer were available and the proper size was chosen based on the arm circumference of the subjects. Published normative data on children and adolescents were used to classify the values taken [10]. Finally, the level of physical activity of the participants was evaluated using the Physical Activity Questionnaire for Children (PAQC). This instrument has been translated and modified to exclude physical activities that are not practised in Brazil. The individuals were classified as active or inactive according to the final questionnaire score. Subjects with scores ≥ 3 were considered active, while the inactive had scores < 3 [11]. For statistical analysis, the data normality was first evaluated using the Shapiro–Wilk test. The variables were described by their mean and standard deviation, or their median and Q25–Q75, depending on their distribution. The Chi-square test and Fisher's exact test were used to compare the proportions between the groups. In addition, the t-Student test for independent samples or the Mann–Whitney test was used to provide comparison between the means of the variables analysed in the groups of boys and girls. With regard to relationships between the variables, either the Pearson correlation or Spearman correlation was used, as appropriate to the data distribution. A value of significance p < 0.05 was considered. Table 1 shows the data for the groups. As can be seen, there was no difference in the data distribution between boys and girls, except with regard to two variables: BMI and PAQ-C. Regarding to the correlations analysed, there was significant association between BP, WC and BMI in the group of girls. However, no such correlation was found in the group of boys (Table 2). Table 1 Distribution of clinical, anthropometric, blood pressure and physical activity level data in the groups of boys and girls.
Age (years)# Weight (kg)# Height(m)* BMI (kg/m2)# WC (increased risk/normal) BP (borderline/adequate) PAQ-C (inactive/active)
Boys (23)
Girls(33)
p
12(11.5–14) 46.4(40.3–50.8) 1.59(0.11) 17.5(16.0–21.1) 1/22 3/20 17/6
13(12–16.5) 49.8(42.6–54.5) 1.57(0.06) 20.3(17.6–22.5) 2/31 2/31 31/2
0.70 0.18 0.45 0.02 0.63 0.33 0.04
# median (Q1–Q3). *mean (standard deviation). BMI – body mass index. WC – waist circumference. BP – blood pressure. Statistically significant values are given in bold type.