Effects of School-Based High-Intensity Interval Training on Hemodynamic Parameters and Heart Rate Variability: A Randomized Controlled Trial.

ABSTRACT: Ketelhut, S, Ketelhut, K, Ketelhut, SR, and Ketelhut, RG. Effects of school-based high-intensity interval training on hemodynamic parameters and heart rate variability: A randomized controlled trial. J Strength Cond Res 38(6): 1033-1040, 2024-The purpose of this study was to assess the effects of a child-specific school-based high-intensity interval training (HIIT) implemented into physical education (PE) classes on various hemodynamic parameters and heart rate variability indices. Forty-six students (age 11 ± 1 year) were randomized into an intervention (INT n = 22) and a control group (CON n = 24). During a 12-week period, the INT and CON groups participated in regular PE twice weekly (45-90 minutes). The INT group received HIIT during the first 20 minutes of the 2 PE classes. Systolic and diastolic blood pressure, total peripheral resistance, aortic pulse wave velocity (aPWV), heart rate, SD of normal to normal heartbeat intervals, the root mean square of successive differences between normal heartbeats (RMSSD), the proportion of differences between adjacent normal to normal heartbeat intervals of more than 50 ms, low-frequency power, high-frequency power, and the LF/HF ratio were assessed before and after the experimental period. A p value ≤0.05 was considered statistically significant. Forty students (20 INT; 20 CON) were included in the analysis. A significant time × group interaction was detected for aPWV ( p = 0.05, η2 = 0.099), RMSSD ( p = 0.010, η2 = 0.161), low-frequency power ( p = 0.009, η2 = 0.165), high-frequency power ( p < 0.001, η2 = 0.272), and the LF/HF ratio ( p < 0.001, η2 = 0.354). The INT group revealed significant improvements for the respective parameters. School-based HIIT can induce improvements in cardiovascular parameters. These results highlight the potential of embedding HIIT within the school setting, offering a time-efficient exercise intervention.

Interval Training in Sports Medicine: Current Thoughts on an Old Idea.

In light of the global physical inactivity pandemic, the increasing prevalence of non-committable diseases, and mounting healthcare costs, effective and feasible prevention and treatment approaches are urgently needed [...].

Influence of Initial Severity of Depression on the Effectiveness of a Multimodal Therapy on Depressive Score, Heart Rate Variability, and Hemodynamic Parameters.

Depression is a major cause of disability among populations worldwide. Apart from primary symptoms, depressed patients often have a higher cardiovascular risk profile. Multimodal therapy concepts, including exercise, have emerged as promising approaches that not only improve depressive symptoms but also have a positive impact on cardiovascular risk profile. However, controversies have arisen concerning the influence of baseline severity on the effects of therapy concepts for this demographic. This study assessed whether pretreatment severity moderates psychological and physiological treatment outcomes of a multimodal therapy. A total of 16 patients diagnosed with mild depression (MD) and 14 patients diagnosed with severe depression (SD) took part in a 3-month outpatient multimodal treatment therapy. Before and after the treatment, depression score (Beck Depression Inventory (BDI)), peripheral systolic (pSBP) and diastolic (pDBP) blood pressure, central systolic (cSBP) and diastolic (cDBP) blood pressure, pulse wave velocity (PWV), heart rate (HR), and parasympathetic parameters of heart rate variability (RMSSD) were assessed. Significant time effects were detected for BDI (−20.0 ± 11.6, p > 0.001, η2 = 0.871), pSBP (−4.7 ± 6.8 mmHg, p < 0.001, η2 = 0.322), pDBP (−3.5 ± 6.9 mmHg, p = 0.01, η2 = 0.209), cSBP (−4.8 ± 6.5 mmHg, p < 0.001, η2 = 0.355), cDBP (−3.6 ± 6.8 mmHg, p = 0.008, η2 = 0.226), PWV (−0.13 ± 0.23 m/s, p = 0.008, η2 = 0.229), HR (4.3 ± 8.8 min−1, p = 0.015, η2 = 0.193), RMSSD (−12.2 ± 23.9 ms, p = 0.017, η2 = 0.251), and and SDNN (10.5 ± 17.8 ms, p = 0.005, η2 = 0.330). Significant time × group interaction could be revealed for BDI (p < 0.001, η2 = 0.543), with patients suffering from SD showing stronger reductions. Pretreatment severity of depression has an impact on the effectiveness of a multimodal therapy regarding psychological but not physiological outcomes.

Gaming Instead of Training? Exergaming Induces High-Intensity Exercise Stimulus and Reduces Cardiovascular Reactivity to Cold Pressor Test.

INTRODUCTION: The present study assessed if an exercise session in an innovative exergame can modulate hemodynamic reactivity to a cold pressor test (CPT) to a similar extent as a typical moderate endurance training (ET). Furthermore, cardiorespiratory, and affective responses of an exergame session and an ET were compared. METHODS: Twenty-seven healthy participants aged 25 ± 4 years (48% female; BMI 23.0 ± 2.1 kg/m2) participated in this cross-sectional study. All participants completed both an ET on a treadmill and training in the ExerCube (ECT). HR and oxygen consumption were recorded during both training sessions. Before and after both exercise sessions, the hemodynamic reactivity to a CPT was determined. RESULTS: During ECT, HR, oxygen consumption, energy expenditure, and the metabolic equivalent of the task were significantly higher than those obtained during ET (p < 0.001). With regard to the CPT, the participants showed significantly lower responses in peripheral systolic (p = 0.004) and diastolic blood pressure (p = 0.009) as well as central systolic (p = 0.002) and diastolic BP (P = 0.01) after ECT compared to ET. The same was true for pulse wave velocity (p = 0.039). CONCLUSION: The ECT induced a significantly higher exercise stimulus compared to the ET. At the same time, it attenuated hemodynamic stress reactivity. The ECT presents a relevant training stimulus that modulates cardiovascular reactivity to stress, which has been proven as a predictor for the development of hypertension. TRIAL REGISTRATION: ISRCTN registry, ISRCTN43067716, 14 April 2020, Trial number: 38154.

A Game-Based Approach to Lower Blood Pressure? Comparing Acute Hemodynamic Responses to Endurance Exercise and Exergaming: A Randomized Crossover Trial.

The present randomized crossover study aimed to determine whether an exergaming session in an innovative, functional fitness game could be an effective exercise approach that elicits favorable blood pressure (BP) responses, such as a typical moderate endurance exercise (ET). Therefore, acute hemodynamic responses after a training session in the ExerCube and an ET on a treadmill were assessed and compared. Twenty-eight healthy recreational active participants (13 women; aged 24.8 ± 3.9 years) completed an exergaming session (EX) and an ET in a randomized and counterbalanced order. Before and throughout the 45 min after the training, the peripheral and central BP were measured. After the ET, there was a moderate decrease in both peripheral systolic (-1.8 mmHg; p = 0.14) and diastolic (-0.8 mmHg; p = 0.003), as well as central diastolic (-1.5 mmHg; p = 0.006) pressure compared to the resting value before the exercise. After the EX, there was a significant decrease in peripheral systolic (-6.3 mmHg; p < 0.001) and diastolic (-4.8 mmHg; p < 0.001), as well as central systolic (-5.8 mmHg; p < 0.001) and diastolic (-5.3 mmHg; p < 0.001) pressure compared to baseline. The interaction effects showed significant differences in peripheral and central systolic BP as well as in peripheral diastolic BP (p = 0.05). The EX seems to be an effective training approach that triggers relevant peripheral and central BP-responses, which are more pronounced than after a typical ET. Therefore, the ExerCube can be a time-efficient training tool to improve cardiovascular health.

Acute Effects of Heart Rate-Controlled Exergaming on Vascular Function in Young Adults.

Objective: Acute and regular moderate-intensity endurance exercise (MIEE) is known to positively affect vascular function. The present study assessed if an exercise session in an innovative exergame called the ExerCube can induce similar vascular reactions as an MIEE session. Materials and Methods: Twenty-eight healthy recreationally active participants (13 females and 15 males; aged 24.8 ± 3.9 years; with body mass index 23.2 ± 2.3 kg/m2) completed an exergaming session (EGS) in the ExerCube (25 minutes) and an MIEE session on a treadmill (35 minutes, 65%-70% of maximal heart rate [HR]) in a randomized order. Both before and throughout the 45 minutes after the training sessions, pulse wave velocity (PWV), total peripheral resistance (TPR), stroke volume (SV), and HR were recorded. The study was approved by the Research Ethics Board of the Martin-Luther-Universität Halle-Wittenberg (Medical Faculty of the Martin-Luther-Universität 2019-177). Results: There were different hemodynamic responses to both types of exercises. PWV was significantly decreased 45 minutes after the EGS (P < 0.001). No significant changes were detected after MIEE (P = 0.109). TPR was significantly lower after both exercise sessions (P < 0.01). Only the EGS resulted in a significant decrease in SV 15 minutes after exercise (P < 0.001). The HR was significantly (P < 0.05) higher after both exercise sessions. After the EGS, the increase in HR was still significantly higher (P = 0.011) 45 minutes after the session. The interaction effects revealed significant differences in PWV (15 minutes, P = 0.035; 30 minutes, P = 0.004; and 45 minutes, P < 0.001), favoring the EGS. Conclusion: The EGS seems to induce a relevant exercise stimulus that can modulate vascular function. Therefore, this exergame may present an effective tool for prevention of cardiovascular diseases.

The New Way to Exercise? Evaluating an Innovative Heart-rate-controlled Exergame.

Exergames may offer novel opportunities to expand physical activity. Most games, however, only result in low to moderate-intensity activities that are too low to allow relevant physical adjustments. In the present study, the exercise intensity of a new, heart rate controlled, functional fitness game was assessed. 28 subjects (aged 24.8±3.8 yrs; 46% female; BMI 23.2±2.3 kg/m2) were enrolled in this study. VO2max and maximal heart rate (HRmax) were assessed during a maximal graded exercise test on a treadmill and compared with the oxygen consumption (VO2) and heart rate (HR) during a game in the ExerCube.In the ExerCube, the subjects reached a peak HR of 187.43±9.22 bpm, which corresponds to 96.57±3.64% of their HRmax. The mean HR throughout the game was 167.11±10.94 bpm, corresponding to 86.07±4.33% of HRmax. VO2peak reached 41.57±5.09 ml/kg/min during the game in the ExerCube, which corresponds to 84.75±7.52% of VO2max. The mean VO2 consumption during the game reached 32.39±4.04 ml/kg/min, which corresponds to 66.01±5.09% of VO2max. The ExerCube provides a form of vigorous physical exercise. Due to its playful, immersive, and motivating nature, the ExerCube seems to be a promising tool to facilitate physical activity.

Adaptive High-Intensity Exergaming: The More Enjoyable Alternative to Conventional Training Approaches Despite Working Harder.

Objective: The purpose of this study was to assess psychological and physiological responses to an exergaming session in the ExerCube (EX) and compare them with the responses of a moderate endurance run (ER). Materials and Methods: Twenty-eight healthy adults (13 women) aged 24.8 ± 3.8 years took part in this study. The first test day, participants performed a graded exercise test on a treadmill to determine maximal heart rate (HR) and lactate levels. The following test days 2 and 3, the participants completed an EX session and an ER on a treadmill in a randomized counterbalanced order. HR, rate of perceived exertion (RPE), and lactate levels were assessed during both sessions. After the sessions, the participants completed the "Physical Activity Enjoyment Scale" and the "Flow Short Scale." Results: The analysis of variance revealed that enjoyment (P = 0.036), flow (P = 0.042), RPE (P = 0.005), as well as mean and peak HR (P < 0.001) during the EX session were significantly higher compared with the ER. Gender did not affect the differences between the two conditions for mean HR (P = 0.61), maximal HR (P = 0.122), RPE (P = 0.862), flow (P = 0.376) nor enjoyment (P = 0.867). During the EX session, the lactate levels of all participants exceeded the individual lactate threshold (LT). During the ER, lactate values remained below the LT. Conclusion: The ExerCube presents both a physiological relevant exercise stimulus and a joyful gaming experience. Despite the higher exercise intensity achieved during the EX session, enjoyment was significantly higher compared with the ER. Therefore, the EX can be a promising and appealing tool to facilitate physical activity. Trial registration: ISRCTN registry, ISRCTN43067716, April 14, 2020. Trial number: 38154.

Effects of Moderate- versus Mixed-Intensity Training on VO2peak in Young Well-Trained Rowers.

The effects of moderate-intensity continuous training (MICT) and a combination of MICT and high-intensity interval training (HIIT) on rowing performance and VO2peak were investigated in young athletes. Seventeen well-trained rowers (aged 15 ± 1.3 years) were randomly allocated to an intervention (IG) (n = 10) and control group (CG) (n = 7). During 8 weeks, both groups took part in the regular rowing training (3×/week MICT, 70-90 min, 65-70% of HRpeak + 2×/week resistance training). The IG completed an additional high-intensity interval training twice weekly (2 × 4 × 2 min at ≈95% of HRpeak, 60 s rest). Instead of the HIIT, the CG completed two more MICT sessions (70-90 min, 65-70% of HRpeak). Before and after the intervention, a 2000 m time trial and an exercise test were performed. The IG showed a significant improvement (p = 0.001) regarding the absolute rowing time in the graded exercise test. Furthermore, the intervention group showed a significant increase in relative VO2peak (p = 0.023), a significant increase in absolute VO2peak (p = 0.036), and a significant improvement in the 2000 m time trail (p = 0.003). No significant changes could be detected in the CG. The interaction effects were not significant. A mixed-intensity training, including HIIT, was beneficial on rowing performance and VO2peak in highly trained athletes.

Hemodynamics in young athletes following high-intensity interval or moderate-intensity continuous training.

BACKGROUND: The present study aimed to investigate the effects of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on blood pressure (BP) and parameters of arterial stiffness in young athletes. METHODS: Seventeen rowers (aged 15±1.3 years) were randomized into an intervention group (IG, N.=10) and the control group (CG, N.=7). During an 8-week intervention period, the IG completed a HIIT on the rowing ergometer twice-weekly (2×4×2 min at ≈95% of maximum heart rate [HRmax], 60 s rest) in addition to the regular rowing training (3×/week MICT 70-90 min, ≈70% HRmax). The CG completed the regular normal rowing training and, instead of the HIIT units, two additional MICT units (70-90 min, ≈70% HRmax). Before and after the intervention period, hemodynamic parameters were recorded non-invasively in both groups. RESULTS: After the intervention period, there was a significant decrease in peripheral systolic (P=0.01) and diastolic (P=0.05) BP, as well as in central systolic (P=0.05) and diastolic BP (P=0.03) in the IG. Furthermore, pulse wave velocity (PWV) (P=0.05) was significantly reduced. Analysis of intervention effects revealed significant between-group differences in central diastolic BP (P=0.05), in augmentation pressure (P=0.02), and in augmentation index (P=0.006) favoring IG. The CG showed no significant changes in the respected parameters throughout the intervention. CONCLUSIONS: Already in adolescent athletes, a HIIT intervention has beneficial effects on peripheral and central BP as well as on PWV, augmentation pressure, and augmentation index.

Type of Exercise Training and Training Methods.

There is general agreement that exercise training leads to functional, morphological, and metabolic adaptations of different biological systems, thereby increasing overall physical performance and promoting good health. Thus, an active lifestyle is propagated in all age groups. However, not every exercise routine or workout is suitable for everyone. Inappropriate training can also pose risks, and too low or too high training intensity or volume often does not lead to the expected success. To ensure significant benefits, specific principles and strategies need to be considered and accustomed to the individual.This chapter summarizes the key exercise variables and training principles to consider when developing a training program to improve or maintain performance and health. In addition, the various steps for creating an individual training program are described, and an overview of the different training methods and training strategies is given.

Left Ventricular Hypertrophy in Hypertensive Athletes can be Reduced by Antihypertensive Medication Despite Continuing Intense Aerobic Exercise.

INTRODUCTION: Left ventricular hypertrophy (LVH) can be successfully reduced by antihypertensive medication. Both hypertension and aerobic exercise can cause increases in left ventricular mass (LV-mass). AIM: Therefore, hypertensive athletes with LVH were studied to investigate the effect of antihypertensive medication on LV-mass reduction despite continuing their regular intensive exercise programs. METHODS: 14 previously untreated hypertensive male athletes (A) with LVH and a prolonged history of endurance training where included in the study. 50 previously untreated inactive comparable hypertensives with LVH served as controls (C). For both groups inclusion criteria were blood pressure (BP) at rest: > 140/90 mmHg, BP during ergometry (at 100 W): > 200/100 mmHg and. LV-mass-index > 125 g/m2. Echocardiography was performed to calculate LV-mass and function before and after 3 years of antihypertensive medication. RESULTS: Despite regularly aerobic training throughout the treatment period, LV mass decreased from 164 ± 19 g/m2 before to 97 ± 16 g/m2 after 3 years of therapy (p < 0.001). Controls with identical pressures demonstrated a decrease from 149 ± 29 g/m2 to 87 ± 15 g m2. There were similar decreases in LV wall thicknesses in both groups, whereas diastolic dimensions did not change significantly. Moreover, there was an increase in fractional fiber shortening as a measure of LV pump function in both groups of 15% in A and 11% in C, respectively. CONCLUSIONS: In hypertensive athletes LVH due to hypertension can be reduced and LV-function can be improved by long-term antihypertensive medication despite regular aerobic exercise. Therefore, exercise does not interfere with the regression of LVH on account of antihypertensive therapy in hypertensive subjects.

Acute Effects of Moderate Continuous Training on Stress Test-Related Pulse Pressure and Wave Reflection in Healthy Men.

INTRODUCTION: Arterial dysfunction develops early in life even in individuals with modest cardiovascular risk. Stress is associated with increased risk in cardiovascular morbidity and mortality. AIM: The main objectives of this study were to investigate the acute effects of moderate continuous training (MCT) on established markers of arterial stiffness and cardiovascular risk during standardized cold pressor stress testing (CPT). METHODS: 29 young healthy male subjects (33.7 ± 8 years, BMI 24 ± 2 kg/m2) performed a 60-min period of moderate upright bicycle exercise with 65% of maximum heart rate. Before (t0), 45 (t45) as well as 60 (t60) min after exercise peripheral pulse pressure (PP) as well as augmentation index at a set heart rate (AIx@75) were assessed non-invasively at rest using an oscillometric device. Immediately after t0 and t60 PP and AIx@75 were registered at the end of a 2 min CPT. RESULTS: PP (p = 0.005) and AIx@75 (p = 0.04) were reduced below pre-exercise level at t60. In contrast to CPT before exercise, there were significant reductions in PP (p = 0.039) as well as AIx@75 (p = 0.002) during CPT after exercise. Additionally, there was a negative correlation between maximal oxygen consumption and AIx@75 (r = -0.42, p = 0.044). CONCLUSIONS: Acute MCT decreased PP and reduces AIx@75 after 60 min of recovery. Furthermore, PP and AIx@75 showed reduced values after completion of MCT indicating attenuated hemodynamic response to stress testing after MCT. Moreover, higher physical conditioning status was associated with more favorable effects on stress test-related arterial compliance.

Influence of a high-intensity interval training session on peripheral and central blood pressure at rest and during stress testing in healthy individuals.

BACKGROUND: Regular physical activity is known to reduce arterial pressure (BP). In a previous investigation, we could prove that even a single bout of moderate-intensity continuous exercise (MICE) causes a prolonged reduction in BP. Whether high-intensity interval training (HIIT) has a favourable influence on BP, and therefore may be followed subjects and methods by a prolonged BP reduction, should be examined on the basis of blood pressure response after exercise and during a subsequent stress test. PATIENTS AND METHODS: In 39 healthy men (aged 34 ± 8 years, BMI 24 ± 2), peripheral and central BP were measured noninvasively at rest and at the end of a 2-min cold pressor test (CPT) using a Mobil-O-Graph (24 PWA monitor, IEM). Following HIIT (6 x 1 min at 98% of the previously determined maximum wattage, 4-min rest between intervals) BP was measured again throughout 60 min of rest and thereafter during a CPT. The results were compared with those obtained before HIIT. RESULTS: Similar to MICE, peripheral and central BPs were significantly (p < 0.05) lower 45 min after HIIT. When analysing peripheral BP during a CPT before and after exercise, significantly lower systolic (p < 0.001) and diastolic (p = 0.008) pressures were established after HIIT. This was true for systolic (p = 0.002) and diastolic (p = 0.006) central BP as well. Although there were no more significant differences between pressures at rest before and 60 min after exercise, the increase in peripheral systolic pressure due to CPT was significantly slower after HIIT (p = 0.019) when compared with BP during CPT before exercise. This was true for central systolic BP as well (p = 0.017). CONCLUSION: HIIT leads to a BP reduction, which can still be detected up to 45 min after completion of the training. Even 60 min after exercise, pressures during a CPT showed a reduced augmentation, indicating an attenuated hemodynamic response to stress testing after HIIT.

Favorable effect of aerobic exercise on arterial pressure and aortic pulse wave velocity during stress testing.

BACKGROUND: Increased central pulse wave velocity is a major risk factor for cardiovascular disease. The favorable influence of exercise on arterial stiffness (AS) and blood pressure (BP) has been reported exclusively at rest. The present study investigated the influence of a single bout of acute cycling on AS and BP during recovery and, moreover, during cold pressor stress testing. PROBANDS AND METHODS: 32 healthy men (33.7 ± 8 years, BMI 24 ± 2.5 kg/m²) performed a 60 minute endurance exercise on a bicycle ergometer (45 % VO2max). Before and after exercise aortic pulse wave velocity (aPWV) as well as central and peripheral BP were measured non-invasively at rest and at the end of a 2 minute cold pressor test (CPT). RESULTS: Even after 60 minutes of recovery aPWV (- 0.22 ± 0.3 m / sec) was significantly reduced (p < 0.01). Exercise decreased peripheral (- 8 ± 7 mmHg) and central (- 7 ± 8 mmHg) systolic BP as well as peripheral (- 3 ± 5 mmHg) and central (- 4 ± 7 mmHg) diastolic BP (p < 0.01). In comparison to measurements during CPT pre-exercise, there was a significant reduction in aPWV (- 0.19 ± 0.3 m / sec), peripheral (- 6 ± 10 mmHg) and central (- 5 ± 8 mmHg) systolic BP as well as peripheral (- 3 ± 6 mmHg) and central (- 3 ± 6 mmHg) diastolic BP during CPT after exercise (p < 0.01). CONCLUSIONS: The present study suggests that acute endurance exercise leads not only to decreased BP but even more reduces aPWV as a measure of AS even after 60 minutes of recovery. In particular, the investigation provides evidence that acute moderate-intensity exercise has a favorable effect on BP and aPWV during stress testing.

Clinical impact of patient adherence to a fixed-dose combination of olmesartan, amlodipine and hydrochlorothiazide.

BACKGROUND AND OBJECTIVES: Recent findings from randomized clinical trials indicate an improved patient adherence and blood pressure (BP) control by using fixed-dose combinations (FDCs) in the treatment of hypertension. The aim of the present study was to verify those data in a large real-world sample of hypertensive patients and to cross-check adherence evaluation performed by physicians and patients self-assessment. METHODS: A European multi-center, prospective, 24-week, non-interventional study was conducted including 14,979 patients with essential hypertension and new treatment with olmesartan, amlodipine and hydrochlorothiazide as an FDC. Patients' adherence was measured using the Morisky Medication Adherence Scale (MMAS-8) and a non-standardized questionnaire was used by physicians and patients for self-assessment. RESULTS: The mean age of the patients was 63.9±11.78 years and 46.5% were women. One or more cardiovascular risk factors were present in 71.9% of patients and 94.7% had been treated for hypertension before study entry. Mean adherence to medication by MMAS-8 improved from 6.0 to 6.9 at study end. Corresponding improvements of adherence were seen on physicians' and patients' self-assessments throughout the study. Mean decrease of systolic/diastolic BP was 26.4/12.8 mmHg without a relevant difference between the MMAS-8 adherence levels. BP target achievement improved from 55.3 to 67.7% in patients with low versus high adherence. The overall rate of patients with adverse drug reactions was very low (1.76%) but more frequent in patients with low adherence. CONCLUSIONS: Our data confirm previous clinical trial data on the improvement of medication adherence by switching antihypertensive combination therapy to an FDC and a subsequent improvement in BP target achievement. An observed trend toward a reduction in adverse drug reactions needs to be further investigated in clinical trials.

Safety, tolerability, and efficacy of a fixed-dose combination of olmesartan 40 mg and hydrochlorothiazide 12.5/25 mg in daily practice.

BACKGROUND: The safety and efficacy of olmesartan 40 mg and hydrochlorothiazide (HCTZ) as a fixed-dose combination has been investigated in clinical trials leading to its approval. The aims of the present study were to confirm these data in an unselected patient population in daily practice and to determine the impact of physical activity on blood pressure control. METHODS: In a multicenter, noninterventional study, 3,333 patients with either insufficient blood pressure control on olmesartan 40 mg alone or on a fixed/free combination of olmesartan 40 mg and HCTZ 12.5/25 mg were primarily assessed for safety and tolerability of the fixed-dose combination of olmesartan 40 mg and HCTZ 12.5/25 mg at 24 ± 2 weeks. Secondary objectives were blood pressure reduction, treatment compliance, and impact of physical activity as measured by the sum of weekly energy costs. RESULTS: The mean patient age was 63.2 ± 11.46 years, mean baseline blood pressure was 159.6 ± 15.28/93.5 ± 9.52 mmHg, and 70.9% had at least one additional cardiovascular risk factor. Adverse drug reactions were rare (n = 19), and no serious adverse drug reactions occurred. Compliance with drug therapy was at least sufficient in more than 99% of patients at the end of the study. Blood pressure at the last available visit was reduced by 26.1 ± 15.5/13.0 ± 10.1 mmHg versus baseline (P < 0.0001), but had reduced effectiveness in patients ≥75 years with diabetes or impaired renal function. In 69% of patients, blood pressure was normalized (<140/90 mmHg). No noteworthy differences in baseline characteristics or baseline blood pressure were found between patients with an activity level (sum of weekly energy costs) above or below the median of 9,460.6. A higher versus lower physical activity score had no impact on blood pressure reduction. CONCLUSION: Our data confirm randomized trial data concerning safe and efficient blood pressure reduction using a fixed-dose combination of olmesartan 40 mg and HCTZ 12.5/25 mg in a large, unselected patient population, independent of physical activity level.

Improving quality of life in hypertension management using a fixed-dose combination of olmesartan and amlodipine in primary care.

OBJECTIVES: To assess quality of life (QoL) in unselected patients in primary care treated with a fixed-dose combination of olmesartan and amlodipine. Research design and methods. Multicenter, noninterventional, noncontrolled observational study in 8241 patients seen by 2187 physicians over 12 - 18 weeks. MAIN OUTCOME MEASURES: Changes in QoL were assessed by using the Short Form 12 (SF-12) questionnaire completed by 5434 patients (65.9%) at baseline and 4924 patients (59.8%) at the follow-up visit. RESULTS: Patients had a mean age of 62.8 ± 11.8 years (48.1% female), mean blood pressure [BP] at baseline was 161.8 ± 16.6/93.6 ± 10.2 mmHg and 74.8% had at least one co-morbid risk factor or condition. All 12 items of the SF-12 improved over the observational period (p < 0.0001) as did the physical (46.8 vs 40.4; p < 0.0001) and mental summary scores (52.4 vs 47.5; p < 0.0001). Correlations of changes in systolic and diastolic BP, pulse pressure and heart rate with scores were significant, although weak (maximum -0.2055 for physical health and changes in systolic blood pressure). CONCLUSIONS: The fixed-dose combination of olmesartan and amlodipine significantly improves QoL in an unselected population of patients in primary-care practice. This might translate into improved patient compliance and improved long-term antihypertensive efficacy.

Effectiveness and tolerability of a fixed-dose combination of olmesartan and amlodipine in clinical practice.

OBJECTIVES: To assess the efficacy and tolerability of a fixed-dose combination of olmesartan and amlodipine in an unselected population of patients in primary care and to compare the results with recent randomized controlled trial evidence. METHODS: A multicenter, noninterventional, noncontrolled observational study with 8241 hypertensive patients seen by 2187 physicians in daily practice. Blood pressure (BP) reduction, comorbid disease, pharmacotherapy, and tolerability were documented over a 12-18-week observational period. RESULTS: Patients had a mean age of 62.8 ± 11.8 years (48.1% female), and 74.8% had at least one comorbid risk factor or condition. In total, 51.3% received olmesartan-amlodipine 20/5 mg, 30.6% received 40/5 mg, and 17.9% received 40/10 mg at baseline, mostly because of lack of efficacy on prior antihypertensive therapy (73.8%). BP at baseline was 161.8 ± 16.6/93.6 ± 10.2 mmHg (39.8% had Grade 2 hypertension), and the observed BP reduction was -29.0 ± 17.1/-13.5 ± 10.9 mmHg (P < 0.0001), with a significant correlation between BP at baseline and BP reduction (Spearman's Rho -0.811 for systolic BP and -0.759 for diastolic BP). BP reduction appeared to be dependent on dose and prior antihypertensive therapy, but not on age, gender, body mass index, duration of hypertension, or the presence of diabetes. At the final visit, 69.4% (4.3% at baseline) were controlled (<140/90 mmHg). Adverse drug reactions were observed in 2.76% of the study population; 94.25% of these adverse drug reactions were judged as nonserious events, and 31.5% of all adverse drug reactions reported were peripheral edema. CONCLUSION: The fixed-dose olmesartan-amlodipine combination was effective and well tolerated in an unselected population of patients in primary care practice. These results confirm prior randomized controlled trial evidence.

Candesartan cilexetil/hydrochlorothiazide treatment in high-risk patients with type 2 diabetes mellitus and microalbuminuria: the CHILI T2D study.

BACKGROUND: Arterial hypertension complicated by the presence of diabetes mellitus and microalbuminuria is a particularly hazardous risk-factor combination. Blockers of the renin-angiotensin system have been shown to be beneficial with respect to these risk factors in randomized clinical trials. OBJECTIVES: To provide proof of effectiveness for a fixed-dose combination such as candesartan cilexetil 16 mg/hydrochlorothiazide (HCTZ) 12.5 mg in clinical practice within the context of a variety of concomitant diseases and medications. METHODS: CHILI T2D was a non-interventional, open-label, non-controlled, multicentre study in clinical practice that evaluated 4110 patients with type 2 diabetes, uncontrolled hypertension and microalbuminuria who were being prescribed a fixed-dose combination of candesartan cilexetil 16 mg/HCTZ 12.5 mg (Blopress). Documented outcomes included blood pressure (BP) reductions, metabolic changes, changes in albuminuria, and adverse events throughout the 12-week treatment period. RESULTS: Patients had a mean +/- SD age of 64.0 +/- 10.3 years, 54.0% were male and the mean +/- SD body mass index was 29.6 +/- 5.8 kg/m2. Coronary heart disease (34.3%), diabetic neuropathy (23.8%), retinopathy (18.6%) and heart failure (20.2%) were frequent co-morbidities. The use of candesartan cilexetil 16 mg/HCTZ 12.5 mg in patients with a mean +/- SD baseline BP of 158.5 +/- 14.2/92.5 +/- 9.1 mmHg resulted in a substantial further reduction of office BP by a mean +/- SD of -27.1 +/- 14.4/-13.1 +/- 9.5 mmHg (p < 0.001). The reduction was particularly pronounced in patients with severe hypertension (mean reduction of -44.7/-19.9 mmHg). Glucose (glycosylated haemoglobin [HbA(1c)], fasting blood glucose) as well as lipid parameters (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and triglycerides) were significantly improved (p < 0.001). Microalbuminuria, indicative of renal and cardiovascular risk, was significantly reduced by 28.8% (p < 0.001). Tolerability was excellent with only 16 out of 4110 patients experiencing any adverse event, of which six were considered to be serious. CONCLUSIONS: The fixed-dose combination of candesartan cilexetil 16 mg/HCTZ 12.5 mg is highly effective in lowering blood pressure in type 2 diabetic patients with all stages of hypertension and microalbuminuria. The data indicate that low-dose HCTZ can safely be added to an existing drug regimen in this patient group to increase the BP-lowering effect, without compromising tolerability and the favourable metabolic profile of candesartan cilexetil monotherapy.