avapro has been researched along with Obesity in 30 studies
Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.
irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension.
Obesity: A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).
| Excerpt | Relevance | Reference |
|---|---|---|
| " Treatment-emergent adverse event rates were similar between treatment groups regardless of the presence of diabetes or body mass index (BMI) status." | 6.76 | A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review. ( Neutel, JM, 2011) |
| "This post hoc analysis of a 7-week, randomized, double-blind trial evaluated the efficacy and safety of initial irbesartan/hydrochlorothiazide treatment in 468 patients with severe, uncontrolled, hypertension (diastolic blood pressure [DBP] > or =100 mm Hg) at high cardiovascular risk." | 5.14 | Efficacy and safety of irbesartan/HCTZ in severe hypertension according to cardiometabolic factors. ( Franklin, SS; Neutel, JM, 2010) |
| "A post hoc pooled analysis of 2 multicenter, randomized, double-blind, active-controlled force-titration studies assessed the antihypertensive efficacy and tolerability of 7 to 8 weeks' once-daily fixed-dose irbesartan/hydrochlorothiazide (HCTZ) 300/25 mg in 796 stage 1 or 2 hypertensive patients according to age (65 years or older or younger than 65) (n=121 or 675) and presence or absence of obesity (n=378 or 414), type 2 diabetes (n=99 or 697), and high World Health Organization-defined cardiovascular risk (n=593 or 202)." | 5.12 | The efficacy and safety of initial use of irbesartan/hydrochlorothiazide fixed-dose combination in hypertensive patients with and without high cardiovascular risk. ( Bhaumik, A; De Obaldia, ME; Lapuerta, P; Neutel, JM; Weir, MR, 2007) |
| "Treatment with irbesartan attenuates cardiac inflammation in type 2 diabetic db/db mice, and this effect was probably associated with the suppression of cardiac angiotensin II and NF-κB signaling pathway." | 3.83 | [Irbesartan ameliorates cardiac inflammation in type 2 diabetic db/db mice]. ( Gong, WQ; Huang, WC; Liang, Y; Liu, B; Yang, CM; Ye, XL; Zheng, YT, 2016) |
| "Angiotensin II (AII) has been shown to contribute to the pathogenesis of hypertension and insulin resistance." | 3.73 | Irbesartan restores the in-vivo insulin signaling pathway leading to Akt activation in obese Zucker rats. ( Argentino, DP; Dominici, FP; Muñoz, MC; Toblli, JE; Turyn, D, 2006) |
| "In this study, we evaluated whether a combination of an angiotensin-converting enzyme (ACE) inhibitor, benazepril (B), with an angiotensin type I receptor antagonist (AT1RA), irbesartan (I), is as effective or more than drugs as monotherapy in controlling renal damage in obese Zucker rats (OZR), a model of metabolic syndrome." | 3.72 | ACE inhibitor and angiotensin type I receptor antagonist in combination reduce renal damage in obese Zucker rats. ( Cao, G; DeRosa, G; Pagano, P; Piorno, P; Toblli, JE, 2004) |
| "Obesity is a major risk factor for incident heart failure (HF)." | 2.76 | Body mass index and adverse cardiovascular outcomes in heart failure patients with preserved ejection fraction: results from the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. ( Anand, IS; Carson, PE; Haass, M; Kitzman, DW; Massie, BM; Miller, A; Zile, MR, 2011) |
| " Treatment-emergent adverse event rates were similar between treatment groups regardless of the presence of diabetes or body mass index (BMI) status." | 2.76 | A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review. ( Neutel, JM, 2011) |
| "Patients with high blood pressure are often overweight or even obese." | 2.71 | [Arterial hypertension in obese patients. Rationale for a prospective medical care study in the family doctor's practice]. ( Bramlage, P; Kirch, W; Sharma, AM, 2004) |
| "Non-alcoholic steatohepatitis (NASH) is the hepatic manifestation of a metabolic syndrome characterized by accumulation of hepatic fat, inflammation and varying degrees of fibrosis." | 1.38 | Therapeutic effects of angiotensin II type 1 receptor blocker, irbesartan, on non-alcoholic steatohepatitis using FLS-ob/ob male mice. ( Kato, J; Kishina, M; Koda, M; Matono, T; Murawaki, Y; Sugihara, T; Tokunaga, S; Ueki, M, 2012) |
| "Non-alcoholic steatohepatitis (NASH), which is a common liver disease in industrialized countries, is associated with obesity, hypertension, and type-2 diabetes (metabolic syndrome)." | 1.35 | ACE inhibition and AT1 receptor blockade prevent fatty liver and fibrosis in obese Zucker rats. ( Cao, G; Mastai, R; Mella, J; Muñoz, MC; Pereyra, L; Toblli, JE, 2008) |
| "As obesity is a common finding in diabetic individuals, and obesity has been linked to an increase in plasma angiotensinogen levels, we enrolled diabetic subjects with a wide range of body mass index (BMI) for this study." | 1.31 | Type 2 diabetes, obesity, and the renal response to blocking the renin system with irbesartan. ( Fisher, ND; Hollenberg, NK; Laffel, LM; Lansang, MC; Osei, SY; Price, DA, 2002) |
| " After chronic administration of irbesartan (21 days at 50 mg." | 1.31 | Selective angiotensin II receptor antagonism reduces insulin resistance in obese Zucker rats. ( Henriksen, EJ; Jacob, S; Kinnick, TR; Krekler, M; Teachey, MK, 2001) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 18 (60.00) | 29.6817 |
| 2010's | 12 (40.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Ye, XL | 1 |
| Huang, WC | 1 |
| Zheng, YT | 1 |
| Liang, Y | 1 |
| Gong, WQ | 1 |
| Yang, CM | 1 |
| Liu, B | 1 |
| Maeda, A | 1 |
| Tamura, K | 1 |
| Wakui, H | 1 |
| Ohsawa, M | 1 |
| Azushima, K | 1 |
| Uneda, K | 1 |
| Kobayashi, R | 1 |
| Tsurumi-Ikeya, Y | 1 |
| Kanaoka, T | 1 |
| Dejima, T | 1 |
| Ohki, K | 1 |
| Haku, S | 1 |
| Yamashita, A | 1 |
| Umemura, S | 1 |
| Russell, JC | 1 |
| Kelly, SE | 1 |
| Vine, DF | 1 |
| Proctor, SD | 1 |
| Muñoz, MC | 3 |
| Giani, JF | 1 |
| Dominici, FP | 2 |
| Turyn, D | 2 |
| Toblli, JE | 4 |
| Franklin, SS | 1 |
| Neutel, JM | 3 |
| Rong, X | 1 |
| Li, Y | 1 |
| Ebihara, K | 1 |
| Zhao, M | 1 |
| Kusakabe, T | 1 |
| Tomita, T | 1 |
| Murray, M | 1 |
| Nakao, K | 1 |
| Kobayashi, T | 1 |
| Akiyama, Y | 1 |
| Akiyama, N | 1 |
| Katoh, H | 1 |
| Yamamoto, S | 1 |
| Funatsuki, K | 1 |
| Yanagimoto, T | 1 |
| Notoya, M | 1 |
| Asakura, K | 1 |
| Shinosaki, T | 1 |
| Hanasaki, K | 1 |
| De Luis, DA | 1 |
| Conde, R | 1 |
| Gonzalez Sagrado, M | 1 |
| Aller, R | 1 |
| Izaola, O | 1 |
| Perez Castrillon, JL | 1 |
| Romero, E | 1 |
| Castro, MJ | 1 |
| Haass, M | 1 |
| Kitzman, DW | 1 |
| Anand, IS | 1 |
| Miller, A | 1 |
| Zile, MR | 1 |
| Massie, BM | 1 |
| Carson, PE | 1 |
| Fogari, R | 1 |
| Mugellini, A | 1 |
| Circelli, M | 1 |
| Cremonesi, G | 1 |
| Ram, CV | 1 |
| Ramaswamy, K | 1 |
| Qian, C | 1 |
| Biskupiak, J | 1 |
| Ryan, A | 1 |
| Quah, R | 1 |
| Russo, PA | 1 |
| Kato, J | 1 |
| Koda, M | 1 |
| Kishina, M | 1 |
| Tokunaga, S | 1 |
| Matono, T | 1 |
| Sugihara, T | 1 |
| Ueki, M | 1 |
| Murawaki, Y | 1 |
| Tsuruoka, S | 1 |
| Kai, H | 1 |
| Usui, J | 1 |
| Morito, N | 1 |
| Saito, C | 1 |
| Yoh, K | 1 |
| Yamagata, K | 1 |
| Price, DA | 1 |
| Lansang, MC | 1 |
| Osei, SY | 1 |
| Fisher, ND | 1 |
| Laffel, LM | 1 |
| Hollenberg, NK | 1 |
| DeRosa, G | 1 |
| Cao, G | 2 |
| Piorno, P | 1 |
| Pagano, P | 1 |
| Bramlage, P | 3 |
| Sharma, AM | 4 |
| Kirch, W | 3 |
| Clasen, R | 1 |
| Schupp, M | 1 |
| Foryst-Ludwig, A | 1 |
| Sprang, C | 1 |
| Clemenz, M | 1 |
| Krikov, M | 1 |
| Thöne-Reineke, C | 1 |
| Unger, T | 1 |
| Kintscher, U | 1 |
| Boschmann, M | 1 |
| Engeli, S | 2 |
| Adams, F | 1 |
| Franke, G | 1 |
| Luft, FC | 1 |
| Jordan, J | 2 |
| Di Filippo, C | 1 |
| Lampa, E | 1 |
| Tufariello, E | 1 |
| Petronella, P | 1 |
| Freda, F | 1 |
| Capuano, A | 1 |
| D'Amico, M | 1 |
| Janiak, P | 1 |
| Bidouard, JP | 1 |
| Cadrouvele, C | 1 |
| Poirier, B | 1 |
| Gouraud, L | 1 |
| Grataloup, Y | 1 |
| Pierre, F | 1 |
| Bruneval, P | 1 |
| O'Connor, SE | 1 |
| Herbert, JM | 1 |
| Argentino, DP | 1 |
| Boye, SW | 1 |
| Le Breton, S | 1 |
| Keefe, DL | 1 |
| Weir, MR | 1 |
| Bhaumik, A | 1 |
| De Obaldia, ME | 1 |
| Lapuerta, P | 1 |
| Mella, J | 1 |
| Pereyra, L | 1 |
| Mastai, R | 1 |
| Sharkey, LC | 1 |
| Holycross, BJ | 1 |
| McCune, SA | 1 |
| Radin, MJ | 1 |
| Bloomgarden, ZT | 1 |
| Henriksen, EJ | 1 |
| Jacob, S | 1 |
| Kinnick, TR | 1 |
| Teachey, MK | 1 |
| Krekler, M | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)[NCT00095238] | Phase 3 | 4,128 participants (Actual) | Interventional | 2002-06-30 | Completed | ||
| Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease[NCT00755677] | Early Phase 1 | 26 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
| A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Resp[NCT00219115] | Phase 3 | 493 participants (Actual) | Interventional | 2005-01-31 | Completed | ||
| Treatment of Essential Hypertension With Rasilez. Evaluation of Different Methods of Blood Pressure Measurements - Efficacy and Safety Evaluation[NCT01060865] | Phase 4 | 50 participants (Actual) | Interventional | 2010-03-31 | Terminated (stopped due to The participants signed an old version of the informed consent.) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14
| Intervention | pg/mL (Geometric Mean) |
|---|---|
| Placebo - Month 6 | 0.98 |
| Irbesartan - Month 6 | 0.93 |
| Placebo - Month 14 | 1.00 |
| Irbesartan - Month 14 | 1.01 |
NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event. (NCT00095238)
Timeframe: Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
| Intervention | participants (Number) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 6 - Improved | Month 6 - Unchanged | Month 6 - Worsened | Month 6 - Major Event | Month 6 - No Data | Month 10 - Improved | Month 10 - Unchanged | Month 10 - Worsened | Month 10 - Major Event | Month 10 - No Data | Month 14 - Improved | Month 14 - Unchanged | Month 14 - Worsened | Month 14 - Major Event | Month 14 - No Data | Final Visit - Improved | Final Visit - Unchanged | Final Visit - Worsened | Final Visit - Major Event | Final Visit - No Data | |
| Irbesartan Baseline All Classes Combined | 936 | 966 | 48 | 10 | 107 | 948 | 911 | 58 | 41 | 109 | 933 | 866 | 61 | 75 | 132 | 928 | 658 | 97 | 324 | 60 |
| Irbesartan Baseline Class I or II | 55 | 310 | 41 | 2 | 18 | 44 | 294 | 53 | 10 | 25 | 38 | 287 | 50 | 22 | 29 | 42 | 230 | 68 | 75 | 11 |
| Irbesartan Class III or IV | 881 | 656 | 7 | 8 | 89 | 904 | 617 | 5 | 31 | 84 | 895 | 579 | 11 | 53 | 103 | 886 | 428 | 29 | 249 | 49 |
| Placebo Baseline All Classes Combined | 881 | 1016 | 51 | 14 | 98 | 902 | 939 | 71 | 42 | 106 | 902 | 890 | 69 | 80 | 119 | 882 | 694 | 107 | 320 | 57 |
| Placebo Baseline Class I or II | 47 | 338 | 47 | 2 | 11 | 42 | 317 | 63 | 9 | 14 | 39 | 312 | 62 | 16 | 16 | 42 | 254 | 78 | 66 | 5 |
| Placebo Class III or IV | 834 | 678 | 4 | 12 | 87 | 860 | 622 | 8 | 33 | 92 | 863 | 578 | 7 | 64 | 103 | 840 | 440 | 29 | 254 | 52 |
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean. (NCT00095238)
Timeframe: Baseline, Month 6, Month 18, Month 30
| Intervention | mL/min/1.73m2 (Mean) | ||
|---|---|---|---|
| Baseline Mean | Post-Baseline Mean | Adjusted Mean Change | |
| Irbesartan - Month 18 | 73.49 | 68.00 | -5.50 |
| Irbesartan - Month 30 | 74.37 | 67.05 | -7.12 |
| Irbesartan - Month 6 | 73.13 | 69.21 | -3.91 |
| Placebo - Month 18 | 73.58 | 70.88 | -2.69 |
| Placebo - Month 30 | 73.34 | 69.51 | -4.02 |
| Placebo - Month 6 | 73.02 | 71.97 | -1.07 |
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean. (NCT00095238)
Timeframe: Baseline, Month 42, Month 54, Month 66
| Intervention | mL/min/1.73m2 (Mean) | ||
|---|---|---|---|
| Baseline Mean | Post-Baseline Mean | Adjusted Mean Change | |
| Irbesartan - Month 42 | 74.95 | 67.48 | -7.36 |
| Irbesartan - Month 54 | 75.17 | 68.24 | -6.93 |
| Irbesartan - Month 66 | 71.84 | 64.85 | -5.46 |
| Placebo - Month 42 | 74.37 | 71.34 | -3.14 |
| Placebo - Month 54 | 75.29 | 72.65 | -2.63 |
| Placebo - Month 66 | 63.47 | 60.09 | -4.91 |
Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure. (NCT00095238)
Timeframe: Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline Mean | Final Visit Mean | |
| Irbesartan - Final Visit | 38.9 | 38.3 |
| Placebo - Final Visit | 42.5 | 42.6 |
Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline Mean Score | Mean Score at Timepoint | Adjusted Mean Change from Baseline | |
| Irbesartan - Month 14 | 42.8 | 32.1 | -10.6 |
| Irbesartan - Month 6 | 43.0 | 33.2 | -9.8 |
| Placebo - Month 14 | 42.7 | 31.6 | -11.2 |
| Placebo - Month 6 | 42.7 | 32.9 | -10.0 |
Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator. (NCT00095238)
Timeframe: Baseline, Final Visit
| Intervention | participants (Number) | |
|---|---|---|
| No prior AF history or Evidence on Baseline ECG | Participants with New Onset Atrial Fibrillation | |
| Irbesartan + ACE-I Use | 366 | 35 |
| Irbesartan no ACE-I Use | 1089 | 103 |
| Placebo + ACE-I Use | 344 | 29 |
| Placebo no ACE-I Use | 1102 | 99 |
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
| Intervention | Participants (Number) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 6 - Improved Markedly | Month 6 - Improved Moderately | Month 6 - Improved Slightly | Month 6 - Unchanged | Month 6 - Worsened Slightly | Month 6 - Worsened Moderately | Month 6 - Worsened Markedly | Month 6 - Major Event | Month 6 - No Data | Month 14 - Improved Markedly | Month 14 - Improved Moderately | Month 14 - Improved Slightly | Month 14 - Unchanged | Month 14 - Worsened Slightly | Month 14 - Worsened Moderately | Month 14 - Worsened Markedly | Month 14 - Major Event | Month 14 - No Data | Final Visit - Improved Markedly | Final Visit - Improved Moderately | Final Visit - Improved Slightly | Final Visit - Unchanged | Final Visit - Worsened Slightly | Final Visit - Worsened Moderately | Final Visit - Worsened Markedly | Final Visit - Major Event | Final Visit - No Data | |
| Irbesartan | 255 | 549 | 512 | 508 | 83 | 22 | 9 | 8 | 121 | 247 | 519 | 460 | 476 | 103 | 28 | 13 | 68 | 153 | 213 | 382 | 328 | 460 | 114 | 64 | 35 | 395 | 76 |
| Placebo | 276 | 536 | 501 | 510 | 83 | 22 | 10 | 7 | 116 | 232 | 531 | 430 | 509 | 90 | 39 | 10 | 74 | 146 | 212 | 339 | 335 | 461 | 145 | 75 | 32 | 384 | 78 |
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
| Intervention | Participants (Number) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 6 - Improved Markedly | Month 6 - Improved Moderately | Month 6 - Improved Slightly | Month 6 - Unchanged | Month 6 - Worsened Slightly | Month 6 - Worsened Moderately | Month 6 - Worsened Markedly | Month 6 - Major Event | Month 6 - No Data | Month 14 - Improved Markedly | Month 14 - Improved Moderately | Month 14 - Improved Slightly | Month 14 - Unchanged | Month 14 - Worsened Slightly | Month 14 - Worsened Moderately | Month 14 - Worsened Markedly | Month 14 - Major Event | Month 14 - No Data | Final Visit - Improved Markedly | Final Visit - Improved Moderately | Final Visit - Improved Slightly | Final Visit - Unchanged | Final Visit - Worsened Slightly | Final Visit - Worsened Moderately | Final Visit - Worsened Markedly | Final Visit - Major Event | Final Visit - No Data | |
| Irbesartan | 193 | 523 | 504 | 579 | 97 | 28 | 13 | 8 | 122 | 195 | 513 | 439 | 525 | 115 | 48 | 11 | 68 | 153 | 157 | 361 | 319 | 479 | 166 | 80 | 34 | 395 | 76 |
| Placebo | 200 | 519 | 471 | 596 | 101 | 38 | 13 | 7 | 116 | 182 | 489 | 443 | 559 | 109 | 43 | 16 | 74 | 146 | 178 | 300 | 337 | 477 | 176 | 90 | 42 | 383 | 78 |
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
| Intervention | Participants (Number) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 6 - Improved Markedly | Month 6 - Improved Moderately | Month 6 - Improved Slightly | Month 6 - Unchanged | Month 6 - Worsened Slightly | Month 6 - Worsened Moderately | Month 6 - Worsened Markedly | Month 6 - Major Event | Month 6 - No Data | Month 14 - Improved Markedly | Month 14 - Improved Moderately | Month 14 - Improved Slightly | Month 14 - Unchanged | Month 14 - Worsened Slightly | Month 14 - Worsened Moderately | Month 14 - Worsened Markedly | Month 14 - Major Event | Month 14 - No Data | Final Visit - Improved Markedly | Final Visit - Improved Moderately | Final Visit - Improved Slightly | Final Visit - Unchanged | Final Visit - Worsened Slightly | Final Visit - Worsened Moderately | Final Visit - Worsened Markedly | Final Visit - Major Event | Final Event - No Data | |
| Irbesartan | 235 | 552 | 529 | 537 | 63 | 13 | 8 | 8 | 122 | 234 | 532 | 461 | 503 | 78 | 30 | 8 | 68 | 153 | 207 | 378 | 332 | 480 | 121 | 52 | 25 | 396 | 76 |
| Placebo | 230 | 563 | 519 | 529 | 69 | 20 | 8 | 7 | 116 | 206 | 534 | 450 | 527 | 82 | 35 | 7 | 74 | 146 | 201 | 339 | 352 | 495 | 109 | 76 | 28 | 383 | 78 |
Treatment comparisons for time to all-cause death (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 4.1 | 8.1 | 12.8 | 17.9 | 25.0 |
| Placebo | 3.8 | 8.6 | 13.8 | 18.5 | 23.6 |
Treatment comparisons for time to cardiovascular death (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage 1 Year | Percentage 2 Years | Percentage 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 3.3 | 6.2 | 9.6 | 13.0 | 18.0 |
| Placebo | 3.0 | 6.5 | 10.0 | 13.1 | 17.1 |
Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 11.6 | 19.2 | 24.2 | 30.0 | 35.0 |
| Placebo | 11.4 | 20.0 | 25.8 | 30.9 | 35.8 |
Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 5.2 | 8.7 | 12.9 | 17.2 | 23.0 |
| Placebo | 4.2 | 9.3 | 13.6 | 17.6 | 22.4 |
Treatment comparisons for time to heart failure mortality or heart failure hospitalization (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 7.9 | 12.9 | 15.7 | 19.8 | 23.6 |
| Placebo | 8.2 | 13.7 | 17.2 | 20.3 | 23.8 |
Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 9.7 | 16.3 | 20.5 | 24.8 | 28.5 |
| Placebo | 9.8 | 17.1 | 21.7 | 25.9 | 29.0 |
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 12.3 | 20.7 | 26.4 | 32.9 | 39.2 |
| Placebo | 12.1 | 21.3 | 28.4 | 34.2 | 39.5 |
Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes. (NCT00095238)
Timeframe: Year 1, Year 2, Year 3, Year 4, Year 5
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Percentage at 1 Year | Percentage at 2 Years | Percentage at 3 Years | Percentage at 4 Years | Percentage at 5 Years | |
| Irbesartan | 0.7 | 2.1 | 3.1 | 4.6 | 5.2 |
| Placebo | 1.2 | 2.8 | 3.9 | 5.4 | 6.2 |
This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly. (NCT00095238)
Timeframe: Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
| Intervention | participants (Number) | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Month 6 - Improved Markedly | Month 6 - Improved Moderately | Month 6 - Improved Slightly | Month 6 - Unchanged | Month 6 - Worsened Slightly | Month 6 - Worsened Moderately | Month 6 - Worsened Markedly | Month 6 - Major Event | Month 6 - No Data | Month 14 - Improved Markedly | Month 14 - Improved Moderately | Month 14 - Improved Slightly | Month 14 - Unchanged | Month 14 - Worsened Slightly | Month 14 - Worsened Moderately | Month 14 - Worsened Markedly | Month 14 - Major Event | Month 14 - No Data | Final Visit - Improved Markedly | Final Visit - Improved Moderately | Final Visit - Improved Slightly | Final Visit - Unchanged | Final Visit - Worsened Slightly | Final Visit - Worsened Moderately | Final Visit - Worsened Markedly | Final Visit - Major Event | Final Visit - No Data | |
| Irbesartan | 230 | 562 | 533 | 528 | 60 | 17 | 0 | 8 | 129 | 214 | 546 | 442 | 507 | 72 | 21 | 5 | 75 | 185 | 180 | 430 | 344 | 477 | 117 | 41 | 23 | 364 | 91 |
| Placebo | 198 | 575 | 529 | 541 | 58 | 16 | 4 | 8 | 132 | 195 | 537 | 435 | 548 | 73 | 19 | 6 | 79 | 169 | 186 | 367 | 361 | 504 | 117 | 56 | 28 | 350 | 92 |
1 review available for avapro and Obesity
| Article | Year |
|---|---|
Combination delapril/manidipine as antihypertensive therapy in high-risk patients.
Topics: Antihypertensive Agents; Biphenyl Compounds; Blood Pressure; Clinical Trials as Topic; Diabetes Comp | 2011 |
9 trials available for avapro and Obesity
| Article | Year |
|---|---|
Efficacy and safety of irbesartan/HCTZ in severe hypertension according to cardiometabolic factors.
Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl Compounds; Body Mas | 2010 |
Effects of olmesartan vs irbesartan on metabolic parameters and visfatin in hypertensive obese women.
Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biomarkers; Biphenyl Compoun | 2010 |
Body mass index and adverse cardiovascular outcomes in heart failure patients with preserved ejection fraction: results from the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial.
Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Biphenyl Compounds; Body Mass Index; Cardiovascular D | 2011 |
A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review.
Topics: Antihypertensive Agents; Biphenyl Compounds; Diabetes Complications; Diabetes Mellitus, Type 2; Doub | 2011 |
Effects of irbesartan on inflammatory cytokine concentrations in patients with chronic glomerulonephritis.
Topics: Adiponectin; Angiotensin II Type 1 Receptor Blockers; Anti-Inflammatory Agents, Non-Steroidal; Biphe | 2013 |
Influences of AT1 receptor blockade on tissue metabolism in obese men.
Topics: Adipose Tissue; Adult; Angiotensin II Type 1 Receptor Blockers; Biphenyl Compounds; Cross-Over Studi | 2006 |
[Arterial hypertension in obese patients. Rationale for a prospective medical care study in the family doctor's practice].
Topics: Albuminuria; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl Compounds; C | 2004 |
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension.
Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds; | 2007 |
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension.
Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds; | 2007 |
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension.
Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds; | 2007 |
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension.
Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds; | 2007 |
The efficacy and safety of initial use of irbesartan/hydrochlorothiazide fixed-dose combination in hypertensive patients with and without high cardiovascular risk.
Topics: Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl | 2007 |
20 other studies available for avapro and Obesity
| Article | Year |
|---|---|
[Irbesartan ameliorates cardiac inflammation in type 2 diabetic db/db mice].
Topics: Actins; Angiotensin II; Animals; Biphenyl Compounds; Cardiovascular Diseases; Diabetes Mellitus, Exp | 2016 |
Effects of Ang II receptor blocker irbesartan on adipose tissue function in mice with metabolic disorders.
Topics: Adaptor Proteins, Signal Transducing; Adipose Tissue; Angiotensin II Type 1 Receptor Blockers; Anima | 2014 |
Irbesartan-mediated reduction of renal and cardiac damage in insulin resistant JCR : LA-cp rats.
Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Cardiovascular Diseases; Infla | 2009 |
Long-term treatment with an angiotensin II receptor blocker decreases adipocyte size and improves insulin signaling in obese Zucker rats.
Topics: Adipocytes; Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Blood Glucose; Blo | 2009 |
Irbesartan treatment up-regulates hepatic expression of PPARalpha and its target genes in obese Koletsky (fa(k)/fa(k)) rats: a link to amelioration of hypertriglyceridaemia.
Topics: Animals; Biphenyl Compounds; Blotting, Western; Gene Expression; Hypertension; Hypertriglyceridemia; | 2010 |
Irbesartan enhances GLUT4 translocation and glucose transport in skeletal muscle cells.
Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biological Transport; Biphenyl Compounds; Body Wei | 2010 |
Blood pressure outcomes in patients receiving angiotensin II receptor blockers in primary care: a comparative effectiveness analysis from electronic medical record data.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Biphenyl Compou | 2011 |
Therapeutic effects of angiotensin II type 1 receptor blocker, irbesartan, on non-alcoholic steatohepatitis using FLS-ob/ob male mice.
Topics: 8-Hydroxy-2'-Deoxyguanosine; Actins; Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Comp | 2012 |
Type 2 diabetes, obesity, and the renal response to blocking the renin system with irbesartan.
Topics: Adult; Angiotensin I; Angiotensin Receptor Antagonists; Biphenyl Compounds; Blood Pressure; Body Mas | 2002 |
ACE inhibitor and angiotensin type I receptor antagonist in combination reduce renal damage in obese Zucker rats.
Topics: Actins; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Animals; | 2004 |
[Arterial hypertension in adipose patients. Rationale for a prospective medical care study in the family physician practice].
Topics: Adolescent; Adult; Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl | 2004 |
PPARgamma-activating angiotensin type-1 receptor blockers induce adiponectin.
Topics: 3T3-L1 Cells; Adipocytes; Angiotensin II; Angiotensin II Type 1 Receptor Blockers; Animals; Benzimid | 2005 |
[Good blood pressure control even in overweight patients].
Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl Compounds; Blood Pr | 2005 |
Effects of irbesartan on the growth and differentiation of adipocytes in obese zucker rats.
Topics: Adipocytes; Adipose Tissue; Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Ce | 2005 |
Long-term blockade of angiotensin AT1 receptors increases survival of obese Zucker rats.
Topics: Angiotensin II Type 1 Receptor Blockers; Animals; Biphenyl Compounds; Blood Glucose; Blood Pressure; | 2006 |
Irbesartan restores the in-vivo insulin signaling pathway leading to Akt activation in obese Zucker rats.
Topics: Adaptor Proteins, Signal Transducing; Analysis of Variance; Angiotensin II; Angiotensin II Type 1 Re | 2006 |
ACE inhibition and AT1 receptor blockade prevent fatty liver and fibrosis in obese Zucker rats.
Topics: Amlodipine; Angiotensin II; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme I | 2008 |
Obese female SHHF/Mcc-fa(cp) rats resist antihypertensive effects of renin-angiotensin system inhibition.
Topics: Angiotensin II; Animals; Antihypertensive Agents; Biphenyl Compounds; Blood Pressure; Dose-Response | 2001 |
Angiotensin II receptor blockers and nephropathy trials.
Topics: Albuminuria; Angiotensin Receptor Antagonists; Animals; Antihypertensive Agents; Biphenyl Compounds; | 2001 |
Selective angiotensin II receptor antagonism reduces insulin resistance in obese Zucker rats.
Topics: Angiotensin Receptor Antagonists; Animals; Area Under Curve; Biological Transport; Biphenyl Compound | 2001 |