Objectives: This multicenter, three-armed, open-labeled study investigated patient compliance of patients receiving irbesartan, angiotensin-converting enzyme (ACE) inhibitors or calcium-channel blockers (CCB) for essential hypertension for a 6-month period. Patients were either newly diagnosed or switched from existing antihypertensive medication due to lack of efficacy or side-effects.
Methods: Patients were started monotherapy with irbesartan (n=377), ACE inhibitors (n=298) or CCB (n=308) and were reevaluated on 1st, 3rd, and 6th months of the treatment. The primary endpoint was patient compliance, assessed by proportion of patients who had taken their study medication every day. Efficacy was recorded as mean reductions in blood pressure and the proportion of patients whose blood pressure normalized. Tolerability was assessed by reported adverse events.
Results: Significantly more patients receiving irbesartan had complied with study medication after 3 and 6 months of treatment than ACE inhibitors or CCB. Significantly fewer patients receiving irbesartan needed to change their antihypertensive medication. All three study treatments exhibited similar efficacy profiles, but irbesartan had significantly less adverse events.
Conclusions: This study demonstrated that patient compliance to irbesartan was significantly superior to other study treatments. Irbesartan is therefore a suitable first-line therapy for essential hypertension in everyday clinical practice.
{"title":"Effect of irbesartan monotherapy compared with ACE inhibitors and calcium-channel blockers on patient compliance in essential hypertension patients: a multicenter, open-labeled, three-armed study.","authors":"Nevres Koylan, Esmeray Acarturk, Aykan Canberk, Nail Caglar, Sali Caglar, Serap Erdine, Sema Guneri, Baris Ilerigelen, Giray Kabakci, Remzi Onder, Olcay Sagkan, Kemalettin Buyukozturk","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Objectives: </strong>This multicenter, three-armed, open-labeled study investigated patient compliance of patients receiving irbesartan, angiotensin-converting enzyme (ACE) inhibitors or calcium-channel blockers (CCB) for essential hypertension for a 6-month period. Patients were either newly diagnosed or switched from existing antihypertensive medication due to lack of efficacy or side-effects.</p><p><strong>Methods: </strong>Patients were started monotherapy with irbesartan (n=377), ACE inhibitors (n=298) or CCB (n=308) and were reevaluated on 1st, 3rd, and 6th months of the treatment. The primary endpoint was patient compliance, assessed by proportion of patients who had taken their study medication every day. Efficacy was recorded as mean reductions in blood pressure and the proportion of patients whose blood pressure normalized. Tolerability was assessed by reported adverse events.</p><p><strong>Results: </strong>Significantly more patients receiving irbesartan had complied with study medication after 3 and 6 months of treatment than ACE inhibitors or CCB. Significantly fewer patients receiving irbesartan needed to change their antihypertensive medication. All three study treatments exhibited similar efficacy profiles, but irbesartan had significantly less adverse events.</p><p><strong>Conclusions: </strong>This study demonstrated that patient compliance to irbesartan was significantly superior to other study treatments. Irbesartan is therefore a suitable first-line therapy for essential hypertension in everyday clinical practice.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"23-31"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24933155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aims: This post-marketing surveillance study assessed the efficacy, safety, and tolerability of the treatment with nifedipine OROS in hypertensive patients in Taiwan.
Results: A total of 2044 patients were included in 204 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine OROS. Mean treatment duration was 15.8 weeks. At endpoint, 91.4% of patients were receiving 30 mg nifedipine OROS. Mean blood pressure reduction was 20.6/10.3 mmHg; 46.1% of patients had a systolic blood pressure < 140 mmHg and 66.8% had a diastolic blood pressure <90 mmHg. Total blood pressure control was achieved in 41.2% of all patients. Beta-blockers were the most commonly used (24.0%) concomitant antihypertensive therapy. A total of 2.3% of patients experienced adverse events. Subjective physicians' assessments of efficacy, tolerability, and patient acceptance of nifedipine OROS treatment had ratings of "very good" and "good" in 82.3% (efficacy), 87.5 (tolerability) and 88.1% (patient acceptance) of the study cohort.
Conclusions: Nifedipine OROS proved to be effective and well tolerated for the treatment of hypertension in 2044 Chinese patients. The results confirm the findings and experience of previously performed controlled clinical studies.
{"title":"Nifedipine OROS in Chinese patients with hypertension--results of a post-marketing surveillance study in Taiwan.","authors":"Kwo-Chang Ueng, Zhih-Cheng Chen, Poh-Shiow Yeh, Kuo-Chun Hung, Shao-An Hu, Yi-Jen Hung, Harald Landen","doi":"10.1080/08038020510040630","DOIUrl":"https://doi.org/10.1080/08038020510040630","url":null,"abstract":"<p><strong>Aims: </strong>This post-marketing surveillance study assessed the efficacy, safety, and tolerability of the treatment with nifedipine OROS in hypertensive patients in Taiwan.</p><p><strong>Results: </strong>A total of 2044 patients were included in 204 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine OROS. Mean treatment duration was 15.8 weeks. At endpoint, 91.4% of patients were receiving 30 mg nifedipine OROS. Mean blood pressure reduction was 20.6/10.3 mmHg; 46.1% of patients had a systolic blood pressure < 140 mmHg and 66.8% had a diastolic blood pressure <90 mmHg. Total blood pressure control was achieved in 41.2% of all patients. Beta-blockers were the most commonly used (24.0%) concomitant antihypertensive therapy. A total of 2.3% of patients experienced adverse events. Subjective physicians' assessments of efficacy, tolerability, and patient acceptance of nifedipine OROS treatment had ratings of \"very good\" and \"good\" in 82.3% (efficacy), 87.5 (tolerability) and 88.1% (patient acceptance) of the study cohort.</p><p><strong>Conclusions: </strong>Nifedipine OROS proved to be effective and well tolerated for the treatment of hypertension in 2044 Chinese patients. The results confirm the findings and experience of previously performed controlled clinical studies.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"32-8"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020510040630","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24933157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Calcium antagonists, angiotensin-converting enzyme (ACE) inhibitors and other drug classes either alone or in combination have been recommended for the treatment of hypertension. Nifedipine gastrointestinal therapeutic system (GITS) 20 mg is a new low-dose formulation with an improved tolerability. The aim of the present study was to compare the effects of nifedipine GITS 20 mg and enalapril 20 mg on blood pressure and circulating adhesion molecules in hypertensive patients.
Methods: This randomized, double-blind, multicentre trial compared the blood pressure lowering effects of a 12-week treatment of nifedipine GITS 20 mg vs enalapril 20 mg in 264 patients with mild-to-moderate hypertension.
Results: Nifedipine GITS 20 mg induced a reduction of clinic blood pressure, which was similar to that observed with enalapril 20 mg. Nifedipine GITS and enalapril lowered mean sitting diastolic blood pressure by 11.8 and 12.4 mmHg, respectively, while systolic blood pressure was reduced by 15.3 and 16.3 mmHg, respectively. Ambulatory blood pressure monitoring-derived blood pressure data showed similar results in both groups without any statistically significant differences between treatments. Both enalapril and nifedipine tended to reduce ICAM-1 and E-selectin, while only nifedipine reduced von Willebrand factor. Both treatments were well tolerated.
Conclusions: Our findings demonstrate a similar antihypertensive effectiveness of a low dose (20 mg) of nifedipine GITS in comparison with a standard dose of enalapril (20 mg). Given its clinical efficacy and good tolerability, low-dose nifedipine GITS may be considered a valuable treatment option for hypertensive patients.
{"title":"Effects of nifedipine GITS 20 mg or enalapril 20 mg on blood pressure and inflammatory markers in patients with mild-moderate hypertension.","authors":"Enrico Agabiti Rosei, Patrizia Morelli, Damiano Rizzoni","doi":"10.1080/08037050510034257","DOIUrl":"https://doi.org/10.1080/08037050510034257","url":null,"abstract":"<p><strong>Objective: </strong>Calcium antagonists, angiotensin-converting enzyme (ACE) inhibitors and other drug classes either alone or in combination have been recommended for the treatment of hypertension. Nifedipine gastrointestinal therapeutic system (GITS) 20 mg is a new low-dose formulation with an improved tolerability. The aim of the present study was to compare the effects of nifedipine GITS 20 mg and enalapril 20 mg on blood pressure and circulating adhesion molecules in hypertensive patients.</p><p><strong>Methods: </strong>This randomized, double-blind, multicentre trial compared the blood pressure lowering effects of a 12-week treatment of nifedipine GITS 20 mg vs enalapril 20 mg in 264 patients with mild-to-moderate hypertension.</p><p><strong>Results: </strong>Nifedipine GITS 20 mg induced a reduction of clinic blood pressure, which was similar to that observed with enalapril 20 mg. Nifedipine GITS and enalapril lowered mean sitting diastolic blood pressure by 11.8 and 12.4 mmHg, respectively, while systolic blood pressure was reduced by 15.3 and 16.3 mmHg, respectively. Ambulatory blood pressure monitoring-derived blood pressure data showed similar results in both groups without any statistically significant differences between treatments. Both enalapril and nifedipine tended to reduce ICAM-1 and E-selectin, while only nifedipine reduced von Willebrand factor. Both treatments were well tolerated.</p><p><strong>Conclusions: </strong>Our findings demonstrate a similar antihypertensive effectiveness of a low dose (20 mg) of nifedipine GITS in comparison with a standard dose of enalapril (20 mg). Given its clinical efficacy and good tolerability, low-dose nifedipine GITS may be considered a valuable treatment option for hypertensive patients.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"14-22"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08037050510034257","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24933156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
This present study assessed the antihypertensive efficacy of the fixed combination of manidipine and delapril by ambulatory blood pressure monitoring in patients with hypertension inadequately controlled by monotherapy with either component. After a 2-week placebo period, 55 mild to moderate hypertensive patients were randomized to manidipine 20 mg o.d. or delapril 30 mg b.i.d. for 4 weeks. After this period, 30 patients, aged 30-76 years (18 males and 12 females) whose diastolic blood pressure was not adequately controlled (> or = 90 mmHg) by monotherapy were treated with the fixed combination of manidipine 10 mg plus delapril 30 mg o.d. for 8 weeks. A 24-h ambulatory blood pressure monitoring recording was performed at the end of the placebo washout, of the monotherapy and of the combination therapy. Blood pressure control over the 24 h was quantified by the trough-to-peak ratio and the smoothness index. As compared to placebo, the fixed combination of manidipine and delapril produced a statistically significant (p<0.01) decrease in sitting clinic (18 +/- 9/14 +/- 5 mmHg) and 24-h blood pressure (12 +/- 7/10 +/- 5 mmHg) without affecting heart rate. This reduction was greater than that observed with single components. At the end of the 8-week combination treatment period, the rate of normalilized patients was 73%. Treatment with the fixed combination was associated with a positively high smoothness index (1.2 +/- 0.7/13.8 +/- 0.8) and with a relatively good trough-to-peak ratio (0.46/0.60). The combination of manidipine and delapril produced significant and smooth reductions in blood pressure values, which persisted over the 24-h dosing interval. These results support the use of fixed manidipine-delapril combination in the treatment of mild to moderate hypertensive patients inadequately controlled by monotherapy.
{"title":"Fixed combination of manidipine and delapril in the treatment of mild to moderate essential hypertension: evaluation by 24-hour ambulatory blood pressure monitoring.","authors":"Amedeo Mugellini, Alvaro Vaccarella, Aldo Celentano, Flavio Scanferla, Annalisa Zoppi, Roberto Fogari","doi":"10.1080/08038020510040621","DOIUrl":"https://doi.org/10.1080/08038020510040621","url":null,"abstract":"<p><p>This present study assessed the antihypertensive efficacy of the fixed combination of manidipine and delapril by ambulatory blood pressure monitoring in patients with hypertension inadequately controlled by monotherapy with either component. After a 2-week placebo period, 55 mild to moderate hypertensive patients were randomized to manidipine 20 mg o.d. or delapril 30 mg b.i.d. for 4 weeks. After this period, 30 patients, aged 30-76 years (18 males and 12 females) whose diastolic blood pressure was not adequately controlled (> or = 90 mmHg) by monotherapy were treated with the fixed combination of manidipine 10 mg plus delapril 30 mg o.d. for 8 weeks. A 24-h ambulatory blood pressure monitoring recording was performed at the end of the placebo washout, of the monotherapy and of the combination therapy. Blood pressure control over the 24 h was quantified by the trough-to-peak ratio and the smoothness index. As compared to placebo, the fixed combination of manidipine and delapril produced a statistically significant (p<0.01) decrease in sitting clinic (18 +/- 9/14 +/- 5 mmHg) and 24-h blood pressure (12 +/- 7/10 +/- 5 mmHg) without affecting heart rate. This reduction was greater than that observed with single components. At the end of the 8-week combination treatment period, the rate of normalilized patients was 73%. Treatment with the fixed combination was associated with a positively high smoothness index (1.2 +/- 0.7/13.8 +/- 0.8) and with a relatively good trough-to-peak ratio (0.46/0.60). The combination of manidipine and delapril produced significant and smooth reductions in blood pressure values, which persisted over the 24-h dosing interval. These results support the use of fixed manidipine-delapril combination in the treatment of mild to moderate hypertensive patients inadequately controlled by monotherapy.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"6-13"},"PeriodicalIF":0.0,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020510040621","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24933252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2004-12-01DOI: 10.1080/08038020310026781
Alejandro de la Sierra, Anna Munoz, Emma Arcos, Juan Salvador Lopez, Jordi Relats
Background: Systolic blood pressure (SBP) and pulse pressure (PP) are accurate predictors of cardiovascular events in the elderly population. In these patients, isolated systolic hypertension (ISH) is an important risk factor for cardiovascular morbidity and mortality.
Study design: A multicentre, observational, prospective study, evaluated the effects of 16 weeks of eprosartan treatment on PP and other blood pressure (BP) parameters. Data from a subgroup of patients from this study, who had ISH, are presented here.
Results: Eprosartan monotherapy reduced SBP, PP and mean blood pressure (MBP) over the duration of treatment, whereas diastolic blood pressure (DBP) remained unchanged. There was no difference in the reductions of these parameters between eprosartan monotherapy and combination therapy. In addition, a high proportion of patients responded to eprosartan therapy. The response to eprosartan therapy was significantly influenced by family history of early cardiovascular disease, but not by gender, body mass index (BMI), raised low-density lipoprotein (LDL)-cholesterol, smoking, left ventricular hypertrophy, or previous history of cardiovascular disease. Patients aged > or =70 years had a decreased reduction in DBP and MBP components. Eprosartan therapy was well tolerated, with only 1% of patients reporting an adverse event.
Conclusions: Eprosartan is an effective and well-tolerated antihypertensive therapy for elderly patients with ISH.
{"title":"Effect of eprosartan on pulse pressure and blood pressure components in patients with isolated systolic hypertension.","authors":"Alejandro de la Sierra, Anna Munoz, Emma Arcos, Juan Salvador Lopez, Jordi Relats","doi":"10.1080/08038020310026781","DOIUrl":"https://doi.org/10.1080/08038020310026781","url":null,"abstract":"<p><strong>Background: </strong>Systolic blood pressure (SBP) and pulse pressure (PP) are accurate predictors of cardiovascular events in the elderly population. In these patients, isolated systolic hypertension (ISH) is an important risk factor for cardiovascular morbidity and mortality.</p><p><strong>Study design: </strong>A multicentre, observational, prospective study, evaluated the effects of 16 weeks of eprosartan treatment on PP and other blood pressure (BP) parameters. Data from a subgroup of patients from this study, who had ISH, are presented here.</p><p><strong>Results: </strong>Eprosartan monotherapy reduced SBP, PP and mean blood pressure (MBP) over the duration of treatment, whereas diastolic blood pressure (DBP) remained unchanged. There was no difference in the reductions of these parameters between eprosartan monotherapy and combination therapy. In addition, a high proportion of patients responded to eprosartan therapy. The response to eprosartan therapy was significantly influenced by family history of early cardiovascular disease, but not by gender, body mass index (BMI), raised low-density lipoprotein (LDL)-cholesterol, smoking, left ventricular hypertrophy, or previous history of cardiovascular disease. Patients aged > or =70 years had a decreased reduction in DBP and MBP components. Eprosartan therapy was well tolerated, with only 1% of patients reporting an adverse event.</p><p><strong>Conclusions: </strong>Eprosartan is an effective and well-tolerated antihypertensive therapy for elderly patients with ISH.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"5-10"},"PeriodicalIF":0.0,"publicationDate":"2004-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020310026781","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25057826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2004-12-01DOI: 10.1080/08038020410004756
Xavier Girerd, Thierry Denolle, Caroline Yau, Béatrice Fiquet, Patrick Brunel, Bruno Moulin, Daniel Herpin
The study objective was to evaluate, by means of automated office and phone-transmitted home blood pressure (OBP and HBP) recordings, the effects of a fixed combination of valsartan 160 mg and hydrochlorothiazide (HCTZ) 25 mg in hypertensive patients previously uncontrolled with the combination of an angiotensin receptor antagonist and HCTZ. From 241 selected patients, 171 (71%) had uncontrolled hypertension OBP and HBP [mean baseline OBP and HBP systolic and diastolic (SBP/DBP): 157/91 and 152/87 mmHg]. In this open-design study, patients were directly switched from other angiotensin receptor blocker combination products to valsartan/HCTZ for 6 weeks. The same validated automated device was used for OBP and HBP recordings. At baseline, mean HBP was 152 +/- 15/87 +/- 10 mmHg and mean OBP was 157 +/- 12/91 +/- 9 mmHg. After 6 weeks of treatment with valsartan 160 mg and HCTZ 25 mg, a significant decrease in BP was observed both at home (146 +/- 17/83 +/- 12 mmHg) and at the office (151 +/- 18/87 +/- 11 mmHg), with a difference from baseline of -4 mmHg, p < 0.001 for DBP and of -6 mmHg for SBP, p < 0.001. The percentage of patients with office and home control was 24% and 23% respectively, with a kappa index at 0.459. Elevated OBP only (office hypertension) was observed in 3.6% and elevated HBP only (masked hypertension) in 10% of patients. In conclusion, treatment with valsartan and HCTZ 25 mg in patients with confirmed uncontrolled hypertension induced a clinically relevant decrease in BP with approximately 23% of additional patients strictly controlled with a single tablet. The use of an automated oscillometric device at the office and at home allowed the detection of controlled subjects with good agreement.
{"title":"Automated office and home phone-transmitted blood pressure recordings in uncontrolled hypertension treated with valsartan and hydrochlorothiazide.","authors":"Xavier Girerd, Thierry Denolle, Caroline Yau, Béatrice Fiquet, Patrick Brunel, Bruno Moulin, Daniel Herpin","doi":"10.1080/08038020410004756","DOIUrl":"https://doi.org/10.1080/08038020410004756","url":null,"abstract":"<p><p>The study objective was to evaluate, by means of automated office and phone-transmitted home blood pressure (OBP and HBP) recordings, the effects of a fixed combination of valsartan 160 mg and hydrochlorothiazide (HCTZ) 25 mg in hypertensive patients previously uncontrolled with the combination of an angiotensin receptor antagonist and HCTZ. From 241 selected patients, 171 (71%) had uncontrolled hypertension OBP and HBP [mean baseline OBP and HBP systolic and diastolic (SBP/DBP): 157/91 and 152/87 mmHg]. In this open-design study, patients were directly switched from other angiotensin receptor blocker combination products to valsartan/HCTZ for 6 weeks. The same validated automated device was used for OBP and HBP recordings. At baseline, mean HBP was 152 +/- 15/87 +/- 10 mmHg and mean OBP was 157 +/- 12/91 +/- 9 mmHg. After 6 weeks of treatment with valsartan 160 mg and HCTZ 25 mg, a significant decrease in BP was observed both at home (146 +/- 17/83 +/- 12 mmHg) and at the office (151 +/- 18/87 +/- 11 mmHg), with a difference from baseline of -4 mmHg, p < 0.001 for DBP and of -6 mmHg for SBP, p < 0.001. The percentage of patients with office and home control was 24% and 23% respectively, with a kappa index at 0.459. Elevated OBP only (office hypertension) was observed in 3.6% and elevated HBP only (masked hypertension) in 10% of patients. In conclusion, treatment with valsartan and HCTZ 25 mg in patients with confirmed uncontrolled hypertension induced a clinically relevant decrease in BP with approximately 23% of additional patients strictly controlled with a single tablet. The use of an automated oscillometric device at the office and at home allowed the detection of controlled subjects with good agreement.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"18-24"},"PeriodicalIF":0.0,"publicationDate":"2004-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020410004756","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25057828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2004-12-01DOI: 10.1080/08038020410035574
Giuseppe Mancia, Stefano Omboni
Objective: To assess efficacy and tolerability of candesartan cilexetil (CC) plus hydrochlorothiazide (HCTZ) fixed combination vs previous monotherapy (PM) plus HCTZ in hypertension.
Design and methods: After 2-4 weeks of run in, 409 outpatients (diastolic blood pressure, DBP >90 and < or =110 mmHg; systolic blood pressure, SBP < or =180 mmHg), aged 26-79 years, under monotherapy, were randomized in a PROBE multicenter trial to CC 16 mg plus HCTZ 12.5 mg or PM plus HCTZ 12.5 mg for 8 weeks. HCTZ was doubled after the first 4 weeks in non-responders (DBP > or =90 mmHg or SBP > 180 mmHg).
Results: Automatic oscillometric (Omron 705 CP) DBP and SBP were similarly reduced by CC + HCTZ and PM + HCTZ after 4 (12/15 and 10/13 mmHg) and 8 weeks (13/20 and 12/18 mmHg) in the intention-to-treat (ITT, n = 398) population. HCTZ dose was doubled in 18.1 and 31.2% of patients in the CC + HCTZ and PM + HCTZ group, respectively (p < 0.05). Rate of normalized patients (DBP <90 and/or SBP < 140 mmHg) after 8 weeks of treatment was greater (p < 0.05) under CC + HCTZ (82.0 vs 72.6% vs PM + HCTZ). Pulse pressure was comparably reduced by CC + HCTZ and PM + HCTZ, at 4 (3 mmHg for both) and 8 weeks (7 and 6 mmHg, respectively). Heart rate was unchanged. Results of per-protocol analysis (n = 316) did not differ from those of ITT analysis. Rate of adverse events was low and comparable between groups.
Conclusions: CC plus HCTZ fixed combination is an effective and safe alternative to other antihypertensive drugs, given either as monotherapy or in combination when they do not satisfactorily control patient's blood pressure.
{"title":"Candesartan plus hydrochlorothiazide fixed combination vs previous monotherapy plus diuretic in poorly controlled essential hypertensive patients.","authors":"Giuseppe Mancia, Stefano Omboni","doi":"10.1080/08038020410035574","DOIUrl":"https://doi.org/10.1080/08038020410035574","url":null,"abstract":"<p><strong>Objective: </strong>To assess efficacy and tolerability of candesartan cilexetil (CC) plus hydrochlorothiazide (HCTZ) fixed combination vs previous monotherapy (PM) plus HCTZ in hypertension.</p><p><strong>Design and methods: </strong>After 2-4 weeks of run in, 409 outpatients (diastolic blood pressure, DBP >90 and < or =110 mmHg; systolic blood pressure, SBP < or =180 mmHg), aged 26-79 years, under monotherapy, were randomized in a PROBE multicenter trial to CC 16 mg plus HCTZ 12.5 mg or PM plus HCTZ 12.5 mg for 8 weeks. HCTZ was doubled after the first 4 weeks in non-responders (DBP > or =90 mmHg or SBP > 180 mmHg).</p><p><strong>Results: </strong>Automatic oscillometric (Omron 705 CP) DBP and SBP were similarly reduced by CC + HCTZ and PM + HCTZ after 4 (12/15 and 10/13 mmHg) and 8 weeks (13/20 and 12/18 mmHg) in the intention-to-treat (ITT, n = 398) population. HCTZ dose was doubled in 18.1 and 31.2% of patients in the CC + HCTZ and PM + HCTZ group, respectively (p < 0.05). Rate of normalized patients (DBP <90 and/or SBP < 140 mmHg) after 8 weeks of treatment was greater (p < 0.05) under CC + HCTZ (82.0 vs 72.6% vs PM + HCTZ). Pulse pressure was comparably reduced by CC + HCTZ and PM + HCTZ, at 4 (3 mmHg for both) and 8 weeks (7 and 6 mmHg, respectively). Heart rate was unchanged. Results of per-protocol analysis (n = 316) did not differ from those of ITT analysis. Rate of adverse events was low and comparable between groups.</p><p><strong>Conclusions: </strong>CC plus HCTZ fixed combination is an effective and safe alternative to other antihypertensive drugs, given either as monotherapy or in combination when they do not satisfactorily control patient's blood pressure.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"11-7"},"PeriodicalIF":0.0,"publicationDate":"2004-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020410035574","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25057827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nebivolol is a new and selective beta1-adrenergic receptor antagonist whose haemodynamic profile is different from that of classical beta-blockers. The blood pressure lowering effects of nebivolol are, at least partially, due to the direct vasodilation as a result of nitric oxide (NO) release from endothelial cells. Several in vitro studies unequivocally show that, at least in certain vascular districts (particularly in small diameter, non-conduit vessels) and in platelets, nebivolol can stimulate an increase of endothelial NO, which becomes available at the smooth muscle layers and induces vasorelaxation. Nebivolol appears to interact with the endothelial NO pathway in two complementary ways: it increases NO synthase (NOS) activity and reduces the NO-scavenging radical superoxide anion, by re-directing deranged NOS activity, from superoxide to NO production. Nebivolol appears also to possess a complementary antioxidant activity, through which the pathological ROS-induced depression of intracellular NO levels can be prevented. Depending on the studies, evidences for a role of different receptors have been obtained. Although the interaction of nebivolol with cell receptors and the mechanisms of signal transduction into eNOS activation are not yet fully delineated, that nebivolol increases NO production and extracellular release has been proved not only by confirming its inhibition by NOS blockers, but also by measuring NO levels in mediums and cells in several different experimental settings.
{"title":"Experimental evidences of nitric oxide-dependent vasodilatory activity of nebivolol, a third-generation beta-blocker.","authors":"Louis J Ignarro","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Nebivolol is a new and selective beta1-adrenergic receptor antagonist whose haemodynamic profile is different from that of classical beta-blockers. The blood pressure lowering effects of nebivolol are, at least partially, due to the direct vasodilation as a result of nitric oxide (NO) release from endothelial cells. Several in vitro studies unequivocally show that, at least in certain vascular districts (particularly in small diameter, non-conduit vessels) and in platelets, nebivolol can stimulate an increase of endothelial NO, which becomes available at the smooth muscle layers and induces vasorelaxation. Nebivolol appears to interact with the endothelial NO pathway in two complementary ways: it increases NO synthase (NOS) activity and reduces the NO-scavenging radical superoxide anion, by re-directing deranged NOS activity, from superoxide to NO production. Nebivolol appears also to possess a complementary antioxidant activity, through which the pathological ROS-induced depression of intracellular NO levels can be prevented. Depending on the studies, evidences for a role of different receptors have been obtained. Although the interaction of nebivolol with cell receptors and the mechanisms of signal transduction into eNOS activation are not yet fully delineated, that nebivolol increases NO production and extracellular release has been proved not only by confirming its inhibition by NOS blockers, but also by measuring NO levels in mediums and cells in several different experimental settings.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"2-16"},"PeriodicalIF":0.0,"publicationDate":"2004-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24851381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2004-10-01DOI: 10.1080/08038020410016548
Alberto Zanchetti
New evidence from recently completed clinical studies performed with nebivolol, a highly selective beta-1 beta-blocker, endowed with additional vasodilating activity mediated by nitric oxide (NO) endothelial release, confirm previous findings that nebivolol differs from other beta-blocking agents and that the combination of beta-1 blockade and NO-mediated vasodilation not only potentiates the blood pressure lowering activity, but leads to a broader favourable haemodynamic profile, which is clinically relevant to the treatment of hypertensive patients. In particular, six new studies focusing on the vasodilation properties of nebivolol demonstrated that: (i) its blood pressure lowering effect is accompanied by a vasodilating action that is seen after single and chronic administration of the usual antihypertensive oral dose of 5 mg once daily; (ii) the vasodilation can be documented systemically, at various regional vascular beds and skin microcirculation, and is accompanied by increased small arterial distensibility; (iii) the NO-endothelium-dependency of its vasodilating action is shown by the model of forearm or cutaneous vasodilating response to acetylcholine and by the blockade of the nebivolol-induced local vasodilation by a blocker of the arginine-NO cascade, L-NMMA. Two more studies demonstrated the ability of nebivolol to increase NO concentrations through preservation of NO from oxidative degradation, and not only by stimulation of its synthesis. Finally, two studies confirmed the favourable haemodynamic action of nebivolol on both systolic and diastolic function and, in particular, an increase in stroke volume, associated with reduction in vascular resistance, resulting in a maintained cardiac output despite reduced heart rate. These properties consistently differentiate nebivolol from non-vasodilating beta-blockers, such as those used for the active comparative studies, i.e. atenolol, metoprolol or bisoprolol. The observation that nebivolol enhances or restores NO-mediated vasodilation in hypertensive patients has important therapeutic implications in view of the well-established protective role of NO against cardiovascular risk factors, and particularly the development of atherosclerosis. Similarly, the favourable haemodynamic profile of nebivolol, as described by the new investigations (preservation of cardiac output, reduction of peripheral resistance and improved diastolic function) appear to have clinically relevant benefits on the impairment in systolic and/or diastolic function often complicating the hypertension.
{"title":"Clinical pharmacodynamics of nebivolol: new evidence of nitric oxide-mediated vasodilating activity and peculiar haemodynamic properties in hypertensive patients.","authors":"Alberto Zanchetti","doi":"10.1080/08038020410016548","DOIUrl":"https://doi.org/10.1080/08038020410016548","url":null,"abstract":"<p><p>New evidence from recently completed clinical studies performed with nebivolol, a highly selective beta-1 beta-blocker, endowed with additional vasodilating activity mediated by nitric oxide (NO) endothelial release, confirm previous findings that nebivolol differs from other beta-blocking agents and that the combination of beta-1 blockade and NO-mediated vasodilation not only potentiates the blood pressure lowering activity, but leads to a broader favourable haemodynamic profile, which is clinically relevant to the treatment of hypertensive patients. In particular, six new studies focusing on the vasodilation properties of nebivolol demonstrated that: (i) its blood pressure lowering effect is accompanied by a vasodilating action that is seen after single and chronic administration of the usual antihypertensive oral dose of 5 mg once daily; (ii) the vasodilation can be documented systemically, at various regional vascular beds and skin microcirculation, and is accompanied by increased small arterial distensibility; (iii) the NO-endothelium-dependency of its vasodilating action is shown by the model of forearm or cutaneous vasodilating response to acetylcholine and by the blockade of the nebivolol-induced local vasodilation by a blocker of the arginine-NO cascade, L-NMMA. Two more studies demonstrated the ability of nebivolol to increase NO concentrations through preservation of NO from oxidative degradation, and not only by stimulation of its synthesis. Finally, two studies confirmed the favourable haemodynamic action of nebivolol on both systolic and diastolic function and, in particular, an increase in stroke volume, associated with reduction in vascular resistance, resulting in a maintained cardiac output despite reduced heart rate. These properties consistently differentiate nebivolol from non-vasodilating beta-blockers, such as those used for the active comparative studies, i.e. atenolol, metoprolol or bisoprolol. The observation that nebivolol enhances or restores NO-mediated vasodilation in hypertensive patients has important therapeutic implications in view of the well-established protective role of NO against cardiovascular risk factors, and particularly the development of atherosclerosis. Similarly, the favourable haemodynamic profile of nebivolol, as described by the new investigations (preservation of cardiac output, reduction of peripheral resistance and improved diastolic function) appear to have clinically relevant benefits on the impairment in systolic and/or diastolic function often complicating the hypertension.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"1 ","pages":"17-32"},"PeriodicalIF":0.0,"publicationDate":"2004-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020410016548","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24851382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2003-12-01DOI: 10.1080/08038020310016369
Carlos Campo, Julian Segura, Cecilia Roldán, José M Alcázar, José L Rodicio, Luis M Ruilope
The objective of this prospective, randomized, open-label, parallel-arm comparative study, with a 4-month follow-up, was to assess the antihypertensive efficacy, tolerability and metabolic safety of doxazosin GITS (gastrointestinal therapeutic system) 4-8 mg/day vs hydrochlorothiazide (HCTZ) 12.5-25 mg/day as add-on therapy in patients not controlled with monotherapy with other drugs. Ninety-eight patients completed the study (mean age 57.4 +/- 15 years, 53% female). Mean systolic/diastolic blood pressure reduction was 8.2/4.5 mmHg in the HCTZ group and 8.9/5.0 mmHg in the doxazosin GITS group, and a strict blood pressure control was achieved in 79% and 83% of the patients, respectively. The incidence rates of adverse events were low and similar in both groups. However, metabolic differences were seen between the groups, doxazosin GITS vs HCTZ, respectively: total cholesterol (mg/dl) 210 +/- 53 vs 231 +/- 62 (p < 0.05), low-density lipoprotein (LDL) cholesterol (mg/dl) 139 +/- 40 vs 161 +/- 57 (p < 0.01), high-density lipoprotein (HDL) cholesterol (mg/dl) 58 +/- 16 vs 48 +/- 13 (p < 0.01), HDL/total cholesterol ratio 27.6 +/- 8 vs 21.2 +/- 7 (p < 0.001), plasma uric acid (mg/dl) 5.3 +/- 2.6 vs 6.8 +/- 3.1 (p < 0.05) and serum potassium (mEq/l) 4.1 +/- 1.3 vs. 3.7 +/- 1.2 (p < 0.01). In conclusion, doxazosin GITS has a tolerability and efficacy profile similar to low doses of thiazide diuretics, with a better evolution of metabolic and electrolyte parameters. Therefore, in patients not controlled with monotherapy, doxazosin GITS can be considered an alternative to the addition of thiazide diuretics.
{"title":"Doxazosin GITS versus hydrochlorothiazide as add-on therapy in patients with uncontrolled hypertension.","authors":"Carlos Campo, Julian Segura, Cecilia Roldán, José M Alcázar, José L Rodicio, Luis M Ruilope","doi":"10.1080/08038020310016369","DOIUrl":"https://doi.org/10.1080/08038020310016369","url":null,"abstract":"<p><p>The objective of this prospective, randomized, open-label, parallel-arm comparative study, with a 4-month follow-up, was to assess the antihypertensive efficacy, tolerability and metabolic safety of doxazosin GITS (gastrointestinal therapeutic system) 4-8 mg/day vs hydrochlorothiazide (HCTZ) 12.5-25 mg/day as add-on therapy in patients not controlled with monotherapy with other drugs. Ninety-eight patients completed the study (mean age 57.4 +/- 15 years, 53% female). Mean systolic/diastolic blood pressure reduction was 8.2/4.5 mmHg in the HCTZ group and 8.9/5.0 mmHg in the doxazosin GITS group, and a strict blood pressure control was achieved in 79% and 83% of the patients, respectively. The incidence rates of adverse events were low and similar in both groups. However, metabolic differences were seen between the groups, doxazosin GITS vs HCTZ, respectively: total cholesterol (mg/dl) 210 +/- 53 vs 231 +/- 62 (p < 0.05), low-density lipoprotein (LDL) cholesterol (mg/dl) 139 +/- 40 vs 161 +/- 57 (p < 0.01), high-density lipoprotein (HDL) cholesterol (mg/dl) 58 +/- 16 vs 48 +/- 13 (p < 0.01), HDL/total cholesterol ratio 27.6 +/- 8 vs 21.2 +/- 7 (p < 0.001), plasma uric acid (mg/dl) 5.3 +/- 2.6 vs 6.8 +/- 3.1 (p < 0.05) and serum potassium (mEq/l) 4.1 +/- 1.3 vs. 3.7 +/- 1.2 (p < 0.01). In conclusion, doxazosin GITS has a tolerability and efficacy profile similar to low doses of thiazide diuretics, with a better evolution of metabolic and electrolyte parameters. Therefore, in patients not controlled with monotherapy, doxazosin GITS can be considered an alternative to the addition of thiazide diuretics.</p>","PeriodicalId":8974,"journal":{"name":"Blood pressure. Supplement","volume":"2 ","pages":"16-21"},"PeriodicalIF":0.0,"publicationDate":"2003-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/08038020310016369","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24195099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}