Evaluation of the efficacy and tolerability of the combination delapril plus indapamide in the treatment of mild to moderate essential hypertension: a randomised, multicentre, controlled study

The aim of the study was to evaluate efficacy and tolerability of two different fixed combinations of an angiotensin-converting enzyme inhibitor and a diuretic: delapril+indapamide (D+I) and captopril+hydrochlorothiazide (C+H) administered for 6 months to patients with mild to moderate essential hyp...

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Veröffentlicht in:Journal of human hypertension 2003-02, Vol.17 (2), p.139-146
Hauptverfasser: Rosei, E A, Rizzoni, D
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description The aim of the study was to evaluate efficacy and tolerability of two different fixed combinations of an angiotensin-converting enzyme inhibitor and a diuretic: delapril+indapamide (D+I) and captopril+hydrochlorothiazide (C+H) administered for 6 months to patients with mild to moderate essential hypertension. In all, 96 centres participated in this randomised, parallel groups, controlled study. A total of 829 patients with uncomplicated mild to moderate hypertension were randomised, and 790 were eligible for the analysis of efficacy (intention to treat). Patients of both sexes, aged 18–75 years, newly diagnosed or untreated during the last month were included in the study if their diastolic blood pressure (DBP) was ⩾95 and ⩽114 mmHg. The starting doses of the drugs were delapril 30 mg+indapamide 1.25 mg tablets o.d. or captopril 50 mg+hydrolchlorothiazide 15 mg tablets o.d. After a 1-month treatment period, nonresponders (DBP >90 mmHg, or decrease in DBP
doi_str_mv 10.1038/sj.jhh.1001514
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In all, 96 centres participated in this randomised, parallel groups, controlled study. A total of 829 patients with uncomplicated mild to moderate hypertension were randomised, and 790 were eligible for the analysis of efficacy (intention to treat). Patients of both sexes, aged 18–75 years, newly diagnosed or untreated during the last month were included in the study if their diastolic blood pressure (DBP) was ⩾95 and ⩽114 mmHg. The starting doses of the drugs were delapril 30 mg+indapamide 1.25 mg tablets o.d. or captopril 50 mg+hydrolchlorothiazide 15 mg tablets o.d. After a 1-month treatment period, nonresponders (DBP &gt;90 mmHg, or decrease in DBP &lt;10 mmHg) had the daily dose increased to either delapril 30 mg+indapamide 2.5 mg or captopril 50 mg+hydrochlorothiazide 25 mg tablets for a further 5 months. The primary assessment of antihypertensive efficacy was the percentage of patients who responded after a 6-month drug treatment. The responder rates were 72.6% with D+I and 62.9% with C+H ( P =0.004 between treatments) after 60 days of treatment, and 92.6% in the D+I and 85.2% in the C+H ( P &lt;0.001 between treatments) at the end of the treatment period. The final value of systolic blood pressure was 134.5±13.1 mmHg with D+I and 138.3±14.0 mmHg with C+H ( P &lt;0.001 between treatments). At the final visit, DBP was 84.57±7.0 mmHg in the D+I group and 85.57±8.0 mmHg in the control group ( P =0.017 between treatments). In all, 11 patients in the D+I group and 19 patients in the C+H group were withdrawn from the study because of adverse events. In all, 30 patients (7.6%) with D+I and 32 patients (8.1%) with C+H experienced adverse events. In conclusion, D+I was more effective than C+H in terms of overall reduction in blood pressure and response rate. Greater efficacy was obtained without any increase in adverse effects, since both treatments were equally well tolerated.</description><identifier>ISSN: 0950-9240</identifier><identifier>EISSN: 1476-5527</identifier><identifier>DOI: 10.1038/sj.jhh.1001514</identifier><identifier>PMID: 12574793</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject><![CDATA[ACE inhibitors ; Adolescent ; Adult ; Aged ; Angiotensin ; Angiotensin-converting enzyme inhibitors ; Angiotensin-Converting Enzyme Inhibitors - administration & dosage ; Angiotensin-Converting Enzyme Inhibitors - adverse effects ; Angiotensin-Converting Enzyme Inhibitors - therapeutic use ; Antihypertensive agents ; Antihypertensive Agents - administration & dosage ; Antihypertensive Agents - adverse effects ; Antihypertensive Agents - therapeutic use ; Antihypertensives ; Biological and medical sciences ; Blood pressure ; Captopril - administration & dosage ; Captopril - adverse effects ; Captopril - therapeutic use ; Cardiovascular system ; Diuretics ; Dosage and administration ; Drug Combinations ; Drug therapy ; Epidemiology ; Essential hypertension ; Female ; Health Administration ; Humans ; Hydrochlorothiazide ; Hydrochlorothiazide - administration & dosage ; Hydrochlorothiazide - adverse effects ; Hydrochlorothiazide - therapeutic use ; Hypertension ; Hypertension - drug therapy ; Indans - administration & dosage ; Indans - adverse effects ; Indans - therapeutic use ; Indapamide ; Indapamide - administration & dosage ; Indapamide - adverse effects ; Indapamide - therapeutic use ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; original-article ; Patients ; Peptidyl-dipeptidase A ; Pharmacology. Drug treatments ; Physiological aspects ; Public Health ; Severity of Illness Index ; Tablets]]></subject><ispartof>Journal of human hypertension, 2003-02, Vol.17 (2), p.139-146</ispartof><rights>Springer Nature Limited 2003</rights><rights>2003 INIST-CNRS</rights><rights>COPYRIGHT 2003 Nature Publishing Group</rights><rights>Copyright Nature Publishing Group Feb 2003</rights><rights>Nature Publishing Group 2003.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c475t-b110904dcc5d04a07eb4230df2466ed5f7ea6af72241c268e2b4c2d254932ad73</citedby><cites>FETCH-LOGICAL-c475t-b110904dcc5d04a07eb4230df2466ed5f7ea6af72241c268e2b4c2d254932ad73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/sj.jhh.1001514$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/sj.jhh.1001514$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=14680581$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12574793$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosei, E A</creatorcontrib><creatorcontrib>Rizzoni, D</creatorcontrib><creatorcontrib>DIMS II (Delapril-Indapamide Multicenter Study II)</creatorcontrib><creatorcontrib>on behalf of DIMS II (Delapril–Indapamide Multicenter Study II)</creatorcontrib><title>Evaluation of the efficacy and tolerability of the combination delapril plus indapamide in the treatment of mild to moderate essential hypertension: a randomised, multicentre, controlled study</title><title>Journal of human hypertension</title><addtitle>J Hum Hypertens</addtitle><addtitle>J Hum Hypertens</addtitle><description>The aim of the study was to evaluate efficacy and tolerability of two different fixed combinations of an angiotensin-converting enzyme inhibitor and a diuretic: delapril+indapamide (D+I) and captopril+hydrochlorothiazide (C+H) administered for 6 months to patients with mild to moderate essential hypertension. In all, 96 centres participated in this randomised, parallel groups, controlled study. A total of 829 patients with uncomplicated mild to moderate hypertension were randomised, and 790 were eligible for the analysis of efficacy (intention to treat). Patients of both sexes, aged 18–75 years, newly diagnosed or untreated during the last month were included in the study if their diastolic blood pressure (DBP) was ⩾95 and ⩽114 mmHg. The starting doses of the drugs were delapril 30 mg+indapamide 1.25 mg tablets o.d. or captopril 50 mg+hydrolchlorothiazide 15 mg tablets o.d. After a 1-month treatment period, nonresponders (DBP &gt;90 mmHg, or decrease in DBP &lt;10 mmHg) had the daily dose increased to either delapril 30 mg+indapamide 2.5 mg or captopril 50 mg+hydrochlorothiazide 25 mg tablets for a further 5 months. The primary assessment of antihypertensive efficacy was the percentage of patients who responded after a 6-month drug treatment. The responder rates were 72.6% with D+I and 62.9% with C+H ( P =0.004 between treatments) after 60 days of treatment, and 92.6% in the D+I and 85.2% in the C+H ( P &lt;0.001 between treatments) at the end of the treatment period. The final value of systolic blood pressure was 134.5±13.1 mmHg with D+I and 138.3±14.0 mmHg with C+H ( P &lt;0.001 between treatments). At the final visit, DBP was 84.57±7.0 mmHg in the D+I group and 85.57±8.0 mmHg in the control group ( P =0.017 between treatments). In all, 11 patients in the D+I group and 19 patients in the C+H group were withdrawn from the study because of adverse events. In all, 30 patients (7.6%) with D+I and 32 patients (8.1%) with C+H experienced adverse events. In conclusion, D+I was more effective than C+H in terms of overall reduction in blood pressure and response rate. Greater efficacy was obtained without any increase in adverse effects, since both treatments were equally well tolerated.</description><subject>ACE inhibitors</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Angiotensin</subject><subject>Angiotensin-converting enzyme inhibitors</subject><subject>Angiotensin-Converting Enzyme Inhibitors - administration &amp; dosage</subject><subject>Angiotensin-Converting Enzyme Inhibitors - adverse effects</subject><subject>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</subject><subject>Antihypertensive agents</subject><subject>Antihypertensive Agents - administration &amp; dosage</subject><subject>Antihypertensive Agents - adverse effects</subject><subject>Antihypertensive Agents - therapeutic use</subject><subject>Antihypertensives</subject><subject>Biological and medical sciences</subject><subject>Blood pressure</subject><subject>Captopril - administration &amp; dosage</subject><subject>Captopril - adverse effects</subject><subject>Captopril - therapeutic use</subject><subject>Cardiovascular system</subject><subject>Diuretics</subject><subject>Dosage and administration</subject><subject>Drug Combinations</subject><subject>Drug therapy</subject><subject>Epidemiology</subject><subject>Essential hypertension</subject><subject>Female</subject><subject>Health Administration</subject><subject>Humans</subject><subject>Hydrochlorothiazide</subject><subject>Hydrochlorothiazide - administration &amp; dosage</subject><subject>Hydrochlorothiazide - adverse effects</subject><subject>Hydrochlorothiazide - therapeutic use</subject><subject>Hypertension</subject><subject>Hypertension - drug therapy</subject><subject>Indans - administration &amp; dosage</subject><subject>Indans - adverse effects</subject><subject>Indans - therapeutic use</subject><subject>Indapamide</subject><subject>Indapamide - administration &amp; dosage</subject><subject>Indapamide - adverse effects</subject><subject>Indapamide - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>original-article</subject><subject>Patients</subject><subject>Peptidyl-dipeptidase A</subject><subject>Pharmacology. 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In all, 96 centres participated in this randomised, parallel groups, controlled study. A total of 829 patients with uncomplicated mild to moderate hypertension were randomised, and 790 were eligible for the analysis of efficacy (intention to treat). Patients of both sexes, aged 18–75 years, newly diagnosed or untreated during the last month were included in the study if their diastolic blood pressure (DBP) was ⩾95 and ⩽114 mmHg. The starting doses of the drugs were delapril 30 mg+indapamide 1.25 mg tablets o.d. or captopril 50 mg+hydrolchlorothiazide 15 mg tablets o.d. After a 1-month treatment period, nonresponders (DBP &gt;90 mmHg, or decrease in DBP &lt;10 mmHg) had the daily dose increased to either delapril 30 mg+indapamide 2.5 mg or captopril 50 mg+hydrochlorothiazide 25 mg tablets for a further 5 months. The primary assessment of antihypertensive efficacy was the percentage of patients who responded after a 6-month drug treatment. The responder rates were 72.6% with D+I and 62.9% with C+H ( P =0.004 between treatments) after 60 days of treatment, and 92.6% in the D+I and 85.2% in the C+H ( P &lt;0.001 between treatments) at the end of the treatment period. The final value of systolic blood pressure was 134.5±13.1 mmHg with D+I and 138.3±14.0 mmHg with C+H ( P &lt;0.001 between treatments). At the final visit, DBP was 84.57±7.0 mmHg in the D+I group and 85.57±8.0 mmHg in the control group ( P =0.017 between treatments). In all, 11 patients in the D+I group and 19 patients in the C+H group were withdrawn from the study because of adverse events. In all, 30 patients (7.6%) with D+I and 32 patients (8.1%) with C+H experienced adverse events. In conclusion, D+I was more effective than C+H in terms of overall reduction in blood pressure and response rate. Greater efficacy was obtained without any increase in adverse effects, since both treatments were equally well tolerated.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>12574793</pmid><doi>10.1038/sj.jhh.1001514</doi><tpages>8</tpages></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; SpringerLink Journals - AutoHoldings
subjects ACE inhibitors
Adolescent
Adult
Aged
Angiotensin
Angiotensin-converting enzyme inhibitors
Angiotensin-Converting Enzyme Inhibitors - administration & dosage
Angiotensin-Converting Enzyme Inhibitors - adverse effects
Angiotensin-Converting Enzyme Inhibitors - therapeutic use
Antihypertensive agents
Antihypertensive Agents - administration & dosage
Antihypertensive Agents - adverse effects
Antihypertensive Agents - therapeutic use
Antihypertensives
Biological and medical sciences
Blood pressure
Captopril - administration & dosage
Captopril - adverse effects
Captopril - therapeutic use
Cardiovascular system
Diuretics
Dosage and administration
Drug Combinations
Drug therapy
Epidemiology
Essential hypertension
Female
Health Administration
Humans
Hydrochlorothiazide
Hydrochlorothiazide - administration & dosage
Hydrochlorothiazide - adverse effects
Hydrochlorothiazide - therapeutic use
Hypertension
Hypertension - drug therapy
Indans - administration & dosage
Indans - adverse effects
Indans - therapeutic use
Indapamide
Indapamide - administration & dosage
Indapamide - adverse effects
Indapamide - therapeutic use
Male
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
original-article
Patients
Peptidyl-dipeptidase A
Pharmacology. Drug treatments
Physiological aspects
Public Health
Severity of Illness Index
Tablets
title Evaluation of the efficacy and tolerability of the combination delapril plus indapamide in the treatment of mild to moderate essential hypertension: a randomised, multicentre, controlled study
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-21T20%3A11%3A39IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_proqu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Evaluation%20of%20the%20efficacy%20and%20tolerability%20of%20the%20combination%20delapril%20plus%20indapamide%20in%20the%20treatment%20of%20mild%20to%20moderate%20essential%20hypertension:%20a%20randomised,%20multicentre,%20controlled%20study&rft.jtitle=Journal%20of%20human%20hypertension&rft.au=Rosei,%20E%20A&rft.aucorp=DIMS%20II%20(Delapril-Indapamide%20Multicenter%20Study%20II)&rft.date=2003-02-01&rft.volume=17&rft.issue=2&rft.spage=139&rft.epage=146&rft.pages=139-146&rft.issn=0950-9240&rft.eissn=1476-5527&rft_id=info:doi/10.1038/sj.jhh.1001514&rft_dat=%3Cgale_proqu%3EA183319390%3C/gale_proqu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=219980436&rft_id=info:pmid/12574793&rft_galeid=A183319390&rfr_iscdi=true