Manidipine versus enalapril monotherapy in patients with hypertension and type 2 diabetes mellitus: A multicenter, randomized, double-blind, 24-week study
Blood pressure reduction is associated with a reduced risk for cardiovascular events and death, particularly in patients with both hypertension and type 2 diabetes mellitus. The aim of this study was to compare theantihypertensive efficacy, tolerability, and effect on metabolic risk factors of manid...
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| description | Blood pressure reduction is associated with a reduced risk for cardiovascular events and death, particularly in patients with both hypertension and type 2 diabetes mellitus.
The aim of this study was to compare theantihypertensive efficacy, tolerability, and effect on metabolic risk factors of manidipine, a new dihydropyridine calcium channel antagonist, and enalapril, a widely used angiotensin-converting enzyme inhibitor, in patients with mild to moderate essential hypertension and type 2 diabetes.
This multicenter, double-blind trial compared manidipine and enalapril in patients with type 2 diabetes and hypertension (diastolic blood pressure [DBP] 90–104 mm Hg, systolic blood pressure [SBP] ≤190 mm Hg). Following a 3-week, single-blind placebo run-in period, eligible patients were randomized to receive either manidipine 10 mg or enalapril 10 mg once daily for 24 weeks. The dose was doubled after 3 weeks in patients who had not responded to treatment (DBP ≥90 mm Hg). The primary efficacy end point was change in DBP from baseline to the end of the study. Secondary outcomes were the responder rate (DBP 3 mm Hg.
One hundred twenty-four patients were enrolled in the study. After the placebo run-in period, 13 patients were excluded from the study: 4 for DBP values outside the specified limits, 7 at their request, and 2 for adverse events. Thus, 111 patients met the eligibility criteria and were randomized to treatment (53 manidipine, 58 enalapril). The population consisted of 61 men and 50 women with a mean (SD) age of 62 (11) years and a body mass index of 28.2 (2.4) kg/m
2. Among patients who completed the study, drug doses were doubled in 67.6% (25/37) of patients in the manidipine group and 60.0% (24/40) of patients in the enalapril group (
P = NS). Similar reductions in blood pressure were |
| doi_str_mv | 10.1016/j.clinthera.2005.02.001 |
| format | Article |
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The aim of this study was to compare theantihypertensive efficacy, tolerability, and effect on metabolic risk factors of manidipine, a new dihydropyridine calcium channel antagonist, and enalapril, a widely used angiotensin-converting enzyme inhibitor, in patients with mild to moderate essential hypertension and type 2 diabetes.
This multicenter, double-blind trial compared manidipine and enalapril in patients with type 2 diabetes and hypertension (diastolic blood pressure [DBP] 90–104 mm Hg, systolic blood pressure [SBP] ≤190 mm Hg). Following a 3-week, single-blind placebo run-in period, eligible patients were randomized to receive either manidipine 10 mg or enalapril 10 mg once daily for 24 weeks. The dose was doubled after 3 weeks in patients who had not responded to treatment (DBP ≥90 mm Hg). The primary efficacy end point was change in DBP from baseline to the end of the study. Secondary outcomes were the responder rate (DBP <90 mm Hg and/or a DBP reduction of ≥10 mm Hg) at the end of the study. Other secondary measures were changes from baseline to the end of the study in heart rate and in the following measures obtained by ambulatory blood pressure monitoring (ABPM): 24-hour, daytime, and nighttime mean DBP and SBP, and the trough:peak ratio. Blood glucose, glycosylated hemoglobin (HbA
1c), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, uric acid, and creatinine were measured at the end of the placebo run-in period and the end of treatment. The study had 80% power to detect a between-treatment difference in mean sitting DBP of >3 mm Hg.
One hundred twenty-four patients were enrolled in the study. After the placebo run-in period, 13 patients were excluded from the study: 4 for DBP values outside the specified limits, 7 at their request, and 2 for adverse events. Thus, 111 patients met the eligibility criteria and were randomized to treatment (53 manidipine, 58 enalapril). The population consisted of 61 men and 50 women with a mean (SD) age of 62 (11) years and a body mass index of 28.2 (2.4) kg/m
2. Among patients who completed the study, drug doses were doubled in 67.6% (25/37) of patients in the manidipine group and 60.0% (24/40) of patients in the enalapril group (
P = NS). Similar reductions in blood pressure were observed in both groups, from a mean (SD) of 164 (12)/97.5 (5) mm Hg at baseline to 141 (12)/84.5 (6) mm Hg at the end of the study in the manidipine group (
P < 0.01), and from 159 (12)/98 (4) mm Hg to 139 (12)/86 (8) mm Hg in the enalapril group (
P < 0.01). The proportion of responders was 66.7% (32/48) in the manidipine group and 60.0% (30/50) in the enalapril group; the difference between groups was not significant. Twenty-four-hour ABPM revealed significant (
P < 0.01) and similar reductions in blood pressure in both groups, with a trough:peak ratio of ∼-50%. Neither drug affected heart rate. Among the statistically significant changes in metabolic parameters, significant reductions in HbA
1c (from 6.7% [1.4%] to 6.2% [1.1%]) and blood glucose concentrations (from 152 [44] to 143 [44] mg/dL) were observed only in the manidipine group (
P < 0.05). The incidence of adverse events was similar between groups.
In the present study, manidipine wasas metabolically neutral and as effective as enalapril in reducing blood pressure in hypertensive patients with type 2 diabetes, providing a sustained 24-hour antihypertensive effect.</description><identifier>ISSN: 0149-2918</identifier><identifier>EISSN: 1879-114X</identifier><identifier>DOI: 10.1016/j.clinthera.2005.02.001</identifier><identifier>PMID: 15811479</identifier><language>eng</language><publisher>Belle Mead, NJ: EM Inc USA</publisher><subject>ambulatoryblood pressure monitoring ; Angiotensin-Converting Enzyme Inhibitors - adverse effects ; Angiotensin-Converting Enzyme Inhibitors - therapeutic use ; Biological and medical sciences ; Blood Glucose - drug effects ; Blood Pressure - drug effects ; Calcium Channel Blockers - adverse effects ; Calcium Channel Blockers - therapeutic use ; diabetes mellitus ; Diabetes Mellitus, Type 2 - complications ; Dihydropyridines - adverse effects ; Dihydropyridines - therapeutic use ; Double-Blind Method ; enalapril ; Enalapril - therapeutic use ; Female ; Heart Rate - drug effects ; Humans ; hypertension ; Hypertension - complications ; Hypertension - drug therapy ; Lipoproteins - blood ; Male ; manidipine ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments</subject><ispartof>Clinical therapeutics, 2005-02, Vol.27 (2), p.166-173</ispartof><rights>2005 Excerpta Medica, Inc.</rights><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c427t-27f9a2c00dd2fbe724e59649c25b6feac1a22349e22680428810641f314d15673</citedby><cites>FETCH-LOGICAL-c427t-27f9a2c00dd2fbe724e59649c25b6feac1a22349e22680428810641f314d15673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1032920001?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64389,72469</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16863957$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15811479$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Otero, Manuel Luque</creatorcontrib><creatorcontrib>Claros, Nieves Marte</creatorcontrib><creatorcontrib>Investigators Group</creatorcontrib><creatorcontrib>Study Investigators Group</creatorcontrib><title>Manidipine versus enalapril monotherapy in patients with hypertension and type 2 diabetes mellitus: A multicenter, randomized, double-blind, 24-week study</title><title>Clinical therapeutics</title><addtitle>Clin Ther</addtitle><description>Blood pressure reduction is associated with a reduced risk for cardiovascular events and death, particularly in patients with both hypertension and type 2 diabetes mellitus.
The aim of this study was to compare theantihypertensive efficacy, tolerability, and effect on metabolic risk factors of manidipine, a new dihydropyridine calcium channel antagonist, and enalapril, a widely used angiotensin-converting enzyme inhibitor, in patients with mild to moderate essential hypertension and type 2 diabetes.
This multicenter, double-blind trial compared manidipine and enalapril in patients with type 2 diabetes and hypertension (diastolic blood pressure [DBP] 90–104 mm Hg, systolic blood pressure [SBP] ≤190 mm Hg). Following a 3-week, single-blind placebo run-in period, eligible patients were randomized to receive either manidipine 10 mg or enalapril 10 mg once daily for 24 weeks. The dose was doubled after 3 weeks in patients who had not responded to treatment (DBP ≥90 mm Hg). The primary efficacy end point was change in DBP from baseline to the end of the study. Secondary outcomes were the responder rate (DBP <90 mm Hg and/or a DBP reduction of ≥10 mm Hg) at the end of the study. Other secondary measures were changes from baseline to the end of the study in heart rate and in the following measures obtained by ambulatory blood pressure monitoring (ABPM): 24-hour, daytime, and nighttime mean DBP and SBP, and the trough:peak ratio. Blood glucose, glycosylated hemoglobin (HbA
1c), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, uric acid, and creatinine were measured at the end of the placebo run-in period and the end of treatment. The study had 80% power to detect a between-treatment difference in mean sitting DBP of >3 mm Hg.
One hundred twenty-four patients were enrolled in the study. After the placebo run-in period, 13 patients were excluded from the study: 4 for DBP values outside the specified limits, 7 at their request, and 2 for adverse events. Thus, 111 patients met the eligibility criteria and were randomized to treatment (53 manidipine, 58 enalapril). The population consisted of 61 men and 50 women with a mean (SD) age of 62 (11) years and a body mass index of 28.2 (2.4) kg/m
2. Among patients who completed the study, drug doses were doubled in 67.6% (25/37) of patients in the manidipine group and 60.0% (24/40) of patients in the enalapril group (
P = NS). Similar reductions in blood pressure were observed in both groups, from a mean (SD) of 164 (12)/97.5 (5) mm Hg at baseline to 141 (12)/84.5 (6) mm Hg at the end of the study in the manidipine group (
P < 0.01), and from 159 (12)/98 (4) mm Hg to 139 (12)/86 (8) mm Hg in the enalapril group (
P < 0.01). The proportion of responders was 66.7% (32/48) in the manidipine group and 60.0% (30/50) in the enalapril group; the difference between groups was not significant. Twenty-four-hour ABPM revealed significant (
P < 0.01) and similar reductions in blood pressure in both groups, with a trough:peak ratio of ∼-50%. Neither drug affected heart rate. Among the statistically significant changes in metabolic parameters, significant reductions in HbA
1c (from 6.7% [1.4%] to 6.2% [1.1%]) and blood glucose concentrations (from 152 [44] to 143 [44] mg/dL) were observed only in the manidipine group (
P < 0.05). The incidence of adverse events was similar between groups.
In the present study, manidipine wasas metabolically neutral and as effective as enalapril in reducing blood pressure in hypertensive patients with type 2 diabetes, providing a sustained 24-hour antihypertensive effect.</description><subject>ambulatoryblood pressure monitoring</subject><subject>Angiotensin-Converting Enzyme Inhibitors - adverse effects</subject><subject>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Blood Glucose - drug effects</subject><subject>Blood Pressure - drug effects</subject><subject>Calcium Channel Blockers - adverse effects</subject><subject>Calcium Channel Blockers - therapeutic use</subject><subject>diabetes mellitus</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Dihydropyridines - adverse effects</subject><subject>Dihydropyridines - therapeutic use</subject><subject>Double-Blind Method</subject><subject>enalapril</subject><subject>Enalapril - therapeutic use</subject><subject>Female</subject><subject>Heart Rate - drug effects</subject><subject>Humans</subject><subject>hypertension</subject><subject>Hypertension - complications</subject><subject>Hypertension - drug therapy</subject><subject>Lipoproteins - blood</subject><subject>Male</subject><subject>manidipine</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. 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Drug treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Otero, Manuel Luque</creatorcontrib><creatorcontrib>Claros, Nieves Marte</creatorcontrib><creatorcontrib>Investigators Group</creatorcontrib><creatorcontrib>Study Investigators Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><jtitle>Clinical therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Otero, Manuel Luque</au><au>Claros, Nieves Marte</au><aucorp>Investigators Group</aucorp><aucorp>Study Investigators Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Manidipine versus enalapril monotherapy in patients with hypertension and type 2 diabetes mellitus: A multicenter, randomized, double-blind, 24-week study</atitle><jtitle>Clinical therapeutics</jtitle><addtitle>Clin Ther</addtitle><date>2005-02-01</date><risdate>2005</risdate><volume>27</volume><issue>2</issue><spage>166</spage><epage>173</epage><pages>166-173</pages><issn>0149-2918</issn><eissn>1879-114X</eissn><abstract>Blood pressure reduction is associated with a reduced risk for cardiovascular events and death, particularly in patients with both hypertension and type 2 diabetes mellitus.
The aim of this study was to compare theantihypertensive efficacy, tolerability, and effect on metabolic risk factors of manidipine, a new dihydropyridine calcium channel antagonist, and enalapril, a widely used angiotensin-converting enzyme inhibitor, in patients with mild to moderate essential hypertension and type 2 diabetes.
This multicenter, double-blind trial compared manidipine and enalapril in patients with type 2 diabetes and hypertension (diastolic blood pressure [DBP] 90–104 mm Hg, systolic blood pressure [SBP] ≤190 mm Hg). Following a 3-week, single-blind placebo run-in period, eligible patients were randomized to receive either manidipine 10 mg or enalapril 10 mg once daily for 24 weeks. The dose was doubled after 3 weeks in patients who had not responded to treatment (DBP ≥90 mm Hg). The primary efficacy end point was change in DBP from baseline to the end of the study. Secondary outcomes were the responder rate (DBP <90 mm Hg and/or a DBP reduction of ≥10 mm Hg) at the end of the study. Other secondary measures were changes from baseline to the end of the study in heart rate and in the following measures obtained by ambulatory blood pressure monitoring (ABPM): 24-hour, daytime, and nighttime mean DBP and SBP, and the trough:peak ratio. Blood glucose, glycosylated hemoglobin (HbA
1c), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, uric acid, and creatinine were measured at the end of the placebo run-in period and the end of treatment. The study had 80% power to detect a between-treatment difference in mean sitting DBP of >3 mm Hg.
One hundred twenty-four patients were enrolled in the study. After the placebo run-in period, 13 patients were excluded from the study: 4 for DBP values outside the specified limits, 7 at their request, and 2 for adverse events. Thus, 111 patients met the eligibility criteria and were randomized to treatment (53 manidipine, 58 enalapril). The population consisted of 61 men and 50 women with a mean (SD) age of 62 (11) years and a body mass index of 28.2 (2.4) kg/m
2. Among patients who completed the study, drug doses were doubled in 67.6% (25/37) of patients in the manidipine group and 60.0% (24/40) of patients in the enalapril group (
P = NS). Similar reductions in blood pressure were observed in both groups, from a mean (SD) of 164 (12)/97.5 (5) mm Hg at baseline to 141 (12)/84.5 (6) mm Hg at the end of the study in the manidipine group (
P < 0.01), and from 159 (12)/98 (4) mm Hg to 139 (12)/86 (8) mm Hg in the enalapril group (
P < 0.01). The proportion of responders was 66.7% (32/48) in the manidipine group and 60.0% (30/50) in the enalapril group; the difference between groups was not significant. Twenty-four-hour ABPM revealed significant (
P < 0.01) and similar reductions in blood pressure in both groups, with a trough:peak ratio of ∼-50%. Neither drug affected heart rate. Among the statistically significant changes in metabolic parameters, significant reductions in HbA
1c (from 6.7% [1.4%] to 6.2% [1.1%]) and blood glucose concentrations (from 152 [44] to 143 [44] mg/dL) were observed only in the manidipine group (
P < 0.05). The incidence of adverse events was similar between groups.
In the present study, manidipine wasas metabolically neutral and as effective as enalapril in reducing blood pressure in hypertensive patients with type 2 diabetes, providing a sustained 24-hour antihypertensive effect.</abstract><cop>Belle Mead, NJ</cop><pub>EM Inc USA</pub><pmid>15811479</pmid><doi>10.1016/j.clinthera.2005.02.001</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0149-2918 |
| ispartof | Clinical therapeutics, 2005-02, Vol.27 (2), p.166-173 |
| issn | 0149-2918 1879-114X |
| language | eng |
| recordid | cdi_proquest_journals_1032920001 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central UK/Ireland |
| subjects | ambulatoryblood pressure monitoring Angiotensin-Converting Enzyme Inhibitors - adverse effects Angiotensin-Converting Enzyme Inhibitors - therapeutic use Biological and medical sciences Blood Glucose - drug effects Blood Pressure - drug effects Calcium Channel Blockers - adverse effects Calcium Channel Blockers - therapeutic use diabetes mellitus Diabetes Mellitus, Type 2 - complications Dihydropyridines - adverse effects Dihydropyridines - therapeutic use Double-Blind Method enalapril Enalapril - therapeutic use Female Heart Rate - drug effects Humans hypertension Hypertension - complications Hypertension - drug therapy Lipoproteins - blood Male manidipine Medical sciences Middle Aged Pharmacology. Drug treatments |
| title | Manidipine versus enalapril monotherapy in patients with hypertension and type 2 diabetes mellitus: A multicenter, randomized, double-blind, 24-week study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-05T14%3A46%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Manidipine%20versus%20enalapril%20monotherapy%20in%20patients%20with%20hypertension%20and%20type%202%20diabetes%20mellitus:%20A%20multicenter,%20randomized,%20double-blind,%2024-week%20study&rft.jtitle=Clinical%20therapeutics&rft.au=Otero,%20Manuel%20Luque&rft.aucorp=Investigators%20Group&rft.date=2005-02-01&rft.volume=27&rft.issue=2&rft.spage=166&rft.epage=173&rft.pages=166-173&rft.issn=0149-2918&rft.eissn=1879-114X&rft_id=info:doi/10.1016/j.clinthera.2005.02.001&rft_dat=%3Cproquest_cross%3E2732772181%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1032920001&rft_id=info:pmid/15811479&rft_els_id=S0149291805000135&rfr_iscdi=true |