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Combined Enalapril and Felodipine Extended Release (ER) for Systemic Hypertension
This multicenter, placebo-controlled, double-blind trial of factorial design evaluated the safety and efficacy of combination treatment with the angiotensin-converting enzyme inhibitor, enalapril, and the vascular selective calcium antagonist felodipine extended release (ER) in patients with essenti...
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Published in: | The American journal of cardiology 1997-02, Vol.79 (4), p.431-435 |
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creator | Gradman, Alan H. Cutler, Neal R. Davis, Pamela J. Robbins, John A. Weiss, Robert J. Wood, Barry C. |
description | This multicenter, placebo-controlled, double-blind trial of factorial design evaluated the safety and efficacy of combination treatment with the angiotensin-converting enzyme inhibitor, enalapril, and the vascular selective calcium antagonist felodipine extended release (ER) in patients with essential hypertension. After a 4-week, single-blind placebo baseline period, 707 patients with sitting diastolic blood pressures (BPs) in the range of 95 to 115 mm Hg received placebo, enalapril (5 or 20 mg), felodipine ER (2.5, 5, or 10 mg), or their combinations for an 8-week double-blind treatment period. All doses of enalapril and felodipine ER had a statistically significant (p |
doi_str_mv | 10.1016/S0002-9149(96)00781-3 |
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The efficacy, safety, and tolerability of combination treatment with enalapril and felodipine extended release (ER) were evaluated in 707 patients with essential hypertension in a multicenter, factorial design study. The combination had significant additive blood pressure-lowering effects compared with each of the monotherapies over a wide range of doses, was generally well tolerated, and was associated with a lower incidence of drug-related peripheral edema than that from higher doses of felodipine ER monotherapy.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/S0002-9149(96)00781-3</identifier><identifier>CODEN: AJCDAG</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Antihypertensive agents ; Biological and medical sciences ; Cardiovascular system ; Drug therapy ; Hypertension ; Medical sciences ; Pharmacology. Drug treatments</subject><ispartof>The American journal of cardiology, 1997-02, Vol.79 (4), p.431-435</ispartof><rights>1997 Elsevier Science Inc.</rights><rights>1997 INIST-CNRS</rights><rights>Copyright Elsevier Sequoia S.A. Feb 15, 1997</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c363t-b0af9485ac6cb3d25636bcf868fad335b9179be0f3021d820481d9bd8f1204db3</citedby><cites>FETCH-LOGICAL-c363t-b0af9485ac6cb3d25636bcf868fad335b9179be0f3021d820481d9bd8f1204db3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2600652$$DView record in Pascal Francis$$Hfree_for_read</backlink></links><search><creatorcontrib>Gradman, Alan H.</creatorcontrib><creatorcontrib>Cutler, Neal R.</creatorcontrib><creatorcontrib>Davis, Pamela J.</creatorcontrib><creatorcontrib>Robbins, John A.</creatorcontrib><creatorcontrib>Weiss, Robert J.</creatorcontrib><creatorcontrib>Wood, Barry C.</creatorcontrib><creatorcontrib>for the Enalapril-Felodipine ER Factorial Study Group</creatorcontrib><title>Combined Enalapril and Felodipine Extended Release (ER) for Systemic Hypertension</title><title>The American journal of cardiology</title><description>This multicenter, placebo-controlled, double-blind trial of factorial design evaluated the safety and efficacy of combination treatment with the angiotensin-converting enzyme inhibitor, enalapril, and the vascular selective calcium antagonist felodipine extended release (ER) in patients with essential hypertension. After a 4-week, single-blind placebo baseline period, 707 patients with sitting diastolic blood pressures (BPs) in the range of 95 to 115 mm Hg received placebo, enalapril (5 or 20 mg), felodipine ER (2.5, 5, or 10 mg), or their combinations for an 8-week double-blind treatment period. All doses of enalapril and felodipine ER had a statistically significant (p <0.05) additive effect in reducing both systolic and diastolic BP. The trough to peak ratios for the combinations ranged from 0.63 (enalapril 5 mg-felodipine ER 2.5 mg) to 0.79 (enalapril 20 mg-felodipine ER 10 mg) and were consistent with effective BP control with 1 dose/day. Patients aged ≥65 years demonstrated a greater reduction in diastolic BP. Combinations of enalapril-felodipine ER were associated with less drug-induced peripheral edema (4.1%) compared to felodipine ER monotherapy (10.8%). There were no serious drug-related adverse effects observed during the study. In this trial, the combination of enalapril and felodipine ER effectively lowered BP and was generally well tolerated with an excellent safety profile when used in the treatment of hypertension.
The efficacy, safety, and tolerability of combination treatment with enalapril and felodipine extended release (ER) were evaluated in 707 patients with essential hypertension in a multicenter, factorial design study. The combination had significant additive blood pressure-lowering effects compared with each of the monotherapies over a wide range of doses, was generally well tolerated, and was associated with a lower incidence of drug-related peripheral edema than that from higher doses of felodipine ER monotherapy.</description><subject>Antihypertensive agents</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular system</subject><subject>Drug therapy</subject><subject>Hypertension</subject><subject>Medical sciences</subject><subject>Pharmacology. 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Drug treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gradman, Alan H.</creatorcontrib><creatorcontrib>Cutler, Neal R.</creatorcontrib><creatorcontrib>Davis, Pamela J.</creatorcontrib><creatorcontrib>Robbins, John A.</creatorcontrib><creatorcontrib>Weiss, Robert J.</creatorcontrib><creatorcontrib>Wood, Barry C.</creatorcontrib><creatorcontrib>for the Enalapril-Felodipine ER Factorial Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>CrossRef</collection><collection>Physical Education Index</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biochemistry Abstracts 1</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>The American journal of cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gradman, Alan H.</au><au>Cutler, Neal R.</au><au>Davis, Pamela J.</au><au>Robbins, John A.</au><au>Weiss, Robert J.</au><au>Wood, Barry C.</au><aucorp>for the Enalapril-Felodipine ER Factorial Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Combined Enalapril and Felodipine Extended Release (ER) for Systemic Hypertension</atitle><jtitle>The American journal of cardiology</jtitle><date>1997-02-15</date><risdate>1997</risdate><volume>79</volume><issue>4</issue><spage>431</spage><epage>435</epage><pages>431-435</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><coden>AJCDAG</coden><abstract>This multicenter, placebo-controlled, double-blind trial of factorial design evaluated the safety and efficacy of combination treatment with the angiotensin-converting enzyme inhibitor, enalapril, and the vascular selective calcium antagonist felodipine extended release (ER) in patients with essential hypertension. After a 4-week, single-blind placebo baseline period, 707 patients with sitting diastolic blood pressures (BPs) in the range of 95 to 115 mm Hg received placebo, enalapril (5 or 20 mg), felodipine ER (2.5, 5, or 10 mg), or their combinations for an 8-week double-blind treatment period. All doses of enalapril and felodipine ER had a statistically significant (p <0.05) additive effect in reducing both systolic and diastolic BP. The trough to peak ratios for the combinations ranged from 0.63 (enalapril 5 mg-felodipine ER 2.5 mg) to 0.79 (enalapril 20 mg-felodipine ER 10 mg) and were consistent with effective BP control with 1 dose/day. Patients aged ≥65 years demonstrated a greater reduction in diastolic BP. Combinations of enalapril-felodipine ER were associated with less drug-induced peripheral edema (4.1%) compared to felodipine ER monotherapy (10.8%). There were no serious drug-related adverse effects observed during the study. In this trial, the combination of enalapril and felodipine ER effectively lowered BP and was generally well tolerated with an excellent safety profile when used in the treatment of hypertension.
The efficacy, safety, and tolerability of combination treatment with enalapril and felodipine extended release (ER) were evaluated in 707 patients with essential hypertension in a multicenter, factorial design study. The combination had significant additive blood pressure-lowering effects compared with each of the monotherapies over a wide range of doses, was generally well tolerated, and was associated with a lower incidence of drug-related peripheral edema than that from higher doses of felodipine ER monotherapy.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><doi>10.1016/S0002-9149(96)00781-3</doi><tpages>5</tpages></addata></record> |
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subjects | Antihypertensive agents Biological and medical sciences Cardiovascular system Drug therapy Hypertension Medical sciences Pharmacology. Drug treatments |
title | Combined Enalapril and Felodipine Extended Release (ER) for Systemic Hypertension |
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