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Copalia HCT - amlodipine / valsartan / hydrochlorothiazide European Medicines Agency Evaluation of Medicines for Human Use 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: email@example.com http://www.emea.europa.eu Doc.Ref: EMEA/CHMP/471143/2009 ASSESSMENT REPORT FOR Copalia HCT International Nonproprietary Name: amlodipine besylate / valsartan / hydrochlorothiazide Procedure No. EMEA/H/C/001159 Assessment Report as adopted (...) new fixed combination products. The applicant applied for the following indication: “Treatment of essential hypertension. Copalia HCT is indicated as replacement therapy in patients whose blood pressure is adequately controlled on amlodipine, valsartan and hydrochlorothiazide (HCT) used as individual or combination therapies”. Information on Paediatric requirements Pursuant to Article 7, the application included an EMEA Decision P/14/2009 for the following condition: • Essential hypertension on
Effects of dietary sodium and hydrochlorothiazide on the antiproteinuric efficacy of losartan 18272844 2008 04 29 2008 05 22 2014 09 04 1533-3450 19 5 2008 May Journal of the American Society of Nephrology : JASN J. Am. Soc. Nephrol. Effects of dietary sodium and hydrochlorothiazide on the antiproteinuric efficacy of losartan. 999-1007 10.1681/ASN.2007060693 There is large interindividual variability in the antiproteinuric response to blockade of the renin-angiotensin-aldosterone system (RAAS (...) ). A low-sodium diet or addition of diuretics enhances the effects of RAAS blockade on proteinuria and BP, but the efficacy of the combination of these interventions is unknown. Therefore, this randomized, double-blind, placebo-controlled trial to determine the separate and combined effects of a low-sodium diet and hydrochlorothiazide (HCT) on proteinuria and BP was performed. In 34 proteinuric patients without diabetes, mean baseline proteinuria was 3.8 g/d, and this was reduced by 22% by a low-sodium diet
Cost-effectiveness of irbesartan/hydrochlorothiazide in patients with hypertension: an economic evaluation for Sweden Cost-effectiveness of irbesartan/hydrochlorothiazide in patients with hypertension: an economic evaluation for Sweden Cost-effectiveness of irbesartan/hydrochlorothiazide in patients with hypertension: an economic evaluation for Sweden Ekman M, Bienfait-Beuzon C, Jackson J Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion (...) on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study examined the cost-effectiveness of irbesartan in combination with hydrochlorothiazide in comparison with other selective angiotensin-II-receptor blockers. The authors concluded that irbesartan combined with hydrochlorothiazide was a cost-effective alternative to valsartan and losartan
Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. 19052124 2008 12 04 2008 12 09 2014 07 31 1533-4406 359 23 2008 Dec 04 The New England journal of medicine N. Engl. J. Med. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. 2417-28 10.1056/NEJMoa0806182 The optimal combination drug therapy for hypertension is not established, although current U.S. guidelines recommend inclusion of a diuretic. We hypothesized (...) that treatment with the combination of an angiotensin-converting-enzyme (ACE) inhibitor and a dihydropyridine calcium-channel blocker would be more effective in reducing the rate of cardiovascular events than treatment with an ACE inhibitor plus a thiazide diuretic. In a randomized, double-blind trial, we assigned 11,506 patients with hypertension who were at high risk for cardiovascular events to receive treatment with either benazepril plus amlodipine or benazepril plus hydrochlorothiazide. The primary end
Losartan/ hydrochlorothiazide (Cozaar-Comp 100/25) Scottish Medicines Consortium Secretariat - Delta House 50 West Nile Street Glasgow G1 2NP Telephone 0141 225 6989 E-mail: Rosie.Murray@nhshealthquality.org Chairman Professor David Webb losartan 100mg/ hydrochlorothiazide 25mg tablets (Cozaar-Comp 100/25) (No. 296/06) Merck, Sharp & Dohme Ltd Product Update 7 July 2006 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises the NHS Boards and Area (...) Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland. The advice is summarised as follows: ADVICE: following an abbreviated submission Losartan 100mg/hydrochlorothiazide 25mg tablet (Cozaar-Comp 100/25 Ò ) is accepted for use within NHS Scotland for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy. No increased costs are associated with this product compared with losartan (Cozaar
CoAprovel - irbesartan / hydrochlorothiazide 1 ?EMEA 2004 SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion and scientific discussion on procedures which have been finalised before 1 November 2004. For scientific information on procedures after this date please refer to module 8B. 1. Introduction The application is a new combination of two previously known active substances in the combinations 150 mg/12.5 mg and 300 mg/12.5 mg of irbesartan and hydrochlorothiazide (...) as an alternative to the titration to 300 mg of irbesartan in subjects not adequately controlled by 150 mg irbesartan or hydrochlorothiazide alone. Similarly, the dose of 300 mg/12.5 mg is proposed as an additional useful step for the subjects not adequately controlled by the combination 150 mg/12.5 mg or by 300 mg monotherapy. 2. Part II: Chemical, pharmaceutical and biological aspects Uncoated tablets Composition The medicinal product is available in the form of tablets with doses of 150 mg/12.5 mg and 300 mg
eprosartan mesylate/ hydrochlorothiazide CEDAC FINAL RECOMMENDATION and REASONS for RECOMMENDATION EPROSARTAN MESYLATE/HYDROCHLOROTHIAZIDE (Teveten® Plus – Solvay Pharma Inc.) Description: Teveten® Plus is a combination product containing an angiotensin II receptor blocker (ARB), eprosartan mesylate 600 mg, and a thiazide diuretic, hydrochlorothiazide (HCTZ) 12.5mg. This combination is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination (...) therapy is appropriate. It is not indicated for initial therapy. Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that this eprosartan/ hydrochlorothiazide combination be listed in a similar manner as drug plans list other ARB/HCTZ combination products. Reasons for the recommendation: 1. Two randomized trials found that the combination of eprosartan and HCTZ provided greater blood pressure lowering than monotherapy using either agent. 2. The combination product
Telmisartan/hydrochlorothiazide (MicardisPlus) Scottish Medicines Consortium Telmisartan, hydrochlorothiazide (MicardisPlus ® ) (No. 39/03) Boehringer Ingelheim Summary of Recommendation 9 May, 2003 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and ADTCs on its use in NHS Scotland. The recommendation is summarised as follows: ADVICE Recommended for restricted use within NHS Scotland. RECOMMENDATION Telmisartan (...) / hydrochlorothiazide (MicardisPlus ®) has efficacy similar to the antihypertensive effects of the individual constituents added together in the treatment of essential hypertension. No increased costs are associated with this product compared with telmisartan (Micardis ®) alone. Angiotensin II receptor antagonists are an alternative to ACE inhibitors where these are not tolerated. Professor David H Lawson Chairman Secretariat - Delta House 50 West Nile Street Glasgow G1 2NP Telephone 0141 225 6997 Fax 0141 248 3778
Low-Dose Hydrochlorothiazide and Preservation of Bone Mineral Density in Older Adults Low-Dose Hydrochlorothiazide and ... preview & related info | Mendeley E-mail address Password ( ) Remember me …or sign in with Search Main Navigation › Short URL Annals of Internal Medicine ( 2000 ) Volume: 133 , Issue: 7 , Pages: 516-526 Available from or Find this paper at: Abstract A Randomized, Double-Blind, Placebo-Controlled Trial Andrea Z. LaCroix, PhD; Susan M. Ott, MD; Laura Ichikawa, MS; Delia (...) Scholes, PhD; and William E. Barlow, PhD Pages 516-526 Background: Thiazide may have beneficial effects on bone mineral density and may reduce risk for hip fracture. However, the existence of a causal role remains uncertain because experimental evidence is limited. Objective: To determine the effect of hydrochlorothiazide on rates of bone loss in older adults. Design: Randomized, double-blind, placebo-controlled trial with 3-year follow-up. Setting: A large health maintenance organization in western
Randomised, double blind, multicentre comparison of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in antihypertensive treatment: results of the HANE study. HANE Trial Research Group. 9251545 1997 08 28 1997 08 28 2013 11 21 0959-8138 315 7101 1997 Jul 19 BMJ (Clinical research ed.) BMJ Randomised, double blind, multicentre comparison of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in antihypertensive treatment: results of the HANE study. HANE Trial Research Group. 154 (...) -9 To compare the effectiveness and tolerability of hydrochlorothiazide, atenolol, nitrendipine, and enalapril in patients with mild to moderate hypertension. Randomised multicentre trial over 48 weeks with double blind comparison of treatments. 48 centres in four countries. 868 patients with essential hypertension (diastolic blood pressure 95-120 mm Hg) Initial treatment (step 1) consisted of 12.5 mg hydrochlorothiazide (n = 215), 25 mg atenolol (n = 215), 10 mg nitrendipine (n = 218), or 5 mg
Comparison of reduction in microalbuminuria by enalapril and hydrochlorothiazide in normotensive patients with insulin dependent diabetes. 8443481 1993 04 08 1993 04 08 2013 11 21 0959-8138 306 6871 1993 Jan 16 BMJ (Clinical research ed.) BMJ Comparison of reduction in microalbuminuria by enalapril and hydrochlorothiazide in normotensive patients with insulin dependent diabetes. 175-82 To compare the effects of sodium depletion and of angiotensin I converting enzyme inhibition (...) on microalbuminuria in insulin dependent diabetes. Randomised, double blind, double dummy parallel study of normotensive diabetic patients with persistent microalbuminuria (30-300 mg/24 h) treated with enalapril or hydrochlorothiazide for one year after a three month, single blind placebo period. Diabetic clinic in a tertiary referral centre. 10 diabetic patients with low microalbuminuria (30-99 mg/24 h) and 11 with high microalbuminuria (100-300 mg/24 h). 11 subjects (six with low microalbuminuria, five
An assessment of diltiazem and hydrochlorothiazide in hypertension. Application of factorial trial design to a multicenter clinical trial of combination therapy. 2407872 1990 04 03 1990 04 03 2016 10 17 0098-7484 263 11 1990 Mar 16 JAMA JAMA An assessment of diltiazem and hydrochlorothiazide in hypertension. Application of factorial trial design to a multicenter clinical trial of combination therapy. 1507-12 This multicenter, factorial-design trial assessed the safety and additive (...) antihypertensive efficacy of a slow-release (SR) formulation of diltiazem hydrochloride given alone or in combination with hydrochlorothiazide for treatment of mild to moderate hypertension. After a 4- to 6-week placebo run-in period, 297 qualifying patients were randomized to receive placebo, 1 of 4 doses of diltiazem SR monotherapy, 1 of 3 doses of hydrochlorothiazide monotherapy, or 1 of 12 possible combinations of diltiazem SR and hydrochlorothiazide for 6 weeks. A dose-related reduction in blood
A comparison of the effects of hydrochlorothiazide and captopril on glucose and lipid metabolism in patients with hypertension. 2671740 1989 10 12 1989 10 12 2013 11 21 0028-4793 321 13 1989 Sep 28 The New England journal of medicine N. Engl. J. Med. A comparison of the effects of hydrochlorothiazide and captopril on glucose and lipid metabolism in patients with hypertension. 868-73 It has been suggested that the metabolic side effects of antihypertensive drugs are responsible for their failure (...) to reduce cardiovascular morbidity in patients with hypertension. Therefore, in 50 patients with essential hypertension, we performed a randomized, double-blind, crossover study comparing the effects of carbohydrate and lipid metabolism of captopril (mean [+/- SD] dose, 81 +/- 24 mg per day) and hydrochlorothiazide (40 +/- 12 mg per day) over two four-month treatment periods. Captopril increased the insulin-mediated disposal of glucose, as compared with placebo, from 5.7 +/- 2.4 to 6.3 +/- 2.5 mg per
Verapamil versus hydrochlorothiazide in the treatment of hypertension: results of long term double blind comparative trial. Verapamil versus Diuretic (VERDI) Trial Research Group. 2510877 1990 01 02 1990 01 02 2013 11 21 0959-8138 299 6704 1989 Oct 07 BMJ (Clinical research ed.) BMJ Verapamil versus hydrochlorothiazide in the treatment of hypertension: results of long term double blind comparative trial. Verapamil versus Diuretic (VERDI) Trial Research Group. 881-6 To compare the efficacy (...) and tolerability of hydrochlorothiazide, sustained release verapamil, and their combination in patients with mild to moderate hypertension. Randomised multicentre trial of 48 weeks' duration with a double blind comparison of hydrochlorothiazide and verapamil followed by an open trial of combined treatment for patients not achieving the target diastolic blood pressure (less than 90 mm Hg) during treatment with a single drug. Outpatient departments in 10 clinics and 10 private practices of general practitioners