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2. Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCT randomized trial results

Author

Kjeldsen, Sverre E, Sica, Domenic, Haller, Hermann, Cha, Gloria, Gil Extremera, Blas, Harvey, Peter, Heyvaert, Frank, Lewin, Andrew J., Villa, Giuseppe, Mancia, Giuseppe, the DISTINCT investigators: Agaiby, J, Aggarwal, N, Ainsworth, P, Akhras, R, Amaluan, V, Ballarin, A, Bardauskiene, L, Berra, Fc, Blagden, M, Bodalia, B, Borghi, C, Bundy, C, Burgess, L, Buynak, R, Cafferata, A, Cahill, T, Capiau, L, Capuano, V, Casanova, R, Cecil, J, Cha, G, Chapman, J, Chilvers, M, Christensen, S, Cho, Yh, Chung, Wb, Cipollone, F, Coca, A, Colombo, H, Contreras, Em, Crowley, D, Cusco Prieto, B, Decarlini, F, Doh, Jh, Dzongowski, P, Dzyak, G, Ellery, A, Extremera, Bg, Farias, E, Farrington, C, Fidelholtz, J, Fouche, L, Gabito, A, Gainza, M, Gani, M, Gaunt, R, Gelersztein, E, Giuliano, M, Glazunov, A, Glorioso, N, Goloschekin, B, Gumbley, M, Gupta, A, Guzman, L, Ha, Jw, Hart, R, Harvey, P, Haworth, D, Henein, S, Henry, D, Her, Sh, Heyvaert, F, Hollanders, G, Hominal, M, Hong, Bk, Hong, Tj, Hwang, Kk, Jacovides, A, Jacqmein, J, Jeon, Hk, Jones, N, Kanani, S, Kang, H, Karpenko, O, Kenton, D, Kimzey, N, Kjeldsen, Se, Kovalenko, V, Kushnir, M, Lasko, B, Lee, Kj, Lee, N, Lewin, A, Litvak, M, Luksiene, D, Majul, C, Mannarino, E, Manuale, O, Marcadis, A, Miller, D, Mills, R, Misik, K, Mortelmans, J, O'Mahony, M, O'Mahony, W, Park, C, Pedrinelli, Roberto, Petrulioniene, Z, Pettyjohn, F, Piskorz, D, Poss, G, Pudi, K, Pyun, Wb, Raad, G, Raila, G, Ramirez Espinosa MF, Ramlachan, P, Rhee, M, Rudenko, L, Ruiz, Ts, Ryan, J, Schacter, G, Shin, Jh, Short, D, Sica, D, Sirenko, Y, Slapikas, R, Somani, R, Stanislavchuk, M, Stewart, R, Svishchenko, Y, Sychov, O, Teitelbaum, I, Tseluyko, V, Van Rensburg DJ, Vaquer Perez JV, Via, Lm, Vico, M, Villa, G, Vizir, V, Vogel, D, Wellmann, H, Yoo, B. S., Kjeldsen, Sverre E, Sica, Domenic, Haller, Hermann, Cha, Gloria, Gil-Extremera, Bla, Harvey, Peter, Heyvaert, Frank, Lewin, Andrew J, Villa, Giuseppe, Mancia, Giuseppe, Borghi, Claudio, Kjeldsen, S, Sica, D, Haller, H, Cha, G, Gil-Extremera, B, Harvey, P, Heyvaert, F, Lewin, A, Villa, G, and Mancia, G

Subjects
Male, Physiology, Ethnic Group, Administration, Oral, Tetrazoles, Blood Pressure, DISTINCT study, Pharmacology, Benzimidazole, law.invention, combination therapy, Randomized controlled trial, candesartan cilexetil, combination therapy, DISTINCT study, essential hypertension, nifedipine GITS, vasodilatory side effects, law, Ethnicity, Tetrazole, Middle Aged, candesartan cilexetil, Biphenyl compound, Antihypertensive Agent, Treatment Outcome, Tolerability, Aged, Antihypertensive Agents, Benzimidazoles, Biphenyl Compounds, Double-Blind Method, Drug Therapy, Combination, Drug-Related Side Effects and Adverse Reactions, Ethnic Groups, Female, Humans, Hypertension, Nifedipine, Cardiology and Cardiovascular Medicine, Internal Medicine, Administration, Combination, Cardiology, Vasodilatory side effect, ORIGINAL PAPERS: Therapeutic aspects, medicine.drug, Human, Oral, medicine.medical_specialty, Side effect, Combination therapy, Drug Therapy, Internal medicine, medicine, vasodilatory side effects, business.industry, essential hypertension, nifedipine GITS, Candesartan, Blood pressure, Biphenyl Compound, business, Drug-Related Side Effects and Adverse Reaction
Abstract

Objectives: DISTINCT (reDefining Intervention with Studies Testing Innovative Nifedipine GITS – Candesartan Therapy) aimed to determine the dose–response and tolerability of nifedipine GITS and/or candesartan cilexetil therapy in participants with hypertension. Methods: In this 8-week, multinational, multicentre, randomized, double-blind, placebo-controlled study, adults with mean seated DBP of at least 95 to less than 110 mmHg received combination or monotherapy with nifedipine GITS (N) 20, 30 or 60 mg and candesartan cilexetil (C) 4, 8, 16 or 32 mg, or placebo. The primary endpoint, change in DBP from baseline to Week 8, was analysed using the response surface model (RSM); this analysis was repeated for mean seated SBP. Results: Overall, 1381 participants (mean baseline SBP/DBP: 156.5/99.6 mmHg) were randomized. Both N and C contributed independently to SBP/DBP reductions [P

Published
2014

3. Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCTrandomized trial results

Author

Kjeldsen, S, Sica, D, Haller, H, Cha, G, Gil-Extremera, B, Harvey, P, Heyvaert, F, Lewin, A, Villa, G, Mancia, G, Kjeldsen, Sverre E., Sica, Domenic, Haller, Hermann, Cha, Gloria, Gil-Extremera, Blas, Harvey, Peter, Heyvaert, Frank, Lewin, Andrew J., Villa, Giuseppe, Mancia, Giuseppe, Kjeldsen, S, Sica, D, Haller, H, Cha, G, Gil-Extremera, B, Harvey, P, Heyvaert, F, Lewin, A, Villa, G, Mancia, G, Kjeldsen, Sverre E., Sica, Domenic, Haller, Hermann, Cha, Gloria, Gil-Extremera, Blas, Harvey, Peter, Heyvaert, Frank, Lewin, Andrew J., Villa, Giuseppe, and Mancia, Giuseppe

Abstract

Objectives: DISTINCT (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) aimed to determine the dose-response and tolerability of nifedipine GITS and/or candesartan cilexetil therapy in participants with hypertension. Methods: In this 8-week, multinational, multicentre, randomized, double-blind, placebo-controlled study, adults with mean seated DBP of at least 95 to less than 110mmHg received combination or monotherapy with nifedipine GITS (N) 20, 30 or 60mg and candesartan cilexetil (C) 4, 8, 16 or 32 mg, or placebo. The primary endpoint, change in DBP from baseline to Week 8, was analysed using the response surface model (RSM); this analysis was repeated for mean seated SBP. Results: Overall, 1381 participants (mean baseline SBP/ DBP: 156.5/99.6mmHg) were randomized. Both N and C contributed independently to SBP/DBP reductions [P < 0.0001 (RSM)]. A positive dose-response was observed, with all combinations providing statistically better blood pressure (BP) reductions from baseline versus respective monotherapies (P < 0.05) and N60C32 achieving the greatest reduction [-23.8/-16.5mmHg; P < 0.01 versus placebo (-5.3/-6.7 mmHg) and component monotherapies]. Even very low-dose (N20 and C4) therapy provided significant BP-lowering, and combination therapy was similarly effective in different racial groups. N/C combination demonstrated a lower incidence of vasodilatory adverse events than N monotherapy (18.3 versus 23.6%), including headache (5.5 versus 11.0%; P = 0.003, chi-square test) and peripheral oedema over time (3.6 versus 5.8%; n.s.). Conclusion: N/C combination was effective in participants with hypertension and showed an improved side effect profile compared with N monotherapy.

Published
2014

4. Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses.

Author

Kjeldsen, Sverre E., Cha, Gloria, Villa, Giuseppe, and Mancia, Giuseppe

Subjects
*COMBINATION drug therapy, *HYPERTENSION, *ANTIHYPERTENSIVE agents, *NIFEDIPINE, *RESEARCH funding, *SECONDARY analysis, *RANDOMIZED controlled trials, *TREATMENT effectiveness, *CANDESARTAN, *DESCRIPTIVE statistics, *EVALUATION
Abstract

DISTINCT was an 8-week, double-blind, randomized study to investigate the antihypertensive efficacy and safety of various nifedipine gastrointestinal treatment system (GITS)/candesartan cilexetil (N/C) dose combinations, vs respective monotherapies or placebo, in patients with diastolic blood pressure (DBP) ≥95 to <110 mm Hg. The current prespecified analysis compared BP reduction in participants with mild vs moderate baseline hypertension (ie, systolic [S]BP <160 mm Hg vs ≥160 mm Hg and DBP <100 mm Hg vs ≥100 mm Hg). A total of 1362 patients were analyzed by descriptive statistics. In all patient subgroups investigated, the NC combinations (ie, N: 20, 30, or 60 mg; C: 4, 8, 16, or 32 mg daily) provided greater SBP and DBP lowering and higher rates of BP control (defined as BP <140/90 mm Hg) than respective monotherapies or placebo, with greatest absolute BP reductions observed in the moderately elevated SBP or DBP subgroups. A trend to dose-response relationship was observed in each subgroup. In each SBP and DBP subgroup, treatment-related vasodilatory events (flushing, headache, or edema) were less frequent for patients receiving NC combination therapy than N monotherapy. These analyses support the use of calcium antagonist and angiotensin receptor blocker combination therapy in patients with both mild and moderate hypertension, for whom effective BP normalization and good drug tolerance would greatly reduce the risk of cardiovascular events. [ABSTRACT FROM AUTHOR]

Published
2016
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