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1. Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial

Author

Mancia, G, Cha, G, Gil-Extremera, B, Harvey, P, Lewin, AJ, Villa, G, Kjeldsen, SE, 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, Chapman, J, Chilvers, M, Christensen, S, Cho, Y-H, Chung, W-B, Cipollone, F, Coca, A, Colombo, H, Contreras, EM, Crowley, D, Cusco-Prieto, B, Decarlini, F, Doh, J-H, 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, J-W, Hart, R, Haworth, D, Henein, S, Henry, D, Her, S-H, Heyvaert, F, Hollanders, G, Hominal, M, Hong, B-K, Hong, T-J, Hwang, K-K, Jacovides, A, Jacqmein, J, Jeon, HK, Jones, N, Kanani, S, Kang, H, Karpenko, O, Kenton, D, Kimzey, N, 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, R, 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, J-H, 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, Vizir, V, Vogel, D, Wellmann, H, Yoo, BS, DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, AREA MIN. 06 - Scienze mediche, Mancia, G, Cha, G, Gil-Extremera, B, Harvey, P, Lewin, A, Villa, G, Kjeldsen, S, Agaiby, J, Aggarwal, N, Ainsworth, P, Akhras, R, Amaluan, V, Ballarin, A, Bardauskiene, L, Berra, F, Blagden, M, Bodalia, B, Borghi, C, Bundy, C, Burgess, L, Buynak, R, Cafferata, A, Cahill, T, Capiau, L, Capuano, V, Casanova, R, Cecil, J, Chapman, J, Chilvers, M, Christensen, S, Cho, Y, Chung, W, Cipollone, F, Coca, A, Colombo, H, Contreras, E, Crowley, D, Cusco-Prieto, B, Decarlini, F, Doh, J, Dzongowski, P, Dzyak, G, Ellery, A, Extremera, B, 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, J, Hart, R, Haworth, D, Henein, S, Henry, D, Her, S, Heyvaert, F, Hollanders, G, Hominal, M, Hong, B, Hong, T, Hwang, K, Jacovides, A, Jacqmein, J, Jeon, H, Jones, N, Kanani, S, Kang, H, Karpenko, O, Kenton, D, Kimzey, N, Kovalenko, V, Kushnir, M, Lasko, B, Lee, K, Lee, N, 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, R, Petrulioniene, Z, Pettyjohn, F, Piskorz, D, Poss, G, Pudi, K, Pyun, W, Raad, G, Raila, G, Ramirez Espinosa, M, Ramlachan, P, Rhee, M, Rudenko, L, Ruiz, T, Ryan, J, Schacter, G, Shin, J, Short, D, Sica, D, Sirenko, Y, Slapikas, R, Somani, R, Stanislavchuk, M, Stewart, R, Svishchenko, Y, Sychov, O, Teitelbaum, I, Tseluyko, V, Van Rensburg, D, Vaquer Perez, J, Via, L, Vico, M, Vizir, V, Vogel, D, Wellmann, H, Yoo, B, Mancia, G., Cha, G., Gil-Extremera, B., Harvey, P., Lewin, A.J., Villa, G., Kjeldsen, S.E., Agaiby, J., Aggarwal, N., Ainsworth, P., Akhras, R., Amaluan, V., Ballarin, A., Bardauskiene, L., Berra, F.C., Blagden, M., Bodalia, B., Borghi, C., Bundy, C., Burgess, L., Buynak, R., Cafferata, A., Cahill, T., Capiau, L., Capuano, V., Casanova, R., Cecil, J., Chapman, J., Chilvers, M., Christensen, S., Cho, Y.-H., Chung, W.-B., Cipollone, F., Coca, A., Colombo, H., Contreras, E.M., Crowley, D., Cusco-Prieto, B., Decarlini, F., Doh, J.-H., Dzongowski, P., Dzyak, G., Ellery, A., Extremera, B.G., 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, J.-W., Hart, R., Haworth, D., Henein, S., Henry, D., Her, S.-H., Heyvaert, F., Hollanders, G., Hominal, M., Hong, B.-K., Hong, T.-J., Hwang, K.-K., Jacovides, A., Jacqmein, J., Jeon, H.K., Jones, N., Kanani, S., Kang, H., Karpenko, O., Kenton, D., Kimzey, N., Kovalenko, V., Kushnir, M., Lasko, B., Lee, K.J., 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, R., Petrulioniene, Z., Pettyjohn, F., Piskorz, D., Poss, G., Pudi, K., Pyun, W.B., Raad, G., Raila, G., Ramirez Espinosa, M.F., Ramlachan, P., Rhee, M., Rudenko, L., Ruiz, T.S., Ryan, J., Schacter, G., Shin, J.-H., Short, D., Sica, D., Sirenko, Y., Slapikas, R., Somani, R., Stanislavchuk, M., Stewart, R., Svishchenko, Y., Sychov, O., Teitelbaum, I., Tseluyko, V., Van Rensburg, D.J., Vaquer Perez, J.V., Via, L.M., Vico, M., Vizir, V., Vogel, D., Wellmann, H., Yoo, B.S., DISTINCT Investigators, and [Mancia,G] Unit and Department of Clinical Medicine, University of Milano-Bicocca, IRCCS Istituto Auxologico Italiano, Milan, Italy. [Cha,G] KRK Medical Research Institute, Dallas, TX, USA. [Gil-Extremera,B] Hospital Universitario San Cecilio, Granada, Spain. [Harvey,P] Formerly in The Crouch Oak Family Practice, Addlestone, UK. [Lewin,AJ] National Research Institute, Los Angeles, CA, USA. [Villa,G] Fondazione Salvatore Maugeri—IRCCS, Pavia, Italy. [Kjeldsen,SE] Oslo University Hospital Ullevaal, University of Oslo, Oslo, Norway.

Subjects
Male, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyridines::Dihydropyridines::Nifedipine [Medical Subject Headings], Phenomena and Processes::Physiological Phenomena::Body Constitution::Body Weights and Measures::Body Mass Index [Medical Subject Headings], Tetrazoles, Blood Pressure, DISTINCT study, Índice de masa corporal, 030204 cardiovascular system & hematology, Benzimidazole, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Risk::Risk Factors [Medical Subject Headings], law.invention, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Bencimidazoles, 0302 clinical medicine, Randomized controlled trial, law, Phenomena and Processes::Reproductive and Urinary Physiological Phenomena::Urinary Tract Physiological Phenomena::Glomerular Filtration Rate [Medical Subject Headings], Medicine, Tasa de filtración glomerular, 030212 general & internal medicine, Hipercolesterolemia, Tetrazole, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 2-Ring::Benzimidazoles [Medical Subject Headings], Middle Aged, Calcium Channel Blockers, Presión sanguínea, Humanos, Antihypertensive Agent, Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Aromatic::Benzene Derivatives::Biphenyl Compounds [Medical Subject Headings], Hypertension, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Glucose Metabolism Disorders::Diabetes Mellitus::Diabetes Mellitus, Type 2 [Medical Subject Headings], Compuestos de bifenilo, Diabetes mellitus Tipo 2, Nifedipino, Original Article, Drug Therapy, Combination, Female, Calcium Channel Blocker, Factores de riesgo, medicine.drug, Human, medicine.medical_specialty, Combination therapy, Nifedipine, Subgroup analysis, Placebo, Nifedipine GITS, Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension [Medical Subject Headings], 03 medical and health sciences, candesartan, high blood pressure, Internal medicine, Hipertensión, Phenomena and Processes::Circulatory and Respiratory Physiological Phenomena::Cardiovascular Physiological Phenomena::Hemodynamics::Blood Pressure [Medical Subject Headings], Internal Medicine, Humans, Antihypertensive Agents, business.industry, Biphenyl Compounds, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Lipid Metabolism Disorders::Dyslipidemias::Hyperlipidemias::Hypercholesterolemia [Medical Subject Headings], Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Azoles::Tetrazoles [Medical Subject Headings], Candesartan, Endocrinology, Blood pressure, Benzimidazoles, business, Body mass index
Abstract

none 140 si The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate

Published
2017

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. Fixed-dose combination of nifedipine gastrointestinal therapeutic system and candesartan cilexetil in patients with moderate-to-severe essential hypertension: an open-label, long-term safety and efficacy study.

Author

Kjeldsen, S. E., Dzongowski, P., Li, N., Wang, L., and Radlmaier, A.

Subjects
COMBINATION drug therapy, CLINICAL medicine, DIURETICS, DRUG side effects, HYPERTENSION, ANTIHYPERTENSIVE agents, EVALUATION of medical care, RESEARCH funding, TREATMENT effectiveness, DESCRIPTIVE statistics, PHARMACODYNAMICS
Abstract

What is known and objective The nifedipine gastrointestinal therapeutic system ( GITS)/candesartan cilexetil (N/C) combination was demonstrated to be an effective, well-tolerated antihypertensive therapy in a short-term study. The current study investigated the long-term safety and efficacy of a fixed-dose combination ( FDC) of N/C therapy in moderate-to-severe essential hypertension. Methods A multinational, 70-centre, open-label study of N/C treatment for 28 or 52 weeks at a target dose of N60 mg/C32 mg. The primary assessment included the incidence of treatment-emergent adverse events ( TEAEs). Efficacy assessments included change from baseline in systolic and diastolic blood pressure ( BP). Results and discussion A total of 508 patients were enrolled, with 417 (82·1%) completing week 28 of treatment. Of these, 200 patients continued treatment, as planned, to week 52, with 193 (96·5%) completing this period. At least one TEAE or drug-related TEAE were reported in 76·8% and 45·3% patients up to week 28, and in 80·7% and 46·9% up to week 52/end of study. Most TEAEs and drug-related TEAEs to week 52 (93·9% and 95·4%, respectively) were mild or moderate in intensity. Rates of drug-related serious AEs were low (0·6%). TEAE-related discontinuations occurred in 10% patients before week 28 and in no additional patients thereafter. N/C provided substantial, sustained reductions in mean systolic and diastolic BP from baseline: 30·1 ± 18·4 and 12·8 ± 10·7 mmHg, respectively, at week 52. What is new and conclusions Nifedipine GITS/candesartan cilexetil FDC at the target dose of 60 mg/32 mg was well tolerated for a study duration up to 52 weeks and provided sustained reductions in systolic and diastolic BP. [ABSTRACT FROM AUTHOR]

Published
2016
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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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