Journal of Hypertension

Skip Navigation LinksHome > December 2014 - Volume 32 - Issue 12 > Nifedipine plus candesartan combination increases blood pres...
Journal of Hypertension:
doi: 10.1097/HJH.0000000000000331
ORIGINAL PAPERS: Therapeutic aspects

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

Kjeldsen, Sverre E.a; Sica, Domenicb; Haller, Hermannc; Cha, Gloriad; Gil-Extremera, Blase; Harvey, Peterf; Heyvaert, Frankg; Lewin, Andrew J.h; Villa, Giuseppei; Mancia, Giuseppej; for the DISTINCT Investigators

Open Access
Supplemental Author Material
Collapse Box


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 < 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/–16.5 mmHg; 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.

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins


Article Tools


Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.