Key result
Nifedipine GITS plus candesartan improves blood pressure reduction and control over monotherapy in high-risk hypertension.
Why the study?
The DISTINCT study aimed to evaluate the blood pressure-lowering efficacy and safety of nifedipine GITS/candesartan cilexetil combinations versus monotherapies and placebo in high-risk hypertensive patients.
Does nifedipine/candesartan combination therapy improve blood pressure reduction compared to monotherapy or placebo in high-risk patients with hypertension?
RCT (n=1,381)
Double-blind
Equal ratios
Yes
Does nifedipine/candesartan combination therapy improve blood pressure reduction compared to monotherapy or placebo in high-risk patients with hypertension?
Nifedipine/candesartan combination therapy provides superior blood pressure reduction and control with fewer vasodilatory side effects compared to monotherapy in high-risk hypertensive patients.
Subgroup BP reductions with combinations appear consistent in high-risk hypertension; leaves open dedicated outcome trials in renal impairment and diabetes.
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<90 ml min −1 , n =422), type 2 diabetes mellitus ( n =202), hypercholesterolaemia ( n =206) and cardiovascular (CV) risk factors ( n =971), as well as the impact of gender, age and body mass index (BMI). Participants with grade I/II hypertension were randomised to treatment with nifedipine GITS (N) 20, 30, 60 mg and/or candesartan cilexetil (C) 4, 8, 16, 32 mg or placebo for 8 weeks. Mean systolic BP and diastolic BP reductions after treatment in high-risk participants were greater, overall, with N/C combinations vs respective monotherapies or placebo, with indicators of a dose–response effect. Highest rates of BP control (ESH/ESC 2013 guideline criteria) were also achieved with highest doses of N/C combinations in each high-risk subgroup. The benefits of combination therapy vs monotherapy were additionally observed in patient subgroups categorised by gender, age or BMI. All high-risk participants reported fewer vasodilatory adverse events in the pooled N/C combination therapy than the N monotherapy group. In conclusion, consistent with the DISTINCT main study outcomes, high-risk participants showed greater reductions in BP and higher control rates with N/C combinations compared with respective monotherapies and lesser vasodilatory side-effects compared with N monotherapy.
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Mancia et al. (2016) conducted an RCT in Hypertension (n=1,381). Nifedipine GITS and candesartan cilexetil combination vs. Nifedipine GITS monotherapy, candesartan cilexetil monotherapy, or placebo was evaluated on Change from baseline in mean seated systolic and diastolic blood pressure at 8 weeks. Nifedipine GITS/candesartan cilexetil combinations provided greater blood pressure reductions and higher control rates compared with respective monotherapies or placebo in high-risk hypertensive patients.
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