Nifedipine prevented carotid intima-media thickness progression compared to co-amilozide in hypertensive patients completing follow-up (P=0.002), though the intent-to-treat difference was P=0.09.
RCT (n=439)
randomized
Yes
Does nifedipine prevent carotid IMT progression compared to co-amilozide in hypertensive patients?
Nifedipine prevents the progression of carotid intima-media thickness compared to co-amilozide in hypertensive patients, despite similar blood pressure reductions.
p-value: p=0.09 (intent-to-treat); 0.002 (until-end-of-study)
BACKGROUND: Common carotid artery intima-media thickness (IMT) progression was compared between 4 years of treatment with nifedipine and diuretic. METHODS AND RESULTS: This study, ancillary to the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT), involved nifedipine 30 mg or co-amilozide (hydrochlorothiazide 25 mg and amiloride 2.5 mg) with optional subsequent titration. Among 439 randomized hypertensive patients, 324 had >/=1 year of follow-up (intent-to-treat group), and 242 completed follow-up (until-end-of-study group). Ultrasonography was performed at baseline, 4 months later, and then every year. Central computerized reading provided far-wall IMT, diameter, and cross-sectional area IMT (CSA-IMT). The primary outcome was IMT progression rate (slope of IMT-time regression). Secondary outcomes were changes from baseline (Delta) in IMT, diameter, and CSA-IMT. In the until-end-of-study population, between-treatment differences existed in IMT progression rate (P=0.002), Delta IMT (P=0.001), and Delta CSA-IMT (P=0.006), because IMT progressed on co-amilozide but not on nifedipine. In the intent-to-treat population, treatment differences existed in Delta IMT (P=0.004) and Delta CSA-IMT (P=0.04) but not in IMT progression rate (P=0.09). Patients with >/=2, 3, or 4 years of follow-up showed treatment differences in IMT progression rate (P=0.04, 0.004, 0.007, respectively), Delta IMT (P=0.005, 0.001, 0.005), and Delta CSA-IMT (P=0.025, 0.013, 0.015). Diameter decreased more on co-amilozide than on nifedipine in the intent-to-treat population (P<0.05), whereas blood pressure decreased similarly on both treatments. CONCLUSIONS: A difference in early carotid wall changes is shown between 2 equally effective antihypertensive treatments.
Simon et al. (Tue,) conducted a rct in Hypertension (n=439). Nifedipine vs. Co-amilozide (hydrochlorothiazide 25 mg and amiloride 2.5 mg) was evaluated on IMT progression rate (slope of IMT-time regression) (p=0.09 (intent-to-treat); 0.002 (until-end-of-study)). Nifedipine prevented carotid intima-media thickness progression compared to co-amilozide in hypertensive patients completing follow-up (P=0.002), though the intent-to-treat difference was P=0.09.