Key result
ACE inhibitors and ARBs equally lower blood pressure in metabolic syndrome or diabetes.
Why the study?
The MEDINA study aimed to determine whether ACE inhibitors have advantages over ARBs, the optimal combination drug (diuretic or CCB), and the risk reduction by statin coadministration in hypertensive patients with metabolic syndrome and/or diabetes mellitus.
Does an ACE-I based strategy compared to an ARB based strategy improve blood pressure and metabolic parameters in hypertensive patients with metabolic syndrome and/or diabetes mellitus?
RCT (n=439)
Open-label, single-blind (PROBE)
Randomized
Does an ACE-I based strategy compared to an ARB based strategy improve blood pressure and metabolic parameters in hypertensive patients with metabolic syndrome and/or diabetes mellitus?
Absolute Event Rate: 24.1% vs 25.9%
p-value: p=0.706
ACE inhibitors and ARBs demonstrate equivalent efficacy in reducing blood pressure in hypertensive patients with metabolic syndrome or diabetes.
Equivalence of ACE-I/ARB and diuretic/CCB confirmed without metabolic differences; reinforces consensus but leaves open need for larger outcome trials.
AIMS: The primary questions asked by the MEDINA (MEtabolic parameters, DIabetes mellitus and NephropAthy) study are: 1) Do angiotensin converting enzyme inhibitors (ACE-I) have any advantages over angiotensin receptor blockers (ARB)? 2) Should the other drug for combination be a diuretic or a calcium-channel blocker (CCB)? 3) How are the risks reduced by the co administration of a statin? METHODS: A total of 439 hypertensive patients with metabolic syndrome and/or diabetes mellitus were randomized to 2 groups: group 1--ramipril (ACE-I) or perindopril and group 2--losartan (ARB). Hydrochlorothiazide (diuretic) or amlodipine (CCB) were added to both groups. As a third step, a statin was added. RESULTS: Blood pressure decreased 24.1/13.3 mmHg in the ACE inhibitor group and 25.9/13.5 in the losartan group. The difference was insignificant. Adding either hydrochlorothiazide or amlodipin was equally effective. There were no significant differences on metabolic parameters in the trial arms. Cholesterol level decreased by 0.95 mmol/L in the ACE-I group and 1.02 mmol/L in the ARB group (ns). CONCLUSION: MEDINA has so far confirmed the equivalence of ACE-I and ARB in hypertension treatment. Adding either diuretic or CCB was equally effective. Our data support the current recommendations on adding a statin to reduce cardiovascular risk.
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Špinar et al. (2013) conducted an RCT in Hypertension with metabolic syndrome and/or diabetes mellitus (n=439). ACE inhibitors (ramipril or perindopril) vs. Angiotensin receptor blocker (losartan 50-100 mg) was evaluated on Decrease in systolic blood pressure at 12 months (p=0.706). ACE inhibitors and angiotensin receptor blockers were equally effective in reducing blood pressure (decrease of 24.1/13.3 mmHg vs 25.9/13.5 mmHg) in hypertensive patients with metabolic syndrome or diabetes mellitus.
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