Valsartan, Captopril, or Both in Myocardial Infarction Complicated by Heart Failure, Left Ventricular Dysfunction, or Both

Pfeffer, Marc A.; McMurray, John J.V.; Velázquez, Eric J.; Rouleau, Jean‐Lucien; Køber, Lars; Maggioni, Aldo P.; Solomon, Scott D.; Swedberg, Karl; Werf, Frans Van de; White, Harvey D.; Leimberger, Jeffrey D.; Henis, Marc; Edwards, Susan; Zelenkofske, Steven L.; Sellers, Mary Ann; Califf, Robert M.

doi:10.1056/nejmoa032292

Cited by 2,163 publications

(1,221 citation statements)

References 29 publications

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“…Valsartan was selected because it is the only ARB agent that has been proven to have equivalent clinical efficacy as an ACE inhibitor in post‐MI patients 5. The results of the present study show that the maximal tolerated dose of the drug did not offer a greater benefit in terms of reducing ventricular size or improving function compared with low‐dose therapy in the study population.…”

Section: Discussionmentioning

confidence: 69%

“…Although current recommendations are based on large‐scale post‐MI trials, the issue of optimal dosing or intensity of angiotensin antagonism has not been directly addressed in those trials. In the VALIANT trial, intensification of therapy via combining ACE inhibitors and ARB has not produced improved clinical outcomes compared with treatment with the target dose recommended in the current guidelines 5. VALIANT clinical results have been mirrored in the VALIANT ECHO study, where combination therapy was not superior to either therapy alone in preserving or improving ventricular size and function after MI 15.…”

Section: Discussionmentioning

confidence: 99%

“…This may be in part responsible for the tendency of favourable change in echocardiographic parameters in the low‐dose group shown in the present study, although it was not statistically significant. But the issue of adverse effect of intensive renin–angiotensin system (RAS) blockade in the presence of beta‐adrenergic blockers is still debatable, because such a finding was not replicated in the larger VALIANT study 5. Another factor may be related to the valsartan dose consumed by the study population.…”

Section: Discussionmentioning

confidence: 99%

“…On the other hand, the doses taken in the maximal‐tolerated‐dose group patients were smaller than those given to the patients' Western counterparts. The mean daily dose in the maximal‐tolerated‐dose group was 196.2 mg/day, with 32% of subjects taking the target dose, as compared with 247 mg/day and 56% taking the target dose in the VALIANT subgroup 5. Although those dosages may still represent the maximal tolerated dose in the Asian population and are 2.5 times greater than the amount given to the low‐dose group, it is possible that the higher doses did not produce as much of a difference in receptor antagonism because of the flatter slope of the dose–effect curve of valsartan in the higher dosage range 22.…”

Section: Discussionmentioning

confidence: 99%

“…Owing to a lack of relevant data in the Asian population, a sample size calculation was performed based on the data from the Valsartan in Acute Myocardial Infarction Trial (VALIANT); the analysis showed that 600 patients were necessary to detect, with 90% power, a 7.6 mL difference in LVEDV between the treatment groups 5. Because the present study enrolled patients with milder LV dysfunction, 279 patients in the low‐dose group and 558 patients in the maximal‐tolerated‐dose valsartan group were required to detect smaller differences in end‐diastolic volume (3.8 mL, two‐sided level of significance α = 5%, and power of 1 − β = 90%) between treatment groups.…”

Section: Methodsmentioning

confidence: 99%

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The impact of a dose of the angiotensin receptor blocker valsartan on post‐myocardial infarction ventricular remodelling

Park

Kim

et al. 2018

ESC Heart Failure

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AimsAlthough clinical guidelines advocate the use of the highest tolerated dose of angiotensin‐converting enzyme inhibitors or angiotensin receptor blockers after acute myocardial infarction (MI), the optimal dosing or the risk–benefit profile of different doses have not been fully identified.Methods and resultsIn this multicentre trial, 495 Korean patients with acute ST segment elevation MI and subnormal left ventricular (LV) ejection fraction (<50%) were randomly allocated (2:1) to receive maximal tolerated dose of valsartan (titrated up to 320 mg/day, n = 333) or low‐dose valsartan (80 mg/day, n = 162) treatment. The primary objective was to assess the changes in echocardiographic parameters of LV remodelling from baseline to 12 months after discharge. After treatment, end‐diastolic LV volume (LVEDV) decreased significantly in the low‐dose group, but the difference in LVEDV changes was insignificant between the maximal‐tolerated‐dose and low‐dose groups. End‐systolic LV volume decreased significantly in both groups, to a similar degree between groups. LV ejection fraction rose significantly in both study groups, to a similar degree. Changes in plasma levels of neurohormones were also comparable between the two groups. Drug‐related adverse effects occurred more frequently in the maximal‐tolerated‐dose group than in the low‐dose group (7.96 vs. 0.69%, P < 0.001).ConclusionsIn the present study, treatment with the maximal tolerated dose of valsartan did not exhibit a superior effect on post‐MI LV remodelling compared with low‐dose treatment and was associated with a greater frequency of adverse effect in Korean patients. Further study with a sufficient number of cases and statistical power is warranted to verify the findings of the present study.

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Section: Discussionmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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The impact of a dose of the angiotensin receptor blocker valsartan on post‐myocardial infarction ventricular remodelling

Park

Kim

et al. 2018

ESC Heart Failure

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Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Toh¹,

Reichman²,

Houstoun³

et al. 2012

Arch Intern Med

180

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Background: Although certain drugs that target the renin-angiotensin-aldosterone system are linked to an increased risk for angioedema, data on their absolute and comparative risks are limited. We assessed the risk for angioedema associated with the use of angiotensinconverting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), and the direct renin inhibitor aliskiren.Methods: We conducted a retrospective, observational, inception cohort study of patients 18 years or older from 17 health plans participating in the Mini-Sentinel program who had initiated the use of an ACEI (n=1 845 138), an ARB (n=467 313), aliskiren (n=4867), or a ␤-blocker (n = 1 592 278) between January 1, 2001, and December 31, 2010. We calculated the cumulative incidence and incidence rate of angioedema during a maximal 365-day follow-up period. Using ␤-blockers as a reference and a propensity score approach, we estimated the hazard ratios of angioedema separately for ACEIs, ARBs, and aliskiren, adjusting for age, sex, history of allergic reactions, diabetes mellitus, heart failure, or ischemic heart disease, and the use of prescription nonsteroidal antiinflammatory drugs.Results: A total of 4511 angioedema events (3301 for ACEIs, 288 for ARBs, 7 for aliskiren, and 915 for ␤-blockers) were observed during the follow-up period. The cumulative incidences per 1000 persons were 1.79 (95% CI, 1.73-1.85) cases for ACEIs, 0.62 (95% CI, 0.55-0.69) cases for ARBs, 1.44 (95% CI, 0.58-2.96) cases for aliskiren, and 0.58 (95% CI, 0.54-0.61) cases for ␤-blockers. The incidence rates per 1000 person-years were 4.38 (95% CI, 4.24-4.54) cases for ACEIs, 1.66 (95% CI, 1.47-1.86) cases for ARBs, 4.67 (95% CI, 1.88-9.63) cases for aliskiren, and 1.67 (95% CI, 1.56-1.78) cases for ␤-blockers. Compared with the use of ␤-blockers, the adjusted hazard ratios were 3.04 (95% CI, 2.81-3.27) for ACEIs, 1.16 (95% CI, 1.00-1.34) for ARBs, and 2.85 (95% CI, 1.34-6.04) for aliskiren.Conclusions: Compared with ␤-blockers, ACEIs or aliskiren was associated with an approximately 3-fold higher risk for angioedema, although the number of exposed events for aliskiren was small. The risk for angioedema was lower with ARBs than with ACEIs or aliskiren.

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Left Ventricular Assessment in Myocardial Infarction

Hernandez¹,

Velázquez²,

Solomon³

et al. 2005

Arch Intern Med

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Valsartan, Captopril, or Both in Myocardial Infarction Complicated by Heart Failure, Left Ventricular Dysfunction, or Both

Cited by 2,163 publications

References 29 publications

The impact of a dose of the angiotensin receptor blocker valsartan on post‐myocardial infarction ventricular remodelling

The impact of a dose of the angiotensin receptor blocker valsartan on post‐myocardial infarction ventricular remodelling

Comparative Risk for Angioedema Associated With the Use of Drugs That Target the Renin-Angiotensin-Aldosterone System

Left Ventricular Assessment in Myocardial Infarction

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