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Cardiovascular and renal outcomes with telmisartan, ramipril, or both in people at high renal risk: results from the ONTARGET and TRANSCEND studies.
- Source :
-
Circulation [Circulation] 2011 Mar 15; Vol. 123 (10), pp. 1098-107. Date of Electronic Publication: 2011 Feb 28. - Publication Year :
- 2011
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Abstract
- Background: In the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial (ONTARGET), dual therapy did not reduce cardiovascular or renal outcomes compared with either angiotensin-converting enzyme inhibitors or angiotensin receptor blockers alone. Previous controlled trials with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers have demonstrated greater cardiovascular and renal benefit in people with renal risk. We hypothesized that dual therapy would be more effective than monotherapy in patients with low glomerular filtration rate and elevated albuminuria.<br />Methods and Results: Post hoc analysis was performed of renal subgroups of dual therapy versus monotherapy for the ONTARGET study and angiotensin receptor blocker versus placebo for the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease (TRANSCEND). The studies featured hazard ratios by subgroups and Cox regression models with factors for treatment, subgroup, and interactions. The main cardiovascular outcome was the composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure, and the main renal outcome was the composite of chronic dialysis or doubling of creatinine. In ONTARGET, there was no cardiovascular or renal benefit from dual over monotherapy in any subgroup, even with low glomerular filtration rate and/or elevated albuminuria. In TRANSCEND, in the comparison of angiotensin receptor blocker with placebo, there was a significant interaction for the main renal outcome (P = 0.01) in the direction of harm for patients with normoalbuminuria (0.37 versus 0.16 events per 100 patient-years; hazard ratio, 2.35; confidence interval, 1.33 to 4.15) but a trend to benefit with microalbuminuria (0.52 versus 0.89 events per 100 patient-years; hazard ratio, 0.60; confidence interval, 0.25 to 1.46) and macroalbuminuria (1.57 versus 2.60 events per 100 patient-years; hazard ratio, 0.71; confidence interval, 0.21 to 2.44).<br />Conclusions: This post hoc analysis does not support dual therapy over monotherapy in high-vascular risk patients with low glomerular filtration rate or albuminuria. This observation is a post hoc comparison and should be interpreted appropriately.<br />Clinical Trial Registration: URL: http://clinicaltrials.gov Identifier: NCT00153101.
- Subjects :
- Aged
Albuminuria drug therapy
Albuminuria mortality
Angiotensin Receptor Antagonists adverse effects
Angiotensin-Converting Enzyme Inhibitors adverse effects
Benzimidazoles adverse effects
Benzoates adverse effects
Creatinine blood
Creatinine urine
Drug Therapy, Combination
Female
Glomerular Filtration Rate drug effects
Heart Failure mortality
Heart Rate drug effects
Humans
Kidney Failure, Chronic mortality
Male
Middle Aged
Myocardial Infarction mortality
Ramipril adverse effects
Stroke mortality
Telmisartan
Treatment Outcome
Angiotensin Receptor Antagonists therapeutic use
Angiotensin-Converting Enzyme Inhibitors therapeutic use
Benzimidazoles therapeutic use
Benzoates therapeutic use
Heart Failure drug therapy
Kidney Failure, Chronic drug therapy
Myocardial Infarction drug therapy
Ramipril therapeutic use
Stroke drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4539
- Volume :
- 123
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Circulation
- Publication Type :
- Academic Journal
- Accession number :
- 21357827
- Full Text :
- https://doi.org/10.1161/CIRCULATIONAHA.110.964171