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Kimberly Dunbar, PA-S2

Follow-up of Cardiovascular R isk M arkers in Hypertensive P atients T reated with I rbesartan : Results of the i -SEARCH Plus Registry.

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Kimberly Dunbar, PA-S2

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  1. Follow-up of Cardiovascular Risk Markers in Hypertensive Patients Treated with Irbesartan: Results of the i-SEARCH Plus Registry Ulrich Tebbe, MD; Peter Bramlage, MD; Stephan Luders, MD; Alessandro Cuneo, MD; Peter Sistig, PhD; Fokko de Haan, MD; Roland Schmieder, MD; Michael Bohm, MD; W. Dieter Paar, MD; Jochen Schrader, MD The Journal of Clinical Hypertension 12 (2010) 909-916 Kimberly Dunbar, PA-S2

  2. Overview • Biomarkers • Substances found in the blood, body fluid, or tissues that can provide information regarding disease occurrence and prognosis as well as efficacy of treatment

  3. Overview • Microalbuminuria (MAU) • Small amount of albumin excreted in the urine • Normal urinary albumin excretion is <30 mg/day • Defined as 30-300 mg/day • Reliable indicator for end organ damage • Recommended for identifying high-risk patients in hypertension treatment • Presence leads to use of ACE-Is and ARBs, which have shown to have an effect on biomarkers

  4. Overview • Highly sensitive C-reactive protein (hsCRP) • Inflammatory marker for early atherosclerosis • Elevated hsCRP associated with increased risk of CVD • Irbesartan has been shown to decrease levels • Normal: <1 mg/L • Intermediate CVD risk: 1-3 mg/L • High CVD risk: 3-10 mg/L • Systemic inflammation: >10 mg/L

  5. Overview • N-terminal pro-brain natriuretic peptide (NT-proBNP) • preproBNP is cleaved into BNP and inactive NT-proBNP • Normal: <100 pg/mL • Elevated levels indicate ventricular expansion and volume overload • Commonly used to diagnose and evaluate heart failure • Also thought to be an important risk marker in CVD

  6. Objective • To determine risk of total mortality and cardiovascular events in relation to baseline values of MAU, NT-proBNP, and hsCRP • Mortality and cardiovascular events defined as: • Newly diagnosed CAD • Myocardial infarction • Unstable angina pectoris • Stroke/TIA

  7. Design • Prospective study • 1649 patients • 43.2% women, 56.8% men • Arterial hypertension (≥140/90) at baseline • Prescribed Irbesartan • Followed for 12 months

  8. Patients • ≥ 18 years old • No contraindications to Irbesartan alone or with HCTZ (12.5mg) • Exclusion Criteria: • Impaired renal function • Serum creatinine ≥2.0 mg/dL • UTI • Febrile infection • Menstruation • Pregnancy • Drug or alcohol abuse

  9. Details • Mean age of patients at baseline was 61.4±11.3 years • Mean BP at baseline was 159.8±20.1/93.4±11.9 • 46.9% received irbesartan alone • 51.1% received irbesartan/HCTZ 12.5mg • Median biomarkers at baseline • Albumin/Creatinine ratio – 9.9 • hsCRP – 2.46 • NT-proBNP – 89.28

  10. Results • Mean BP at endpoint was 137.6±17.8/83.0±10.3 • MAU positive (≥20 mg/g) at baseline was associated with an increased risk for CV events • CV events at 12 months • Total of 33 • 9 newly diagnosed CAD • 1 MI • 5 stroke/TIA • 5 deaths • 13 hospitalized during follow-up

  11. Results • No influence of hsCRP or NT-proBNP on endpoint • A significant correlation of NT-proBNP with total death was corrected after adjusting for age and presence of MAU

  12. Correlations among risk markers • MAU-positive patients at baseline AND those who developed MAU had higher median values of both hsCRP and NT-proBNP compared to those who developed AND remained MAU-negative

  13. Conclusion • Microalbuminuria is predictive of future cardiovascular events in hypertensive patients despite treatment with angiotensin receptor blockers and is superior to hsCRP and NT-proBNP in predicting cardiovascular risk.

  14. Limitations • Non-randomized open study • Follow-up was only 12 months • No control group

  15. Level of Evidence

  16. References • Tebbe U, Bramlage P, Luders S et al. Follow-up of Cardiovascular Risk Markers in Hypertensive Patients Treated with Irbesartan: Results of the I-SEARCH Plus Registry. The Journal of Clinical Hypertension. 2010; 12: 909-916.

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