Valsartan Single-Pill Combination Versus Other Single-Pill Combinations for Hypertension

Abstracts / Journal of the American Society of Hypertension 10(S1) (2016) e1–e9 or >160 mg/dl for LDL. In total, 140,000 workers underwent screening tests, and 49,214 showed elevation in one of the three items. For each of the examinees, clinical records (so-called ‘receipt’, a type of invoice from clinical facilities to health-insurance systems for clinical service) were examined to elucidate if the subject with elevated values subsequently had detailed examinations in clinical facilities. Results: With regard to hypertension, high blood pressure was detected in 11,954 subjects and 1412 cases visited clinical facilities for detailed examination (12.7%). In cases of FBG, the FBG values were elevated in 1,697 cases and 437 subjects (25.7%) had detailed health examinations. LDL levels exceeded the criteria in 36,263 cases, and 2,425 subjects among them (9.4%) had detailed health examinations. The break-down by age and sex is summarized in Table 1. Conclusion: These results show that many people did not visit clinics for further medical examinations even when they were informed of possible unhealthy situations in screening tests. We have to more positively advise the people to have further medical examinations and possible clinical treatments in case screening medical check-up suggests unhealthy conditions. Keywords: Hypertension, Health check, Further examination, Clinic CLINICAL TRIALS IN HYPERTENSION AND RELATED MORBIDITIES Non-Pharmacological Therapy

LB-P-14 RDN in Hypertensives: Results from a Novel Anatomical Approach F. Cagnoni,1 P. Sganzerla,2 E. Bontempelli,1 A. Belotti Masserini,1 C. Cavalleri,1 P. Negrini,2 G. Maccagni,3 M. Destro.1 1Medical Science, ASST Bergamo Ovest, Treviglio, Italy; 2Cardiology Ward and Cath Lab, ASST Bergamo Ovest, Treviglio, Italy; 3Sport Medicine, Minerva Medica Sport Medicine Center, Cassano D’Adda, Italy Background: Renal sympathetic denervation (RDN) has been largely studied and it is considered as one of the last possibility to cure refractory and resistant hypertension. Unfortunately the inadequate knowledge of the nerves distribution on the wall of renal artery modify the outcomes of the procedures, as much as the experience of the operators do. Purpose: Previous indications advised to perform 4-8 ablation distributed along the length and circumference of main trunk of renal artery. Recent studies show that the number of fibers available for denervation is small in proximal but high in the distal part of the renal artery. Our aim was to assess whether also in clinical practice there were differences in the outcomes performing ablations at those two different levels. Method: 12 consecutive patients with resistant hypertension were included. The first 5 were treated with Medtronic Symplicity unipolar

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catheter (n ¼ 5); for the last 7 patients, the multi-electrode catheter by Medtronic was used (n ¼ 7). The first group was treated with 4 to 5 ablation points for artery in the main trunk only (Group A). The second group was treated with 10 to 14 ablation points for each side distributed among the main artery plus the branches (if diameter > 3 mm) (Group B). Office BP and ABPM was measured at baseline, 1, 3, 6 and 12 months after RDN. Results: Office and 24-hours SBP and DBP decreased at 1, 3, 6 and 12 months in all 12 patients. While office SBP decreased in Group A likewise in the Group B (-24 and -22 mmHg, respectively), the reduction in office DBP was stronger in Group B than Group A (-23 vs -14 mmHg). Similarly, Group B 24-hours SBP and DBP values decreased more than in Group A (A: -12/-6, B: -19/-10, mmHg; Figure A). Conclusion: Our data confirm that ablation in both main trunk and distal branch of the artery is more effective to reduce BP in real life as seen in controlled Studies. Keywords: resistant hypertension, renal denervation, ablation ENDOTHELIAL FUNCTION LB-P-15 Prenatal Lipopolysaccharide Exposure Causes Mesenteric Vascular Dysfunction Through NO-cGMP Pathway in Offspring X. Wang,1 J. Wang,1 P.A. Jose,2 C. Zeng.1 1Cardiology, The Third Military Medical University, Chongqing, China; 2Medicine, The George Washington University, Washington, DC Cardiovascular diseases, such as hypertension, could be programmed in fetal life. Prenatal lipopolysaccharide (LPS) exposure in utero results in increased blood pressure in the offspring, but the vascular mechanisms involved are unclear. Pregnant Sprague-Dawley (SD) rats were intraperitoneally injected with LPS (0.79 mg/kg, 0.5 ml) or saline (0.5 ml) on gestation days 8, 10, and 12. The offspring of LPS-treated dams had increased blood pressure and decreased acetylcholine (ACh)-induced relaxation and increased phenylephrine (PE)-induced contraction in endothelium-intact mesenteric arteries. Endothelium removal significantly enhanced the PE-induced contraction in offspring of control but not LPS-treated dams. The arteries pretreated with L-NAME to inhibit nitric oxide synthase (eNOS) in the endothelium or ODQ to inhibit cGMP production in the vascular smooth muscle, had attenuated ACh-induced relaxation but augmented PE-induced contraction in arteries from offspring of control dams, relative to those from LPStreated dams. In addition, the endothelium-independent relaxation caused by sodium nitroprusside (SNP) was also decreased in arteries from offspring of LPS-treated dams. The functional results were accompanied by a reduction in the expressions of eNOS and soluble guanylate cyclase (sGC) and production of NO and cGMP in arteries from offspring of LPS-treated dams. Furthermore, LPS-treated dam’s offspring arteries had increased oxidative stress and decreased antioxidant capacity. Three-week treatment with TEMPOL, a reactive oxygen species (ROS) scavenger, normalized the alterations in the levels of ROS, eNOS, and sGC, as well as in the production of NO and cGMP and vascular function in the arteries of the offspring of LPS-treated dams. In conclusion, prenatal LPS exposure programs vascular dysfunction of mesenteric arteries through increased oxidative stress and impaired NOcGMP signaling pathway. Keywords: hypertension, fetal programming, endothelium, nitric oxide OBESITY AND HYPERTENSION LB-P-16

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Additivity of Nebivolol/Valsartan Single-Pill Combination Versus Other Single-Pill Combinations for Hypertension J. Ishak,1 M. Rael,2 H. Punzi,3 A. Gradman,4 M. Patel,5 S. Ali,5 W. Ferguson,5 J. Neutel.6 1Evidera, Montreal, QC, Canada; 2Evidera, San Francisco, CA; 3UT Southwestern Medical Center, Carrollton, TX; 4 Temple University School of Medicine, Philadelphia, PA; 5Allergan plc, Jersey City, NJ; 6Orange County Research Center, Tustin, CA

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Abstracts / Journal of the American Society of Hypertension 10(S1) (2016) e1–e9 SPCs versus several comparators. Both components had a substantial contribution to the overall additivity. Additivity measures were generally stable across subpopulations. In conclusion, the additivity of nebivolol/valsartan SPCs is comparable to the additivity of other SPCs for hypertension. Funding: Allergan plc. Keywords: Hypertension, Nebivolol, Valsartan, Single-pill combinations CLINICAL TRIALS IN HYPERTENSION AND RELATED MORBIDITIES LB-P-17 Systolic Blood Pressure as a Novel Determinant of Nocturia in NonHispanic Black Men O.R. Mason,1 K. Lynch,1 M. Rashid,1 A. Reid,1 R.M. Elashoff,2 R.G. Victor.1 1Heart Institute, Hypertension Center, Cedars-Sinai Medical Center, Los Angeles, CA; 2Department of Biomathematics, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA

Figure. Placebo-adjusted ration score for mean seated systolic and diastolic BP.

Better efficacy and/or tolerability are achieved when combining two antihypertensive drugs versus doubling the monotherapy dose. The blood-pressure (BP) lowering effect of single-pill combinations (SPCs) of nebivolol—a well-tolerated b1 selective adrenergic blocker with vasodilatory properties via b3 agonism—and valsartan, an angiotensin receptor blocker, is the only SPC of these two pharmacological classes to demonstrate a greater therapeutic effect than either monotherapy component. The objective of this analysis is to compare the additive effects (or additivity score) of nebivolol/valsartan SPCs to other SPCs for hypertension. Additivity was quantified as the ratio of incremental (ie, placebo-adjusted) reduction in seated systolic and diastolic BP with an SPC to the sum of incremental reductions with monotherapy components. Several doses of 6 approved SPCs for hypertension were identified for a total of 18 SPC comparators. Using the Drugs@FDA website, data were abstracted to calculate an additivity score for each comparator, and a weighted average additivity score for the comparators was calculated. Efficacy data for 4 nebivolol/valsartan SPCs (nebivolol 5 mg/valsartan 80 mg, 5/160, 10/160, 10/320) were taken from the phase 3 trial (NCT01508026), and subpopulation results were used to assess whether additivity varies by patient characteristics. The additivity of nebivolol/valsartan SPCs was not statistically different from the weighted average of comparator SPCs for both SBP and DBP (Figure), with numerically greater additivity for nebivolol/valsartan

Nocturia (awakening one or more times at night to urinate) has been associated with hypertension and non-Hispanic black race/ethnicity in a small number of previous studies none of which actually measured blood pressure (BP). To determine if systolic or diastolic BP, or both, are independent determinants of nocturia, in 2,011 black men 35 to 79 years of age being screened in their barbershops for participation in an on-going barbershopbased hypertension intervention trial in Los Angeles (ClinicalTrials.gov Identifier NCT 02321618), professional field interviewers both: a) obtained accurate measures of BP with a highly rated oscillometric monitor (Mindray Accutor V) that took 5 successive readings and averaged the last 3, and b) administered an in-person computer-assisted health questionnaire that included structured response items on nocturia and its known determinants. The men had a mean age of 52  11 (SD) years and 995 men (49%) had hypertension; of these, 32% were untreated (with BP medication) and another 27% were treated but uncontrolled (BP>140/90 mmHg). The overall prevalence of any nocturia was high: 77%, ranging from 69% of normotensive men (n¼355, mean BP 112/68) to 91% of men with treated but uncontrolled hypertension (n¼272, mean BP 151/89 mmHg). In stepwise multivariable logistic regression models that accounted for age, diabetes, history of enlarged prostate, and current treatment with BP medication, systolic BP but not diastolic BP was found to be an independent determinant of nocturia: for every 10 mmHg increase in systolic BP, the odds of having any nocturia increased by 13%, adjusted odds ratio (aOR) and 95% confidence interval (CI), 1.13, [1.05-1.21] and the odds of having severe nocturia (3 or more episodes per night, which was present in 17% of the sample) increased by 24% (aOR [95% CI], 1.24 [1.12-1.38]). The effect associated with each 10 mmHg increase in systolic BP was similar to that with each 10 year increase in age. In conclusion, this study of a large unselected community based-sample of middle-aged and older non-Hispanic black men provides the first evidence that systolic BP constitutes an independent and relatively potent determinant of nocturia. Prospective studies are underway to determine if nocturia—and thus sleep quality, and quality of life—improve with effective management of systolic hypertension. Funding: R01/3R01HL117383. Keywords: Hypertension, Nocturia, Non-Hispanic Black Men

EPIDEMIOLOGY/SPECIAL POPULATIONS LB-P-18 Prevalence of Eligibility Criteria for the Systolic Blood Pressure Intervention Trial in US Adults Among Excluded Groups: Age <50 Years, Diabetes, or a History of Stroke A. Bress,1 R.M. Tanner,2 R. Hess,3 S.S. Gidding,4 L.D. Colantonio,2 D. Shimbo,5 P. Muntner.2 1Pharmacotherapy, University of Utah, Salt Lake City, UT; 2Epidemiology, University of Alabama at Birmingham,