Economic evaluation of a single-pill triple antihypertensive therapy with valsartan, amlodipine, and hydrochlorothiazide against its dual components.

The aim of this study was to compare the cost-utility of the first available single-pill triple combination antihypertensive therapy containing valsartan (V), amlodipine (A) and hydrochlorothiazide (H), with each of the same components dual combinations in patients with moderate to severe hypertension. A Markov model with eight health states was constructed. The short-term effect of antihypertensive treatment on blood pressure was extrapolated through the Hellenic SCORE and Framingham risk equations, estimating the long-term survival and quality-adjusted life-years (QALYs) saved. Costs and outcomes were evaluated over lifetime, divided into annual cycles and discounted at 3.0 % with 2013 as reference year. The analysis was conducted by the Greek third-party-payer perspective. The triple combination treatment cost was estimated at €16,525 compared to €15,480 for V/A, €14,125 for V/H and €11,690 for A/H. The QALYs saved with the triple combination were 12.76 vs. 12.64, 12.61 and 12.38 for double combinations respectively. The incremental cost-effectiveness ratio of the triple combination versus V/A and A/H was far lower than the Greek GDP per capita (€8,690/QALY and €12,695/QALY, respectively) and really close for V/H (€16,192/QALY), suggesting V/A/H combination to be cost-effective. Extensive sensitivity analyses confirmed the robustness of the results. The probability that the triple combination is cost effective was more than 90 % at a willingness-to-pay threshold of €18,000/QALY. This is the first study to evaluate the cost-utility of a single-pill triple combination. The single-pill V/A/H therapy is a cost-effective antihypertensive choice for the treatment of moderate to severe hypertension, compared to its dual components.

Observational study assessing demographic, economic and clinical factors associated with access and utilization of health care services of patients with multiple sclerosis under treatment with interferon beta-1b (EXTAVIA).

Multiple sclerosis (MS) results in an extensive use of the health care system, even within the first years of diagnosis. The effectiveness and accessibility of the health care system may affect patients' quality of life. The aim of the present study was to evaluate the health care resource use of MS patients under interferon beta-1b (EXTAVIA) treatment in Greece, the demographic or clinical factors that may affect this use and also patient satisfaction with the health care system. Structured interviews were conducted for data collection. In total, 204 patients (74.02% females, mean age (SD) 43.58 (11.42) years) were enrolled in the study. Analysis of the reported data revealed that during the previous year patients made extensive use of health services in particular neurologists (71.08% visited neurologists in public hospitals, 66.67% in private offices and 48.53% in insurance institutes) and physiotherapists. However, the majority of the patients (52.45%) chose as their treating doctor private practice neurologists, which may reflect accessibility barriers or low quality health services in the public health system. Patients seemed to be generally satisfied with the received health care, support and information on MS (84.81% were satisfied from the information provided to them). Patients' health status (as denoted by disease duration, disability status and hospitalization needs) and insurance institute were found to influence their visits to neurologists. Good adherence (up to 70.1%) to the study medication was reported. Patients' feedback on currently provided health services could direct these services towards the patients' expectations.

Plasma brain natriuretic peptide: a biochemical marker of effective blood pressure management?

OBJECTIVE: To investigate plasma brain natriuretic peptide (BNP) concentrations in association with blood pressure (BP) at baseline and after antihypertensive drug treatment. PATIENTS AND METHODS: We prospectively examined 186 individuals with newly diagnosed essential hypertension without target organ damage, whose mean age was 48.7 +/- 10.9 years. Treatment initiation began with irbesartan 150 mg/day and was doubled at 4 weeks in cases of inadequate BP control. If indicated, at 8-week-follow-up hydrochlorothiazide 12.5 mg alone or with amlodipine 5-10 mg was added. BNP levels were measured at baseline and after 3 months of antihypertensive treatment. RESULTS: At baseline plasma BNP levels were found to be related to systolic BP (r = 0.27, P < 0.001), independent of age, sex, smoking status, BMI and left ventricular mass index estimated by echocardiography (beta = 11.81, SE = 3.82, P = 0.002). Additionally, higher BNP concentrations were observed in patients with stage 2 hypertension compared with those with stage 1 (median 38.9 vs. 29.9 pg/ml, P = 0.022). Multivariate analysis showed a positive association between BNP and systolic BP variability (beta = 0.03, SE = 0.01, P = 0.034). At follow-up, 64.7% of the participants who had achieved BP control showed decreased BNP levels in contrast to those with poor BP control (median change -14.5 vs. -1.3 and median range from -34.4 to -4.4 vs. -9.6 to 10.9, respectively, P < 0.001). CONCLUSION: In this hypertensive population, increased BNP concentrations are associated with higher BP levels and systolic BP variability. The fall of BNP observed in those who achieved BP control indicates that BNP could be used as a biochemical marker of effective BP control and target organ protection.

Metabolic syndrome and incident cardiovascular morbidity and mortality in a Mediterranean hypertensive population.

BACKGROUND: Although the metabolic syndrome (MetS) is associated with adverse cardiovascular disease (CVD) risk in the general population, it is not clear whether its existence is independently associated with CVD in hypertensives. We investigated the presence of MetS in subjects with hypertension and its impact on the incidence of CVD. METHODS: We prospectively investigated 1007 hypertensive individuals. The MetS was assessed using the National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) criteria. The incidence of fatal and nonfatal cardiovascular events was ascertained during a median follow-up period of 2.1 years. RESULTS: The prevalence of MetS was 42.1% (39.0% in men and 44.7% in women). In addition to hypertension, four MetS components were present in 3.6% of the individuals, three in 13.7%, two in 24.8%, and only one in 33.7%. The incidence of cardiac, cerebrovascular, and total cardiovascular events/1000 person-years was higher among MetS subjects than among those without (31.0% v 21.3%, P = .050, 25.5% v 13.7%, P = .045, and 55.4% v 35.8% P = .009, respectively). After adjustment, MetS subjects had higher risk for cardiac, cerebrovascular, and total cardiovascular events (by 72%, 90%, and 75%, respectively). Hypertensive subjects with three or more components of MetS had threefold higher risk for cardiac events, 2.59 for cerebrovascular, and 2.26 for total cardiovascular events compared with those with no other component. CONCLUSIONS: The MetS is a significant predictor of cardiovascular morbidity and mortality. The clustering of three or more components of the syndrome in addition to hypertension recognizes a population of even higher cardiovascular risk independently of other traditional risk factors.

Insulin resistance and blood pressure circadian variation in an obese hypertensive population.

Insulin resistance (IR) is related to arterial hypertension and target organ damage. Hypertensive individuals exhibiting a diminished nocturnal blood pressure (BP) reduction (non-dippers) have an increased incidence of cardiovascular events. The association, however, of IR with BP circadian variation has not been evaluated so far. Therefore, this study examined 226 (116 male and 110 female) overweight and obese subjects (BMI > 27kg/m2) with newly diagnosed essential hypertension who underwent clinical and laboratory evaluation, including an oral glucose tolerance test and ambulatory BP measurement (ABPM). IR was estimated using the homeostasis model assessment (HOMA-IR). The population was grouped according to HOMA-IR values > 2.75 (insulin resistance type) or < 2.75 (insulin sensitive type). Results. No significant differences were observed between dippers (n = 137) and non-dippers (n = 89) with respect to age, gender, BMI, serum cholesterol, triglycerides, LDL-C, and HDL-C levels, nor smoking habits. The proportion of IR subjects among dippers (59.1%) and non-dippers (56.7%) was similar (p = 0.833). Moreover, no significant association was found when the HOMA-IR was examined as a continuous component (p = 0.96). Conclusions. Insulin resistance is not associated with nocturnal blood pressure reduction in obese hypertensives. This may be explained by the notion that insulin secretion does not follow a circadian mode of variation.

Intermediate postchallenge hyperglycemia in overweight and obese subjects: a new marker of impaired glucose regulation?

The objective of this study was to compare subjects with intermediate postchallenge hyperglycemia (INPH) to those with normal glycemic status, impaired fasting glucose (IFG), and/or impaired glucose tolerance (IGT), as well as type 2 diabetes mellitus. Furthermore, the authors evaluated the impact of INPH on target organ damage. In total, 487 overweight and obese adults (BMI > or =27 kg/m(2)), 252 men and 235 women, mean age 52.9 +/-10.2 years, were studied. All participants underwent a clinical and laboratory evaluation, as well as an oral glucose tolerance test (OGTT). They were also investigated by echocardiography, carotid ultrasonography, and pulse wave analysis. Overall, 302 (62%) subjects had normal glycemic status, 64 (13.1%) had IFG and/or IGT, 95 (19.5%) had type 2 diabetes mellitus, and 26 (5.4%) had INPH. Individuals with INPH had an increased index of insulin resistance (higher homeostasis model assessment-insulinogenic index [HOMA-IR], p<0.0001), impaired insulin secretion (lower insulinogenic index, p<0.0001), and higher glycosylated hemoglobin (HbA(1c)) levels (p<0.0001) in comparison with the normoglycemic subjects, but not to those with IFG and/or IGT or diabetes (p = 0.6). No difference was observed concerning the risk factors studied, left ventricular mass and vascular remodeling, among subjects with INPH, IFG and/or IGT, and diabetes. However, individuals with INPH had a higher proportion of echolucent carotid artery plaques in comparison with the normoglycemic subjects (p = 0.04) and those with IFG and/or IGT (p = 0.01). Intermediate postchallenge hyperglycemia seems to represent a new category of glucose metabolism disturbances with increased atherogenic impact. Therefore, evaluating intermediate glucose levels in an OGTT could contribute to better identify overweight individuals at risk of developing diabetes mellitus and cardiovascular events.