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Real-world effectiveness and safety of sofosbuvir plus daclatasvir with or without ribavirin for genotype 2 chronic hepatitis C in Taiwan.
Cheng, PN, Chiu, YC, Chien, SC, Chiu, HC
Journal of the Formosan Medical Association = Taiwan yi zhi. 2019;(5):907-913
Abstract
BACKGROUND AND PURPOSE Sofosbuvir (SOF) and daclatasvir (DCV) treatment achieves excellent efficacy and safety in treating chronic hepatitis C (CHC) with various genotypes. Real world experience of SOF/DCV regimen to treat genotype 2 CHC was scanty in Asia. This study aimed to evaluate the effectiveness and safety of SOF/DCV with or without ribavirin to treat genotype 2 CHC patients in real world practice in Taiwan. METHODS Patients with genotype 2 CHC treated with 12-week of SOF/DCV or SOF/DCV/ribavirin were enrolled prospectively. Effectiveness was evaluated by sustained virological response (SVR) which was defined as undetectable hepatitis C virus (HCV) RNA at post-treatment week 12. Adverse events were recorded for safety analysis. RESULTS In total of 32 patients were enrolled from October 2016 to June 2017. All were infected with genotype 2 HCV. Sixteen patients (50%) exhibited cirrhosis including 6 patients with decompensation. Regimens of SOF/DCV and SOF/DCV/ribavirin were used to treat 14 and 18 patients, respectively. SVR was achieved in all 31 patients (100%) who completed follow-up. Significantly higher levels of cholesterol (p = 0.013) and higher low density lipoprotein-cholesterol (p = 0.015) were exhibited after successful viral clearance. SOF/DCV/ribavirin regimen resulted in more adverse events, significantly higher bilirubin levels, and decline of hemoglobin during treatment than SOF/DCV regimen. Four patients with chronic kidney disease maintained renal function during treatment. Overall, SOF/DCV or SOF/DCV/ribavirin treatment was well tolerated. CONCLUSION SOF/DCV with or without ribavirin is highly effective and safe for patients with genotype 2 HCV infection in real-world experience in Taiwan.
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Interim analysis of a 3-year follow-up study of NS5A and NS3 resistance-associated substitutions after treatment with grazoprevir-containing regimens in participants with chronic HCV infection.
Lahser, F, Galloway, A, Hwang, P, Palcza, J, Brunhofer, J, Wahl, J, Robertson, M, Barr, E, Black, T, Asante-Appiah, E, et al
Antiviral therapy. 2018;(7):593-603
Abstract
BACKGROUND In HCV-infected people who fail to achieve sustained virological response after receiving a direct-acting antiviral regimen, virological failure is almost always accompanied by the presence of resistance-associated substitutions (RASs) in the target protein(s). The aim of this long-term observational study was to evaluate the persistence of NS3/4A and NS5A RASs in participants with genotype (GT) 1 infection who relapsed following treatment with a grazoprevir-containing treatment regimen. METHODS RASs were evaluated at baseline (that is, pre-dose on day 1 of the original treatment), at the time of virological failure, and up to follow-up week 96. A total of 58 participants were included. RESULTS In participants treated with elbasvir/grazoprevir ± ribavirin, observed baseline NS3 RASs included 56F, 80K/L, 122N and 170V/I, and observed treatment-emergent NS3 RASs included 36M, 56F/H, 122G, 132I, 156G/I/L/P/T, 168A/E/G/V/Y and 170T. Observed baseline NS5A RASs included 28M/T/V, 30H/R, 31M/V and 93H/N, and treatment-emergent NS5A RASs included 28A/G/S/T, 30H/R, 31M/V and 93H/N/S. Baseline NS3 and NS5A RASs present at time of failure tended to persist during follow-up, and most were detectable for more than 2 years following virological failure. Treatment-emergent NS5A RASs present at time of failure also tended to persist for more than 2 years following virological failure (93%). By contrast, >80% of treatment-emergent NS3 RASs detected at failure had been supplanted by wild type by week 36. CONCLUSIONS Treatment-emergent NS5A RASs can persist for extended periods of time. Retreatment strategies should take account of the presence of these RASs.
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Medication-taking behavior in hypertensive patients with a single-tablet, fixed-dose combination in Japan.
Saito, I, Kushiro, T, Matsushita, Y, Sato, Y, Sagawa, K, Tanaka, Y, Tanigawa, M, Okutani, Y
Clinical and experimental hypertension (New York, N.Y. : 1993). 2016;(2):131-6
Abstract
Non-persistence rate (defined as not remaining on treatment) in patients taking a renin angiotensin system inhibitor plus calcium channel blocker was studied in three integrated 12-weeks surveys by matching separate drug combination therapy (CT) and fixed-dose combination (FDC). We also investigated medication adherence measured by proportion of days covered by using a claims database. The non-persistence rate was significantly lower in FDC than CT (p = 0.0074). In the database study, the medication adherence was higher in FDC than CT for 3, 6, and 12 months (all p < 0.001). In conclusion, use of single-tablet FDC antihypertensive therapy was associated with better medication-taking behavior.
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Lipid and blood pressure control for the prevention of cardiovascular disease in hypertensive patients: a subanalysis of the OMEGA study.
Teramoto, T, Kawamori, R, Miyazaki, S, Teramukai, S, Sato, Y, Okuda, Y, Shirayama, M
Journal of atherosclerosis and thrombosis. 2015;(1):62-75
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Abstract
AIM: The aim of this analysis was to investigate the relationships between dyslipidemia, achieved blood pressure (BP) values and the lipid levels, as well as the control of four cardiovascular risk factors (BP, low-density lipoprotein: LDL cholesterol, hemoglobin A1c: HbA1c and smoking) and the incidence of cardiovascular disease (CVD), in Japanese patients receiving antihypertensive therapy. METHODS A total of 13,052 patients with no history of CVD were included in this subanalysis of the prospective observational OMEGA study in Japanese hypertensive patients treated with olmesartan. Multivariable Cox regression models were used to evaluate the relationship with the risk of CVD. RESULTS The incidence of CVD during the 36-month study period was 5.59/1,000 patient-years among the patients with dyslipidemia (n = 6,297) and 5.57/1,000 patient-years among the patients without dyslipidemia (n = 6,755), with no significant differences between the two groups. Higher achieved BP values tended to be associated with an increased CVD risk in both the patients with and without dyslipidemia. In addition, the risk of CVD tended to be higher in the patients with an achieved LDL cholesterol level of ≥ 120 mg/dL than in those with an LDL level of < 120 mg/dL (trend p = 0.0005) and in the patients with an achieved high-density lipoprotein cholesterol level of < 60 mg/dL than in those with an HDL level of ≥ 60 mg/dL (trend p = 0.0017). Furthermore, the risk of CVD was higher among the patients with fewer controlled risk factors than among those with control of all four risk factors (trend p < 0.0001). CONCLUSIONS In order to prevent CVD in olmesartan-treated hypertensive patients with no history of CVD, it is important to control both the lipid and BP levels and aim for comprehensive risk factor control.
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Urinary angiotensin-converting enzyme 2 in hypertensive patients may be increased by olmesartan, an angiotensin II receptor blocker.
Furuhashi, M, Moniwa, N, Mita, T, Fuseya, T, Ishimura, S, Ohno, K, Shibata, S, Tanaka, M, Watanabe, Y, Akasaka, H, et al
American journal of hypertension. 2015;(1):15-21
Abstract
BACKGROUND Angiotensin-converting enzyme 2 (ACE2) is highly expressed in the kidney and converts angiotensin (Ang) II to Ang-(1-7), a renoprotective peptide. Urinary ACE2 has been shown to be elevated in patients with chronic kidney disease. However, the effects of antihypertensive agents on urinary ACE2 remain unclear. METHODS Of participants in the Tanno-Sobetsu cohort study in 2011 (n = 617), subjects on no medication (n = 101) and hypertensive patients treated with antihypertensive agents, including the calcium channel blockers amlodipine and long-acting nifedipine; the ACE inhibitor enalapril; and the Ang II receptor blockers losartan, candesartan, valsartan, telmisartan, and olmesartan, for more than 1 year (n = 100) were enrolled, and urinary ACE2 level was measured. RESULTS Glucose and hemoglobin A1c were significantly higher in patients treated with enalapril, telmisartan or olmesartan than in the control subjects. Urinary albumin-to-creatinine ratio (UACR) was significantly higher in patients treated with enalapril than in the control subjects. Urinary ACE2 level was higher in the olmesartan-treated group, but not the other treatment groups, than in the control group. Urinary ACE2 level was positively correlated with systolic blood pressure (r = 0.211; P = 0.003), UACR (r = 0.367; P < 0.001), and estimated salt intake (r = 0.260; P < 0.001). Multivariable regression analysis after adjustment of age, sex, and the correlated indices showed that the use of olmesartan was an independent predictor of urinary ACE2 level. CONCLUSIONS In contrast with other antihypertensive drugs, olmesartan may uniquely increase urinary ACE2 level, which could potentially offer additional renoprotective effects.
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Impact of socio-economic factors on the long-term effectiveness of antihypertensive treatment with an angiotensin II receptor blocker: an observational study.
Scholze, J, Weinstock, A, Kirchner, F, Limberg, R, Kreutz, R
Current medical research and opinion. 2014;(10):1947-55
Abstract
OBJECTIVE To investigate the role of socio-economic factors on the therapeutic effectiveness of and therapeutic adherence to the angiotensin II receptor blocker (ARB) olmesartan (OM) alone or in combination with hydrochlorothiazide in the treatment of arterial hypertension. RESEARCH DESIGN AND METHODS In a multi-center, open-label, prospective and long-term observational study, data from hypertensive patients treated with OM were analyzed at baseline, month 3 and month 12 within the context of patients' socio-economic status (SES), determined using pre-defined criteria by physicians in outpatient practices and including multivariate analysis. RESULTS Overall, 7724 patients were assigned to three subgroups representing low, medium and high socio-economic status. Baseline conditions differed significantly between the subgroups. Patients of low SES had worse nutritional habits, less physical activity and more concomitant medication compared to patients of high SES. Cardiovascular risk factors were more common in the low SES group as were concomitant diseases such as heart failure, coronary heart disease, atherosclerosis and renal failure. OM therapy led to a significant decrease in blood pressure (23.0/11.6 mmHg) in all patients. The blood pressure target of <140/90 mmHg was achieved in about 70% of the documented population. Effectiveness was comparable between patients with low, medium or high SES. Treatment adherence was high in the overall population with only minor differences between the subgroups. In total the incidence of adverse events (AEs) was 1.6% documented in 98 patents (1.3%) during the course of the study. Of this total number only 1.0% was related to the drug, matching the percentage expressed in the Summary of Product Characteristics (SmPC). CONCLUSIONS The ARB OM is effective and well tolerated in all patients, irrespective of their socio-economic status. The risk status and the established cardiovascular disease of hypertensive patients are strongly influenced by the SES. To validate these interesting data a randomized controlled trial is needed.
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The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation.
Menne, J, Ritz, E, Ruilope, LM, Chatzikyrkou, C, Viberti, G, Haller, H
Journal of the American Heart Association. 2014;(2):e000810
Abstract
BACKGROUND The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study showed that 40 mg Olmesartan medoxomil (OM) versus placebo delayed microalbuminuria onset in patients with type 2 diabetes and normoalbuminuria. METHODS AND RESULTS One thousand seven hundred and fifty-eight ROADMAP patients (placebo arm: 877; OM arm: 881) participated in the observational follow up (OFU) with an average of 3.3 years. They received standard medical care and micro- and macrovascular events were documented. During observational follow-up 62.9% and 60.1% in the former OM and placebo group, respectively, received treatment with a RAS blocking agent. During the OFU period the systolic blood pressure (SBP) increased to mean values of 135 mm Hg in both groups. Patients who had developed microalbuminuria during ROADMAP had a higher incidence of cardio- and cerebrovascular events (OR 1.77, CI 1.03 to 3.03, P=0.039) during the OFU period compared with patients in whom this was not the case. Diabetic retinopathy was significantly reduced in the former OM group (8 [0.9%] versus 23 [2.6%], OR: 0.34, CI 0.15 to 0.78, P=0.011) and the rate of microalbuminuria was numerically reduced. Congestive heart failure requiring hospitalization (3 [0.3%] versus 12 [1.4%], OR: 0.23, CI 0.06 to 0.85, P=0.027) was reduced and there was a trend of reduced cardio-/cerebrovascular events (OM versus Pb: 73 [8.3%] versus 86 [9.8%] patients). Seven (0.8%) deaths (including 2 CV events) were reported in former placebo patients versus 3 (0.3%) (non-CV events) in former OM patients. CONCLUSIONS Development of microalbuminuria is a valid marker for future CV events. RAS blockade with Olmesartan might cause sustained reduction (legacy effect) of micro- and macrovascular events.