scholarly journals Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Shoko Takahashi ◽  
Megumi Hiramatsu ◽  
Shinichi Hotta ◽  
Yukie Watanabe ◽  
Osamu Suga ◽  
...  

Prospective postmarketing surveillance of Selara (eplerenone), a selective mineralocorticoid receptor antagonist, was performed to confirm its safety and efficacy for hypertension treatment in Japan. The change in blood pressure after initiation of eplerenone treatment was also examined. Patients with essential hypertension who were eplerenone-naïve were recruited regardless of the use of other antihypertensive drugs. For examination of changes in blood pressure, patients were excluded if eplerenone was contraindicated or used off-label. Patients received 50–100 mg of eplerenone once daily and were observed for 12 weeks. No treatments including antihypertensive drugs were restricted during the surveillance period. Across Japan, 3,166 patients were included for safety analysis. The incidence of adverse drug reactions was 2.4%. The major adverse drug reactions observed were hyperkalemia (0.6%), dizziness, renal impairment, and increased serum potassium (0.2% each). The mean systolic blood pressure decreased from 152.1±19.0 mmHg to 134.8±15.2 mmHg at week 12, and the mean diastolic blood pressure decreased from 85.8±13.7 mmHg to 77.7±11.4 mmHg. There were no significant new findings regarding the type or incidence of adverse reactions, and eplerenone had a clinically significant antihypertensive effect, leading to favorable blood pressure control.

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Mohammad Alshuniaber ◽  
Omar Alhaj ◽  
Qasem Abdallah ◽  
Haitham Jahrami

Purpose This study aims to investigate the antihypertensive effect of camel milk hydrolysate in rats with fructose-induced hypertension. Design/methodology/approach The antihypertensive effect of fermented camel milk was determined using 6 groups comprising 36 Wistar male rats. Blood pressure of rats was altered via exposure to a 10% fructose (w/v) diet in drinking water for 3 weeks before conducting 21 days of treatment. The authors conducted the experiment for short and long term using different doses of 800 and 1,200 mg/kg body weight. Serum was used to assay total cholesterol (TC), triglyceride (TG), glucose and insulin levels using standard biochemical kits. Findings The group that received 1,200 mg hydrolysate camel milk (HM) has significantly (p = 0.003) reduced systolic and diastolic blood pressure after a short exposure time (4–8 h). These effects were significantly (p = 0.005) comparable to the nifedipine (NIF) drug group. Similar long-term (21 days) effects on blood pressure were observed in 1,200 mg HM and NIF groups. Angiotensin-converting enzyme (ACE) activity and levels were also reduced in a correlation with blood pressure reduction only in HM1200 and HM800 treated groups. The authors observed no significant effect on blood pressure in groups receiving the 800 mg HM or 1,200 mg unhydrolyzed camel milk (UM). Rats receiving the 10% fructose diet showed significant differences from control rats regarding their blood biochemistry, including TG, TC, blood glucose and insulin levels. Rats in groups NIF, HM1200 and HM800 showed a significant (p < 0.05) reduction in serum glucose, insulin, TG and TC levels toward the baseline level. Research limitations/implications Further mechanistic investigation on the HM antihypertensive activity is highly recommended before suggesting HM as a product to reduce blood pressure. While drug–food interaction between HM and antihypertensive drugs, especially ACE inhibitors, is probable, UM seems not to affect blood pressure or ACE activity and therefore is expected to have no or minimal effects on the activity of other antihypertensive drugs. Investigation of ACE expression from various organs including lungs and leukocytes is highly recommended in future works using sodium dodecyl-sulfate polyacrylamide gel electrophoresis and western blot analysis or reverse transcription polymerase chain reaction. Originality/value No previous studies have measured the antihypertensive activity of milk hydrolysate mediated by the reduction of ACE activity and levels in plasma. Mechanisms involved in attenuating the levels of ACE warrant further investigation.


2018 ◽  
Vol 5 (2) ◽  
pp. 121-129
Author(s):  
Siti Khoiroh

Background : Hypertension is a condition of high blood pressure in the arteries that lasted continuously for the long term. Hypertension can be overcome in two ways: pharmacology and non-pharmacology. Pharmacology treatment usually use medicine while one of the ways for non-pharmacology treatment is to consumes apple juice.Research Objective : The aim of this research is to know the effect of apple juice on blood pressure decrease in elderly people with hypertension at Muara Kaman Community Health Center.Methods : The design of this research used quasi experimental design (quasi experiment) with pretest posttest control group design. The sample of the research was hypertensive respondents at Muara Kaman Community Health Center as many as 30 respondents were divided into 2 groups, 15 intervention groups and 15 control groups. The sampling technique used purposive sampling. The research instruments were stethoscope and sphygmomanometer, data analysis using t test dependent and t test independent.Results : There were a significant influence between pretest and posttest of apple juice in the intervention group (P value = 0,000; P <0.005). The mean difference in systolic blood pressure in the intervention group and the control group also had significant differences (P value = 0.002; P <0.05), where as the mean difference in diastolic blood pressure in the intervention group and the control group also had significant differences (P value = 0,039; P <0,05).The Conclusions : The results of this research showed that consumes apple juice gives an effect on the blood pressure of hypertensive patients by consumes regularly.The Suggestions : Nurses and the public can use apple juice as one of the ways to handling to hypertension sufferers besides antihypertensive drugs.


Hypertension ◽  
2012 ◽  
Vol 60 (suppl_1) ◽  
Author(s):  
Bruno Igreja ◽  
Nuno M Pires ◽  
Lyndon C Wright ◽  
Patrío Soares-da-Silva

The sympathetic nervous system can alter blood pressure by modulation of cardiac output, peripheral vascular resistance and renal function. One strategy for controlling sympathetic nerve function is to reduce the biosynthesis of norepinephrine (NE) via inhibition of dopamine β-hydroxylase (DβH; EC 1.14.17.1 ), the enzyme that catalyses the conversion of dopamine (DA) to NE in sympathetic nerves. BIA 5-1058 is a reversible DβH inhibitor that decreases NE levels in peripheral sympathetically innervated tissues slowing down sympathetic nervous system drive, without effect in brain tissues. In freely moving SHR implanted with radio-telemetry transmitters single administration of BIA 5-1058 showed a dose (3, 30 and 100 mg/Kg) and time dependent effect on blood pressure with no significant effect on heart rate (HR) and total activity monitored over a 96-hour period. The maximum reduction on systolic blood pressure (SBP) was -10.8, -21.1 and -35.2 mmHg for 3, 30 and 100 mg/Kg, respectively and the maximum reduction on diastolic blood pressure (DBP) was -9.9, -18.4 and -24.8 mmHg for 3, 30 and 100 mg/Kg, respectively. The antihypertensive effect of BIA 5-1058 (30 mg/Kg) was further evaluated in combination with efficacious doses of well-known antihypertensive drugs, like the ACE inhibitor captopril, the AT1 receptor antagonist losartan, the diuretic hydrochlorothiazide, beta-blocker metoprolol, the alpha-1 receptor antagonist prazosin, and the calcium channel blocker diltiazem. All drugs were administered orally (single dose) in a cross-over design and the effect was monitored for 72 hours. The combination of BIA 5-1058 with any of the tested antihypertensive drugs caused a stronger and prolonged blood pressure decrease than any of the compounds alone.In conclusion, peripheral DβH inhibitors can be used, alone or in combination with others antihypertensive drugs, to reduce blood pressure.


2020 ◽  
Vol 145 (02) ◽  
pp. 87-91
Author(s):  
Rainer Düsing

AbstractHypertension is defined as resistant to treatment when treatment fails to lower office systolic and diastolic blood pressure values to < 140/90 mmHg. The treatment strategy should include lifestyle measures and appropriate doses of three or more drugs acting by different mechanisms including a diuretic. An updated definition of treatment resistance includes all patients with ≥ 4 antihypertensive agents of different classes irrespective of their on-treatment blood pressure. The term “refractory” hypertension has been suggested for patients with uncontrolled blood pressure on ≥ 5 antihypertensive drugs including the thiazide-like diuretic chlorthalidone and the mineralocorticoid receptor antagonist spironolactone. “Pseudo resistance” especially due to white coat hypertension and non-adherence with the prescribed medication has to be ruled out to be able to identify patients with “true” treatment resistance. Therefore, before distinguishing true from pseudo resistance, the term “apparent” resistance should be used. While the prevalence of apparent resistance may be in the range of 10–15 % of treated patients, the exact prevalence of true resistance remains unknown due to the lack of appropriate studies but is likely to be rather small including a high proportion of patients with secondary forms of hypertension. Once identified most patients with true treatment resistance should receive intensified drug treatment primarily by expanded diuretic usage. Thus, resistant hypertension is primarily a diagnostic challenge: identifying patients with true resistance and those with secondary hypertension.


2015 ◽  
Vol 9 (4) ◽  
pp. 362
Author(s):  
Aurelio Negro ◽  
Rosaria Santi ◽  
Antonio Manari ◽  
Franco Perazzoli

A 52-year-old Caucasian woman with essential resistant and refractory hypertension despite optimal medical therapy, including 6 different antihypertensive drugs was referred for the catheter-based renal denervation. Due to unfavourable anatomy because of non-critical fibromuscular dysplasia on the right renal artery, renal denervation of only the left renal artery was performed. Before and after the renal denervation, the patient’s blood pressure was monitored by <em>office</em> measurements and ambulatory blood pressure measurements (ABPM). Before the procedure, the mean <em>office</em> blood pressure was 157/98 mmHg; at ABPM, the mean blood pressure values were 145/94 mmHg. At 6 months of follow-up, the mean <em>office</em> blood pressure was 134/90 mmHg and 121/76 mmHg at ABPM. In latest 12 months of follow-up, <em>office</em> and ABPM blood pressure were 125/80 and 127/80 mmHg respectively. This unique case suggests that unilateral renal denervation may be effective in lowering blood pressure in patients with refractory hypertension and unfavorable renal arteries anatomy.


1980 ◽  
Vol 8 (1) ◽  
pp. 44-49 ◽  
Author(s):  
Jaakko Tuomilehto ◽  
Aulikki Nissinen

The antihypertensive effect and the tolerability of metoprolol Durules® have been studied in fifty-five patients with mild to moderate hypertension. The patients' diastolic blood pressure was ≥95 mm Hg in order to qualify for entry. Thirty-seven out of fifty-three patients completing the study (70%) were treated with metoprolol Durules® monotherapy throughout the study. The mean blood pressure was reduced from 153/101 to 138/92 mm Hg after metoprolol Durules® compared to placebo (p < 0.001). Twenty-seven patients received one Durules® daily and ten patients received two Durules® daily as the final dose. Of the sixteen patients not responding on metoprolol Durules®, six patients achieved satisfactory control, i.e. a diastolic blood pressure below 95 mm Hg, when given 200 mg metoprolol + 25 mg hydrochlorothiazide (HCT). The results indicate that most patients with, mild or moderate hypertension can be controlled with metoprolol Durules® monotherapy given once daily. The addition of HCT gives a significant benefit in moderate hypertension, where metoprolol monotherapy is not sufficient.


Author(s):  
Amanjot Kaur ◽  
Shakti B. Dutta ◽  
Amandeep Singh ◽  
Amit Varma ◽  
Mirza A. Beg ◽  
...  

Background: Rheumatoid arthritis (RA) a chronic autoimmune inflammatory disease and Methotrexate being widely used as monotherapy and in combination for the treatment of RA. Combination therapy provides additional or even more potentiating effects, therefore have been widely used. This study is aimed at comparing the efficacy and safety of Methotrexate either alone or in combination.Methods: This study was conducted for one year from 1st January to 31st December 2015. 52 patients diagnosed with RA were included in this study and were divided in two groups, Group-1 (n=29) patients received methotrexate (MTX) 7.5-15mg/week and Group-2 (n=23) patients received methotrexate 7.5mg once a week + Hydroxychloroquine (HCQ) 200mg twice daily. The patients were followed up for a period of 16 weeks. Statistical analysis was done by using graph pad insta and p value of <0.05 was considered significant.Results: A total of 52 patients were included in the study. The mean age of patients was 50.53±14.81 years. 43 (82.69%) patients were females and 9 (17.30%) were males. 23 (44.23%) patients had positive family history of the disease. The Rheumatoid factor was positive in 42 (80.70%) and anti-CCP was raised in 50 (96.15%) patients. The RAPID-3 and DAS-28 scores on intragroup comparison was highly significant (p <0.0001) and the intergroup comparison was significant (p <0.01) between baseline and 16 weeks in both the groups. The improvement in inflammatory marker CRP was highly significant on intragroup (p <0.0001) and intergroup (p<0.001) comparison between baseline and 16 weeks in both the groups. The mean changes in Vitamin-D3 between baseline and at 16 weeks were insignificant (p >0.05) in both the groups. Total of Adverse drug reactions reported were 42 (50.60%) in group-1 and 41 (49.40%) in group-2.Conclusions: The combination therapy was found to be more efficacious than MTX monotherapy in improving symptoms and quality of life. The adverse drug reactions were mild, more in combination therapy and none of the patients required withdrawal of treatment.


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