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Randomized study of antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan monotherapy in hypertensive participants with type 2 diabetes mellitus.

ABSTRACT: In this double-blind study, 1143 hypertensive participants with type 2 diabetes and stage 1 or 2 chronic kidney disease (CKD) were randomized to receive combination aliskiren/valsartan 150/160 mg or valsartan 160 mg monotherapy for 2 weeks, with force-titration to 300/320 mg and 320 mg, respectively, for another 6 weeks. Ambulatory blood pressure (ABP), the primary outcome, was available for 665 participants. Reductions from baseline to week 8 in 24-hour ABP were -14.1/-8.7 mm Hg with aliskiren/valsartan vs -10.2/-6.3 mm Hg with valsartan (P<.001). Adverse events were reported in 202 participants (35.2%) taking aliskiren/valsartan and 182 participants (32.2%) taking valsartan. No participant had blood urea nitrogen values>40 mg/dL or serum creatinine values>2.0 mg/dL. There were no confirmed cases of serum potassium values≥6.0 mEq/L. Combination aliskiren/valsartan has additive effects on blood pressure reduction and tolerability similar to valsartan in hypertensive/diabetic participants with early-stage (stages 1 and 2) CKD.

SUBMITTER: Bakris GL

PROVIDER: S-EPMC8108251 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Comparative efficacy of aliskiren/valsartan vs valsartan in nocturnal dipper and nondipper hypertensive patients: a pooled analysis.

Project description:This pooled analysis of ambulatory blood pressure (BP) monitoring data from two 8-week randomized controlled trials compared the antihypertensive efficacy and safety of combination aliskiren/valsartan vs valsartan alone in hypertensive patients (nocturnal dippers or nondippers). At study end, patients were taking aliskiren/valsartan 300/320 mg or valsartan 320 mg. In dippers (n=138) and nondippers (n=132), aliskiren/valsartan provided significantly (P<.05) greater reductions from baseline to week 8 than valsartan in 24-hour, daytime, and last-4-hour mean ambulatory systolic BP (maSBP). Treatment differences were more pronounced in nondippers. Nighttime maSBP reductions with aliskiren/valsartan were significantly greater vs valsartan in nondippers (-17.0 mm Hg vs -8.9 mm Hg; P<.05) but not dippers (-7.6 mm Hg vs -4.5 mm Hg; P=.16). In all time periods, combination therapy was generally associated with BP reductions that were greater in nondippers than dippers. Conversion from nondipper to dipper status was 32% vs 22% for aliskiren/valsartan vs valsartan (P=.48). Both treatments were similarly well tolerated. Although the addition of aliskiren to valsartan did not significantly alter dipper status, our data suggest an increased contribution of the renin-angiotensin-aldosterone system to the nondipper status of hypertensive patients.

| S-EPMC8108859 | biostudies-literature

Effects of Aliskiren Monotherapy versus Amlodipine Monotherapy in Hypertensive Patients with Obesity or Type 2 Diabetes Mellitus.

Project description:IntroductionRenin-angiotensin system inhibitors have been reported to exert protective effects against organ damage and failure; however, the impact of direct renin inhibitor as monotherapy has not been assessed. Here we investigated the effects of 24-week monotherapy with aliskiren compared to amlodipine in hypertensive patients with type 2 diabetes or obesity.MethodsIn this randomized intervention study, 62 adult hypertensive patients with visceral obesity (defined as a body mass index [BMI] greater than 25 kg/m2 and visceral adipose tissue area [VFA] greater than 100 cm2) or type 2 diabetes mellitus (age 57 ± 13, 65% men, BMI 28.8 ± 4.8 kg/m2, VFA 134.8 ± 47.0 cm2, blood pressure 141 ± 16/86 ± 13 mmHg) were randomized to receive 24-week treatment with aliskiren (max. 300 mg) or amlodipine (max. 10 mg). The primary outcome was the change in VFA at 24 weeks post-treatment.ResultsChange in VFA did not differ significantly from baseline in either group. Systolic blood pressure significantly decreased at 12 weeks (-10 mmHg, P = 0.001) and 24 weeks (-10 mmHg, P = 0.001) in the amlodipine group and at 24 weeks (-11 mmHg, P = 0.001) in the aliskiren group. Diastolic blood pressure significantly decreased at 24 weeks (-6 mmHg, P = 0.009) only in the amlodipine group. Although the estimated glomerular filtration rates did not significantly change in either group, the logarithm of urinary albumin excretion significantly decreased at 24 weeks only in the aliskiren group (-0.60, P < 0.001). The 24-week changes in the urinary albumin excretion significantly correlated with the changes in the plasma renin activity in the aliskiren group (r = 0.51, P = 0.008).ConclusionAliskiren monotherapy did not show any superiority to amlodipine monotherapy on VFA, estimated glomerular filtration rates, or urinary albumin excretion in obese or type 2 diabetic hypertensive patients.

| S-EPMC10652658 | biostudies-literature

Comparison of aliskiren/hydrochlorothiazide combination therapy and amlodipine monotherapy in patients with stage 2 systolic hypertension and type 2 diabetes mellitus.

Project description:Patients with stage 2 hypertension and diabetes are at high cardiovascular risk and require large blood pressure (BP) reductions to reach treatment goals. This randomized double-blind study compared aliskiren/hydrochlorothiazide (HCTZ) combination therapy with amlodipine monotherapy in 860 patients with mean sitting systolic BP (msSBP) ≥160 mm Hg to <200 mm Hg and type 2 diabetes. Patients received either once-daily aliskiren/HCTZ 150/12.5 mg or amlodipine 5 mg for 1 week then force-titrated to double the doses for 7 weeks. Baseline BP was 167.7/91.4 mm Hg. At week 8 end point, aliskiren/HCTZ provided significantly greater reductions in msSBP than amlodipine (28.8 mm Hg vs 26.2 mm Hg; P<.05). Mean sitting diastolic BP reductions were similar with aliskiren/HCTZ (9.9 mm Hg) and amlodipine (9.0 mm Hg). Achievement of BP control (<130/80 mm Hg) was significantly greater with aliskiren/HCTZ (23.2%) than amlodipine (13.8%; P<.0001). Aliskiren/HCTZ provides substantial msSBP reductions and greater BP control rates than amlodipine, and offers an attractive treatment option for patients with hypertension and diabetes mellitus.

| S-EPMC8108762 | biostudies-literature

Sacubitril/valsartan: evaluation of safety and efficacy as an antihypertensive treatment.

Project description:Hypertension (HTN) is a common disease state associated with extensive morbidity and mortality worldwide. It is often difficult for patients with HTN to achieve and maintain a goal blood pressure (BP), despite there being many effective treatment options available. Sacubitril/valsartan is a first-in-class angiotensin receptor neprilysin inhibitor (ARNI) that has garnered approval by the US Food and Drug Administration and the European Medicines Agency as a first-line treatment for heart failure with reduced ejection fraction. During clinical trials for heart failure as well as in independent trials for HTN, sacubitril/valsartan has demonstrated safety and efficacy when it comes to BP lowering, making it a promising antihypertensive agent. Most trials of sacubitril/valsartan were 8 to 12 weeks in length and demonstrated a clinically relevant BP lowering that was frequently more significant than its comparators. While more data are needed to confirm its role as an antihypertensive agent, the data available are promising and it is anticipated that sacubitril/valsartan will gain an indication of HTN.

| S-EPMC6089617 | biostudies-literature

Efficacy and safety of olanzapine/fluoxetine combination vs fluoxetine monotherapy following successful combination therapy of treatment-resistant major depressive disorder.

Project description:This study assessed prevention of relapse in patients with treatment-resistant depression (TRD) taking olanzapine/fluoxetine combination (OFC). Patients with major depressive disorder (MDD) who failed to satisfactorily respond to ≥ 2 different antidepressants for ≥ 6 weeks within the current MDD episode were acutely treated for 6-8 weeks, followed by stabilization (12 weeks) on OFC. Those who remained stable were randomized to OFC or fluoxetine for up to 27 weeks. Time-to-relapse was the primary efficacy outcome defined as 50% increase in Montgomery-Åsberg Depression Rating Scale score with Clinical Global Impressions-Severity of Depression score of ≥ 4; hospitalization for depression or suicidality; or discontinuation for lack of efficacy or worsening of depression or suicidality. A total of 444 patients were randomized 1:1 to OFC (N=221) or fluoxetine (N=223). Time-to-relapse was significantly longer in OFC-treated patients compared with fluoxetine-treated patients (p<0.001). Treatment-emergent weight gain and some mean and categorical fasting metabolic changes were significantly greater in OFC-treated patients. Clinically significant weight gain (≥ 7%) was observed in 55.7% of patients who remained on OFC throughout the study, including the relapse-prevention phase (up to 47 weeks). There were no significant differences between patients treated with OFC and fluoxetine in extrapyramidal symptoms or serious adverse events. We believe this is the first controlled relapse-prevention study in subjects with TRD that supports continued use of a second-generation antipsychotic beyond stabilization. A thorough assessment of benefits and risks (in particular metabolic changes) associated with continuing treatment with OFC or fluoxetine must be done based on individual patient needs.

| S-EPMC4207330 | biostudies-other

Clinical efficacy, safety and tolerability of aliskiren monotherapy: a protocol for an umbrella review.

Project description:INTRODUCTION:Aliskiren is a newly developed medicine. As one of the effective renin-angiotensin-aldosterone system inhibitors, its role in lowering blood pressure has been recognised. However, its safety and tolerability still remain controversial. The aim of the paper is to systematically summarise the published studies about the clinical efficacy and side effects of aliskiren monotherapy. METHODS AND ANALYSIS:A comprehensive review of PubMed, Embase and Cochrane Library databases published from inception until June 2019 will be conducted. The selected articles are meta-analyses that integrated the randomised controlled studies, which evaluated efficacy, safety and tolerability of aliskiren monotherapy. Two people will select eligible articles and extract data independently. Any disputes will be resolved by discussion or the arbitration of a third person. The quality of reporting evidence will be assessed using the AMSTAR 2 tool. Study selection process will be presented using a flowchart. We will re-analyse each outcome with the random effect methods if necessary. If possible, we will also calculate 95% prediction intervals for each random effect estimate, by using Egger's test to evaluate if the reporting bias existed. ETHICS AND DISSEMINATION:Ethical approval is not required for the study, as we only collected data from available published materials. This umbrella review will be also submitted to a peer-reviewed journal for publication after completion. PROSPERO REGISTRATION NUMBER:CRD42019142141.

| S-EPMC7045264 | biostudies-literature

Efficacy and Safety of S-Amlodipine 2.5 and 5 mg/d in Hypertensive Patients Who Were Treatment-Naive or Previously Received Antihypertensive Monotherapy.

Project description:The aim of the present study was to evaluate the efficacy and safety of S-amlodipine 2.5 and 5 mg/d in patients with hypertension who were treatment-naive or previously received antihypertensive monotherapy. During the 8-week treatment period, all patients received S-amlodipine 2.5 mg/d for the first 4 weeks, followed by S-amlodipine 5 mg/d for the second 4 weeks. For efficacy assessments, ambulatory and office blood pressure (BP) measurements were performed during the baseline, fourth-week, and eighth-week visits. For safety assessments, all adverse events and abnormal laboratory findings were recorded. This study is registered with ClinicalTrials.gov (NCT03038451). Of 43 patients evaluated at the screening visit, 33 were enrolled. In the treatment-naive arm, significant reductions in both office and ambulatory systolic BP (SBP) and diastolic BP (DBP) were observed with S-amlodipine 2.5 mg/d and additional significant reductions were achieved with dose titration (S-amlodipine 5 mg/d). At the end of the study, the rate of the treatment-naive patients with BP under control (SBP/DBP <140/90 mm Hg) was 53% with S-amlodipine 2.5 mg and increased to 78% with S-amlodipine 5 mg. For the noninferiority evaluation, S-amlodipine 2.5 and 5 mg/d treatments were generally noninferior to both office and ambulatory BP levels achieved with the medications that the patients received before participating in the study. Five nonserious adverse events likely to be associated with the study drug were observed. No serious adverse event was encountered. Consequently, S-amlodipine can be suggested as an effective and safe treatment option for patients with hypertension.

| S-EPMC5974697 | biostudies-literature

Practical application of the ATOM study: Treatment efficacy of antihypertensive drugs in monotherapy or combination (ATOM metaanalysis according to PRISMA statement); tables for the use of antihypertensive drugs in monotherapy or combination.

Project description:BackgroundThe response to antihypertensive drugs is predictable. The absence of precise prescription recommendations to treat arterial hypertension (HT) lead to use drugs unable to reduce blood pressure (BP) to target values.We published ATOM study, in which we found significant differences in the ability to reduce BP between the different drugs.The objective of the study was to determine the expected decrease in blood pressure with the use of commercialized doses of the drugs commonly used in the treatment of HT in clinical practice, to avoid the use of drugs or combinations that even with the best response, are unable to obtain the necessary BP decrease to reach the goal.MethodsThe analysis was based on the results of the ATOM study. To convert the mean doses of the different drugs and combinations in commercialized doses, the conclusions of the study by Law et al have been applied.ResultsBased on the results, two tables were drawn, one for systolic BP and the other for diastolic BP, where the doses of the different drugs and combinations are classified according to the BP decrease that can be expected from them. In order to favor the use of the tables in clinical practice, the different drugs have been grouped in intervals of 10 millimeters of mercury (mmHg) for the decrease of the systolic BP and of 5 mmHg for the diastolic BP.ConclusionsRecommendations for the use of antihypertensive treatments should not be limited to pharmacological families. They should also consider differences between drugs or specific combinations. From the data of the ATOM study we have implemented tables that express the effect of the drugs commonly used in clinical practice and that should allow the clinicians to choose with care the treatment to use.

| S-EPMC6485836 | biostudies-literature

Treating systolic hypertension in the very elderly with valsartan-hydrochlorothiazide vs. either monotherapy: ValVET primary results.

Project description:This 16-week trial investigated the efficacy and safety of single-pill valsartan/hydrochlorothiazide (HCTZ) vs. the individual components in patients 70 years and older with systolic hypertension. Patients were randomized to valsartan/HCTZ 160/12.5 mg (n=128), HCTZ 12.5 mg (n=128), or valsartan 160 mg (n=128) for 4 weeks. Patients whose blood pressure (BP) was ≥140/90 mm Hg at weeks 4, 8, or 12 were up-titrated to a maximum of valsartan/HCTZ 320/25 mg. Week 4 systolic BP reduction (primary efficacy outcome) was greater with valsartan/HCTZ than valsartan (-17.3 mm Hg vs. -8.6 mm Hg, P <.0001) but only marginally greater than HCTZ (-13.6 mm Hg, P =.096). Median time to BP control was shorter with valsartan/HCTZ (4 weeks) vs HCTZ (8 weeks, P<.05) or valsartan (12 weeks, P<.0001). Thiazide monotherapy was more effective than angiotensin receptor blocker monotherapy (by about 5 mm Hg), but greater antihypertensive efficacy was achieved by initiating treatment with combination valsartan/HCTZ in the elderly.

| S-EPMC8108961 | biostudies-literature

Efficacy/safety of a fixed-dose amlodipine/olmesartan medoxomil-based treatment regimen in hypertensive blacks and non-blacks with uncontrolled BP on prior antihypertensive monotherapy.

Project description:In this secondary analysis of a dose-titration study of patients with hypertension uncontrolled on prior monotherapy, blacks (n=234) and non-blacks (n=765) were switched to amlodipine (AML)/olmesartan medoxomil (OM) 5/20 mg, with uptitration every 4 weeks to AML/OM 5/40 mg and then AML/OM 10/40 mg to achieve a seated cuff blood pressure (SeBP) of <120/70 mm Hg. Hydrochlorothiazide 12.5 and 25 mg could be added if SeBP was ≥125/75 mm Hg. The cumulative proportions of patients achieving systolic SeBP <140 mm Hg (<130 mm Hg if diabetic) at 12 weeks were 71.6% for blacks and 77.2% for non-blacks. Mean SeBP change from baseline in blacks (mean baseline BP: 153.0/93.7 mm Hg) ranged from -11.7/-6.1 mm Hg for AML/OM 5/20 mg to -23.6/-12.9 mm Hg for AML/OM 10/40 mg +hydrochlorothiazide 25 mg (all P<.0001). Antihypertensive efficacy was maintained throughout the 24-hour dosing interval. An AML/OM-based regimen was effective in blacks with hypertension uncontrolled on prior monotherapy.

| S-EPMC8033789 | biostudies-literature

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