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Tolvaptan

Tolvaptan is a selective V2 vasopressin receptor antagonist used for the treatment of hyponatremia and autosomal dominant polycystic kidney disease.
It works by inhibiting the action of vasopressin, a hormone that regulates water balance in the body.
Tolvaptan has been shown to increase urine output and decrease serum sodium levels in patients with hyponatremia, and to slow the progression of kidney cysts in those with polycystic kidney disease.
Researchers can optimize their Tolvaptan studies using PubCompare.ai's AI-driven protocol comparison tools, which help enhance reproducibility and accuaracy by easily locating the best Tolvaptan protocols from published literature, preprints, and patents.

Most cited protocols related to «Tolvaptan»

1
Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
Cited 30 times
We enrolled patients at 129 sites worldwide from January 2007 through January 2009. Eligible persons were from 18 to 50 years of age, with a diagnosis of ADPKD (see the Supplementary Appendix, available with the full text of this article at NEJM.org),13 (link) a total kidney volume of 750 ml or more14 (link),15 (link) as measured with the use of magnetic resonance imaging (MRI), and a creatinine clearance of 60 ml per minute or more as estimated by means of the Cockcroft–Gault formula.16 (link) Randomization was carried out centrally, with patients randomly assigned in a 2:1 ratio to receive tolvaptan or placebo and with stratification according to hypertension status (present vs. absent), creatinine clearance (<80 vs. ≥80 ml per minute), total kidney volume (<1000 vs. ≥1000 ml), and geographic area.12 (link)Tolvaptan dosing was started in daily morning and afternoon doses of 45 mg and 15 mg, respectively, with weekly increases to 60 mg and 30 mg and then to 90 mg and 30 mg, according to patient-reported tolerability. For 36 months, patients took the highest dose that they reported as tolerable. Patients who reported that they could not tolerate the lowest dose were asked to continue follow-up by telephone. Adherence to treatment was self-reported and confirmed by means of pill counts. The use of diuretics and drugs inhibiting the cytochrome P-450 enzyme CYP3A4 was avoided, given their effects on urine output and tolvaptan blood levels, respectively.
The institutional review board or ethics committee at each site approved the protocol; written informed consent was obtained from all participants. A steering committee of investigators and representatives of the sponsor, Otsuka Pharmaceuticals, oversaw the trial design and conduct with the assistance of the independent data and safety monitoring committee and the clinical event committee. The sponsor collected and analyzed the data. The first author assumes responsibility for the overall content and integrity of the manuscript, with substantial contributions from the coauthors, who all had access to the data and jointly decided to submit the manuscript for publication. All authors vouch for the accuracy and completeness of the reported data, as well as the fidelity of this report to the protocol. The protocol is available at NEJM.org and has been published previously.12 (link)
Torres V.E., Chapman A.B., Devuyst O., Gansevoort R.T., Grantham J.J., Higashihara E., Perrone R.D., Krasa H.B., Ouyang J, & Czerwiec F.S. (2012). Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease. The New England journal of medicine, 367(25), 2407-2418.
Publication 2012
BLOOD Contraceptives, Oral Creatinine Cytochrome P-450 CYP3A4 Diagnosis Diuretics Ethics Committees Ethics Committees, Research High Blood Pressures Kidney Patients Pharmaceutical Preparations Placebos Polycystic Kidney, Autosomal Dominant Safety Tolvaptan Urine
2
Derivation and Validation of Short KCCQ
Cited 12 times
To create a shorter KCCQ, we used data from 2 randomized trials and one observational cohort study of HF patients, all of which have been previously used to demonstrate some of the psychometric properties of the full instrument: (1) the Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) study, a randomized trial of patients hospitalized with HF;23 (link) (2) the Eplerenone Post-AMI Heart Failure Efficacy and Survival (EPHESUS) study, a randomized trial of patients with HF complicating acute myocardial infarction;24 (link) and (3) the KCCQ Interpretability Study (KCCQINT), a 14-center North American cohort study of patients presenting at outpatient HF clinics.13 (link) Descriptions of the studies and KCCQ samples used in the various analyses are provided in Figure. Using these studies, we derived and validated the short KCCQ within 3 distinct clinical settings: (1) stable HF, (2) outpatient HF clinic visits, and (3) acute HF recovery (1 week after hospitalization for decompensated HF). Within each setting, data were split randomly into 2 50% samples, one for derivation (ie, item selection) and one for validation of the final short-version scores. All studies underwent IRB approval before their conduct, and each patient signed informed consent to participate.
Spertus J.A, & Jones P.G. (2015). Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circulation. Cardiovascular Quality and Outcomes, 8(5), 469-476.
Publication 2015
Clinic Visits Congestive Heart Failure Eplerenone Hospitalization Myocardial Infarction North American People Patients Psychometrics Tolvaptan Vasopressin Antagonist
3
Tolvaptan for Autosomal Dominant Polycystic Kidney Disease
Cited 9 times
The primary end point was the annual rate of percentage change in total kidney volume. The composite secondary end point was the time to investigator-assessed clinical progression, defined as worsening kidney function (a 25% reduction in the reciprocal of the serum creatinine level from the value at the end of the dose-adjustment period, reproduced after at least 2 weeks); clinically significant kidney pain necessitating medical leave, pharmacologic treatment (narcotic or last-resort analgesic agents), or invasive intervention; worsening hypertension (changes in blood-pressure category, as defined in the protocol, or worsening of hypertension requiring an increase in hypertensive treatment); and worsening albuminuria (according to sex-specified categories as defined in the protocol). These events were further adjudicated by an independent clinical events committee for a sensitivity analysis.
The next secondary end point was the change in the slope of kidney function as measured by the reciprocal of the serum creatinine level.18 (link) The reciprocal of the serum creatinine level has a linear relationship with the GFR, unlike the serum creatinine level, which has a curvilinear relationship. These values, expressed as (mg per milliliter)−1, approximate GFR values, with which clinicians are familiar. Other secondary end points are outlined in the protocol12 (link) and in the Supplementary Appendix. Equations from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) that are adjusted for ethnic group were used to determine the estimated GFR.17 (link),19 (link) Kidney-function end points were analyzed during treatment, with the use of measurements obtained at the end of the dose-escalation period and at the last treatment visit, since tolvaptan reversibly increases the serum creatinine level.11 (link),20 (link),21 Sensitivity analyses that included data obtained before and after treatment were used to confirm the results obtained during treatment.
Torres V.E., Chapman A.B., Devuyst O., Gansevoort R.T., Grantham J.J., Higashihara E., Perrone R.D., Krasa H.B., Ouyang J, & Czerwiec F.S. (2012). Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease. The New England journal of medicine, 367(25), 2407-2418.
Publication 2012
Aftercare Analgesics Blood Pressure Clinical Investigators Creatinine Disease Progression Ethnicity High Blood Pressures Hypersensitivity Kidney Narcotics Pain Pharmacotherapy Serum Tolvaptan
4
Long-Term Tolvaptan Extension Trial
Cited 3 times
TEMPO 4:4 was an open-label, extension trial. Participation was elective for TEMPO 3:4 (clinical trial identifier: NCT00428948, 2006-002768-24) sites and their subjects. In Japan, a separate long-term follow-up extension trial was offered to most subjects (NCT01280721).
Eligible subjects had to enroll within 6 months of successful completion of TEMPO 3:4 and have an eGFR by Modification of Diet in Renal Disease (MDRD ≥30 mL/min/1.73 m2 within 45 days prior to the baseline visit. Detailed inclusion and exclusion criteria are presented in Supplementary data, Table S1. Oral tolvaptan was administered in daily split-dose regimens of 45/15 mg, 60/30 mg or 90/30 mg upon waking and approximately 9 h later. Subjects were titrated to the highest dose tolerated in TEMPO 3:4 and were able to titrate up or down per investigator discretion to maximize tolerability and urine osmolality suppression. Adherence to treatment was self-reported and monitored by tablet count. Use of diuretics and drugs inhibiting the cytochrome P-450 enzyme CYP3A4 were discouraged.
TEMPO 4:4 (clinical trial identifier: CT01214421, 2010-018401-10) was in compliance with International Conference on Harmonization Good Clinical Practice guidelines. The informed consent form, protocol and amendments were approved by institutional review boards or independent ethics committees of all trial sites. A steering committee of investigators and sponsor representatives oversaw the trial design and conduct with assistance of the Independent Data Monitoring Committee and Hepatic Adjudication Committee.
Torres V.E., Chapman A.B., Devuyst O., Gansevoort R.T., Perrone R.D., Dandurand A., Ouyang J., Czerwiec F.S, & Blais J.D. (2017). Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrology Dialysis Transplantation, 33(3), 477-489.
Publication 2017
Conferences Cytochrome P-450 CYP3A4 Dietary Modification Diuretics EGFR protein, human Ethics Committees Ethics Committees, Research Kidney Diseases Pharmaceutical Preparations Tablet Tolvaptan Treatment Protocols Urine
5
Multiscale Liver Modeling for DILI Assessment
Cited 3 times
DILIsym has been described previously (Bhattacharya et al., 2012 (link); Shoda et al., 2014 (link); Woodhead et al., 2012 (link)). Briefly, DILIsym is a multi-scale and “middle-out” platform focused on the liver as the primary organ of interest, which includes detailed liver cellular dynamics and biochemistry, extends to whole body drug distribution and systemic circulation of mediators and biomarkers, and accounts for inter-individual differences through variation in anthropometrics and biochemistry. Essential processes occur in interacting sub-models: physiologically based pharmacokinetics (PBPK), bile acid transporter inhibition, mitochondrial dysfunction, oxidative stress, hepatocyte life cycle, and macrophage and endothelial cell life cycles. Parameter values are informed by experimental data, with sub-model and system-level behaviors optimized for consistency with exemplar compounds (Howell et al., 2012 (link); Woodhead et al., 2014 (link), 2012 (link)). Parameter solutions include those consistent with human, rat, and mouse data (Woodhead et al., 2012 (link), 2014 (link)). Generally, simulations for the current study were conducted in the baseline simulated human, and in simulated populations (SimPops) as described previously (Longo et al., 2016 (link); Yang et al., 2015 (link)); tolvaptan-specific adjustments are described in detail below.
Woodhead J.L., Brock W.J., Roth S.E., Shoaf S.E., Brouwer K.L., Church R., Grammatopoulos T.N., Stiles L., Siler S.Q., Howell B.A., Mosedale M., Watkins P.B, & Shoda L.K. (2016). Application of a Mechanistic Model to Evaluate Putative Mechanisms of Tolvaptan Drug-Induced Liver Injury and Identify Patient Susceptibility Factors. Toxicological Sciences, 155(1), 61-74.
Publication 2016
bile acid transporter Biological Markers Drug Kinetics Endothelial Cells Hepatocyte Homo sapiens Human Body Liver Macrophage Mitochondria Mus Oxidative Stress Pharmacy Distribution Population Group Psychological Inhibition Tolvaptan

Most recents protocols related to «Tolvaptan»

1
Cirrhotic Rat Model for Therapeutic Evaluation
Male SD rats were purchased from the Animal Center of Peking University Health Science Center. According to the Guide for the Care and Use of Laboratory Animals published by the US National Institutes of Health, the rats were fed under pathogen-free conditions with a 12 h light/dark cycle at 22 ± 3 °C. Animal experiment was proven by the Institutional Animal Care and Use Committee of Peking University Health Science Center (laboratory animal use license No. SYXK(JING)2021-0064; laboratory animal production license No. SCXK(JING)2021-0013).
Based on the description in a previous report [27 (link)] with a few modifications, a cirrhotic rat model was established by an injection of N-Nitrosodimethylamine, DMN (TCI, Shanghai, China, D0761). DMN was diluted with saline to a final concentration of 1% [28 (link)]. Cirrhosis was induced by an intraperitoneal injection (i.p.) of DMN (10 mg/kg body weight/day) on 3 consecutive days of each week for 4 weeks. DMN administration was stopped once during the 5th week and restarted from the 6th week to the 8th week on 2 consecutive days of each week. After successful modeling, 21 rats with a similar abdominal circumference, body weight and general condition were selected and randomly divided into 3 groups: the model group (n = 7), the 25a group (n = 7) and the tolvaptan group (n = 7).
The rats were placed in a metabolic cage and the body weight and abdominal circumference were measured. Urine samples were collected every 24 h. After the onset of ascites, a 24 h observation period was conducted, followed by the administration of 25a (100 mg/kg), tolvaptan (3 mg/kg) or a vehicle (0.5% poloxamer) to the rats by gavage. The treatment period was 6 days. The rats were given free access to food. The water intake was limited to the previous day’s intake amount plus 10 mL, as previously described [27 (link)]. During the treatment, blood samples were collected from the rats every 3 days. At the end of the treatment, liver and kidney samples were collected from the rats.
Ying Y., Li N., Wang S., Zhang H., Zuo Y., Tang Y., Qiao P., Quan Y., Li M, & Yang B. (2023). Urea Transporter Inhibitor 25a Reduces Ascites in Cirrhotic Rats. Biomedicines, 11(2), 607.
Full text: Click here
Publication 2023
Abdomen Animals Animals, Laboratory Ascites BLOOD Body Weight Dimethylnitrosamine Food Injections, Intraperitoneal Institutional Animal Care and Use Committees Kidney Liver Liver Cirrhosis Males pathogenesis Poloxamer Rattus norvegicus Saline Solution Tolvaptan Tube Feeding Urine Water Consumption
2
Tolvaptan for Acute Stanford Type A Aortic Dissection
Fifty-one patients with acute Stanford type A AD were surgically treated at our hospital between January 1, 2018, and December 31, 2020. Four of these patients died after surgery, and two were excluded from the study due to incomplete clinical data.
Of the remaining 45 patients, 21 received tolvaptan after surgery (Group T), while 24 patients did not (Group L).
The normal procedure for cardiac surgery in our hospital is that that patients return to the ward from the intensive care unit (ICU) when their pain VAS score is below 5 and their blood oxygen saturation is continuously higher than 90%.
All patients started oral diuretic therapy (torasemide 20 mg/day oral) on the first day after transfer to the department of cardiac surgery from the ICU and continued for at least one week. The patients receiving tolvaptan were given oral tolvaptan in addition to oral torasemide. Tolvaptan was administered at a 15 mg/day dose for at least one week. Intravenous injection of furosemide (20 mg/potion) or torasemide (10 mg/potion) was used intermittently according to the patient's urine volume.
Wang W., Gao F., He X., Gao Y., Shi L., Liu W, & Zhuang X. (2023). Efficacy of tolvaptan in postoperative volume therapy for acute Stanford type A aortic dissection. BMC Cardiovascular Disorders, 23, 95.
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Publication 2023
Diuretics Furosemide Operative Surgical Procedures Oximetry Patients Surgical Procedure, Cardiac Therapeutics Tolvaptan Torsemide Urine Visual Analog Pain Scale
3
Triglyceride-Glucose Index and Cardiovascular Outcomes
Normally distributed variables were presented as mean ± standard deviation (SD) and compared between the groups by means of ANOVA test. Categorical variables were presented as number (percentage) and the Chi-squared test was conducted to compare differences among groups.
An analysis of Cox proportional hazards regression was conducted to estimate the HR and the 95% CI for the primary and secondary observational endpoints. Variables added to the multiple regression were identified through univariate analysis (P< 0.05). The first quartile group of TyG served as the reference group. No variables were adjusted in model 1. In model 2, age and sex were incorporated into the adjustment. In model 3, sex, heart rate, body mass index, NYHA class, prior PCI, albumin, TC(total cholesterol), LDL-C(low-density lipoprotein cholesterol), HDL-C(high-density lipoprotein cholesterol), potassium, uric acid, LVEF, ARB(angiotensin receptor blocker), thiazide diuretics, spironolactone, tolvaptan, sacubitril/valsartan, diffuse lesion, SYNTAX score, LM (left main artery) disease, in-stent restenosis, chronic total occlusion target vessel (LM) were incorporated into the model. In order to assess the incidence rate of adverse events among groups stratified by TyG quartiles, Kaplan–Meier survival analyses were performed and the log-rank test was conducted to determine discrepancies among four quartiles. Subgroup analysis was conducted to assess the influence of the TyG index on MACE in the DM and no-DM groups and P for interaction was calculated.
The nonlinear association between TyG index as a continuous variable and MACE was evaluated using the adjusted RCS model. The variables in the model were consistent with the model 3. The number of knots was based on the lowest value of the Akaike information criterion and four knots were chosen for the analysis. Statistical analyses were performed using Stata version 15.0 software (4905 Lakeway Drive, College Station, Texas 77845 USA) and R software (R-project ®; R Foundation for Statistical Computing, Vienna, Austria, ver. 4.2.1). P < 0.05 was considered statistically significant.
Sun T., Huang X., Zhang B., Ma M., Chen Z., Zhao Z, & Zhou Y. (2023). Prognostic significance of the triglyceride-glucose index for patients with ischemic heart failure after percutaneous coronary intervention. Frontiers in Endocrinology, 14, 1100399.
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Publication 2023
Albumins Angiotensin Receptor Antagonists Arteries Blood Vessel Cholesterol Cholesterol, beta-Lipoprotein Dental Occlusion High Density Lipoprotein Cholesterol Index, Body Mass Left Main Coronary Artery Disease Myristica fragrans neuro-oncological ventral antigen 2, human Potassium Rate, Heart sacubitril-valsartan Spironolactone Stents Thiazide Diuretics Tolvaptan Uric Acid
4
Tolvaptan Dosing for Pediatric ADPKD
Subjects taking tolvaptan tablets receive daily split doses (upon awakening and 8 h later) based on body weight and tolerability as reported in a pediatric ADPKD clinical trial (Online Resource 1) [25 (link)]. As with adults [31 ], split-dose regimens with the larger dose taken in the morning are used to minimize overnight aquaretic effects while maintaining vasopressin V2 receptor inhibition. Each tolvaptan dose is to be administered with 240 mL of water as part of the effort to maintain proper hydration status. Subjects may down-titrate at any time during the trial if the current dose is not tolerable; however, subjects are asked to stay on the highest tolerable dose possible.
Mekahli D., Liebau M.C., Cadnapaphornchai M.A., Goldstein S.L., Greenbaum L.A., Litwin M., Seeman T., Schaefer F, & Guay-Woodford L.M. (2023). Design of two ongoing clinical trials of tolvaptan in the treatment of pediatric patients with autosomal recessive polycystic kidney disease. BMC Nephrology, 24, 33.
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Publication 2023
Adult Body Weight Polycystic Kidney, Autosomal Dominant Psychological Inhibition Tolvaptan Treatment Protocols Vasopressin V2 Receptor
5
Tolvaptan Dosing Adjustments for CYP3A4 Inhibitors
For subjects taking suspension and needing to take a moderate CYP3A4 inhibitor (e.g., fluconazole, erythromycin), both morning and afternoon doses are to be reduced by half, with timing of doses unchanged. For subjects taking the suspension and a strong CYP3A4 inhibitor, both morning and afternoon doses (as applicable), should be reduced by dividing the dose by 4.
For subjects taking tablets and requiring moderate CYP3A4 inhibitors, doses should be divided by 2 when possible. For 15/7.5 mg and 7.5/7.5 mg regimens, only the morning dose should be taken. For 7.5 mg once daily, tolvaptan dosing should be interrupted. For subjects taking tablets and requiring strong CYP3A4 inhibitors, if total daily tolvaptan dose is ≥ 45 mg, 15 mg once daily should be taken; if not well tolerated, then tolvaptan should be down titrated to 7.5 mg once daily. If total daily dose is ≥ 22.5 mg to < 45 mg, 7.5 mg once daily should be taken, with dose interruption if not well tolerated. Treatment should be interrupted if total daily dose is < 22.5 mg.
Relevant safety assessments are performed in accordance with the institution’s local standard of care after any dosing changes for concomitant medications, including but not limited to diuretics, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.
Mekahli D., Liebau M.C., Cadnapaphornchai M.A., Goldstein S.L., Greenbaum L.A., Litwin M., Seeman T., Schaefer F, & Guay-Woodford L.M. (2023). Design of two ongoing clinical trials of tolvaptan in the treatment of pediatric patients with autosomal recessive polycystic kidney disease. BMC Nephrology, 24, 33.
Full text: Click here
Publication 2023
Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Cytochrome P-450 CYP3A4 Inhibitors Diuretics Erythromycin Fluconazole Pharmaceutical Preparations Safety Tolvaptan Treatment Protocols

Top products related to «Tolvaptan»

1
Tolvaptan by Merck Group
Sourced in United States
Tolvaptan is a lab equipment product manufactured by Merck Group. It is a selective vasopressin V2-receptor antagonist.
2
Dimethyl sulfoxide (dmso) by Merck Group
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DMSO is a versatile organic solvent commonly used in laboratory settings. It has a high boiling point, low viscosity, and the ability to dissolve a wide range of polar and non-polar compounds. DMSO's core function is as a solvent, allowing for the effective dissolution and handling of various chemical substances during research and experimentation.
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Tolvaptan by Bio-Techne
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Tolvaptan is a laboratory equipment product manufactured by Bio-Techne. It is a selective vasopressin V2 receptor antagonist, which is primarily used for research purposes in the field of biology and biochemistry.
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Opc41061 by Merck Group
OPC41061 is a laboratory equipment product manufactured by Merck Group. It is designed to facilitate scientific research and analysis. The core function of this product is to provide a reliable and precise measurement tool for researchers and laboratory professionals. No further details about the intended use or interpretation of this product are provided.
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More about "Tolvaptan"

Tolvaptan is a selective V2 vasopressin receptor antagonist, also known as OPC41061 or Eclipse Ts2-FL, that is used for the treatment of hyponatremia and autosomal dominant polycystic kidney disease (ADPKD).
It works by inhibiting the action of vasopressin, a hormone that regulates water balance in the body.
Tolvaptan has been shown to increase urine output and decrease serum sodium levels in patients with hyponatremia, and to slow the progression of kidney cysts in those with polycystic kidney disease.
Researchers can optimize their Tolvaptan studies using PubCompare.ai's AI-driven protocol comparison tools, which help enhance reproducibility and accuracy by easily locating the best Tolvaptan protocols from published literature, preprints, and patents.
These tools can be particularly useful for researchers working with related compounds like DMSO, Forskolin, 8-Br-cAMP, and DDAVP, which may interact with or modulate the effects of Tolvaptan.
PubCompare.ai's platform also offers integration with SAS 9.4 and WinNonlin Pro, popular software for statistical analysis and pharmacokinetic modeling, respectively.
This can streamline the data analysis and reporting process for Tolvaptan studies, further enhancing the accuracy and reproducibility of the research.