ArticleClinical pharmacokinetics2006
Aliskiren exhibits similar pharmacokinetics in healthy volunteers and patients with type 2 diabetes mellitus.
Article in Clinical pharmacokinetics, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed, 66 citations in OpenAlex.
- Antihypertensive efficacy of the oral direct renin inhibitor aliskiren as add-on therapy in patients not responding to amlodipine monotherapy.Journal of clinical hypertension (Greenwich, Conn.) · 2007Trial
- Pharmacokinetics, mass balance, and metabolism of [Frontiers in pharmacology · 2026Article
- Aliskiren, the first direct renin inhibitor: assessing a role in pediatric hypertension and kidney diseases.Pediatric nephrology (Berlin, Germany) · 2014Review
- Spectrofluorimetric determination of aliskiren in tablets and spiked human plasma through derivatization with dansyl chloride.Journal of fluorescence · 2012Article
- Aliskiren: An orally active renin inhibitor.Journal of pharmacy & bioallied sciences · 2011Article
- Renin and cardiovascular disease: Worn-out path, or new direction.World journal of cardiology · 2011Article
- Role of aliskiren in blood pressure control and renoprotection.International journal of nephrology and renovascular disease · 2011Article
- Aliskiren: a review of its use as monotherapy and as combination therapy in the management of hypertension.Drugs · 2010Review
- New class of agents for treatment of hypertension: focus on direct renin inhibition.Vascular health and risk management · 2010Review
- Blocking the RAAS at different levels: an update on the use of the direct renin inhibitors alone and in combination.Vascular health and risk management · 2010Review
- Cardiovascular risk in hypertension - can we ask for more? : focus on aliskiren.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2008Article
- Oral direct renin inhibition: premise, promise, and potential limitations of a new antihypertensive drug.The American journal of medicine · 2008Review
- Clinical pharmacokinetics and pharmacodynamics of aliskiren.Clinical pharmacokinetics · 2008Review
- Direct renin inhibitors: a new approach to antihypertensive drug treatment.Journal of clinical hypertension (Greenwich, Conn.) · 2007Review
- Aliskiren--an orally active renin inhibitor. Review of pharmacology, pharmacodynamics, kinetics, and clinical potential in the treatment of hypertension.Vascular health and risk management · 2007Review
- Review
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Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe renin system is an attractive target for antihypertensive therapy in patients with diabetes mellitus. However, diabetes is associated with changes in gastrointestinal, renal and hepatic function that may affect the absorption and disposition of oral drugs. This study compared the pharmacokinetics and pharmacodynamics of the orally active direct renin inhibitor, aliskiren, in healthy volunteers and patients with type 2 diabetes.
methodsThis was an open-label study conducted in 30 patients with type 2 diabetes and 30 healthy volunteers matched for age, bodyweight and race. Following a 10-hour fast, all participants received a single oral dose of aliskiren 300mg. Blood samples were taken at frequent intervals for 96 hours post-dose for determination of plasma concentrations of aliskiren (using a high-performance liquid chromatography-tandem mass spectroscopy method). Plasma renin activity (PRA) and renin concentration (RC) were also measured for 24 hours after dosing.
resultsAliskiren exhibited similar pharmacokinetics in patients with type 2 diabetes and healthy volunteers. Exposure to aliskiren was slightly higher in patients with type 2 diabetes compared with healthy volunteers (mean area under the plasma concentration-time curve from 0 to 24 hours 1859 vs 1642 ng . h/mL; maximum observed plasma drug concentration 394 vs 348 ng/mL), while apparent clearance corrected for bioavailability was slightly lower (205 vs 234 L/h) and elimination half-life slightly longer (44 vs 39.9 hours), but there were no statistically significant differences for any pharmacokinetic parameters. There was no significant correlation between glycaemic control (% glycosylated haemoglobin) and any of the measured pharmacokinetic parameters in patients with type 2 diabetes. Aliskiren caused sustained suppression of PRA for at least 24 hours after dosing despite increasing RC; there were no major differences in the pharmacodynamic effects of aliskiren between patients with type 2 diabetes and healthy volunteers. Aliskiren was well tolerated in both patient groups, with no clinically significant changes in laboratory values and a low risk of adverse events.
conclusionAliskiren showed a similar pharmacokinetic profile in healthy volunteers and patients with type 2 diabetes, and administration of a single oral 300 mg dose of aliskiren was well tolerated by both patients and healthy volunteers. The pharmacodynamic effects of aliskiren were also similar in healthy volunteers and diabetic patients, with sustained inhibition of renin system activity observed for at least 24 hours after dosing.
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