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Medical research on lisinopril
Prioritizing Future Research on Off-Label Prescribing: Results of a Quantitative Evaluation.
Pharmacotherapy. 2008 Dec; 28(12): 1443-1452
Walton SM, Schumock GT, Lee KV, Alexander GC, Meltzer D, Stafford RS
Abstract Study Objective. To develop a prioritized list of individual drugs for which future research regarding off-label uses is warranted. Design. Retrospective, cross-sectional study. Data Sources. Commercial database that provides ongoing estimates of drug prescribing practices of office-based physicians in the United States and an Internet database of comprehensive evidence-based drug information. Measurements and Main Results. The base analyses incorporated three key factors based on the theory of value of information: volume of off-label use with inadequate evidence, drug safety, and cost and market considerations. Nationally representative prescribing data were used to estimate the number of off-label drug uses by indication from January 1, 2005-June 30, 2007, in the United States, and these indications were then categorized according to the adequacy of scientific support. Black-box warnings and safety alerts, drug cost, date of market entry, and marketing expenditures were also incorporated into the final model to produce a priority score. Sensitivity analyses were conducted by varying key model parameters. Our findings identified a high volume of off-label prescribing in the absence of good evidence for a substantial number of drugs, particularly antidepressants, antipsychotics, and anxiolytic-sedatives. Drugs that consistently ranked high in both our base model and sensitivity analyses were quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa. Conclusion. Future research into off-label drug use should focus on drugs used frequently with inadequate supporting evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Our quantitative analysis identified particular concerns with the off-label use of antipsychotic and antidepressant drugs. Targeted research and policy activities on our list of prioritized drugs have high potential value.
Angiotensin inhibition stimulates PPARgamma and the release of visfatin.
Eur J Clin Invest. 2008 Nov; 38(11): 820-6
Storka A, Vojtassakova E, Mueller M, Kapiotis S, Haider DG, Jungbauer A, Wolzt M
Background Angiotensin converting enzyme inhibitors (ACE-I) and angiotensin receptor blockers (ARB) exhibit beneficial antidiabetic effects in patients with type 2 diabetes independent of their blood pressure-lowering effects. Some antidiabetic properties of ARB and ACE-I might by exerted by activation of peroxisome proliferator-activated receptor gamma (PPARgamma). However, it is not clear whether this action is drug specific. Materials and methods The binding affinity of telmisartan, valsartan, lisinopril, rosiglitazone and angiotensin II to PPARgamma was assessed in a cell-free assay system. PPARgamma signalling was studied in isolated skeletal muscle cells using Western blot analysis of phosphorylated protein kinase B (pAKT) and phosphorylated insulin like growth factor-1 receptor (pILGF-1R). Further, the ability of the drugs under study to stimulate the release of the adipocytokine visfatin was investigated in isolated human adipocytes, skeletal muscle cells, and umbilical vein endothelial cells (HUVEC). Results The binding affinity to PPARgamma was highest for telmisartan with a half-maximal effective concentration of 463 nM, followed by lisinopril (2.9 microM) and valsartan (6.2 microM). In skeletal muscle cells phosphorylation of ILGF-1R was 2-fold increased after incubation with telmisartan or valsartan and 1.7-fold with lisinopril. pAKT expression was enhanced after incubation with telmisartan, valsartan and with lisinopril. The release of visfatin from adipocytes was 1.6-fold increased after treatment with lisinopril and about 2.0-fold increased with telmisartan and valsartan. Similar results were obtained in skeletal muscle cells and HUVEC. Conclusions Our data confirm agonism of telmisartan, valsartan and lisinopril on PPARgamma. Pharmacokinetic differences may explain different potencies of PPARgamma stimulation by drugs acting on the renin-angiotensin system in clinical settings.
Kidney Blood Press Res. 2008 Nov 19; 31(5): 350-359
Waanders F, van Goor H, Navis G
Background/Aims: Advanced glycation end products (AGEs) are involved in diabetic nephropathy. The AGE inhibitor pyridoxamine (PM) is renoprotective in experimental chronic allograft nephropathy supporting its potential in non-diabetic renal damage. Methods: We studied the effects of PM in adriamycin nephropathy (AN; 1.5 mg/kg i.v.). Six weeks after disease induction, treatment started with vehicle (VEH), lisinopril (ACEi; 75 mg/l drinking water), PM (2 g/l) and PM + lisinopril (PM/ACEi) (n = 12 per group) for 18 weeks. Age-matched healthy rats (n = 6) served as controls (CON). Results: ACEi reduced proteinuria, blood pressure, and renal damage. PM gradually increased blood pressure and not affected proteinuria. In PM/ACEi the antiproteinuric and blood pressure-lowering effects of ACEi were abrogated during long-term treatment. Remarkably, creatinine, focal glomerulosclerosis and interstitial fibrosis were considerably increased under PM/ACEi. Pronounced hypercholesterolemia, which occurred in both PM-treated groups, was accompanied by marked glomerular lipid deposition. Conclusion: PM was not renoprotective in AN. By contrast, renal damage was aggravated when PM was combined with ACEi. Despite the fact that there is no current evidence that these findings apply to the drug as used in human diabetic nephropathy, we emphasize the importance of close monitoring of blood pressure, lipids and possible direct toxic effects in future studies with PM in renal patients, especially when combining PM with ACEi.
Biomed Chromatogr. 2008 Nov 17;
Dasandi B, Shah S,
A novel, specific and sensitive ultraperformance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method was developed for the simultaneous determination of quinapril and its active metabolite quinaprilat in human plasma. The method involves a simple, one-step extraction procedure coupled with an Acquity UPLCtrade mark BEH C(18 )column (100 x 2.1 mm, i.d., 1.7 microm) with isocratic elution at a flow-rate of 0.2 mL/min and lisinopril as the internal standard. Detection was performed on a triple-quadrupole tandem mass spectrometer in multiple reaction monitoring mode via electrospray ionization. Using 250 microL plasma, the methods were validated over the concentration range 5.010-500.374 ng/mL for quinapril and 10.012-1000 ng/mL for quinaprilat, with a lower limit of quantification of 5.010 ng/mL for quinapril and 10.012 ng/mL for quinaprilat. The intra- and inter-day precision and accuracy were within 10.0%. The recovery was 85.8, 62.6 and 61.3% for quinapril, quinaprilat and lisinopril, respectively. Total run time was 3.0 min only. Copyright (c) 2008 John Wiley & Sons, Ltd.
J Chromatogr Sci. 2008 Nov-Dec; 46(10): 848-53
Zhou N, Liang YZ, Chen BM, Wang P, Chen X, Liu FP
A rapid, simple, and specific liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS) method has been developed and validated for the determination of lisinopril in human plasma. Enalaprilat was used as the internal standard (IS). Sample preparation of the serum involved deproteination with methanol twice, repeatedly. Samples were separated using a Thermo Hypersil-HyPURITY C18 reversed-phase column (150 x 2.1 mm i.d., 5 microm). Mobile phase consisted of formic acid solution (pH 2.9)-methanol-acetonitrile (58:25:17, v/v). Lisinopril and its internal standard were measured by electrospray ion source in positive selected ion monitoring mode. The method was validated with a linear range of 2.5-320 ng/mL and the lowest limits of quantitation were 2.5 ng/mL for lisinopril. The extraction efficiencies were approximately 80% and recoveries of method were in range of 94.4-98.2%. The intra-day relative standard deviation (RSD) was less than 8.8% and inter-day RSD was within 10.3%. QC samples were stable when kept at ambient temperature for 24 h, at -20 degrees C for 30 days and after four freeze/thaw cycles. The method has been successfully applied to the evaluation of pharmacokinetics and bioequivalence of 2 lisinopril formulations in 18 healthy Chinese volunteers after an oral dose of 20 mg.
Circulation. 2008 Nov 25; 118(22): 2259-2267
Davis BR, Kostis JB, Simpson LM, Black HR, Cushman WC, Einhorn PT, Farber MA, Ford CE, Levy D, Massie BM, Nawaz S,
BACKGROUND: Heart failure (HF) developing in hypertensive patients may occur with preserved or reduced left ventricular ejection fraction (PEF [>/=50%] or REF [
J Hum Hypertens. 2008 Nov 6;
Zou Z, Xi GL, Yuan HB, Zhu QF, Shi XY
Telmisartan and angiotensin-converting enzyme inhibitors (ACEIs) are both effective and widely used antihypertensive drugs targeting renin-angiotensin-aldosterone system. The study aimed to estimate the efficacy and tolerability of telmisartan in comparison with different ACEIs as monotherapy in the treatment of hypertension. Cochrane Central Register of Controlled Trials, PubMed and Embase were searched for relevant studies. A meta-analysis of all randomized controlled trials fulfilling the predefined criteria was performed. A random-effect model was used to account for heterogeneity among trials. Twenty-eight randomized controlled trials involving 5157 patients were ultimately identified out of 721 studies. Telmisartan had a greater diastolic blood pressure (DBP) reduction than enalapril (weighted mean difference (WMD) 1.82, 95% confidence interval (CI) 0.66-2.99), ramipril (WMD 3.09, 95% CI 1.94-4.25) and perindopril (WMD 1.48, 95% CI 0.33-2.62). Telmisartan also showed a greater DBP response rate than enalapril (relative risk (RR) 1.15, 95% CI 1.05-1.26), ramipril (RR 1.34, 95% CI 1.11-1.61) and perindopril (RR 1.22, 95% CI 1.05-1.41). There was no statistical difference in DBP reduction or therapeutic response rate between telmisartan and lisinopril (WMD -0.30, 95% CI -0.65 to 0.05; RR 0.99, 95% CI 0.80-1.23, respectively). Telmisartan had fewer drug-related adverse events than enalapril (RR 0.57, 95% CI 0.44-0.74), ramipril (RR 0.44, 95% CI 0.26-0.75), lisinopril (RR 0.70, 95% CI 0.56-0.89) and perindopril (RR 0.52, 95% CI 0.28-0.98). The meta-analysis indicates that telmisartan provides a superior BP control to ACEIs (enalapril, ramipril and perindopril) and has fewer drug-related adverse events and better tolerability in hypertensive patients.Journal of Human Hypertension advance online publication, 6 November 2008; doi:10.1038/jhh.2008.132.
Brain imaging findings predict blood pressure response to pharmacological treatment.
Hypertension. 2008 Dec; 52(6): 1113-9
Jennings JR, Muldoon MF, Whyte EM, Scanlon J, Price J, Meltzer CC
Hypertension appears to alter brain morphology, as well as the cerebrovascular support for information processing. Because these effects might reflect progressive effects of essential hypertension on the brain, we asked whether structural and functional brain indices would predict the success of pharmacological treatment of hypertension among 45 previously unmedicated individuals. After initial structural MRI and functional positron emission tomography imaging, subjects were randomly assigned in a double-blind fashion for treatment for 1 year with either lisinopril or atenolol. Systolic and diastolic blood pressure decreases after treatment stabilization were correlated to a pretreatment index of brain aging (combined ratings of ventricle and sulcal size and white matter hyperintensities) and the pretreatment change in regional cerebral blood flow during working memory in the thalamus and posterior parietal regions of interest. In multiple regression analyses, the structural brain index and the blood flow response in the thalamus predicted 20% of the variance in the systolic blood pressure response to treatment controlling for pretreatment blood pressure, age, gender, and type and dose of medication. Alcohol use influenced the thalamic response measure, but covariates did not alter the relation between greater indices of brain aging and less successful blood pressure response to treatment. The state of the brain may be an important factor in the remediation of blood pressure.
Diabetologia. 2008 Oct 31;
Schjoedt KJ, Astrup AS, Persson F, Frandsen E, Boomsma F, Rossing K, Tarnow L, Rossing P, Parving HH
AIMS/HYPOTHESIS: The purpose of this study was to evaluate the optimal renoprotective effect of ultrahigh doses of lisinopril, as reflected by short-term changes in urinary albumin excretion rate (UAER), in type 1 diabetic patients with diabetic nephropathy. METHODS: At the Steno Diabetes Center, 49 type 1 diabetic patients with diabetic nephropathy completed this double-masked randomised crossover trial consisting of an initial washout period followed by three treatment periods each lasting 2 months, where all patients received lisinopril 20, 40 and 60 mg once daily in randomised order in addition to slow-release furosemide. Allocation was concealed by sequentially numbered opaque sealed envelopes. UAER, 24 h ambulatory blood pressure (ABP) and estimated GFR were determined at baseline and after each treatment period. RESULTS: All 49 patients completed all three treatment periods. Baseline values were: UAER (geometric mean [95% CI]) 362 (240-545) mg/24 h, 24 h ABP (mean [SD]) 142 (14)/74 (8) mmHg and estimated GFR 75 (29) ml min(-1) 1.73 m(-2). Reductions in UAER from baseline were 63%, 71% and 70%, respectively, with the increasing doses of lisinopril (p < 0.001). Compared with lisinopril 20 mg there was a further reduction in UAER of 23% with lisinopril 40 mg and 19% with 60 mg, p < 0.05. ABP was reduced from baseline by 10/5, 13/7 and 12/7 mmHg (p < 0.001 vs baseline, p < 0.05 for diastolic ABP 20 vs 40 mg, otherwise NS between doses). The difference in UAER between 20 and 40 mg lisinopril was significant after adjustment for changes in ABP (p < 0.01). Two patients were excluded from the study because of an increase in plasma creatinine and one because of high BP; otherwise the study medication was well tolerated with few, mild, dose-independent adverse effects. CONCLUSIONS/INTERPRETATION: Lisinopril 40 mg once daily is generally safe and offers additional reductions in BP and UAER in comparison with the currently recommended dose of 20 mg. Lisinopril 60 mg offers no further beneficial effect. Trial registration: ClinicalTrials.gov NCT00118976 Funding: This study was financed out of local funds and was not supported by the medical industry.
J Pharm Belg. 2008 Sep; 63(3): 78-83
De Braekeleer K, Corthout J
Preparations containing lisinopril and the combination lisinopril/hydrochlorothiazide, and formulated as tablets were evaluated with different tests, including in vitro dissolution, assay and content uniformity, and determination of related compounds. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements.