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Topic: Everolimus



  
 Article #1816, Cardiac-Allograft Vasculopathy Is Significantly Lower Among Heart Transplant Patients Treated with ...
The severity and incidence of cardiac-allograft vasculopathy was significantly lower among first heart transplant patients treated with everolimus compared with those treated with azathioprine.
The researchers report that the significant reduction in the frequency of rejection of at least grade 3A was the individual variable most responsible for the benefit of everolimus therapy.
"Our finding that everolimus significantly reduced the frequency and severity of vasculopathy, as measured by intravascular ultrasonography, offers a note of cautious optimism with respect to the control of this disorder," Dr. Eisen and colleagues write.
http://www.perfusion.com/cgi-bin/absolutenm/anmviewer.asp?a=1816&z=8

  
 News 14 Carolina 24 Hour Local News HEALTH
Edson was part of a study with an experimental drug called Everolimus.
But with the help of this new drug, Edson is living life to the fullest.
This was compared to about 47 percent of participants who were given other commonly used drugs that suppress the immune system attack.
http://www.news14charlotte.com/content/health/?ArID=68605&SecID=26

  
 EVEROLIMUS REDUCES CARDIAC ALLOGRAFT VASCULOPATHY IN DE NOVO HEART TRANSPLANT RECIPIENTS: 24 MONTH FOLLOW-UP
The incidence of acute rejection was significantly lower with everolimus (1.5mg: 34.9%, 3mg: 22.7%, AZA: 48.1%).
On the intent-to-treat analysis, everolimus (1.5 and 3mg daily) reduced the incidence of acute rejection in a dose-dependent fashion.
As measured by IVUS, the incidence of vasculopathy was significantly reduced with everolimus.
http://www.pulsus.com/ccc2003/abs/a153.htm

  
 Healthcare Sales & Marketing Network News: Guidant Reports Positive Six-Month Results from the SPIRIT FIRST Everolimus ...
MACE at six-month follow-up for the everolimus eluting arm of Future I and Future II was 7.7 percent and 4.8 percent, respectively.
These results are consistent with the outstanding results from the FUTURE I and FUTURE II clinical trials utilizing a stainless steel stent platform with everolimus and a bioabsorbable polymer.
FUTURE I and FUTURE II evaluated safety and performance of an everolimus eluting stent with a bioabsorbable polymer drug carrier and stainless steel stent platform.
http://www.salesandmarketingnetwork.com/news_release.php?ID=2000778&key=Cordis

  
 Pharmalicensing.com: : Guidant becomes exclusive licensee of Everolimus
With paclitaxel and everolimus, Guidant has a very strong portfolio of drug eluting stent therapies to bring to patients and physicians worldwide."
Guidant Corporation has agreed with Novartis Pharma AG to expand their current license agreement by granting Guidant exclusive worldwide rights to utilize everolimus in drug eluting stents for the prevention and treatment of coronary and peripheral vascular diseases.
Results of our pre-clinical work with everolimus have been positive.
http://www.pharmalicensing.com/news/headlines/1032339002_3d883e3acc77b

  
 Press and News - News Brief
The general nature of the discussion, combined with the experimental nature of the drug, make it unlikely that the Cardiology Domain article will single out everolimus at this time.
The double-blind, randomized study, led by Howard J. Eisen, MD, of Temple University School of Medicine and underwritten by the drug's manufacturer, Novartis, included 52 participating medical centers.
The Content Team will continue to monitor clinical trials on everolimus.
http://www.northpointdomain.com/news_briefs/c_090403.cfm

  
 ACC: First Human Experience Using New Everolimus Stent Coating Is Positive
ACC: First Human Experience Using New Everolimus Stent Coating Is Positive
[Study Title: First Human Experience Using a New everolimus Stent Coating: Procedural and Six-Month Follow-Up Results of the FUTURE Trial.
Title: ACC: First Human Experience Using New Everolimus Stent Coating Is Positive
http://www.docguide.com/dg.nsf/PrintPrint/95439BC8209F792B85256CFB0057E8B7

  
 Guidant News Release —January 2, 2003
Guidant’s positive pre-clinical data on everolimus in coronary stenting applications was presented at the 2002 Transcatheter Cardiovascular Therapeutics (TCT) conference.
Guidant previously acquired an exclusive, worldwide license to the drug everolimus from Novartis Pharma AG for use in drug eluting stents.
The statements are based on assumptions about many important factors, including satisfaction of the conditions described in the release, clinical and regulatory timelines and developments, and other factors identified on Exhibit 99.1 to the company’s most recent 10-Q. Actual results may differ materially.
http://www.guidant.com/news/300/web_release/nr_000320.shtml

  
 Immunosuppressant everolimus significantly reduces life-threatening heart transplant complications
PHILADELPHIA, Pa. (August 28, 2003) — Treatment with the new immunosuppressant drug everolimus is significantly more effective in reducing the severity and incidence of serious complications in heart transplant patients than the current therapy, according to a study in the Aug. 28 The New England Journal of Medicine.
Rates of CMV infection reached only 7.6 percent and 7.7 percent in the 3.0 and 1.5 mg/d everolimus groups, respectively, in comparison to nearly three times that, or 21.5 percent, in the azathioprine group.
The incidence rate of severe adverse events was slightly higher among patients treated with everolimus 3mg/day compared to everolimus 1.5mg/day and azathioprine-treated patients.
http://www.eurekalert.org/pub_releases/2003-08/pn-ies082703.php

  
 Sirolimus (Rapamune)
As with many other therapeutic agents, therapeutic monitoring is considered to be useful as an aid to therapy.
SIROLIMUS (RAPAMYCIN) TACROLIMUS, EVEROLIMUS, and CYCLOSPORINE ANALYSIS BY HPLC/MS/MS RML provides research and therapeutic drug monitoring analysis for the new anti-rejection and anti-proliferative drugs Sirolimus (rapamycin), everolimus (Certican), tacrolimus (FK-506), cyclosporine, and other immuno-suppressants using state-of-the-art technology.
Because rapamycin, tacrolimus, and everolimus are macrolide biotechnology products, there are significant analytical concerns with respect to stability and purity.
http://www.rockylab.com/Sirolimus(Rapamune)1.html

  
 Guidant News Release —March 30, 2003
Dr. Peter Fitzgerald, Associate Professor of Cardiovascular Medicine, and co-director of the Center for Research in Cardiovascular Interventions and director of the Cardiovascular Core Analysis Laboratory will present additional results from the IVUS analysis of FUTURE I patients during the American College of Cardiology meeting.
Guidant also obtained a nonexclusive license to utilize this technology with other drugs in drug eluting stents.
Data Supports Use of Everolimus for Drug Eluting Stents
http://www.guidant.com/news/300/web_release/nr_000357.shtml

  
 Novartis licenses Everolimus, the active ingredient in CerticanTM, to Guidant for use .....
Novartis Pharma AG announced today that it had entered into a worldwide co-exclusive license agreement with Guidant Corporation, granting Guidant rights to utilize the drug everolimus in drug eluting stents for the treatment of coronary and peripheral vascular diseases.
Guidant and Novartis have independently observed positive results in animal studies evaluating the drug's effectiveness for the prevention of restenosis.
Everolimus, a new investigational drug, is a potent proliferation inhibitor that targets primary causes of chronic rejection in organ transplantation patients.
http://www.prdomain.com/companies/n/novartis/news_releases/200203mar/pr20020328.htm

  
 Biosensors to Sell Everolimus Eluting Stent Program to Guidant
Preliminary results presented from the FUTURE I first-in-man clinical trial utilizing everolimus demonstrated no restenosis in 11 patients receiving the drug eluting stent at six-month angiographic follow up.
"We view Guidant as the logical partner to help drive our everolimus research to successful commercialization, and fully expect that this arrangement will be only the first of many licensing agreements that will bring to the clinical marketplace the broad, diverse range of exciting drug and polymer compound technologies that we are developing."
It also provides a non-exclusive license to utilize Biosensors' bioabsorbable polymer formulation technology with other drugs in drug eluting stents controlled by Guidant.
http://www.forrelease.com/D20030319/law099.P2.03192003171531.00143.html

  
 Oral Everolimus Inhibits In-Stent Neointimal Growth -- Farb et al. 106 (18): 2379 -- Circulation
that everolimus was associated with neither positive nor negative
and hypocellularity in the everolimus group; the mean medial
Everolimus treatment (groups 1 and 2) was not
http://circ.ahajournals.org/cgi/content/full/106/18/2379

  
 HON - News : Pill Prevents Rabbit Stents from Re-Blocking
"Although I would like to study everolimus in individuals who undergo stent procedures, there are presently no plans for clinical trials with human patients," says Virmani.
"Although there have been other promising advances in treating restenosis that use radiation or stents that slowly release a medication, I believe an orally administered drug like everolimus provides a better, more cost-effective long-term solution."
A new study from researchers at the Armed Forces Institute of Pathology suggests that orally administered everolimus, one of a class of drugs known as proliferation inhibitors, may prevent new blockage at stent sites.
http://www.hon.ch/News/HSN/509435.html

  
 Australian Prescriber
Everolimus is a derivative of the immunosuppressant drug sirolimus.
This was significantly more than the 41.6% of the 209 patients given everolimus 1.5 mg, and the 32.2% of the 211 patients given everolimus 3.0 mg.
Even if the patients are taking 'statins' their triglyceride and cholesterol concentrations are likely to increase.
http://www.australianprescriber.com/index.php?content=/latestdrugs/2005/apr_everolimus.htm

  
 ARUP: Everolimus (Certican)
The therapeutic and toxic ranges for everolimus are not well defined, and will likely depend on coadministered medications, the organ transplanted, time post-transplant, and other aspects of the specific clinical application.
For example, a Cmin target range of 7.8-15 ng/mL has been suggested for everolimus administered with cyclosporine, in the early post renal transplant period.
http://www.aruplab.com/guides/ug/tests/0092118.jsp

  
 New drug is safer and more effective in preventing heart tranplant rejection
According to lead author Howard Eisen, M.D., professor of medicine at Temple University School of Medicine and medical director of cardiac transplant at Temple University Hospital, everolimus is not only more effective, but also safer than standard therapy in preventing heart transplant rejection.
"Our findings over a two-year period reinforce what we learned in the first year of this study, as well as add to our understanding of everolimus.
Although cyclosporine is widely used to prevent rejection in organ transplant recipients over the long term, two problems remain for heart transplant patients: acute rejection, which occurs within the first three months after transplantation, and cardiac allograft vasculopathy, a thickening of the heart wall that can restrict blood flow.
http://www.eurekalert.org/pub_releases/2004-04/tu-ndi042304.php

  
 HealthScout - Better Drug for Heart Transplant
After one year, researchers say it was clear everolimus was significantly more effective than azathioprine in preventing vasculopathy.
(Ivanhoe Newswire) -- A new study shows the drug everolimus is better at reducing problems in heart transplant patients than one of the currently used drugs.
Researchers report the patients on either dose of everolimus fared much better than the patients on azathioprine.
http://www.heartinfo.org/printerFriendly.asp?id=8006887

  
 [No title]
Everolimus (Certican() is an immunosuppressant drug that is significantly more effective in reducing the severity and incidence of serious complications in organ transplants as compared to current therapies.1 Everolimus is a compound initially developed for the prevention of allograft dysfunction.
Below are the important test specifications for everolimus.
National Medical Services has analytical techniques that are able to accurately detect low levels of the compound in whole blood by using state-of-the-art High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS).
http://www.nmslab.com/uploads/Everolimus.doc

  
 ASHP News: New Immunosuppressant Class Not Without Serious Concerns
By the 24-month point in the 36-month randomized, double-blind study of 213 stable lung transplant recipients, Snell said, 61% of those assigned to everolimus therapy had stopped taking the drug, whereas only 46% of azathioprine users had discontinued the therapy.
In the first 12 months, 22% of the 211 patients assigned to the higher dosage had discontinued therapy because of adverse events, compared with 16% of the 209 patients in the lower-dosage group and 13% of the 214 patients assigned to azathioprine 1–3 mg/kg/day.
Eisen said patients' drug concentrations were measured "but there was no therapeutic drug monitoring," adding that the study was designed several years ago.
http://www.ashp.org/news/ShowArticle.cfm?cfid=1353939&CFToken=20432447&id=6054

  
 Effect of Food on Everolimus Absorption: Quantification in Healthy Subjects and a Confirmatory Screening in Patients ...
To quantify the influence of a high-fat meal on the oral bioavailability of the immunosuppressant everolimus in a single-dose study in healthy subjects and to confirm the results in a small food-effect screening assessment in patients with renal transplants who were receiving multiple-dose everolimus.
The six patients received everolimus 2.5 mg/day orally, in addition to cyclosporine and prednisone.
Twenty-four healthy male volunteers; six clinically stable patients with renal transplants who were originally part of a phase I dose-escalation study.
http://www.extenza-eps.com/extenza/loadHTML?objectIDValue=33542&type=abstract

  
 Efficacy and safety of Guidant's everolimus eluting stent system.
Four key studies have been conducted or are in progress/planning.
In 2002 Novartis licensed everolimus out to Guidant for use in drug eluting stents for the treatment of coronary and peripheral arterial diseases.
After 30 days there was no in-stent restenosis or major adverse cardiac events in patients treated with the everolimus eluting stent indicating safety.
http://www.bioportfolio.com/LeadDiscovery/PubMed-120408.html

  
 Newsdetail :: 25-07-2005 23:21:37
This phenomenon is a major therapeutic challenge, occurring in 50 percent or more of heart-transplant recipients in the first years after surgery.
The results of intravascular ultrasonography showed that the incidence of vasculopathy was lower in the everolimus groups, particularly the higher-dose group (35.7 percent in the 1.5mg group; 30.4 percent in the 3.0 mg group; and 52.8 percent in the azathioprine group).
However, there was a greater increase in mean serum creatinine levels in the two everolimus groups than in the azathioprine group.
http://www.eurotransplant.nl/index.php?id=newsdetail&newsid=433

  
 EFFICACY AND SAFETY OF EVEROLIMUS AS PART OF A TRIPLE IMMUNOSUPPRESSIVE REGIMEN IN DE NOVO CARDIAC TRANSPLANT ...
However, there were no differences with regard to increase of mean LDL- and HDL-cholesterol among all three treatment groups.
Everolimus (RAD), an investigational new drug, is a proliferation signal inhibitor that targets the causes of chronic rejection (eg, acute rejection and CMV infection).
400 mg/dL: 32.7%, 26.6%, 14.5%; cholesterol > 240 mg/dL: 62.8%, 66.8%, 45.8%) and maximum mean serum creatinine during treatment (mol/L: 235, 238, 194) occurred more frequently in patients treated with everolimus and statins.
http://www.ccs.ca/society/congress2002/abstracts/abs/a452.htm

  
 CHFpatients.com - Heart Transplant - Updates
The trial's primary end point was death, need for another heart transplant, acute rejection grade 3A or worse, or rejection that seriously reduced heart function.
everolimus patients developed CAD than azathioprine patients (53%)
A new drug named everolimus (Certican) was tested against a standard anti-rejection drug called Imuran (azathioprine) for preventing transplant disease.
http://www.chfpatients.com/tx/txextras.htm

  
 CardioValens.com:Matters of the Heart
The late breaking results were presented by Dr. Ricardo A. Costa, (Interventional Cardiologist, Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York) at the scientific sessions 2004 of the American College of Cardiology.
The safety and performance of everolimus-eluting stent (EES) was assessed in two clinical trials, referred to as the FUTURE-I and FUTURE-II (First Use To Underscore restenosis Reduction with Everolimus).
The two-part animal study first compared neointimal thickness and percent area stenosis in an animal model.
http://www.cardiovalens.com/centers/desr/reviews/rev-20.asp

  
 Everolimus Scheme
The scheme was intended to monitor the performance of centres providing a central laboratory service for Novartis Pharma sponsored clinical studies.
The format of the scheme is similar to that adopted for the other immunosuppressive drugs we test, in that three samples of blood are circulated in each challenge, including pooled samples from patients receiving everolimus and blood samples to which everolimus has been added to known concentrations.
Following registration of the drug throughout most of Europe, and the introduction of an immunoassay to measure the drug on the TDx platform ( http://www.seradyn.com), we have decided to make this scheme available to laboratories offering routine TDM services for everolimus.
http://www.bioanalytics.co.uk/html/everolimus_scheme.html

  
 Everolimus, 99% pure, by LC Laboratories
"Sirolimus, but not the structurally related RAD (everolimus), enhances the negative effects of cyclosporine on mitochondrial metabolism in the rat brain." Br J Pharmacol.
Everolimus, a rapamycin analog with potent immunosuppressive activity, has been shown to work in synergism with cyclosporin, both in vivo and in vitro.
Unlike sirolimus (rapamycin), everolimus does not enhance the inhibition of rat brain mitochondrial glucose metabolism caused by cyclosporin.
http://www.lclabs.com/PRODFILE/D-F/E-4040.php4

  
 Everolimus
Armstrong VW, Streit F. Drug monitoring of Sirolimus and Everolimus.
Everolimus should also not be taken together with grapefruit juice since this juice can increase the bioavailability of various drugs by inhibition of the intestinal cytochrome P450-isoenzyme CYP3A4.
Everolimus is approved for the prevention of organ rejection after kidney and heart transplantations in combination with cyclosporine and corticosteroids.
http://www.labor-limbach.de/Everolimus.256.0.html?&L=1

  
 News - Everolimus-Eluting Stent Shows Significant Benefit at Six Months: Presented at TCT
"Everolimus is an analogue of sirolimus," said Eberhard Grube, MD, Siegburg Heart Center, Germany, who presented the results from both the FUTURE I and FUTURE II studies at a late-breaking clinical trials session.
FUTURE I, conducted at a single center, randomized 27 patients to the everolimus-eluting stent (EES) and 15 to the bare metal stents.
WASHINGTON, DC -- September 29, 2003 -- Everolimus-eluting stents might be as effective as sirolimus-eluting stents, according to the results of 2 trials presented here on September 17
http://www.docguide.com/news/content.nsf/news/8525697700573E1885256DB0005F0238

  
 Cardiac-Allograft Vasculopathy
in the group receiving 3.0 mg of everolimus (nearly 40 percent),
With approximately 75 percent of patients receiving prophylaxis
Several other effects of everolimus in this study are of potential
http://www.medical-journals.com/r03288c.htm

  
 The Journal of Invasive Cardiology
7 Grube E, Gerckens U, Buellesfeld E. First human experience using a new everolimus stent coating: Early findings of the FUTURE trial.
A recent study4 involving a small number of patients showed that sirolimus-eluting stents with biostable polymer coating were effective in treating ISR, but the efficacy of sirolimus-eluting stents has not yet been established for the treatment of ISR, especially for diffuse ISR lesions.
The mechanism of action of everolimus at the cellular and molecular levels may be similar to sirolimus.
http://www.invasivecardiology.com/jic/displayArticle.cfm?articleID=article3722

  
 Blood Concentrations of Everolimus Are Markedly Increased by Ketoconazole -- Kovarik et al. 45 (5): 514 -- The Journal ...
Key Words: Everolimus • ketoconazole • drug interaction
received the reference treatment of a single 2-mg dose of everolimus.
Blood Concentrations of Everolimus Are Markedly Increased by Ketoconazole -- Kovarik et al.
http://jcp.sagepub.com/cgi/content/abstract/45/5/514

  
 ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies: Trial List
AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma Multiforme
Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate
Everolimus in Treating Patients With Stage IV Melanoma
http://www.clinicaltrials.gov/ct/gui/search?term=everolimus

  
 Clinical Trial: Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive ...
Determine whether a pharmacokinetic interaction exists between everolimus and gefitinib in patients treated with this regimen.
Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer
Determine the association between clinical outcomes and markers that may predict sensitivity of a tumor in patients treated with this regimen.
http://clinicaltrials.gov/ct/show/NCT00085566?order=43

  
 Everolimus - Wikipedia, the free encyclopedia
Everolimus is a new mTOR inhibitor drug used as an immunosuppressant to prevent rejection of organ transplants.
Everolimus may have a role in heart transplantation as it has been shown to reduce chronic allograft vasculopathy in such transplants.
It also may have a similar role to sirolimus in kidney and other transplants.
http://en.wikipedia.org/wiki/Everolimus

  
 New drug may reduce 'transplant disease' in heart patients
According to a study published in today's issue of the New England Journal of Medicine, patients who took the experimental drug, called everolimus, were less likely than those taking a conventional drug to develop a progressive narrowing of the coronary arteries.
The amount of narrowing also was less in the everolimus patients.
In all three cases, the drugs were combined with the anti-rejection drug cyclosporine and corticosteroids.
http://www.post-gazette.com/pg/03240/215750.stm

  
 certican drug information, certican side effects
New immunosuppressant Certican_ outperforms azathioprine in lung transplant patients
In one of the largest studies of its kind, Certican _ (everolimus) was shown to outperform azathioprine in preventing acute rejection and preserving pulmonary function in stable lung transplant patients (reducing the risk of chronic allograft...
Novel Novartis drug Certican® has been shown to target many of the underlying causes of chronic allograft dysfunction or late graft loss...
http://www.drugs.com/drug/certican

  
 ALS TDF
CONCLUSIONS: Everolimus displays a potent inhibitory effect on PTLD-derived cells in vitro and in vivo in a dose range leading to prevention of allograft rejection and may prove effective in both the prevention and treatment of PTLDs in transplant patients.
Because the subsequent pharmacokinetic analysis indicated rapid everolimus absorption, distribution, and clearance in mice (with a half-life of 3 to 6 hr and maximum drug blood concentration reached after 0.5 to 1 hr), treatment was changed to a twice-daily regimen.
METHODS: We tested the effect of everolimus (RAD, Novartis Pharma AG, Basel, Switzerland) on human PTLD-derived cells using in vitro assays and an in vivo severe combined immunodeficiency disease mouse xenotransplant model.
http://www.als.net/articles/articleDetail.asp?articleId=2629

  
 Liver Facts
The failure rate was higher for patients given a smaller dose of everolimus in the trial, 36.4 percent, but that was still well below that of the patients given azathioprine.
Everolimus "works by inhibiting the proliferation of muscle cells and also proliferation of the immune cells that cause rejection," Eisen says.
Studies must also be done to see whether everolimus treatment "can accomplish secondary prevention, to stop or decrease the severity of the disease in people who already have the disease," Eisen says.
http://www.liverfacts.com/ms/news/514832/main.html

  
 British Journal of Pharmacology - Abstract of article: Everolimus treatment downregulates renocortical cyclooxygenase-2 ...
Everolimus treatment downregulates renocortical cyclooxygenase-2 expression in the rat kidney
British Journal of Pharmacology - Abstract of article: Everolimus treatment downregulates renocortical cyclooxygenase-2 expression in the rat kidney
Based on recent evidence that renal cyclooxygenase-2 (COX-2) gene expression is suppressed by immunosuppressive agents such as cyclosporin A (CsA), tacrolimus and dexamethasone, this study aimed to characterize the effect of the new immunosuppressant everolimus on COX-2 expression in the rat kidney.
http://www.nature.com/bjp/journal/vaop/ncurrent/abs/0706259a.html

  
 Subject Consultant Review
The incidence of cytomegalovirus infection was significantly lower in patients receiving everolimus.
At 12 months, there were no statistically significant differences between the groups for the incidence of biopsy-proven acute rejection, graft loss or death.
The effectivness of Everolimus (1.5 mg or 3 mg daily) was compared with MMF (2 g daily) in a randomized, multicenter trial in de novo renal allograft recipients (n=588) who also received cyclosporine and corticosteroids as part of a triple immunosuppressive regimen.
http://www.ndt-educational.org/watschinger315.asp

  
 Pharmacy and Pharmacists :: Transplants: From cyclosporine to everolimus :: Pharmaceutical Information and Articles
Everolimus, a proliferation signal inhibitor, has been approved for use in Europe for the prevention of organ rejection in patients receiving an allogenic renal or cardiac transplant.
The drug works by blocking the growth factor proliferation of human T cells, B cells, and the vascular smooth muscle cells, an important mechanism in chronic allograft dysfunction.
Novartis' Transplantation and Immunology division received an "approvable letter" from the Food and Drug Administration last October for everolimus (Certican) and is expecting final approval by the end of 2004.
http://www.pharmainfo.net/displayarticle8814.html

  
 AllRefer Health - Medical News
Washington, Aug 28 (ANI): New research shows that Everolimus, a new immuno-suppressant drug, can effectively reduce post-heart transplant complications.
New drug lowers post-heart transplant recovery risk: Study
http://health.allrefer.com/news/index.php?tim=29-8-2003

  
 SSM Online - News
The study is blinded, therefore, it is not known at this time which group received the everolimus- eluting coronary stent and which group received the control stent.
As defined in SPIRIT FIRST, the major adverse cardiac event rate includes any deaths, heart attacks, or clinically driven target lesion revascularizations within the 30- day period.
http://www.ssmonline.org/News/ViewRelease.asp?ReleaseID=4721

  
 ECONOMIC EVALUATION OF EVEROLIMUS AS PART OF TRIPLE IMMUNOSUPPRESSIVE THERAPY IN A PHASE 3 DE NOVO HEART TRANSPLANT ...
There were no significant differences among treatment arms in mean total costs of treatment (excluding the costs of everolimus and AZA) over 1 year.
Further analyses with longer follow-up are required to fully evaluate the cost-effectiveness of using everolimus in the treatment of de novo heart transplant recipients.
CONCLUSION: Over a 12-month follow-up period everolimus did not significantly increase treatment costs while providing significant clinical benefits.
http://www.pulsus.com/ccc2003/abs/a055.htm

  
 Subject Consultant Review
Everolimus and reduced-exposure cyclosporine in de novo renal-transplant recipients: a three-year phase II, randomized, multicenter, open-label study.
In de novo renal-transplant recipients, the regimen of everolimus (3 mg/day) plus reduced-dose Neoral (CsA trough levels 50-100 ng/mL) was well tolerated, with low efficacy failure and better renal function in comparison with everolimus plus full-dose Neoral (CsA trough levels 125-250 ng/ mL).
Nashan B, Curtis J, Ponticelli C, Mourad G, Jaffe J, Haas T; 156 Study Group.
http://www.ndt-educational.org/watschinger317.asp

  
 Molcan Everolimus
Everolimus is a macrolide immunosuppressant produced by semisynthesis from sirolimus.
http://www.molcan.com/everolimus.htm

  
 Antibiotika/Chemotherapeutika
Die Blutspiegel von Everolimus sollten überwacht werden, insbesondere wenn der Patient CYP3A4-Induktoren oder -Inhibitoren einnimmt.
Die zusätzliche zweimalige Gabe des monoklonalen Antikörpers Basiliximab (Studie mit 256 Patienten) verringerte die Abstoßungsraten auf 13,7 und 15,8 Prozent.
Allerdings litten die Patienten unter 3 mg Everolimus deutlich häufiger an bakteriellen Infektionen.
http://www.pharmazeutische-zeitung.de/51-04.htm

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