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ABSTRACT: Spinal disorders are a major cause of disability and compromise in health-related quality of life. The direct and indirect costs of treating spinal disorders are estimated at more than $100 billion per year. With limited resources, the cost-utility of interventions is important for allocating resources.
We therefore performed a systematic review of the literature on cost-utility for nonoperative and operative interventions for treating spinal disorders.
We searched four databases for cost-utility analysis studies on low back pain management and identified 1004 items. The titles and abstracts of 752 were screened before selecting 27 studies for inclusion; full texts of these 27 studies were individually evaluated by five individuals.
Studies of nonoperative treatments demonstrated greater value for graded activity over physical therapy and pain management; spinal manipulation over exercise; behavioral therapy and physiotherapy over advice; and acupuncture and exercise over usual general practitioner care. Circumferential fusion and femoral ring allograft had greater value than posterolateral fusion and titanium cage, respectively. The relative cost-utility of operative versus nonoperative interventions was variable with the most consistent evidence indicating superior value of operative care for treating spinal disorders involving nerve compression and instability.
The literature on cost-utility for treating spinal disorders is limited. Studies addressing cost-utility of nonoperative and operative management of low back pain encompass a broad spectrum of diagnoses and direct comparison of treatments based on cost-utility thresholds for comparative effectiveness is limited by diversity among disorders and methods to assess cost-utility. Future research will benefit from uniform methods and comparison of treatments in cohorts with well-defined pathology.
Clinical Orthopaedics and Related Research 04/2012; 470(4):1106-23. · 2.53 Impact Factor
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ABSTRACT: Risk of new-onset diabetes after transplant (NODAT) is well characterized for adults but much less understood in pediatric transplant. This study examines the incidence and risk factors of NODAT in pediatric renal transplant patients.
The incidence of NODAT over the first 3 years after transplant was examined with the United States Renal Data System data for primary renal transplant recipients (ages 0-21 years, transplanted between 1995 and 2004) with Medicare primary. Patients had no evidence of diabetes before transplant. We estimated the cumulative incidence rate and used Cox proportional hazards regression to identify the risk factors for NODAT. Propensity scores were calculated for immunosuppression choice to adjust for potential confounding factors.
Two thousand one hundred sixty-eight recipients with valid immunosuppression records and without pretransplant evidence of diabetes were included. Unadjusted, cumulative NODAT incidence at 3 years posttransplant was 7.1%. Significant factors for increased risk of NODAT included cytomegalovirus D+/R- serostatus (adjusted hazard ratio [aHR]=1.60), age 13 to 18 years (aHR=2.18), age 19 to 21 years (aHR=2.60), body mass index more than or equal to 30 kg/m (aHR=2.17), and use of tacrolimus (aHR=1.51). We failed to find any significant relationships between NODAT and graft failure or death.
Although the incidence of NODAT among patients aged 0 to 21 years is lower than that for adult patients, it is higher than suggested by earlier research and may represent an increase over time. The lack of association between NODAT and graft or failure death has important implications for posttransplant care. A clearer understanding of risk factors can help guide posttransplant monitoring and clinical decision making.
Transplantation 09/2009; 88(3):367-73. · 4.00 Impact Factor
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ABSTRACT: Methods of crossmatch testing prior to kidney transplantation are not standardized and there are limited large-scale data on the use and outcomes implications of crossmatch modality. Data describing the most sensitive crossmatch modality for crossmatch-negative kidney transplants were drawn from the Organ Procurement and Transplant Network Registry. Within the cohort transplanted in 1999-2005, we identified patient and transplant characteristics predictive of each testing modality by multivariate logistic regression. We assessed associations of crossmatch modality with rejection risk by logistic regression and with graft survival by Cox's hazards analysis. Among 230,995 transplants, use of flow cytometry with T-and B-lymphocytes (T&B FC) increased progressively in 1987-2005. Among the recent transplants performed in 1999-2005 (n=64,320), negative T&B FC crossmatch was associated with 15% lower relative risk of first-year acute rejection (adjusted HR 0.85, 95% CI 0.80-0.89) compared to negative T-antihuman-globulin and B-National Institutes of Health/Wash (T AHG &B) crossmatch. Five-year graft survival after transplant with negative T&B FC (82.6%) was modestly better than after negative T AHG &B (81.4%, P= 0.008) or T AHG crossmatch (81.1%, P 0.0001), but on adjusted analysis was significantly different only among recipients from deceased donors and patients aged > 60 years. Many subgroups for whom negative T&B FC crossmatch predicted lower rejection risk (Caucasians, deceased donor recipients, re-transplants) were not more likely to be crossmatched by this method. We conclude that current practice patterns have not aligned utilization of T&B FC crossmatch with associated benefits. Prospective evaluation of the relationship of crossmatch modality with outcomes is warranted.
Saudi journal of kidney diseases and transplantation: an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia 07/2009; 20(4):577-89.
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ABSTRACT: Fabry disease is a rare but important cause of end-stage renal disease (ESRD) among young men. Postkidney transplantation outcomes among patients with Fabry disease remain controversial.
Using data from Organ Procurement Transplant Network/United Network for Organ Sharing, 197 kidney transplant recipients with ESRD because of Fabry disease from 1987 to 2007 were identified. We compared rates of graft loss and death with those of kidney transplant recipients with other (non-Fabry) causes of ESRD. Fabry patients were then compared with a 10:1 matched cohort of transplant recipients with other causes of ESRD.
Five-year graft survival was superior among Fabry patients (74%) compared with those with other causes of ESRD (69%), but was similar to those in the matched cohort (P=0.64). Five-year patient survival among Fabry patients (81%) was similar to those with other causes of ESRD (P=0.33), but was inferior to the matched cohort (90%). Cox multivariate analysis revealed that Fabry patients had a 40% lower risk of returning to dialysis compared with both matched and unmatched cohorts, but had a higher risk of death (2.15; 1.52-3.02) compared with the matched cohort.
This analysis of 197 kidney transplant recipients with Fabry indicates that they have superior graft survival and similar patient survival compared with patients with other causes of ESRD. However, Fabry patients had a higher risk of death compared with a matched cohort of patients with other causes of ESRD. This requires further investigation and may suggest a need for further attention to the minimization of cardiovascular death in this group of patients.
Transplantation 02/2009; 87(2):280-5. · 4.00 Impact Factor
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ABSTRACT: Transplant options for type I diabetics with end-stage renal disease include simultaneous pancreas-kidney (SPKT), living donor kidney (LDKT), and deceased donor kidney transplant (DDKT). It is unclear whether SPKT offers a survival benefit over LDKT in the current era of transplantation. The authors compared outcomes of kidney transplant recipients with type I diabetes using data from the Organ Procurement and Transplant Network/United Network for Organ Sharing.
Adult (age 20 to 59) type I diabetics who received a solitary first-time kidney transplant between 2000 and 2007 were studied. Outcomes included overall kidney graft and patient survival. Multivariate analysis was performed using a stepwise Cox proportional hazards model.
Kidney graft survival was better for recipients of LDKT compared with SPKT (P = 0.008), although patient survival was similar (P = 0.346). On multivariate analysis, LDKT was associated with lower adjusted risks over 72 mo follow-up of kidney graft failure (HR 0.71; 95% CI 0.61 to 0.83) and patient death (HR 0.78; 95% CI 0.65 to 0.94) versus SPKT. Compared with DDKT, SPKT had superior unadjusted kidney graft and patient survival, partly due to favorable SPKT donor and recipient factors.
Despite more transplants from older donors and among older recipients, LDKT was associated with superior outcomes compared with SPKT and was coupled with the least wait time and dialysis exposure. LDKT utilization should be considered in all type I diabetics with an available living donor, particularly given the challenges of ongoing organ shortage.
Clinical Journal of the American Society of Nephrology 02/2009; 4(4):845-52. · 5.23 Impact Factor
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ABSTRACT: The maximum age of recipients expected to benefit with a kidney transplant has increased in the past three decades. In 1980, patients older than age 50 were not listed for a transplant. In 2004, almost 90% aged 50-60 yr with end-stage renal disease were listed, and some were even older than age 80. We summarize previous articles to illustrate how the notion of "senior" has evolved for kidney transplantation, and using data reported to the Organ Procurement Transplant Network, describe characteristics, treatments and outcomes in recipients older than 50 yr. Fractions of male, white, non-obese, unsensitized recipients and use of expanded criteria donors increased in cohorts with increasing recipient age. The percentage of recipients with hypertension or diabetes decreased, but the percentage with cancer increased. The fraction spared steroids increased with increasing age, but other aspects of immunosuppression were not remarkably different. No differences in early outcomes were notable, and elderly recipients likely did not return to dialysis. However, both graft and patient survival rates decreased with increasing age. Although a small fraction was selected, and survival rates were lower, patients older than 80 yr received kidney transplants.
Clinical Transplantation 09/2008; 22(6):794-802. · 1.67 Impact Factor
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ABSTRACT: Gastrointestinal complications after kidney transplantation are associated with inferior graft outcomes. We examined the incidence, risk factors, and outcomes of posttransplantation diarrhea.
Historic cohort study.
We examined first kidney transplant recipients in the United States from 1995 to 2002, with follow-up through December 2002. Recipients of multiple organs were excluded. We limited our study population to Medicare beneficiaries.
Recipient, donor, and transplant characteristics were ascertained by means of US Renal Data System database inquiry.
Incidence of diarrhea, graft loss, and death after transplantation. First episodes of diarrhea after transplantation were ascertained by using International Classification of Disease, Ninth Revision, Clinical Modification codes using Medicare billing data. Cause of diarrhea was classified as infectious or not and according to specific cause. Graft loss and death were ascertained from the date of the first diarrhea episode.
We enrolled 41,442 patients. Mean follow-up was 758 +/- 399 days. We observed 7,103 diarrhea cases and 8,104 graft losses (4,201 deaths). The 3-year cumulative incidence of diarrhea was 22%, with 18% diagnosed as noninfectious diarrhea with an unspecified cause. Using multivariate Cox proportional hazards analysis, factors associated with increased risk of unspecified noninfectious diarrhea were female sex (hazard ratio [HR], 1.40; 95% confidence interval, 1.33 to 1.48), type 1 diabetes (HR, 1.20; 95% confidence interval, 1.06 to 1.37), and regimens containing tacrolimus and mycophenolate mofetil (HR, 1.37; 95% confidence interval, 1.28 to 1.46). Unspecified noninfectious diarrhea was associated with increased risk of graft failure (HR, 2.13; 95% confidence interval, 1.98 to 2.28) and patient death (HR, 2.04; 95% confidence interval, 1.85 to 2.24).
Use of claims data to ascertain patient characteristics and events; inability to make causal inference based on retrospective designs.
Regimens containing tacrolimus and mycophenolate mofetil were associated with increased risk of noninfectious diarrhea. Episodes of noninfectious diarrhea doubled the hazard of graft loss and patient death.
American Journal of Kidney Diseases 03/2008; 51(3):478-86. · 5.43 Impact Factor
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ABSTRACT: Gastrointestinal complications are common in patients who undergo kidney transplantation and may affect posttransplant outcomes. We examined the incidence and predictors of gastroesophageal reflux disease (GERD) and dyspepsia and their associations with graft survival and mortality after transplant.
We examined United States Renal Data System data and Medicare billing claims to identify diagnoses of dyspepsia and GERD among Medicare beneficiaries transplanted in 1995-2002 (n=42,257). Among GERD cases, we identified patients with reflux esophagitis (RE). We determined independent predictors of upper gastrointestinal complications and modeled these conditions as time-dependent outcomes predictors with Cox regression.
The 3-year cumulative incidences of GERD, RE, and dyspepsia were 20%, 5%, and 6%, respectively. Overall, 23% of transplant recipients received a diagnosis of at least one of these complications by 3 years after transplant. Female gender and a pretransplant upper gastrointestinal disease diagnosis predicted posttransplant gastrointestinal complications. Older age, obesity, Caucasian, and African-American race were associated to increased risk of developing GERD. Patients diagnosed with any of the examined upper gastrointestinal complications experienced an increased risk of graft-failure (hazard ratio 1.58; 95% confidence interval 1.48-1.69) and death (hazard ratio 1.61; 95% confidence interval 1.46-1.77).
Upper gastrointestinal complications are relatively common after kidney transplantation and are associated with a significantly increased risk of graft loss and death. Further research is needed to elucidate mechanisms underlying the observed adverse prognoses conferred by diagnosis of upper gastrointestinal complications after kidney transplant.
Transplantation 03/2008; 85(3):344-52. · 4.00 Impact Factor
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ABSTRACT: Clinical practice guidelines for management of chronic kidney disease (CKD) have been developed within the Kidney Disease Outcomes Quality Initiative (K/DOQI). Adherence patterns may identify focus areas for quality improvement.
We retrospectively studied contemporary CKD care patterns within a private health system in the United States, and systematically reviewed literature of reported practices internationally. Five hundred and nineteen patients with moderate CKD (estimated GFR 30-59 ml/min) using healthcare benefits in 2002-2005 were identified from administrative insurance records. Thirty-three relevant publications in 2000-2006 describing care in 77,588 CKD patients were reviewed. Baseline demographic traits and provider specialty were considered as correlates of delivered care. Testing consistent with K/DOQI guidelines and prevalence of angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEi/ARB) medication prescriptions were ascertained from billing claims. Care descriptions in the literature sample were based on medical charts, electronic records and/or claims.
KDOQI-consistent measurements of parathyroid hormone (7.1 vs. 0.6%, P = 0.0002), phosphorus (38.2 vs. 1.9%, P < 0.0001) and quantified urinary protein (23.8 vs. 9.4%, P = 0.008) were more common among CKD patients with versus without nephrology referral in the administrative data. Nephrology referral correlated with increased likelihood of testing for parathyroid hormone and phosphorus after adjustment for baseline patient factors. Use of ACEi/ARB medications was more common among patients with nephrology contact (50.0 vs. 30.0%; P = 0.008) but appeared largely driven by higher comorbidity burden. The literature review demonstrated similar practice patterns.
Delivery of CKD care may be monitored by administrative data. There is opportunity for improvement in CKD guideline adherence in practice.
Clinical and Experimental Nephrology 02/2008; 12(1):41-52. · 1.37 Impact Factor
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ABSTRACT: Administrative claims data facilitate ascertainment of outcomes not collected by the transplant registry and provide the opportunity to examine prescribed doses of immunosuppressive medications. Here, we examine the impact of human leukocyte antigen (HLA) matching on traditional outcomes, rejection and survival, and use novel methods to examine immunosuppresion doses and complication rates. The central hypothesis tested in this analysis is that HLA-matched recipients receive lower doses of immunosuppression and have fewer posttransplant complications. We break from tradition by examining HLA matching in both living and deceased donor kidney transplants. As secondary aims, we compare the relative impact of class I and II mismatches and describe outcomes achieved with older donors. Medicare claims linked to the United States Renal Data System database for 23,443 kidney transplants were included in the study. A total of 15,793 transplants were DR mismatched (DRMM), 5,340 manifested no DR mismatches (NODRMM), and 2,310 manifested no ABDR mismatches (NOABDRMM). Patients with NOABDRMM experienced lower adjusted risk of rejection (0.66, 95% confidence interval 0.59-0.74, P < 0.001) and lower hazard of graft loss (0.69, 0.61-0.77, P < 0.001) and death (0.76, 0.63-0.92, P < 0.001) compared with those with DRMM. The hazard of cardiac and diabetic complications was similar between recipients of NOADRMM and DRMM transplants, but the hazard of diarrhea was significantly lower (0.82, 0.73-0.92, P < 0.001) in patients with NOABDRMM. The 6-month dose of mycophenolate mofetil was lower in patients with NOABDRMM. This study validates previous studies that indicated significantly lower risks of rejection, graft loss, and death among patients with 0 HLA-A,B,DR mismatches. Use of administrative claims revealed similar rates of cardiovascular complications. However, HLA-matched deceased donor recipients received lower dosages of mycophenolate mofetil and manifested a lower risk of developing posttransplant diarrhea.
Human Immunology 06/2007; 68(6):491-9. · 2.84 Impact Factor
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ABSTRACT: The advent of improved immunosuppression and enhanced allograft outcomes has resulted in a growing number of patients taking expensive immunosuppression medications for the rest of their lives. Healthcare costs for the majority of transplantation procedures in the USA currently are covered by Medicare, but coverage ends for outpatient immunosuppression medications 36-44 months after transplantation. Two or three immunosuppressive agents typically are included in post-transplant regimens with a total annual cost that can exceed 13,000 dollars. This represents a significant financial burden for families no matter if they have adequate health insurance coverage because of co-payment obligations. Evidence suggests that some patients have reduced immunosuppression doses because of an inability to afford their medication, increasing the risk of graft failure. The purpose of this article was to review these and other issues pertaining to medical insurance coverage and transplantation, particularly for adolescent recipients as they transition to adulthood.
Pediatric Transplantation 04/2007; 11(2):127-31. · 1.48 Impact Factor
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ABSTRACT: Prior analyses of transplant outcomes in lupus transplant recipients have not consisted of multivariate analyses in the modern immunosuppressive era. Here, we compared patient and graft outcomes in lupus and non-lupus recipients transplanted between 1996 to 2000 using the United Network of Organ Sharing/Organ Procurement Transplant Network database. We evaluated the impact of recipient and donor demographic factors, time on dialysis and the initial immunosuppression regimen on rejection rates and transplant outcomes. Univariate analysis showed similar graft but better patient survival rates for primary lupus and non-lupus transplant recipients (5-year patient survival rates for lupus cohort 85.2% for deceased donor transplants and 92.1% for living donor transplants as opposed to 82.1% and 89.8% respectively for the non-lupus cohort; P=0.05 and 0.03) but similar patient survival rates for deceased donor retransplant patients. After controlling for confounding factors, no differences in patient or graft survival were seen between the two groups. No difference in acute rejection rates were observed in deceased donor transplants, but there was a small but significant increase in the risk of acute rejection in living donor lupus transplant recipients (hazard ratio=1.19, P=0.05). Risk of graft failure was lower for deceased donor recipients receiving MMF (five-year graft loss rate=29.6% for MMF vs. 40.2% for those not receiving MMF, P<0.0001), but no differences were seen among living donor recipients. Outcomes were similar regardless of type of calcineurin inhibitor, induction therapy, and time on dialysis. We conclude that lupus transplant recipients have outcomes generally equivalent to non-lupus transplant recipients.
Transplantation 09/2006; 82(5):612-8. · 4.00 Impact Factor
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ABSTRACT: The Organ Procurement and Transplantation Network (OPTN) collects intermittent survey data on immunosuppressive medication use that are studied frequently as research measures. Pharmacy billing claims may provide an accurate measure of immunosuppression use over time. Herein is characterized the agreement of Medicare pharmacy claims for immunosuppressive medications with OPTN reports. Data were drawn from the United States Renal Data System. Participants received a kidney transplant in 2000 to 2001 and had an OPTN record and a Medicare pharmacy claim for an immunosuppressive drug at transplant discharge and 6 mo and 1 yr after transplantation. The concordance (kappa) of the OPTN and claims (+/-30 d of survey) for indicated medication use was compared, and sensitivity, specificity, and predictive values for claims were computed, assuming OPTN as a "gold standard." Clinical trial participation and regimen changes were examined as explanations for discordance. A total of 4357 eligible subjects were identified. Concordance over observation ranged from excellent for calcineurin inhibitors (kappa > 0.86) to generally very good for adjunctive agents (kappa = 0.49 to 0.75) to poor for corticosteroids (kappa <0.15). Claims demonstrated high positive predictive values (> or =97%) but low negative predictive values (< or =13%) for OPTN-reported corticosteroid use. Regimen changes (28 to 75%) but not clinical trial participation (< or =21%) were identified frequently among cases with discordant indications of nonsteroid medication use. Close agreement of Medicare billing claims and the OPTN for indicated use of nonsteroid immunosuppressive medications supports both as useful measures of drug exposure. Low detection rates of OPTN-indicated corticosteroid use within claims require further examination.
Journal of the American Society of Nephrology 09/2006; 17(8):2299-306. · 9.66 Impact Factor
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Transplantation 07/2006; 82(1):488. · 4.00 Impact Factor
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Transplantation 07/2006; 82(1):382. · 4.00 Impact Factor
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Transplantation 07/2006; 82(1):480. · 4.00 Impact Factor
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ABSTRACT: The risk for and predictors of atrial fibrillation (AF) after kidney transplantation are not well described. Registry data that were collected by the United States Renal Data System were used to investigate retrospectively new-onset AF among adult first renal allograft recipients and transplant candidates who received a transplant or were wait-listed in 1995 to 2001 with Medicare as the primary payer. AF events were ascertained from billing records, and participants were followed until loss of Medicare coverage or December 31, 2001. Cox hazards analysis was used to identify independent correlates of posttransplantation AF (adjusted hazard ratio [AHR]; 95% confidence interval [CI]) and to examine AF as an outcomes predictor. Among 31,136 eligible transplant recipients, the cumulative incidence of new-onset AF was 3.6% (95% CI 3.4 to 3.8%) and 7.3% (95% CI 7.0 to 7.6%) at 12 and 36 mo and declined below the demographics-adjusted cumulative incidence on the waiting list by approximately 17 mo. Risk factors for posttransplantation AF included older recipient age, male gender, white race, renal failure from hypertension, and coronary artery disease. Extended pretransplantation dialysis duration, posttransplantation diabetes, and graft failure were identified as potentially modifiable correlates of AF. In separate analyses, AF independently predicted death (AHR 3.2; 95% CI 2.9 to 3.6) and death-censored graft loss (AHR 1.9; 95% CI 1.6 to 2.3). As the population of renal transplant recipients grows older, the incidence and prevalence of AF among these patients will likely increase. Appropriate risk stratification may identify transplant recipients who are in need of close monitoring for and management of this adverse cardiovascular event.
Clinical Journal of the American Society of Nephrology 04/2006; 1(2):288-96. · 5.23 Impact Factor
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Steven K Takemoto,
Adriana Zeevi,
Sandy Feng,
Robert B Colvin,
Stanley Jordan,
Jon Kobashigawa,
Jerzy Kupiec-Weglinski,
Arthur Matas,
Robert A Montgomery,
Peter Nickerson,
Jeffrey L Platt,
Hamid Rabb,
Richard Thistlethwaite,
Dolly Tyan,
Francis L Delmonico
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ABSTRACT: The process of humoral rejection is multifaceted and has different manifestations in the various types of organ transplants. Because this process is emerging as a leading cause of graft loss, a conference was held in April 2003 to comprehensively address issues regarding humoral rejection. Though humoral rejection may result from different factors, discussion focused on a paradigm caused by antibodies, typically against donor HLA antigens, leading to the term 'antibody-mediated rejection' (AMR). Conference deliberations were separated into four workgroups: The Profiling Workgroup evaluated strengths and limitations of different methods for detecting HLA reactive antibody, and created risk assessment guidelines for AMR; The Diagnosis Workgroup reviewed clinical, pathologic, and serologic criteria for assessing AMR in renal, heart and lung transplant recipients; The Treatment Workgroup discussed advantages, limitations and possible mechanisms of action for desensitization protocols that may reverse AMR; and The Basic Science Workgroup presented animal and human immunologic models for humoral rejection and proposed potential targets for future intervention. This work represents a comprehensive review with contributions from experts in the fields of Transplantation Surgery, Medicine, Pathology, Histocompatibility, Immunology, and clinical trial design. Immunologic barriers once considered insurmountable are now consistently overcome to enable more patients to undergo organ transplantation.
American Journal of Transplantation 08/2004; 4(7):1033-41. · 6.39 Impact Factor
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Rita R Alloway,
Ross Isaacs,
Kathleen Lake,
Peter Hoyer,
Roy First,
Harold Helderman,
Suphamai Bunnapradist,
Alan Leichtman,
M William Bennett,
Amir Tejani, Steven K Takemoto
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ABSTRACT: Considerable economic and health-related costs are associated with the life-long maintenance immunosuppressive therapy required to prevent transplant rejection. Generic medications have the potential of providing equivalent therapeutic efficacy at a lower economic cost. In 2001, the American Society of Transplantation invited experts to review the data and issues associated with the approval and use of generic immunosuppressants. A summary of that meeting is reported here. The generic medication approval process has been in effect for more than 30 years. All marketed generic cyclosporin formulations have met FDA criteria demonstrating bioequivalence in healthy subjects, and some were also tested in transplant recipients. Most participants agreed that generic narrow therapeutic index immunosuppressive agents provide adequate de novo immunosuppression in low-risk transplant recipients. However, some participants expressed concern regarding the currently unquantified risk that may be associated with switching immunosuppressive agents under uncontrolled circumstances. There was broad agreement among the participants that generic medications should be clearly labeled and distinguishable from innovator drugs, and that patients should be educated to inform their physicians of any switch to or among generic alternatives. There was also strong support in favor of requiring studies to demonstrate bioequivalence in potentially at-risk patient populations, specifically African-Americans and pediatric patients.
American Journal of Transplantation 11/2003; 3(10):1211-5. · 6.39 Impact Factor
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ABSTRACT: Registry databases offer the statistical power to analyze differences in graft survival rates that may not be detected in randomized clinical trials. This study analyses 2-year graft survival using tacrolimus (tac) or cyclosporine (CsA) with mycophenolate mofetil (MMF) and steroids.
Data reported to the United Network for Organ Sharing Renal Transplant Registry for living-donor kidney patients receiving a transplant during 1998 to 1999 were included. The primary end point was graft survival after adjustment for confounding variables. A Cox model multivariate analysis was used to adjust for potential confounding factors.
Patients receiving CsA-MMF (n=4,686) and tac-MMF (n=2,393) were included. Unadjusted all-cause 2-year graft survival rate was significantly higher with CsA-MMF than tac-MMF (94.3% vs. 92.2%, P=0.0006). After adjustment for potential confounding factors, risk of graft failure at 2 years was significantly higher in patients receiving tac-MMF versus CsA-MMF for both all-cause graft failure (hazards ratio [HR] 1.28, 95% confidence interval [CI] 1.09-1.49, P=0.002) and death-censored graft failure (HR 1.25, 95% CI 1.05-1.49, P=0.013). Other independent risk factors for graft failure were recipient or donor age greater than 55 years, female sex, pretransplant blood transfusions, one or two haplotype mismatches compared with zero haplotype mismatch, and panel reactive antibody (PRA) greater than 30%.
Our findings demonstrate that 2-year renal allograft survival is significantly higher in living-donor recipients receiving CsA compared with tac as initial immunosuppression in combination with MMF.
Transplantation 08/2003; 76(1):10-5. · 4.00 Impact Factor
