Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis

Molnar, Amber O.; Fergusson, Dean; Tsampalieros, Anne; Bennett, Alexandria; Fergusson, Nicholas A; Ramsay, Tim; Knoll, Greg

doi:10.1136/bmj.h3163

Cited by 72 publications

(66 citation statements)

References 68 publications

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“…Doubts were raised in the literature regarding clinical equivalence of generic drugs after substitution versus their brand-name counterpart in several therapeutic fields. [7][8][9][10][11][12][13][14][15][16][17] A recent meta-analysis including studies of generic and brandname cardiovascular drugs did not show a significant difference in terms of safety or tolerability between the 2 types of drug. 18 However, a systematic review of editorials addressing generic drug substitution in cardiology depicted a majority of negative views on clinical equivalence.…”

Section: Leclerc Et Al Generics Commercialization and Adverse Eventsmentioning

confidence: 99%

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Leclerc

Blais

Rochette

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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To achieve substantial healthcare cost reductions, the provincial government of Quebec, Canada, promotes generic substitutions and restricts access to brand-name drugs by economical and administrative strategies. 5 Once generic analogs become available, market is then shared between brand-name and generics, but little is published about the rate of this market sharing, neither regarding the clinical impact of generics commercialization. Generic and brand-name drugs are assumed to be clinically equivalent and are used interchangeably once approved Background-Once the patent of a brand-name drug expires, generic drugs are commercialized, and substitution from brand-name to generics may occur. Generic drug equivalence is evaluated through comparative bioavailability studies. Few studies have assessed outcomes after generic drug commercialization at a population level. We evaluated the impact of 3 generic angiotensin II receptor blockers commercialization on adverse events: hospitalizations or emergency room consultations. Methods and Results-This is an interrupted time series analysis using the Quebec Integrated Chronic Disease Surveillance System. Rates of adverse events for losartan, valsartan, and candesartan users (N=136 177) aged ≥66 years were calculated monthly, 24 months before and 12 months after generics commercialization. Periods before and after generics commercialization were compared by negative binomial segmented regression models. Sensitivity analyses were also conducted. For all users, there was a monthly mean rate of 100 adverse events for 1000 angiotensin II receptor blocker users before and after generic commercialization.

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Section: Leclerc Et Al Generics Commercialization and Adverse Eventsmentioning

confidence: 99%

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Leclerc

Blais

Rochette

et al. 2017

Circ: Cardiovascular Quality and Outcomes

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“…150 Another potential source of tacrolimus variability is conversion to generic formulations; however, the evidence is scarce and of low quality. 151 Bioequivalence between generic tacrolimus and its innovator has been demonstrated in healthy volunteers and kidney transplant recipients. In the subgroup of kidney transplant patients older than 60 years caution is needed as 1 randomized study showed bioequivalence standards were not met by generic tacrolimus.…”

Section: Highly Modifiable Contributors To Variabilitymentioning

confidence: 99%

“…Uncontrolled switching, particularly between generic formulations, should be avoided. 151,154 The conversion from twice-daily to prolonged-release tacrolimus (capsules), both in kidney and liver transplant recipients, leads to lower blood trough concentrations and a reduced IPVof tacrolimus. 155,156 In a single study performed in liver transplant recipients, the early conversion to prolonged-release tacrolimus capsules was accompanied by a significant reduction of TCMR rates.…”

Section: Highly Modifiable Contributors To Variabilitymentioning

confidence: 99%

Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients

et al. 2017

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Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes. COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group's remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant. The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting. 12 Department of Gastroenterology and Hepatology, Erasmus MC, University Hospital Rotterdam, the Netherlands. 13 Department of Gastroenterology and Hepatology, University Hospitals KU Leuven, Belgium.14 Abdominal Transplant Surgery, Microbiology and Immunology Department, University Hospitals KU Leuven, Belgium. 15 Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC, CIBERehd, Spain. www.transplantjournal.com S1 S olid organ transplantation has evolved from an experimental procedure to an established treatment option for many types of end-stage organ failure. Both patient and graft outcomes are continuing to improve, and 1-year patient and graft survival currently exceed 80%.1,2 However, survival rates gradually decline over the long term. In kidney transplant, 5-and 10-year graft survival rates in Europe are 77% and 56%, and for liver transplant, 64% and 54% (Figures 1 and 2). 3,4 Although most European countries have seen an increase in both living and deceased donation, transplantation is not available to all who would benefit from the procedure, and there is considerable morbidity and mortality for those listed for transplant.6 Therefore, maximizing long-term graft survival and reducing the need for retransplantation is paramount, not only in improving outcomes for the recipients but also for those awaiting a graft. The improvement in outcomes is predominantly due to reduction in (Transplantation. 2017;101:S1-S41). The authors were approached by Astellas to discuss the practical implementation o...

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Section: Tick-borne Encephalitis (Tbe) Vaccinationmentioning

confidence: 99%

“…[94][95][96] Adults with weakened immune systems are particularly vulnerable to infection and the burden of transmissible disease is heavier than that in immunocompetent patients because infections recur, persist longer and are often more severe than usual. [94][95][96] Recurrent infections can place "frequent flier" patients at hospitals at greater risk of further contracting hospital-acquired infections. 97 The list of conditions that can cause relevant immunocompromise include: primary immunodeficiencies; malignancy, particularly in patients undergoing treatment; human immunodeficiency virus (HIV) infection; iatrogenic immunosuppression for organ transplantation; rheumatologic disorders; and autoimmune diseases.…”

Section: Tick-borne Encephalitis (Tbe) Vaccinationmentioning

confidence: 99%

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

Esposito

Bonanni

Maggi

et al. 2016

Human Vaccines & Immunotherapeutics

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Rapid population aging has become a major challenge in the industrialized world and progressive aging is a key reason for making improvement in vaccination a cornerstone of public health strategy. An increase in age-related disorders and conditions is likely to be seen in the near future, and these are risk factors for the occurrence of a number of vaccine-preventable diseases. An improvement in infectious diseases prevention specifically aimed at adults and the elderly can therefore also decrease the burden of these chronic conditions by reducing morbidity, disability, hospital admissions, health costs, mortality rates and, perhaps most importantly, by improving the quality of life. Among adults, it is necessary to identify groups at increased risk of vaccine-preventable diseases and highlight the epidemiological impact and benefits of vaccinations using an evidence-based approach. This document provides clinical practice guidance on immunization for adults in order to provide recommendations for decision makers and healthcare workers in Europe. Although immunization is considered one of the most impactful and cost-effective public health measures that can be undertaken, vaccination coverage rates among adults are largely lower than the stated goal of 95% among adults, and stronger efforts are needed to increase coverage in this population. Active surveillance of adult vaccine-preventable diseases, determining the effectiveness of the vaccines approved for marketing in the last 5 y, the efficacy and safety of vaccines in immunocompromised patients, as well as in pregnant women, represent the priorities for future research.

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Generic immunosuppression in solid organ transplantation: systematic review and meta-analysis

Abstract: ObjeCtiveTo compare the clinical efficacy and bioequivalence of generic immunosuppressive drugs in patients with solid organ transplants.Design Systematic review and meta-analysis of all studies comparing generic with innovator immunosuppressive drugs.

Cited by 72 publications

References 68 publications

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada

Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients

Recommended immunization schedules for adults: Clinical practice guidelines by the Escmid Vaccine Study Group (EVASG), European Geriatric Medicine Society (EUGMS) and the World Association for Infectious Diseases and Immunological Disorders (WAidid)

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