Nonadherent Behaviors After Solid Organ Transplantation

Germani, Giacomo; Lázzaro, Silvia; Gnoato, Francesca; Senzolo, Marco; Borella, V.; Rupolo, Giampietro; Cillo, Umberto; Rigotti, Paolo; Feltrin, Giuseppe; Loy, Monica; Martin, A. Daniel; Sturniolo, G.C.; Burra, Patrizia

doi:10.1016/j.transproceed.2010.09.103

Cited by 79 publications

(77 citation statements)

References 20 publications

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“…11,28 Unfortunately, a lack of adherence has been reported to be common in transplant recipients. [29][30][31] A greater dose frequency is inversely related to medication adherence. 8,9,32,33 Thus, the once daily dosing afforded by LCP-Tacro may be associated with increased medication adherence.…”

Section: Discussionmentioning

confidence: 99%

Conversion from twice daily tacrolimus capsules to once daily extended‐release tacrolimus (LCP‐Tacro): Phase 2 trial of stable liver transplant recipients

et al. 2014

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LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing. Studies in renal transplantation demonstrate greater bioavailability with similar safety and efficacy vs. twice-daily tacrolimus capsules. In this phase 2 study, adult stable liver transplant patients on tacrolimus capsules (Prograf) twice-daily were converted to tacrolimus tablets (LCPTacro) once-daily; patients continued on LCP-Tacro once-daily for days 8-21; target trough levels were 5-15 ng/mL; 24-hour pharmacokinetic (PK) assessments were done on days 7 (baseline pre-switch), 14, and 21. A 6 month extension study phase evaluated PK and safety following a total of 52 weeks of LCP-Tacro. Fifty-seven patients completed LCP-Tacro dosing in the core study; 43 completed the extension phase. The mean conversion ratio was 0.71 (Prograf:LCP-Tacro). PK data demonstrated consistent exposure (AUC) at the lower conversion dose. C max , C max /C min ratio, percent fluctuation and swing were significantly (P<0.001) lower and T max significantly (P<0.001) longer for LCP-Tacro vs. Prograf. AUC 24 and C min correlation coefficients after 7 and 14 days of therapy were 0.93. There were no significant differences in PK parameters at week 26 vs. 14. One patient experienced an unrelated serious adverse event (SAE) during the core study and discontinued. There were six unrelated SAEs in the extension and 1 possibly related (rejection) that resolved; there were 3 discontinuations due to AEs during the extension. In this study, patients were safely converted from Prograf twice-daily to LCP-Tacro. The greater bioavailability of LCP-Tacro allowed for once-daily dosing and similar (AUC) exposure at a dose approximately 30% less than the total daily dose of Prograf. LCP-Tacro displayed significantly lower peak and peak-trough Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; AUC, area under the curve; AUC 24 , area under the curve at 24 hours; C 24 , concentration at 24 hours; C avg , average concentration; C max , maximum concentration; C min , minimum concentration; CV, coefficient of variation; ECG, electrocardiogram; H&C, hematology and chemistry; PK, pharmacokinetic; RGM, ratio of geometric means; SAE, serious adverse event; SE, standard error; TDD, total daily dose; T max , time of the maximum concentration.Some of the data were presented at the

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Section: Discussionmentioning

confidence: 99%

Conversion from twice daily tacrolimus capsules to once daily extended‐release tacrolimus (LCP‐Tacro): Phase 2 trial of stable liver transplant recipients

et al. 2014

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“…Nevertheless, it is important to emphasize that the results will be maintained according to the physical activity and care inherent of lung transplant recipients, fact that reflects the adherence or not to the treatment. In the same way, patients who do not do the transplant after the PR due the clinical improvements also need the maintenance of the physical activity to control the progression of the disease (31,35) .…”

Section: Discussionmentioning

confidence: 99%

Pulmonary rehabilitation programs in lung transplant: a literature review

Pinto¹,

Vale²,

Rodrigues³

et al. 2015

RBPS

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To analyze, using a literature review, Pulmonary Rehabilitation (RP) Programs in lung transplant. Methods: A literature review in July 2014 in Ebsco Host, Periódicos Capes, BVS and Science Direct data bases using descriptors in English ("lung transplantation", "lung transplant" AND/OR "rehabilitation") and Portuguese ("reabilitação" AND/OR "transplante pulmonar"). The eligibility criterions were interventional studies of PR before and/or after lung transplant; participants who were candidates to lung transplant or lung transplant recipients; studies that applied any kind of PR program (hospital-based, homebased or outpatient) and articles published in English, Spanish or Portuguese. Literature reviews, guidelines and case reports were excluded. The search process yielded 46 articles of which two were duplicated. After title and abstract screening 13 articles remained for full text reading. Six studies met the inclusion eligibility and were included in the review. Results:The studies involved patients with Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Pulmonary Hypertension, Interstitial Lung Disease and Pulmonary Fibrosis. Pulmonary function, exercise capacity, quality of life (QoL) and quadriceps force were evaluated. Most interventions were outpatient programs with three months duration, three times a week and session with at least one hour. Protocols included physical training, educational approach and just one included nutritional, psychiatric and social assistant follow-up. The studies presented significant change in the six-minute walking distance, QoL and quadriceps force after PR programs. Conclusion: This review showed the benefits of the PR in the QoL and exercise capacity contributing to the Health Promotion of the patients. Descriptors

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“…This is illustrated by consistent reimbursement for drug-eluting cardiac stents, even though more than 10 % of patients fail to continue antiplatelet therapy beyond the first month, increasing stent thrombosis and increasing mortality by a factor of 10 [97]. Similarly, solid organ transplants are routinely offered with full reimbursement coverage, even though up to 38 % of patients fail to take their anti-rejection medication [98]. Thus, it is crucial to raise stakeholders' awareness about the limitations of patients' willpower to prevent and reverse obesity, and thus the importance of treating obesity as a disease with appropriate treatment.…”

Section: Obesity Biasmentioning

confidence: 99%

Gap Between Evidence and Patient Access: Policy Implications for Bariatric and Metabolic Surgery in the Treatment of Obesity and its Complications

et al. 2015

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Despite consistently supportive evidence of clinical effectiveness and economic advantages compared with currently available non-surgical obesity treatments, patient access to bariatric and metabolic surgery (BMS) is impeded. To address this gap and better understand the relationship between value and access, the objectives of this study were twofold: (i) identify the multidimensional barriers to adoption of BMS created by clinical guidelines, public policies, and health technology assessments; and, most importantly, (ii) develop recommendations for stakeholders to improve patient access to BMS. Updated public policies focused on treatment and clinical guidelines that reflect the demonstrated advantages of BMS, patient education on safety and effectiveness, updated reimbursement policies, and additional data on long-term BMS effectiveness are needed to improve patient access.

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Nonadherent Behaviors After Solid Organ Transplantation

Cited by 79 publications

References 20 publications

Conversion from twice daily tacrolimus capsules to once daily extended‐release tacrolimus (LCP‐Tacro): Phase 2 trial of stable liver transplant recipients

Conversion from twice daily tacrolimus capsules to once daily extended‐release tacrolimus (LCP‐Tacro): Phase 2 trial of stable liver transplant recipients

Pulmonary rehabilitation programs in lung transplant: a literature review

Gap Between Evidence and Patient Access: Policy Implications for Bariatric and Metabolic Surgery in the Treatment of Obesity and its Complications

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