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Abstract

F. Bergesio, G. Monzani, A. Guasparini, R. Ciuti, M. Gallucci, C. Cristofano, E. Castrignano, A. Cupisti, G. Barsotti, R. Marcucci, R. Abbate, S. Bandini, M. Gallo, P.L. Tosi and M. Salvadori

¹Department of Nephrology, Dialysis and Transplantation, Azienda Ospedale Careggi, Florence, ²Renal Unit Ospedale di Torregalli, Azienda Sanitaria Firenze, Florence, ³Dietary Service, ⁴Clinical Chemistry, Azienda Ospedale Careggi, Florence, ⁵Renal Unit Ospedale di Galatina, Azienda Ospedale Galatina, ⁶Renal Unit Ospedale di Manduria, Azienda Ospedale Manduria,

⁷Renal Unit Ospedale di Campi salentina, Azienda Ospedale di Campi Salentina, ⁸Nephrology Unit, Department of Internal Medicine, University of Pisa, ⁹Thrombosis Center, University of Florence, Florence, Italy
Background: Lipoprotein abnormalities and increased oxidized LDL (OxLDL) are often observed in uremia and are reported to play a central role in the development of cardiovascular disease (CVD). Vegan diet, known for its better lipoprotein profile and antioxidant vitamins content, could protect against CVD. Aim of this study was to investigate the influence of vegan diet supplemented with essential amino acids (EAA) and ketoanalogues (VSD) on both traditional and non-traditional cardiovascular risk factors (CVRF). Methods: Twenty-nine patients (18 M, 11 F) aged 55 years (range 29 – 79 years) with advanced chronic renal failure (median sCr: 5.6 mg/dl) on very low protein vegetarian diet (0.3 g/kg/day) supplemented with a mixture of EAA and ketoacids (VSD) and 31 patients (20 M, 11 F) aged 65 years (range 29 – 82 years) on conventional low-protein diet (CD: 0.6 g/kg/day) with a similar renal function (median sCr: 5.2 mg/dl), were investigated for lipids and apolipoprotein parameters (traditional CVRF) as well as for oxidative stress (oxidized LDL, antibodies against OxLDL and thiobarbituric acid-reactive substances (TBARS)), total homocysteine (tHcy), lipoprotein(a) (Lp(a)), albumin and c-reactive protein (CRP) (non-traditional CVRF) including vitamins A, E, B12 and folic acid. Results: Compared to patients on CD, those on VSD showed increased HDL cholesterol levels (p < 0.005) with a reduction of LDL cholesterol (p < 0.01) and an increase of apoA1/ apoB ratio (p < 0.02). Among non-traditional CVRF, a mild but significant reduction of OxLDL (p < 0.05) with lower TBARS concentrations (p < 0.01) and a significant reduction of total homocysteine (p < 0.002), Lp(a) (p < 0.002) and CRP levels (p < 0.05) were also observed in these patients. Concentrations of vitamin E and A were not different between the two groups while vitamin B12 and folic acid resulted markedly increased in patients on VSD. OxLDL significantly correlated with total and LDL cholesterol, triglycerides and Apo B in CD but not in VSD patients. Patients on CD also showed a significant correlation between urea and CRP. After a multivariate analysis, only urea (p < 0.001) and OxLDL (p < 0.006) were associated to a risk of CRP > 0.3 mg/dl. Conclusions: These results indicate a better lipoprotein profile in patients on vegan diet including non-traditional CVRF. In particular, these patients show a reduced oxidative stress with a reduced acute-phase response (CRP) as compared to patients on conventional diet. We hypothesize that urea, significantly lower in patients on VSD, may account, possibly together with the reduction of other protein breakdown products, for the decreased acute-phase response observed in these patients. Our findings suggest that low-protein diets, and vegan in particular, may exert a beneficial effect on the development of cardiovascular disease in patients with end-stage renal disease (ESRD).Correspondence to:
Dr. F. Bergesio

Via del Pino

50137 Firenze, Italy
Email: [email protected]

Abstract

G. Monga, G. Banfi, M. Salvadore, O. Amatruda, C. Bozzola and G. Mazzucco

¹Dipartimento di Scienze Mediche, Facoltà di Medicina e Chirurgia, Università del Piemonte, ²Divisione di Nefrologia e Dialisi, Ospedale Maggiore IRCCS, Milano, ³Servizio di Anatomia Patologica, ⁴Divisione di Nefrologia, Ospedale di Circolo e Fondazione Macchi, Varese, ⁵Dipartimento di Scienze Biomediche e Oncologia Umana, Facoltà di Medicina e Chirurgia, Università di Torino, Italy
Karyomegalic interstitial nephritis is a rare, but perhaps an “underdiagnosed” condition. Peculiar nuclear changes characterize it, involving mainly tubular cells along with glomeruli and blood vessels. Herein, 3 bioptically proven new cases of patients with chronic renal failure are discussed. The first case had a recently diagnosed karyomegalic nephritis which, to date, still does not require dialysis. The other 2 (brother and sister) required dialysis 4 and 1 years after diagnosis. Karyomegalic changes were found not only in the skin and duodenal biopsies of the male, in skin and liver biopsies of the female and in the urine cells of both patients, but also in several organs (brain, thyroid, lung, esophagus, arteries) as shown at the autopsy of the female. There was a fatal outcome for both patients. The data reported in this study emphasize the usefulness of pathologic investigation of both tissue and urine samples in the identification of this disease. Moreover, as karyomegalic interstitial nephritis is strongly suspected to have a genetic background, its identification may well not only be of clinical relevance, due to its ominous outcome, but may also bear eugenetic value.
Correspondence to:
Dr. G. Monga
Dipartimento di Scienze Mediche
Facolta di Medicina e Chirurgia
Via Solaroli 17
28100 Novara, Italy
Email: [email protected]

Abstract

M. Salvadori, H. Holzer, G. Civati, H. Sollinger, B. Lien, S. Tomlanovich, E. Bertoni, Y. Seifu and A.-C. Marrast on behalf of the ERL B³⁰¹ Study Group

¹Renal Unit Careggi University Hospital, Florence, Italy, ²Division of Nephrology and Hemodialysis, Medical University Graz, Graz, Austria, ³Az. Osp Niguarda Ca Granda, Milan, Italy, ⁴University of Wisconsin-Madison, Madison, USA, ⁵Rikshospitalet, Oslo, N
Background: To date, there are no data on long-term use of enteric-coated mycophenolate sodium (EC-MPS; myfortic®) from time of renal transplantation. We report the first long-term safety and efficacy data on EC-MPS when administered for up to 3 years post transplant. Methods: De novo renal transplant recipients completing 1 year of treatment in a multicenter, randomized, double-blind trial of EC-MPS versus mycophenolate mofetil (MMF) were invited to take part in an open-label extension during which all patients received EC-MPS 720 mg b.i.d. Results from the period 12 – 36 months post transplant were compared to comparable data from MMF-treated patients taking part in two studies of everolimus versus MMF (RAD 201 and RAD 251). Results: Of 367 patients completing the blinded core study, 247(62%) entered the open-label extension phase. During the first 24 months of the extension, the incidence, type and severity of adverse events were comparable between the newly-exposed and long-term EC-MPS patients. There were 2 deaths in the newly-exposed group and 4 among long-term EC-MPS patients, with 1 and 2 graft losses, respectively. Six patients (5%) in the newly-exposed group and 4 (3%) in the long-term EC-MPS group experienced biopsy-proven acute rejection. Cross-study comparisons indicated that the tolerability profile of EC-MPS was similar to MMF, including the incidence of adverse events, infections and malignancies, as was the incidence of efficacy events. Conclusion: These results demonstrate that EC-MPS with cyclosporine and steroids provides good long-term efficacy and tolerability, and confirm the safety of converting renal transplant patients from MMF to EC-MPS.Correspondence to:
Prof. M. Salvadori

Renal Unit Careggi University Hospital

Viale Pieraccini 18

50139 Florence, Italy
Email: [email protected]

Abstract

X. Cabarrocas¹, M. Salva¹, M. Pavesi¹ and J. Costa²

¹Research Center, Almirall Prodesfarma, Barcelona, and ²Clinical Pharmacology Department, Hospital Universitario “Germans Trias i Pujol”, Universitat Autonoma de Barcelona, Badalona, Spain
Objective: A number of clinical reports have revealed a link between the use of alcohol and the onset or exacerbation of migraine headaches. This open, randomized, crossover, single-dose, phase I clinical trial evaluated the possible pharmacokinetic interactions between a single oral dose of almotriptan 12.5 mg, a 5-HT1B/1D receptor agonist for the acute treatment of migraine, and ethanol in 16 healthy male volunteers. Tolerability and safety of this combined treatment were also assessed. Methods: Subjects received a crossed oral dose of almotriptan (12.5 mg) with and without concomitant alcohol intake (target plasma concentration 0.8 g/kg) in two different treatment periods. Almotriptan was administered alone, while ethanol was diluted with orange juice, which was also given to the control group. There was a washout period of 7 days between treatments. Plasma levels of almotriptan were analyzed using a sensitive and specific liquid chromatographic-tandem mass spectrometry method. Results: The 90% non-parametric confidence interval for the median tmax of almotriptan plus ethanol compared to almotriptan alone (0.61/2.72) was outside the acceptable range (0.70 – 1.30), demonstrating that concomitant ethanol administration slightly increases the variability of absorption of almotriptan 12.5 mg. In contrast, the main bioavailability criteria parameters, Cmax and AUC, which show the rate and extent of systemic absorption, were not affected by alcohol ingestion. Therefore, it is unlikely that concomitant ethanol intake would produce clinically relevant differences in the therapeutic effect of almotriptan at the dose studied here. Tolerability of treatments was good throughout the entire study period. Conclusions: Almotriptan 12.5 mg, with or without concomitant alcohol ingestion, showed similar plasma concentrations after a single dose in healthy volunteers with no clinically relevant drug-to-drug interactions.Correspondence to:
J. Costa, MD
Clinical Pharmacology Department
University Hospital Germans Trias i Pujol
Ctra. de Canyet s/n; 08916 Badalona, Spain
Email: [email protected]

Abstract

V. Kliem¹, U. Michel², M. Burg¹, A. Bock³, J. Chapman⁴, B. Dussol⁵, L. Fritsche⁶, Y. Lebranchu⁷, F. Oppenheimer⁸, E. Pohanka⁹, M. Salvadori¹⁰ and G. Tufveson¹¹

¹Nephrological Center Niedersachsen Hann. Münden, ²Novartis Pharma GmbH Nürnberg, Germany, ³Nephrology Division, Kantonsspital Aarau, Switzerland, ⁴Centre for Transplant and Renal Research, Millennium Institute, Westmead Hospital, University of Sydney, Australia, ⁵Hôpital de la Conception, Marseille, France, ⁶Department of Nephrology, University Hospital Campus Charité Mitte, Berlin, Germany, ⁷CHU Tours, Hopital Bretonneau, Tours, France, ⁸Hopital Clinic de Barcelona, Unitat de Transplantament Renal, Barcelona, Spain, ⁹Division of Nephrology and Dialysis, Internal Medicine III, Medizinische Universität Wien, Vienna Austria, ¹⁰Renal Unit, Careggi University Hospital, Florence, Tuscany, Italy, and ¹¹Department of Transplantation, Uppsala University Hospital, Uppsala, Sweden
Background: Hepatitis B (HBV) and hepatitis C (HCV) virus infections are major risk factors affecting long-term morbidity and mortality after renal transplantation. Hepatitis prevalence is subject to geographical variations. Objective: To compare and analyze the geographical prevalence, risk factors and impact of HBV and HCV infection in multinational cohorts of renal transplant recipients. Methods: From 1989 – 2002, data on 12,856 kidney transplant recipients in 37 countries were collected within the prospective MOST (Multinational Observational Study in Transplantation). Subgroup analyses of hepatitis-related prevalence, risk factors and impact were conducted on patients whose HBV and HCV status was available at time of transplantation. Countries were substratified according to population prevalence of >= 5% HBV or >= 10% HCV. Results: The prevalence of HBV was 2.9%, of HCV 8.7% and of HBV together with HCV 0.4%. Risk factors for hepatitis infection in renal transplant recipients were long dialysis time, retransplantation and blood transfusions. At each study endpoint up to 5 years after transplantation, no significant differences in graft function were observed, although the 1-year acute rejection rate tended to be lower in HCV+ patients. At 5 years post-transplant, there were no differences between the subgroups and regions regarding infections, post-transplant diabetes mellitus or malignancies including PTLD. Conclusions: Overall, HCV infections are more prevalent than HBV. Despite large geographical differences in prevalence, HBV and HCV status did not appear to have a significant impact on renal graft function, infections, malignancies and post-transplant diabetes mellitus up to 5 years after renal transplantation throughout the MOST countries.Correspondence to:
PD Dr. med. V. Kliem; Nephrological Center Niedersachsen, Vogelsang 105, 34346 Hann. Münden, Germany
Email: [email protected]

Abstract

Clinical Nephrology, Vol. 73 – No. 6/2010 (439-445)

Keratinocyte cancer prevention with ACE inhibitors, angiotensin receptor blockers or their combination in renal transplant recipients

L. Moscarelli, M. Zanazzi, G. Mancini, E. Rossi, L. Caroti, G. Rosso, E. Bertoni and M. Salvadori

Renal Unit Careggi University Hospital, Florence, Italy
Background: Skin cancer (SC) is the most frequent malignancy after renal transplantation (RT), especially squamous and basal cell carcinoma. The observation that angiotensin II is a potent angiogenic and growth factor raises the possibility that blocking its effects could reduce the incidence of skin cancer. Objectives: To evaluate the incidence of keratinocyte cancer in RT recipients, the timing of occurrence of the skin events after RT; to compare the incidence of SC in our RT recipients and in RT patients on angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers therapy (ARBs) and their combination. Risk factors were also evaluated. Results: During follow up, 52 of 565 patients (9.2%), 38 males 14 females, developed SC at a median time of 59 months (range 29 – 74) after RT. 12 of 52 patients (23%) with SC were on ACEi, ARBs therapy or their combination. The incidence was significantly lower in user patients compared to non user (5.6% and 11.4% respectively). BCC was the most frequent type of keratinocyte cancer in non users and in users. No association with incidence of BCC or SCC was observed for other classes of antihypertensive drugs (calcium antagonists, β-blockers, α-blockers). Conclusion: This study confirms that RT patients are at high risk of SC. The use of ACEi or ARBs is associated with an approximately two-fold reduced risk of Keratinocyte cancers compared to non users in RT recipients. We did not observe an association between the incidence of SC and the use of other classes of antihypertensive drugs. Any chemoprotective effect of these agents may reflect inhibition of the growth factor activity of angiotensin II. Use of ACEi or ARBs, when this is possible, should be considered in RT patients with multiple risk factors.Correspondence to:
Dr. L. Moscarelli
Renal Unit Careggi
University Hospital
Viale Pieraccini 18
50139 Florence, Italy
Email: [email protected]

Abstract

Clinical Nephrology, Vol. 75 – No. 5/2011 (440-450)

Renin angiotensin system blockade and activated vitamin D as a means of preventing deep vein thrombosis in renal transplant recipients

L. Moscarelli, M. Zanazzi, E. Bertoni, L. Caroti, G. Rosso, S. Farsetti, F. Annunziata, N. Paudice and M. Salvadori

Renal Unit Careggi University Hospital, Florence, Italy
Background: Venous thromboembolism (VTE) is one of the thrombotic complications that occur in renal transplant recipients (RTR). The observation that vitamin D receptor activators, angiotensin-converting enzyme inhibitors (ACEi), and angiotensin receptor blockers (ARBs) have a protective effect against protrombotic state suggests that their possible combination could reduce the incidence of VTE in RTR. Objectives: to evaluate the incidence of VTE in RTR and the timing of occurrence after renal transplantation (Tx); to compare the incidence of VTE in our RTR and RTR on calcitriol, ACEi, ARBs and their combination therapy. Risk factors were also evaluated. Results: During follow-up, 96 of 769 RTRs, 73 males 23 females, developed a first episode of VTE: 23 in the first 3 months after Tx; 15 from 3 to 6 months; 9 from 6 to 12 months; 13 from 12 to 48 months and 36 after more than 48 months. The incidence was significantly lower in RTR on treatment with a combination of calcitriol 0.25 µg/day, an ACEi and an ARB and in RTR on treatment with only calcitriol 0.5 µg/day (9.4% and 9%, respectively, vs. 14.5% (p < 0.05)). However, the most decreased rate (5.6% vs. 14.5% (p < 0.01)) was in patients treated with a combination of calcitriol 0.5 µg/day, an ACEi and an ARB. Conclusion: A combination therapy with calcitriol 0.5 µg/day, ACEi, and ARB is associated with a 60% lower rate risk of VTE.Correspondence to:
Dr. L. Moscarelli
Renal Unit Careggi
University Hospital
Viale Pieraccini 18
50139 Florence, Italy
Email: [email protected]

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