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Originals

Dyspepsia and gastroparesis in chronic renal failure: the role of Helicobacter pylori

R. Schoonjans, B. Van Vlem, W. Vandamme, N. Van Heddeghem, H. Verdievel, R. Vanholder, N. Lameire and M. De Vos

Volume 57 (2002) p. 201 - 207

Abstract

R. Schoonjans, B. Van Vlem, W. Vandamme, N. Van Heddeghem, H. Verdievel, R. Vanholder, N. Lameire and M. De Vos

¹Department of Internal Medicine, Gastroenterology Division, and ²Department of Internal Medicine, Renal Division, Ghent University Hospital, Ghent, Belgium
Aims: Many patients with chronic renal failure have dyspeptic symptoms. In the present study, we assessed the Helicobacter pylori (Hp) status, dyspeptic symptoms and gastric emptying rates in uremic patients. The present study was undertaken to compare chronic renal failure patients not under dialysis therapy (predialysis), hemodialysis (HD) patients and peritoneal dialysis (PD) patients for these variables and to search for a possible causative role of Hp. Methods: We used a standardized questionnaire to assess dyspeptic symptoms. Gastric emptying rates were determined by the 13C-octanoic acid breath test. HD patients were examined outside a dialysis session, PD patients were examined with a ?full? abdomen. Specific Helicobacter pylori IgG was measured by a second-generation enzyme-linked immunosorbent assay. Results: Sixty-six HD patients, 58 predialytic patients and 28 PD patients were included. Prevalences of Hp infection were highest in HD patients (46.2%) and predialysis patients (42.3%) compared to PD patients (28.6%) (p < 0.02). On the contrary, the prevalence of dysmotility-like dyspepsia was higher in PD patients (67.9%) when compared to HD patients (33.3%) (p < 0.01) and predialytic patients (53.6%) (difference not significant). Neither dyspepsia nor delayed gastric emptying were related to the presence of Helicobacter pylori IgG antibodies. Conclusion: A positive Helicobacter status based on serology was not related to the presence of dyspepsia or gastroparesis in uremic patients, whether on dialysis therapy or not. Dyspeptic complaints as well as gastroparesis are most prevalent in patients on peritoneal dialysis. The physiopathological mechanisms and clinical impact of these findings merit further investigation.

Original

C.E.R.A. safety profile: a pooled analysis in patients with chronic kidney disease

F. Locatelli, J.F.E. Mann, J.-C. Aldigier, D. Sanz Guajardo, R. Schmidt, B. Van Vlem, W. Sulowicz, F. C. Dougherty and U. Beyer

Volume 73 (2010) p. 94 - 103

Abstract

Clinical Nephrology, Vol. 73 – No. 2/2010 (94-103)

C.E.R.A. safety profile: a pooled analysis in patients with chronic kidney disease

F. Locatelli¹, J.F.E. Mann², J.-C. Aldigier³, D. Sanz Guajardo⁴, R. Schmidt⁵, B. Van Vlem⁶, W. Sulowicz⁷, F. C. Dougherty⁸ and U. Beyer⁸

¹Department of Nephrology and Dialysis and Renal Transplant, A. Manzoni Hospital, Lecco, Italy, ²KFH Kidney Center, Munich, Germany, ³Néphrologie-Hémodialyse Hôpital Dupuytren, Limoges, France, ⁴University Hospital Puerta de Hierro Majadahonda, Madrid, Spain, ⁵West Virginia University School of Medicine, Morgantown, WV, USA, ⁶Department of Nephrology, Dialysis and Hypertension, O.L. Vrouw Ziekenhuis, Aalst, Belgium, ⁷Department of Nephrology, Collegium Medicum Jagiellonian University, Cracow, Poland, and ⁸F. Hoffmann-La Roche Ltd., Basel, Switzerland
Background: C.E.R.A., a continuous erythropoietin receptor activator, is a long-acting erythropoiesis-stimulating agent (ESA) that is approved for the treatment of renal anemia. This analysis evaluated the safety profile of C.E.R.A. in comparison to that of other ESAs in patients with chronic kidney disease (CKD). Methods: Safety parameters were analyzed in a pooled population comprising all patients with CKD on dialysis and not on dialysis from the completed Phase II and Phase III studies in the C.E.R.A. clinical program (Phase II/III population); patients were treated with either C.E.R.A. (n = 1,789) or comparator ESA (n = 948). Differences between treatment groups in safety parameters were identified by either a 2% difference in incidence between groups, or a statistically significant difference between groups (p ≤ 0.05 with the Fisher’s exact test, which was used as a conservative screening tool). To assess changes in safety findings over time, long-term safety data were analyzed from patients who were given the option to enter long-term safety studies upon completing their initial Phase II/III study (safety extension population). Results: Compared with the C.E.R.A. group, the incidence of adverse events (AEs) was higher in the comparator ESA group in the Phase II/III population (C.E.R.A. vs. comparator ESA, 89.5% vs. 91.8%, p = 0.067), and significantly so in the safety extension population (93.0% vs. 95.8%, p = 0.003). The incidence of serious AEs was significantly higher in the comparator ESA group than in the C.E.R.A. group in both analysis populations (Phase II/III population, 37.8% vs. 42.4%, p = 0.021; safety extension population, 53.3% vs. 59.7%, p = 0.001). However, there was no consistent pattern of clinical events that could explain these differences between the treatment groups. Conclusion: Analysis of safety events in patients with renal anemia receiving long-term treatment with C.E.R.A. shows a safety profile comparable to that of other ESAs.Correspondence to:
Prof. F. Locatelli
Azienda Ospedaliera di Lecco
Ospedale “Alessandro Manzoni”
Via Dell’ Eremo 9/11
23900 Lecco, Italy
Email: [email protected]

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