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Biomedical subjects

C Baldamus

Publications and source records attributed to C Baldamus.

13 recordsLinked to original sources
PubMed2002

A rationale for an individualized administration frequency of epoetin beta: a pharmacological perspective.

Several studies have compared the efficacy of once-weekly subcutaneous (s.c.) epoetin treatment with two or three times weekly treatment in renal anaemia. Epoetin administration frequency has attracted a high level of attention in recent years, and numerous small-scale studies have shown comparable efficacy and tolerability of once-weekly vs more frequent administration. The results of two large-scale, randomized, controlled trials of once-weekly administration of epoetin beta became available recently. One of these studies, by Locatelli et al., was the first to be designed specifically to demonstrate therapeutic equivalence between once-weekly and three times weekly epoetin beta treatment, using rigorous statistical methods. This was a large, multicentre, randomized, parallel group, 24-week study in 173 chronic renal failure patients. Treatment regimens were considered equivalent if: (i) the 90% confidence interval (CI) of the difference between treatment groups was within +/-2% for the time-adjusted area under the haematocrit (Hct) curve (AUC); and (ii) for mean weekly epoetin beta dose, the 90% CI of the ratio of the groups was between 0.8 and 1.25. As recommended by current guidelines for statistical analysis of clinical trial data, multiple analysis populations were examined in order to demonstrate robustness of the results with regard to the population chosen for analysis. Findings from the primary analysis, the per-protocol population, were confirmed by both the intent-to-treat analysis and an exploratory analysis that examined the influence of five patients who received dose increases above the mean. In all three analyses, the 90% CIs were within the pre-specified equivalence ranges for both the difference between treatment groups for Hct AUC and the ratio of mean weekly epoetin beta dose. In conclusion, once-weekly and three times weekly s.c. epoetin beta treatment regimens are statistically equivalent in terms of maintaining stable Hct levels and dose requirements in haemodialysis patients. The agreement of the three analysis populations provides a convincing demonstration of the robustness of the results. These results confirm that a once-weekly epoetin beta regimen is an effective option for management of renal anaemia that may improve patient convenience and compliance.

Drug Administration Schedule↗
PubMed1993

Cyclosporin A: early or delayed onset by prophylactic immunosuppression?

In a prospective randomized trial, 57 renal transplant patients received sequential immunosuppression consisting of lymphocytoglobulin (ALG), azathioprine, and steroids for 14 days (group A) and another 57 patients for only 2 days (group B). In each case therapy was continued with cyclosporin A and steroids. The purpose of this study was to find the most favourable time to switch over to continuous cyclosporin A therapy with avoidance of its nephrotoxic side-effects during the perioperative phase. As a consequence of ALG intolerance, conventional immunosuppression had to be changed in group A after a mean of 7.8 days, as opposed to 2.1 days in group B. The patients receiving a prophylactic therapy with ALG, azathioprine, and steroids for 14 days (group A) had to be dialysed at a significantly greater frequency than patients with an early start to cyclosporin A (group B) from the second to the fourth week. Patient survival rates 1 and 2 years after transplantation of group A (95 and 92%) and group B (96 and 92%) were not distinct, and there was no significant difference in graft survival rates of group A (79 and 79%) and B (89 and 82%) after the same time. A delayed start of cyclosporin A after 14 days showed no further advantage but rather a significantly greater frequency of dialysis; thus the early onset of cyclosporin A treatment post-transplant is preferable.

Adult↗
PubMed1992

The risk of infection following OKT3 and antilymphocyte globulin treatment for renal transplant rejection: results of a single center prospectively randomized trial.

Some 43 of 60 (72%) renal allograft recipients who were prospectively randomized to receive either OKT3 monoclonal antibody (n = 30) or ALG (antilymphocyte globulin) polyclonal antibody (n = 30) for steroid-resistant rejection suffered from infection, 25 (83%) following OKT3 and 18 (60%) following ALG treatment (P < 0.05). Clinically evident herpes infection was most frequently seen (9 and 7, respectively), followed by pneumonia (6 and 1, respectively P < 0.05), urinary tract infection and wound infection (2 of each in both groups) fungal (Candida) and multibacterial infections. One patient died in each group due to cytomegalovirus (CMV) pneumonia, giving a mortality of 4.3% in each group. Actuarial 1-year graft and patient survival rates were 80% and 97% in both groups, respectively. It is concluded that ALG and OKT3 are equally effective in renal allograft rejection resistant to steroid treatment, however, the risk of infection appears to be higher with OKT3.

Adult↗
PubMed1992

Early or delayed onset of cyclosporine by sequential immunosuppression?

In a prospective randomized trial, 57 renal transplant patients (group A) received a sequential course of 14 days conventional immunosuppression (anti-lymphocyte globulin (ALG), azathioprine and steroids) and cyclosporine and steroids thereafter, while 57 patients (group B) received the conventional immunosuppression for 2 days followed by cyclosporine and steroids. In group A, ALG was tolerated for a mean of 7.8 days while, in group B, conventional therapy had to be changed to cyclosporine therapy after a mean of 2.1 days due to ALG intolerance. Patient survival rates 1 and 2 years after transplantation were 95% and 92% in group A and 96% and 92% in group B, and graft survival rates were 79% and 79% in group A and 89% and 82% in group B. In group A, the dialysis frequency in the second, third and fourth weeks after transplantation was significantly higher than in group B. Serum creatinine 1 year post-transplant showed no significant difference between the two groups.

Antilymphocyte Serum↗
PubMed1992

CMV prophylaxis after renal transplantation with immunoglobulin or CMV-hyperimmunoglobulin--a prospective clinical trial.

Three groups of 40 patients each entered this prospective randomized trial. Patients of group A received 2 ml/kg body weight CMV-Polyglobulin, patients of group B 15 g Intraglobin and patients of group C, serving as controls, received no specific anti-CMV prophylaxis. All patients were given the same sequential immunosuppressive therapy. Patient survival and graft function did not show any significant differences at 2 years follow up. The incidence of fever, CMV infections, dialysis and steroid bolus therapy were lower in group A, but without statistical significance. Patients receiving a graft from a CMV-AK-positive donor were at high risk of developing an infection or reactivation of CMV. A study examining this subgroup seems appropriate.

Adrenal Cortex Hormones↗
PubMed1992

Donor conditions and graft survival--a retrospective study.

In a retrospective study (one centre) the influence of donor and recipient factors were evaluated (n = 308). Head injury as the cause of death and anastomotic time less than 35 min were associated with a significantly better graft survival rate (P < 0.05). Although some of the donor factors influence graft survival, a stricter selection of grafts is not advisable, firstly because fewer kidneys would then be offered, and secondly because even comparatively bad graft survival rates are still better than dialysis.

Adolescent↗
PubMed1987

Graft survival and long-term renal function after sequential conventional cyclosporin A therapy in cadaver kidney transplantation--a prospective randomized trial.

In a prospective randomized trial 50 renal transplant patients (group A) received a sequential course of 14 days conventional immunosuppression (Lymphocytoglobulin (ALG), azathioprine, steroids) and cyclosporin and steroids thereafter, while 50 patients (group B) received the conventional immunosuppression for 7 days followed by cyclosporin and steroids. In the latter group ALG was tolerated for the whole period while in the first group conversion from conventional to cyclosporin A therapy had to be performed after a mean of 11 days, due to ALG intolerance. Actual patient survival rates 1 year posttransplant were 100% in both groups and graft survival rates 96% in group A and 86% in group B (P less than 0.05). There was a mean dialysis frequency per patient of 0.7 +/- 2.0 in group A and 1.8 +/- 3.4 in group B (P = 0.064). Serum creatinine 1 year posttransplant was 1.8 +/- 0.8 mg/dl in group A and 2.2 +/- 1.4 in group B. A total of 58 patients had a serum creatinine of less than 2 mg/dl at the time of conversion to cyclosporin. These patients had a significantly better graft survival rate (98.3%) and serum creatinine 1 year posttransplant (1.6 +/- 0.5 mg/dl) than the 40 patients with a serum creatinine of more than 2 mg/dl at the time of conversion (85%; 2.4 +/- 1.4 mg/dl), indicating that a delayed onset of cyclosporin therapy might benefit the kidney in the immediate posttransplant period when it is susceptible to nephrotoxicity due to the damage from hypothermic storage.

Adult↗