TY - JOUR
T1 - Long-term progression of chronic renal insufficiency in the AIPRI extension study
AU - Locatelli, F.
AU - Carbarns, I. R I
AU - Maschio, G.
AU - Mann, J. F E
AU - Ponticelli, C.
AU - Ritz, E.
AU - Alberti, D.
AU - Motolese, M.
AU - Janin, G.
AU - Zucchelli, P.
PY - 1997
Y1 - 1997
N2 - The Angiotensin-converting-enzyme Inhibition on Progressive Renal Insufficiency (AIPRI) Study showed that the ACE inhibitor benazepril provides protection against loss of renal function in patients with chronic renal insufficiency (CRI) caused by various renal diseases. As a result of unexpectedly low mortality in the placebo group, there was a substantial imbalance in mortality during the course of this study (8 patients on benazepril vs. 1 on placebo). The aim of the extension study was to follow- up the patients from the AIPRI core study until autumn 1996, focusing on CRI progression and mortality. Data collection was post hoc. Patients were treated according to investigators' usual practices, without knowledge of the core study trial medication or (initially) the core trial results A new primary efficacy parameter was defined as the time from the start of core study treatment to the occurrence of the first event in the combined composite end-point of dialysis, renal transplantation or death related to renal disease Serial serum creatinine levels and all-cause mortality were also recorded. The median total follow-up for core -extension periods was 6.6 years. Many patients from both treatment groups (64% on benazepril and 61% on placebo) received ACE inhibitors during follow-up in the intention-to-treat analysis of the core + extension data, only 79 of 300 patients from the benazepril group, compared to 102 of the 283 patients from the placebo group needed dialysis or renal transplantation, or died related to renal disease (P <0.013. log-rank test). The mortality imbalance seen in the core trial was nor evident with the longer follow-up (25 deaths in the benazepril and 23 in the placebo group before dialysis): These data clearly demonstrate a long- term beneficial effect in patients randomized to take benazepril during the core study, but because treatment during the extension period was not randomized, the results of this intention-to-treat analysis need to be interpreted with care.
AB - The Angiotensin-converting-enzyme Inhibition on Progressive Renal Insufficiency (AIPRI) Study showed that the ACE inhibitor benazepril provides protection against loss of renal function in patients with chronic renal insufficiency (CRI) caused by various renal diseases. As a result of unexpectedly low mortality in the placebo group, there was a substantial imbalance in mortality during the course of this study (8 patients on benazepril vs. 1 on placebo). The aim of the extension study was to follow- up the patients from the AIPRI core study until autumn 1996, focusing on CRI progression and mortality. Data collection was post hoc. Patients were treated according to investigators' usual practices, without knowledge of the core study trial medication or (initially) the core trial results A new primary efficacy parameter was defined as the time from the start of core study treatment to the occurrence of the first event in the combined composite end-point of dialysis, renal transplantation or death related to renal disease Serial serum creatinine levels and all-cause mortality were also recorded. The median total follow-up for core -extension periods was 6.6 years. Many patients from both treatment groups (64% on benazepril and 61% on placebo) received ACE inhibitors during follow-up in the intention-to-treat analysis of the core + extension data, only 79 of 300 patients from the benazepril group, compared to 102 of the 283 patients from the placebo group needed dialysis or renal transplantation, or died related to renal disease (P <0.013. log-rank test). The mortality imbalance seen in the core trial was nor evident with the longer follow-up (25 deaths in the benazepril and 23 in the placebo group before dialysis): These data clearly demonstrate a long- term beneficial effect in patients randomized to take benazepril during the core study, but because treatment during the extension period was not randomized, the results of this intention-to-treat analysis need to be interpreted with care.
KW - Benazepril
KW - Chronic renal insufficiency
KW - Mortality in renal disease
KW - Progression to chronic renal insufficiency
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M3 - Article
C2 - 9407424
AN - SCOPUS:0002552612
VL - 51
JO - Kidney International, Supplement
JF - Kidney International, Supplement
SN - 0098-6577
IS - 63
ER -