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1.
Ann Cardiol Angeiol (Paris) ; 47(8): 589-94, 1998 Oct.
Article in French | MEDLINE | ID: mdl-9809145

ABSTRACT

31 male and female patients, between the ages of 18 and 65 years, presenting mild-to-moderate hypertension (DBP between 95 and 114 mmHg) and stable chronic renal failure (creatinine clearance between 60 and 25 ml/min) after a preinclusion placebo phase were included in a multicentre open study designed to evaluate the clinical, electrocardiographic and laboratory safety, as well as the antihypertensive efficacy of Diltiazem 300 mg Retard, as monotherapy for 3 months, or combined with a diuretic (furosemide) or angiotensin converting enzyme inhibitor (captopril) for 45 days. After an 8-day placebo run-in period, the study consisted of a 45-day phase of strict monotherapy with Diltiazem 300 mg Retard, followed by a final 45-day phase during which either monotherapy was continued (if safety was satisfactory and supine DBP < or = 90 mmHg), or two-agent combination therapy was instituted (when supine DBP was between 91 and 115 mmHg), 6 clinical evaluations were performed during the 3 months of this trial. Overall, 21 patients (mean age: 50 +/- 14 years) completed the study until the 3rd month: 13 remained on monotherapy, and 8 required two-agent combination therapy. Supine and standing systolic and diastolic blood pressures and heart rate were significantly decreased. The number of responding patients controlled (supine DBP < or = 90 mmHg) progressed between D10 (40%) and D90 (57%). The observed adverse events and reasons for drop-outs from the trial for adverse events were mostly related to the vasodilator effects of Diltiazem. The cardiac safety was good, with no significant variation of the PR interval on the ECG (0.15 +/- 0.03 sec on D-8, 0.17 +/- 0.02 sec on D90). No marked modification of blood and urinary laboratory constants (serum electrolytes, blood glucose, liver function tests) was observed during this trial. Renal function, evaluated by creatinine clearance, was not altered by treatment (40.5 +/- 15.2 ml/min on D0, 41.7 +/- 16.9 ml/min on D90). Overall, this study confirmed the good clinical, laboratory and electrocardiographic safety as well as the antihypertensive efficacy of Diltiazem 300 mg Retard administered as monotherapy for 3 months or possibly in combination for 45 days, in hypertensive patients with chronic renal failure.


Subject(s)
Antihypertensive Agents/therapeutic use , Diltiazem/therapeutic use , Hypertension/complications , Kidney Failure, Chronic/complications , Adolescent , Adult , Aged , Antihypertensive Agents/pharmacology , Delayed-Action Preparations/therapeutic use , Diltiazem/pharmacology , Drug Tolerance , Female , Humans , Hypertension/drug therapy , Kidney Failure, Chronic/drug therapy , Male , Middle Aged , Treatment Outcome
3.
Arch Mal Coeur Vaiss ; 88(8): 1153-7, 1995 Aug.
Article in French | MEDLINE | ID: mdl-8572864

ABSTRACT

UNLABELLED: When early kidney transplant biopsies showed benign hypertensive nephrosclerosis, i.e. hyalin arteriosclerosis and/or interlobular arteries intimal thickening, they are thought to be of donor origin. Between 1987 and 1992, 439 cadaveric renal transplantations have been performed in our department: amongst them 97, i.e. 22% patients underwent a graft biopsy before the end of the first post transplant month (13 +/- 9.5 days). To ascertain if findings of early renal biopsy was predictive of eventual clinical outcome we analyzed renal function and blood pressure (BP) in the short and mid term. Nephrosclerosis lesions were found in 33 cases (group I) and were absent in the remaining 64 cases (group II). The 2 groups were not statistically different according to the time on dialysis, the recipient's age, the HLA matching, the cold ischemia time. The only statistically significant difference was the donor's age: 39.1 +/- 7 years in group I vs 26.9 +/- 8 years in group II (p = 0.0001). Delayed graft function was not different in the 2 groups (13 +/- 9 days group I vs 11 +/- 6 days group II). On the other hand, 30% of group I, patients required hemodialysis (9.8% in group II; p < 0.005). The incidence in graft rejection episodes was similar in both groups (50%) as well as surgical complications. Renal function was assessed by creatinine clearance at 1 and 2 years and at last follow-up visit (mean follow-up: 50.5 +/- 44 months in group I and 46.9 +/- 24 months in group II; p = Ns): it was similar in both groups (see table). The prevalence of hypertension (HTA) was significantly higher in group I than in group II at two years and last follow-up (*: p < 0.005). [table: see text] CONCLUSIONS: The age of donor is of importance in determining nephrosclerosis of the graft observed on early biopsies. Donor-related nephrosclerosis is a risk factor for the recipient of developing HTA without impairment of graft function in the mid term. In the context of early nephrosclerosis, the occurrence of acute rejection episode(s) is detrimental for the graft function.


Subject(s)
Graft Rejection , Kidney Transplantation , Nephrosclerosis/complications , Adult , Age Factors , Biopsy , Creatinine/analysis , Female , Follow-Up Studies , Graft Rejection/etiology , Graft Survival , Humans , Hypertension, Renovascular/etiology , Kidney/pathology , Kidney Transplantation/adverse effects , Male , Middle Aged , Nephrosclerosis/pathology , Tissue Donors
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