P-168: Long term efficacy and tolerability of irbesartan in elderly hypertensive patients with renal impairment

• Published in: American journal of hypertension 2001-04, Vol.14 (S1), p.86A-86A
• Main Authors: De Rosa, Maria Leonarda M.L, Cardace, Piercarmine P., Rossi, Massimiliano M., de Cristofaro, Alessandro A., Baiano, Antonio A., Vigorito, Carlo C.
• Format: Article
• Language: English
• Subjects: Elderly Hypertensive Patients; Irbesartan; Renal Impairment
• ISSN: 0895-7061; 1941-7225; 1879-1905
• DOI: 10.1016/S0895-7061(01)01813-1

Objective: We evaluated the blood pressure lowering activity, tolerability and safety of Irbesartan (I) in 32 elderly hypertensive (sitting diastolic blood pressure, 90 to 115 mmHg) patients with chronic renal insufficiency including mild renal insufficiency (30 to 60 ml/min x 1.73 m2; n=30), moderate to severe renal insufficiency (10 to 29 ml/min x 1.73 m2; n=2) in one year trial. Design and Methods: After a 3-week placebo period, once daily I was administered for 12 months at daily dose of 150 mg. A second, non-angiotensin-converting enzyme inhibitor, antihypertensive drug was added after 8 weeks as needed. Twenty-four-hour creatinine clearance was determined and renal clearance studies of inulin and paraminohippurate were done in a subset of 11 patients. Results: Through sitting blood pressure were reduced at the end of the first week in all groups. At weeks 4, 8, 12 and after one year the reductions in systolic blood pressure/diastolic blood pressure averaged were -11.9/-8.7,-10.8/-9.4,and -14.7/-12.1mmHg in patients with mild renal insufficiency; -7.7/-6.3,-13.1/-11.8, and -14.1/-10.6 mmHg in moderate to severe renal insufficiency.Creatine clearance,glomerular filtration rate and effective renal plasma flow were stable.I was withdrawn in only 6 patients because of a clinical or laboratory adverse experience. Hyperkaliemia(>6mEq/L) requiring discontinuation of I occurred in only one(group 2)patient. Conclusion: We conclude that once-daily I given as monotherapy at dose of 150 mg or in combination with other antihypertensive drugs,was effective in reducing blood pressure in elderly hypertensive patients with chronic renal disease and that I regimens were well tolerated in all groups.