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Aliskiren Produces Sustained Blood Pressure Reduction Even After Missed Dose: Presented at ESH

By Betty S. Riggs

Berlin -- June 19, 2008 -- The renin inhibitor aliskiren produces sustained blood pressure reductions beyond the 24-hour dosing interval after a missed dose, according to results of a comparative ambulatory blood pressure monitoring study.

Therefore, this new drug could be an important treatment option for hypertensive patients in whom occasional non-adherence is common, the researchers said in a presentation here at the 18th Scientific Meeting of the European Society of Hypertension (ESH).

Werner Jung, MD, Cardiology Department, Academic Hospital Villingen, Villingen-Schwenningen, Germany, and colleagues reported the findings from their 9-week, double-blind, randomised, multicentre, parallel-group study in a poster session on June 18.

Eligible patients were at least 18 years old and had a mean office sitting diastolic blood pressure (BP) between 95 and 110 mm Hg and a mean ambulatory diastolic BP >85 mm Hg.

After a 7-day washout period and a 2-week placebo run-in period, 654 patients were randomised to aliskiren 150 mg, irbesartan 150 mg, or ramipril 5 mg once daily. On day 14, the dose of each drug was doubled and continued until day 42, at which time patients were equally randomised in each group to receive 1 day of placebo on either day 42 or 49 to simulate a missed dose. Active treatment was maintained on all other days.

The primary endpoint was change from baseline in 24-hour diastolic BP following a missed dose on either day 42 or 49. Comparisons between groups for efficacy variables were made using a 2-way repeated measures analysis of covariance model with treatment, country, and visit of missed dose as factors, and the baseline mean value as the covariate. These analyses were performed on the population who completed the required 24-hour ambulatory BP monitoring (completers) at baseline (days 42 and 49).

Mean age of patients was 53 years. The majority of patients were white males with a mean body mass index of 29 kg/m². Baseline 24-hour mean ambulatory BP was 146/93 mm Hg. There were 155 patients who completed aliskiren treatment, 171 who completed treatment with irbesartan, and 152 who completed treatment with ramipril.

Following a missed dose on day 42 or 49, mean reductions from baseline in 24-hour ambulatory BP were not significantly different in the patients treated with aliskiren (-9.3/-7.0 mm Hg) and irbesartan (-9.5/-7.3 mm Hg). However, these reductions were significantly greater than the mean reductions in patients treated with ramipril (-7.1/-5.0 mm Hg; systolic P = .008; diastolic P = .0004).

After a simulated missed dose, aliskiren maintained 91% of the 24-hour BP reduction compared with 73% to 77% of irbesartan patients, and 64% to 65% of ramipril patients.

All study treatments were well tolerated and adverse events (AEs) were reported by approximately one-third of patients in each group. The majority of AEs were mild to moderate in severity, and the most commonly reported AEs were headache, cough, and nasopharyngitis. Cough occurred in 0.5% of patients treated with aliskiren, 1.8% of irbesartan patients, and in 6.1% of ramipril patients.

Dr. Jung concluded: "If you miss a dose of aliskiren, it doesn't matter." The researchers concluded that aliskiren represents an important new option for the treatment of patients with hypertension in whom occasional nonadherence is common.

Funding for this study was provided by Novartis Pharmaceuticals Corporation.


[Presentation title: Blood Pressure Reduction Following a Simulated Missed Dose of Aliskiren, Irbesartan, or Ramipril: A Comparative Ambulatory Blood Pressure Monitoring Study. Abstract PS32]

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