Safety and tolerability in hypertensive patients

An acceptable safety profile in patients with hypertension and/or chronic angina

Hypertension and/or angina

Adalat GITS has demonstrated an acceptable safety profile in placebo-controlled studies. For further information, please refer to the local label.1

Angina

The adverse and serious adverse events reported in the ACTION trial demonstrate that Adalat GITS is a well-tolerated drug for use in the treatment of angina.2

* Number of patients with events per 100 patient-years at risk.
† % of AEs.

Tolerability profile similar to diuretics and placebo in hypertensive patients with high CV risk

Adalat GITS has demonstrated a tolerability profile similar to diuretics and placebo in the INSIGHT and ACTION clinical trials.2,3

  • In INSIGHT, hypertensive patients with additional risk factors for cardiovascular disease received either Adalat GITS (n=3157) or co-amilozide (n=3164). Serious adverse events (AEs) were more frequent in the co-amilozide group vs Adalat GITS (880 [28%] vs 796 [25%], p=0.02)3
  • In ACTION, 7665 patients with stable angina pectoris were randomly assigned Adalat GITS 30 mg, titrated up to 60 mg, once-daily (n=3825) or placebo (n=3840), and followed for a mean of 4.9 years. The safety profile for Adalat GITS was similar to placebo apart from the known AEs, which included peripheral oedema2

References

  1. Adalat Health Care Professional Information.
  2. Poole-Wilson PA, et al. Cardiovasc Drugs Ther 2006;20:45-54.
  3. Brown MJ, et al. Lancet 2000;356:366-72.