Trapidil is as effective as isosorbide-dinitrate for treating stable angina pectoris: a multinational, multicenter,...

Area of Science:

• Cardiology
• Pharmacology

Background:

• Nitrates are a standard treatment for stable angina pectoris.
• Trapidil is a triazolo-pyrimidine with a distinct mechanism of action compared to nitrates.

Purpose of the Study:

• To demonstrate that trapidil is not inferior to isosorbide-dinitrate (ISDN) in treating stable angina pectoris.
• To compare the efficacy and safety of trapidil and ISDN in patients with chronic stable angina.

Main Methods:

• A 12-week study comparing trapidil (200 mg t.i.d.) with ISDN (20 mg b.i.d.) in patients with chronic stable angina.
• Efficacy was assessed by responder rate, defined as a change in total exercise time (TET) of at least 60 seconds using a bicycle ergometer test.
• 648 patients were included in the study.

Main Results:

• Responder rates were similar between trapidil (50.4%) and ISDN (52.5%) groups in the Per-Protocol population (p = 0.233).
• Non-inferiority of trapidil compared to ISDN was concluded, with 95% confidence intervals excluding the lower non-inferiority limit.
• Headache was significantly more frequent in the ISDN group (34.1%) than in the trapidil group (19.3%; p <0.0001).

Conclusions:

• Trapidil and ISDN are equally effective and safe for the short-term treatment of chronic stable angina pectoris.
• Trapidil can be considered therapeutically equivalent to ISDN for managing stable angina.