[Intramuscular injections of PGE1 in patients with severe claudication]

In this pilot study we selected 12 patients with short range claudication and treated, after informed consent, 6 patients (mean age 63 +/- 5; range 55-65) with severe claudication (walking distance < 100 m). Selection criteria were patent common and deep femoral artery, occluded superficial femoral artery with patent popliteal artery, with posterior tibial Doppler pressure > 50 mmHg and anterior tibial > 40 mmHg.

Patients were evaluated with a treadmill test performed to their walking limit. PGE1 was used by intramuscular injections (for a total of 80 micrograms, divided in 4 injections). The injections were about 2 cm deep in the posterior calf muscles. An exercise program was associated. Patients were required to walk 20 minutes just after the injections and to follow an exercise program (walking slowly at least 30 minutes, 3 times daily, in the following 4 weeks).

Both the PGE1 group and a comparable control group (12 patients mean age 62 +/- 4; range 56-65) were treated with ASA and pentoxyfillin (400 mg t.i.d.). In the PGE1 group the average total walking distance at inclusion was 25 +/- 16 (range 0-52); it increased to 113 +/- 55 (range 50-289) (after 1 week) and to 117 +/- 27 (range 30-1020) at 4 weeks. No important changes were observed in the control group (54 +/- 6 m at inclusion, 58 +/- 8 after one week and 63 +/- 7 after 4 weeks). There were no important side effects. One patient experienced important injection pain which disappeared in a few hours. No significant changes in tibial pressures were observed.

Intramuscular injection of PGE1 may be an interesting treatment option in patients with severe intermittent claudication but these preliminary findings should be verified in larger randomised studies.