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We compared the effects of an original structured home-based exercise program and revascularization in elderly patients with peripheral arterial disease over a 4-month period. Twenty-seven participants (n = 21; age = 68 ± 7 years) with moderate to severe claudication were randomized into (1) a test in-train out group (Ti-To; n = 18) that performed a home-based walking program prescribed and controlled at the hospital or (2) a revascularization group (Rev; n = 9) that underwent an endovascular and/or surgical procedure. The primary end point was quality of life as evaluated by the physical component summary (PCS) score of the Medical Outcomes Study Short Form 36 questionnaire. Secondary outcome measures included initial claudication distance (ICD) and absolute claudication distance (ACD), 6-minute walk distance (6MWD) and pain-free walk distance (PFWD), ankle-brachial index (ABI), and cost per walking meter gained. The PCS score significantly increased for both treatments at follow-up without a significant intergroup difference, as did ICD, ACD, and PFWD. The 6MWD and ABI significantly improved in the Rev group, and the Ti-To group exhibited a markedly lower cost per meter gained. The comparable effects of the 2 treatments need to be confirmed in a larger, randomized controlled trial., (© The Author(s) 2015.)

The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied by comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study. The study included 109 patients (96 completed the study) with an average total walking distance of 65.5 +/- 8 m (range 20-109). Phase 1 was a 2-week run-in phase (no treatment) for both protocols. In LTP, phase 2 was the main treatment phase. In the LTP, treatment was performed with 2-hour infusions (60 microg PGE1, 5 days each week for 4 weeks). In phase 3 (4-week interval period) PGE1 was administered twice a week (same dosage). In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used. In STP, phase 2 treatment was performed in 2 days by a 2-hour infusion (1st day: morning 20 microg, afternoon 40 microg; 2nd day morning and afternoon 60 microg). The reduced dosage was used only at the first cycle (week 0) to evaluate reduced tolerability or side effects. Full dosage (60 microg b.i.d.) was used for all other cycles. The same cycle was repeated at the beginning of weeks 4, 8, and 12. The observation period was between weeks 12 and 20. A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of the 20th week. A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. Intention-to-treat analysis indicated an increase in walking distance, which improved at 4 weeks (101.5% in STP vs 78.3% in LTP), at 8 weeks (260.9% STP vs 107.3% LTP), and at 20 weeks (351% STP vs 242% LTP). Comparable increases in pain-free walking distance were observed in the two groups. No serious drug-related side effects were observed. Local, mild adverse reactions were seen in 7% of the treated subjects in the LTP and 5% in the STP. Average cost of LTP was approximately 6,588 ECU; for STP the average cost was approximately 1,881 ECU. The cost to achieve an improvement in walking distance of 1 m was 35.6 ECU with the LTP and 9.45 ECU with the STP (26% of the LTP cost; p<0.02). For an average 100% increase in walking distance the LTP cost was 1,937 ECU vs 550 ECU with STP (p<0.02). The cost of PGE1 (including infusion and operative costs) was 25% of the total cost for LTP (24.9% for STP). In summary, between-group-analysis favors STP, in terms of walking distance and costs. Results indicate good efficacy and tolerability of PGE1 treatment. With STP less time is spent in infusion and more can be spent in the exercise program. STP reduces costs, speeds up rehabilitation, and may be used in a larger number of nonspecialized units available to follow the protocol.