Efficacy of pergolide in treatment of restless legs syndrome: the PEARLS Study.

OBJECTIVE: To evaluate the short- and long-term safety and efficacy of pergolide therapy for restless legs syndrome (RLS) in a double-blind, placebo-controlled, randomized trial (Pergolide European Australian RLS [PEARLS] study). METHODS: We randomized 100 patients with idiopathic RLS were randomized to pergolide, 0.25 to 0.75 mg, in the evening or placebo for 6 weeks (phase 1); thereafter, patients with response on the Patient Global Impression (PGI) scale continued on double-blind pergolide or placebo, and nonresponders received open-label pergolide up to 1.5 mg/d for 12 months of treatment (phase 2). Sleep efficiency (SE) and periodic limb movements during sleep (PLMS) arousal index were monitored by centrally evaluated polysomnography (PSG). The severity of RLS was assessed using the validated International RLS Scale (IRLS). RESULTS: In phase 1 (change from baseline to week 6), pergolide reduced PLMS arousal index vs placebo (mean +/- SD, -12.6 +/- 10.0 vs -3.6 +/- 15.9; p = 0.004), and SE did not improve (mean +/- SD, +11.3 +/- 11.9% vs +6.1 +/- 18.6%; p = 0.196). Pergolide improved RLS severity score (-12.2 +/- 9.9 vs -1.8 +/- 7.5 placebo; p < 0.001) and was associated with a higher PGI response (68.1% vs 15.1%; p < 0.001) and improvements in periodic limb movements (PLM) index, PGI improvement scale, Clinical Global Impression improvement, and IRLS (all p < 0.001), patient-reported SE (p = 0.019), and quality of sleep (p < 0.001). After 12 months (phase 2), double-blind pergolide maintained improvements in PLMS arousal index and PLM index. Placebo patients switched to open-label pergolide in phase 2 exhibited marked improvements in these measures that were maintained at 12 months. Pooled results from the blinded and open-label pergolide groups demonstrated improvements at 12 months in the PLMS arousal index (p = 0.028) and PLM index (p < 0.0001) compared with placebo. Nausea and headache were more frequent with pergolide than with placebo treatment. CONCLUSIONS: Pergolide substantially improves periodic limb movement measures and subjective sleep disturbance associated with restless legs syndrome. Low-dose pergolide was well tolerated and maintained its efficacy in the long term.

Temperature-controlled radiofrequency tissue volume reduction in the human soft palate.

OBJECTIVE: To validate the use of temperature-controlled radiofrequency energy applied to the soft palate in a multicenter setting for reduction of snoring in a minimally morbid manner. METHODS: Prospective, nonrandomized multicenter study of 113 patients who had a respiratory disturbance index less than 15 and minimum oxygen saturation not less than 85% and who were seeking treatment for habitual disruptive snoring. Patients were given either single or multiple lesions to the soft palate during each treatment session. RESULTS: Patients received 1978 J on average with an overall average of 2.4 treatments. Snoring scores went from an average of 7.8 (visual analog scale (VAS), 0-10) pretreatment to 3.2 posttreatment. Pain was minimal, averaging 1.7 (VAS 0-10) on days 1 to 6. Complications were few and transient, and mild. CONCLUSIONS: The multiple lesion protocol was the most successful; reducing snoring from 7.6 to 2.7, on a VAS with an average of 1232 J delivered over 1.6 treatments. Temperature-controlled radiofrequency was found to be a minimally invasive, well-tolerated procedure that was safe and efficacious in this study group.

Effects of cardiac dysfunction on non-hypercapnic central sleep apnea.

INTRODUCTION: Non-hypercapnic central sleep apnea (CSA) commonly occurs during nonrapid eye movement (non-REM) sleep in adults with congestive heart failure (CHF) and in some subjects without signs or symptoms of CHF. Hyperventilation, reduced lung volume, and circulatory delay are known to contribute to CSA, but to differing degrees depending on presence or absence of CHF. AIM: To determine whether the pattern of ventilation during sleep could be used to determine the presence of CHF. METHODS: Full polysomnographs demonstrating CSA were examined in 10 consecutive subjects with CHF and in 10 without CHF. Ventilatory, apnea, and cycle lengths, and circulation time (from the onset of ventilatory effort to the nadir of oximeter trace) were measured from cyclic apneas during non-REM sleep. RESULTS: The non-CHF group had a greater left ventricular ejection fraction (LVEF) (59.7+/-1.9% vs 19.2+/-2.2%). Circulation time (11.8+/-0.5 s vs 24.9+/-1.7 s; p < 0.001) and cycle length (35.1+/-2.8 s vs 69.5+/-4.5 s; p < 0.001) were significantly greater in the CHF group compared with the non-CHF group, but not apnea length (21.3+/-1.8 s vs 26.8+/-2.0 s; p=0.06). Ventilatory length to apnea length ratio (VL:AL) was uniformly > 1.0 in the CHF group (mean, 1.65; range, 1.02 to 2.33), and in the non-CHF group < 1.0 (mean, 0.66; range, 0.54 to 0.89). LVEF correlated negatively with both circulation time (r=-0.86; p < 0.001) and cycle length (r=-0.79; p < 0.001). CONCLUSION: The VL:AL ratio > 1.0, as well as both circulation time > 15 s and cycle length > 45 s, can be used to recognize the presence of CHF in subjects with CSA.