Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.

An interim analysis will be performed when 25 patients per group will be included.

Secondary objectives of this clinical trial :

• To evaluate the effect of Atorvastatin in comparison with the placebo on the inflammation occurring during OSAS, after 3 months of treatment.
• To evaluate the effect of Atorvastatin in comparison with the placebo on the insulin-resistance associated to OSAS, after 3 months of treatment.
• To evaluate the effect of Atorvastatin in comparison with the placebo on the hypercholesterolemia associated to OSAS, after 3 months of treatment.
• To evaluate at 6 months, the effect of the continuous positive airway pressure (CPAP) + Atorvastatin association on the previously cited parameters, in comparison with Atorvastatin, CPAP and placebo.
• To measure the CPAP efficiency in comparison with sham CPAP in patients receiving the placebo, after 3 months of treatment.

Inclusion Criteria:

• Men or women > 18 years old
• Subjects diagnosed with OSAS (apnea/hypopnea index = AHI > 30/h)
• Subjects with clinical ATH from grade I or II controlled with mono-therapy(140<SAP<180 mmHg and 90<DAP<110 mmHg)

Exclusion Criteria:

• Patients with a history of prior stroke or coronary ischemic disease
• Chronic respiratory disease (PaO2 < 60 mmHg and/or PaCO2 > 45 mmHg)
• Lung disease
• Hypothyroidism
• Statin treatment
• Antihypertensive treatment with more than one drug
• Pregnant or lactating women
• Alcohol consumption > 3 units/day
• Treatment by itraconazole, ketoconazole, antiprotease, fibrates, antivitamin K, diltiazem, verapamil, erythromycin, clarithromycin, cyclosporin.
• Hypersensitivity to one of the drug compounds
• Patients with modified concomitant treatments during the 3 months before inclusion
• Potentially dangerous sleepiness
• Jobs at risk