Primary Prevention of Graves’ Orbitopathy by Pentoxifylline (Randomized Controlled Trial)

The prospective controlled study was designed for comparing the influence of methimazole (MMI + placebo)(control group) and MMI + pentoxiphylline (PTX) with respect to grades of Thyroid Associated Ophthalmopathy (TAO). The control group consisted of 112 patients with hyperthyroidism (mean age 44.0 ± 12.4 yr, 83 females and 29 males). PTX treated group of 112 (mean age 47.7 ± 10.2 yr, 83 female and 29 male) hyperthyroid patients were treated with MMI + PTX. At the onset of the study there were no remarkable differences between the two treated groups. After six- and twelve-month observation periods the manifestations of TAO with moderate and severe forms were significantly lower in the PTX treated patients. Various risk factors were analyzed in both groups. Smoking by itself without genetic factors greatly increased the risk of TAO (OR: 7.1, CI 95% 9.3–5.4). If the smoking habit was associated with a genetic background, the manifestation of TAO significantly increased (OR: 9.2 CI 95%, 12.1–6.9, p < 0.0001). PTX therapy had a beneficial preventive effect on the manifestation of eye symptoms and decreased the number of smoking patients both with and without genetic susceptibility (OR: 2.62 CI 95%, 1.5–3.7, p < 0.001 and 2.12: 95% CI 1.5–3.1, p < 0.001), respectively. It was concluded that PTX was able to decrease the development of TAO during a 1-year observation period, therefore, the administration of this drug was advised if the patients refused to abstain from smoking.