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PHOENIX 2 evaluated 1230 patients who began the study receiving STELARA ® 45 mg or 90 mg or placebo. Patients randomized to STELARA® received STELARA ® at Weeks 0 and 4, followed by the same dose every 12 weeks through Week 28. Patients in the placebo group (n=410) crossed over to receive either STELARA ® 45 mg or 90 mg at Weeks 12 and 16, followed by the same dose every 12 weeks. Eligible patients were adults with a diagnosis of plaque psoriasis for ≥6 months involving ≥10% body surface area (BSA), PASI score ≥12, and who were candidates for phototherapy or systemic therapy. 1,2

At sub-anesthetic doses, dissociatives alter many of the same cognitive and perceptual processes affected by other hallucinogenic drugs such as mescaline , LSD , and psilocybin ; hence they are also considered hallucinogenic , and psychedelic . [11] [12] [13] [14] Perhaps the most significant subjective differences between dissociatives and the classical hallucinogens (such as LSD and mescaline ) are the dissociative effects, including: depersonalization , the feeling of being unreal, disconnected from one's self, or unable to control one's actions; and derealization , the feeling that the outside world is unreal or that one is dreaming. [15]

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma
A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients () compared to non-XOLAIR-treated patients (). Increases in rates were observed for transient ischemic attack ( vs ), myocardial infarction ( vs ), pulmonary hypertension ( vs 0), pulmonary embolism/venous thrombosis ( vs ), and unstable angina ( vs ), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

Corticosteroids moa

corticosteroids moa


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