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References

  1. JEVTANA Prescribing Information. Bridgewater, NJ: sanofi-aventis . LLC; September 2017.
  2. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version ). Eur J Cancer . 2009;45(2):228-247.
  3. Data on file. Clinical study report (TROPIC). A randomized, open label multicenter study of XRP6258 at 25 mg/m 2 in combination with prednisone every 3 weeks compared to mitoxantrone in combination with prednisone for the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere-containing regimen. Study number EFC6193. Sanofi-aventis. March 18, 2010.
  4. National Comprehensive Cancer Network ® . Clinical Practice Guidelines in Oncology™: Prostate Cancer. V2. 2017

References: 1. Wilson T, Nelson SD, Newbold J, et al. The clinical epidemiology of male osteoporosis: a review of the recent literature. Clin Epidemiol. 2015;7:65−76. 2. Prolia ® (denosumab) prescribing information, Amgen. 3. Orwoll E, Teglbjaerg CS, Langdahl BL, et al. A Randomized, Placebo-Controlled Study of the Effects of Denosumab for the Treatment of Men with Low Bone Mineral Density. J Clin Endocrinol Metab. 2012;97:3161-3169. 4. Rowland M, Tozer TN. Clinical Pharmacokinetics: Concepts and Applications. 2nd ed. Philadelphia, London: Lea & Febiger; 1989. 5. CMS Coverage Database Search Results for Denosumab, February 2014.

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.

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