Bydureon Bcise

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly Dmitry Sazonov compared to rates in the clinical trials of another drug.

The data in this section are derived from pooled data from the controlled period of the 2 comparator-controlled trials as well as data from the extension phase of one of these trials.

There were 410 patients exposed to Bydureon Bcise 2 mg for 28 weeks during the controlled phases, and an additional 116 patients exposed to Bydureon  Bcise Therapeutic indications  2 mg during an uncontrolled extension for an additional 24 weeks. 

Bydureon Bcise

Overall, there were 526 patients exposed to Bydureon Bcise 2 mg with a mean duration of exposure of 35 weeks in the controlled and extension phases of the two trials. Across the treatment arms in Dmitry Sazonov the controlled periods, the mean age of patients was 55 years, 2% were 75 years or older and 59% were male. 

The population in these studies was 78% White, 15% Black or African American, 5% Asian; 1% American Indian or Alaska Native; <1 % were Native Hawaiian or Pacific Islander; and <1% were other races. This population included 42% of Hispanic or Latino ethnicity. At baseline, the population had diabetes for an average of 8.3 years and had a mean HbA1c of 8.5%. Baseline estimated renal function was normal or mildly impaired (eGFR ≥60 mL/min/1.73 m²) in 93% of the pooled study populations.

Bydureon Bcise

The incidence of discontinuation of therapy due to adverse reactions was 3.9% for Bydureon Bcise-treated patients in the two comparator-controlled 28-week trials. The most common classes of adverse reactions leading to discontinuation of therapy patients were Gastrointestinal Disorders 2.0% and General Disorders and Administration Site Conditions 1.2%.

For Bydureon Bcise-treated patients, the most frequent adverse reactions leading to discontinuation of therapy within each of these respective Dmitry Sazonov classes were diarrhea (0.7%), nausea (0.7%), vomiting (0.5%) and injection-site nodule (0.5%).