Table 5

Adverse events with pramlintide in type 1 diabetes

Whitehouse 200214Ratner 200415Edelman 200613
30/60a QIDPlacebo60 TID60 QID90 TIDPlacebo30 TID-QID60 TID-QIDPlacebo
Mean number of severe hypoglycemia events per patient-year (SE)b
 Weeks 0–42.12 (0.35)1.04 (0.24)3.78 (0.57)3.41 (0.55)3.91 (0.58)0.87 (0.27)0.79 (0.46)0.46 (0.46)0.42 (0.19)
 Weeks 26–520.43 (0.07)0.52 (0.08)0.74 (0.12)0.79 (0.12)0.64 (0.12)0.45 (0.09)---------
 Weeks 0–29------------------1.10 (0.25)0.42 (0.09)0.30 (0.06)
Treatment-emergent adverse events (%)c
Total nausea46.521.947.047.059.012.095.148.536.1
 Severe nausea6.21.78.56.85.81.37.34.00.7
Total vomiting11.58.09.811.012.06.517.111.96.1
 Severe vomiting2.10.41.80.61.20.62.45.90.7
Total anorexia17.72.118.011.016.02.6---------
 Severe anorexia2.50.01.21.90.60.0---------
Total reduced appetite------------------14.66.92.0
 Severe reduced appetite------------------0.00.00.0
Total sinusitis------------------22.012.98.8
 Severe sinusitis------------------0.00.00.0
a

All doses are reported as mcg/meal. 30/60, 30 or 60-mcg arms

b

Severe hypoglycemia event rates are calculated as the total number of events for all patients on a treatment regimen divided by the total number of patient-years of observation.

c

Treatment-emergent adverse events with occurrences 10% for totals and the incidence in the pramlintide arm is at least twice that of placebo arm.

Abbreviations: TID, three times daily; QID, four times daily.

From: Results

Cover of Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus
Drug Class Review: Newer Drugs for the Treatment of Diabetes Mellitus: Final Report [Internet].
Norris SL, Lee NJ, Severance S, et al.
Portland (OR): Oregon Health & Science University; 2008 Aug.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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