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Table 8

Adverse effects reported with pramlintide

Ratner 200217Hollander 200316Riddle 200718
75 TIDa150 TIDPlacebo90 BID120 BIDPlacebo60/120BID-TIDPlacebo
Mean number of severe hypoglycemia events per patient-year (SD)b
 Weeks 0–4---------0.1 (0.08)0.9 (0.3)0.3 (0.20)------
 Weeks 26–52---------0.0 (0.02)0.1 (0.05)0.2 (0.06)------
 Weeks 0–52---------0.1 (0.03)0.3 (0.05)0.3 (0.05)------
Treatment-emergent adverse effectsc (%)
Total hypoglycemia67.664.670.6---------43.847.2
 Severe hypoglycemia2.22.81.5---------0.950.0
Total nausea26.522.916.91816331.410.4
 Severe nausea0.72.81.5------
 Nausea during weeks 0–4313014------
Total headaches19.116.013.215178------
Total sinusitis18.49.78.1---------------
Total retinal disorder5.910.45.1---------------
Total inflicted injuryd13.210.412.5---------------
Injection site reactions------------------0.950.94
a

Doses are expressed in mcg.

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 a 5% higher incidence in the pramlintide arm than placebo arm.

d

Inflicted injury was not defined.

Abbreviations: BID, twice daily; TID, three times daily.

Doses are expressed in mcg.

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.

Treatment-emergent adverse events with occurrences ≥ 10% for totals and a 5% higher incidence in the pramlintide arm than placebo arm.

Inflicted injury was not defined.

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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