Efficacy and harms of the hypoglycemic agent pramlintide in diabetes mellitus

Nancy J. Lee, Susan L. Norris, Sujata Thakurta

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

PURPOSE: We conducted a study to examine the efficacy, effectiveness, and harms of pramlintide as adjunct therapy in adults and children with type 1 or type 2 diabetes. METHODS: We searched multiple bibliographic databases to January 2010, the US Food and Drug Administration Web site, and other sources to identify randomized controlled trials (RCTs) fulfilling inclusion criteria. Syntheses were qualitative because data were too heterogeneous for meta-analysis. RESULTS: Three published RCTs in type 1 diabetes and 4 in type 2 disease fulfilled inclusion criteria. All trials were conducted with adults, and none was longer than 52 weeks. In type 1 diabetes with intensive insulin therapy, pramlintide was as effective as placebo in lowering glycated hemoglobin (HbA1c) levels in one trial. Pramlintide was somewhat more effective than placebo in patients using conventional insulin therapy, with a between-group difference in HbA1c levels of 0.2% to 0.3% (2 studies). In patients with type 2 diabetes, pramlintide was more effective at reducing HbA1c levels than placebo when added to flexibly dosed glargine (without prandial insulin) and when added to fixed-dose insulin therapies, with or without oral hypoglycemic agents (between-group differences in HbA1c were approximately 0.4%). Weight loss was observed with pramlintide in both type 1 and type 2 diabetes, whereas placebo-treated patients tended to gain weight. Pramlintide-treated patients experienced more frequent nausea and severe hypoglycemia compared with patients treated with placebo. CONCLUSIONS: Pramlintide was somewhat more effective than placebo as adjunct therapy for improving HbA1c levels and weight in adults with type 1 diabetes on conventional insulin therapy, or type 2 diabetes and inadequate glycemic control with their current therapies, with between-group differences in HbA1c levels in the range of 0.2% to 0.4%. Further research is needed to determine pramlintide's durability of hypoglycemic effect, as well as effects on patient-reported outcomes, morbidity, mortality, and long-term harms.

Original languageEnglish (US)
Pages (from-to)542-549
Number of pages8
JournalAnnals of Family Medicine
Volume8
Issue number6
DOIs
StatePublished - Nov 2010

Fingerprint

Hypoglycemic Agents
Diabetes Mellitus
Placebos
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Insulin
Therapeutics
Randomized Controlled Trials
Bibliographic Databases
pramlintide
Glycosylated Hemoglobin A
Cytomegalovirus Infections
United States Food and Drug Administration
Hypoglycemia
Nausea
Weight Gain
Meals
Meta-Analysis
Weight Loss
Morbidity

Keywords

  • Amylin
  • Diabetes mellitus
  • Pramlintide
  • Systematic review

ASJC Scopus subject areas

  • Family Practice

Cite this

Efficacy and harms of the hypoglycemic agent pramlintide in diabetes mellitus. / Lee, Nancy J.; Norris, Susan L.; Thakurta, Sujata.

In: Annals of Family Medicine, Vol. 8, No. 6, 11.2010, p. 542-549.

Research output: Contribution to journalArticle

Lee, Nancy J. ; Norris, Susan L. ; Thakurta, Sujata. / Efficacy and harms of the hypoglycemic agent pramlintide in diabetes mellitus. In: Annals of Family Medicine. 2010 ; Vol. 8, No. 6. pp. 542-549.
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