Abstract | BACKGROUND: OBJECTIVE: This article reviews the available literature on pramlintide with respect to its mechanism of action, pharmacokinetics and pharmacodynamics, clinical efficacy in type 1 and type 2 diabetes, safety and tolerability, dosing, contraindications, and drug interactions. METHODS: MEDLINE (1966-April 2005), Iowa Drug Information Service (1966-April 2005), and International Pharmaceutical Abstracts (1970-April 2005) were searched for clinical trials and therapeutic reviews published in the English language. The search terms were pramlintide and amylin. The bibliographies of identified articles were reviewed for additional references. All relevant studies were included in the review. RESULTS: Six studies, ranging in duration from 4 to 52 weeks, examined the effect of administering pramlintide with premeal insulin in patients with type 1 diabetes. In these trials, pramlintide 120 to 270 microg/d reduced glycosylated hemoglobin (HbA(1c)) by 0.1 % to 0.67%, 1-hour postprandial glucose (PPG) by 4.4 to 7 mmol/L, and 2-hour PPG by 3.6 to 4.8 mmol/L. Five studies, also ranging from 4 to 52 weeks' duration, examined the effect of administering premeal pramlintide in patients with type 2 diabetes. In these trials, pramlintide 90 to 450 microg/d reduced HbA(1c) by 0.3% to 0.62%, 1-hour PPG by 4.8 mmol/L, and 2-hour PPG by 3.4 mmol/L. The principal adverse events reported in clinical trials were nausea and hypoglycemia. The incidence of hypoglycemia in the first 4 weeks of therapy was 2 to 4 times greater with pramlintide compared with placebo; thus, the manufacturer recommends reducing the dose of premeal insulin by 50% when starting pramlintide. Close monitoring of blood glucose levels is recommended when initiating pramlintide therapy. CONCLUSIONS:
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Authors | Gina J Ryan, Lynetta J Jobe, Rhonda Martin |
Journal | Clinical therapeutics
(Clin Ther)
Vol. 27
Issue 10
Pg. 1500-12
(Oct 2005)
ISSN: 0149-2918 [Print] United States |
PMID | 16330288
(Publication Type: Journal Article, Review)
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Chemical References |
- Amyloid
- Blood Glucose
- Hypoglycemic Agents
- Insulin
- Islet Amyloid Polypeptide
- Glucagon
- pramlintide
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Topics |
- Amyloid
(administration & dosage, pharmacology, therapeutic use)
- Blood Glucose
(analysis)
- Clinical Trials as Topic
- Diabetes Mellitus, Type 1
(blood, drug therapy)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Drug Interactions
- Drug Therapy, Combination
- Glucagon
(blood)
- Humans
- Hypoglycemic Agents
(pharmacology, therapeutic use)
- Insulin
(administration & dosage)
- Islet Amyloid Polypeptide
- Postprandial Period
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