Effects of saxagliptin added to sub-maximal doses of metformin compared with uptitration of metformin in type 2 diabetes: the PROMPT study.
Curr Med Res Opin
; 28(10): 1635-45, 2012 Oct.
Article
em En
| MEDLINE
| ID: mdl-23020253
ABSTRACT
OBJECTIVE:
The PROMPT study compared efficacy and tolerability of two treatment intensification strategies adding saxagliptin or uptitrating metformin monotherapy, in patients with type 2 diabetes (T2D) and inadequate glycaemic control on a sub-maximal metformin dose. RESEARCH DESIGN ANDMETHODS:
In this double-blind, 24-week study, metformin-tolerant patients with T2D on metformin monotherapy were randomised to receive fixed-dose metformin 1500 mg/day, plus either add-on saxagliptin 5 mg/day (SAXA-MET) or a two-step metformin uptitration (MET-UP) to a maximum dose (2500 mg/day). CLINICAL TRIAL REGISTRATION NCT01006590. MAIN OUTCOMEMEASURES:
Primary absolute change from baseline in glycated haemoglobin A(1c) (HbA(1c)) (Week 24). Secondary proportion of patients achieving a therapeutic glycaemic response (Week 24); change from baseline in fasting plasma glucose (Week 24); safety and tolerability. Exploratory analyses comprised three patient-related questionnaires, including the validated 5-dimension Digestive Health Status Index (DHSI).RESULTS:
A total of 286 patients were randomised (SAXA-MET 147; MET-UP 139). Baseline mean (SD) HbA(1c) 7.71 (0.85; SAXA-MET); 7.80 (0.82; MET-UP). Adjusted mean reductions from baseline in HbA(1c) (Week 24) -0.47% (SAXA-MET); -0.38% (MET-UP); mean (95% CI) difference in treatment effect, -0.10% (-0.26, 0.07); p = 0.260. The proportion of patients (95% CI) achieving a therapeutic glycaemic response (HbA(1c) < 7%) 43.8% (34.8, 49.6) (SAXA-MET) vs. 35.0% (29.0, 43.8) (MET-UP). Of the five DHSI domains, mean (95% CI) differences were observed for diarrhoea-predominant score (+0.8 [-2.5, 4.0] vs. +7.9 [4.6, 11.2]) and dysmotility score (-0.5 [-2.0, 1.0] vs. +1.9 [0.3, 3.4]), (SAXA-MET and MET-UP, respectively). The most common adverse event was diarrhoea 6.1% (SAXA-MET) vs. 12.2% (MET-UP).CONCLUSIONS:
In metformin-tolerant patients with T2D (inadequately controlled on sub-maximal metformin monotherapy), saxagliptin was well tolerated. Although HbA(1c) reduction was not significantly different between treatment groups, the lower occurrence of gastrointestinal symptoms in the SAXA-MET group suggests that saxagliptin add-on treatment may be a suitable alternative treatment strategy to metformin uptitration.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
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3_ND
Base de dados:
MEDLINE
Assunto principal:
Adamantano
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Diabetes Mellitus Tipo 2
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Dipeptídeos
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Tolerância a Medicamentos
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Inibidores da Dipeptidil Peptidase IV
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Hipoglicemiantes
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Metformina
Tipo de estudo:
Clinical_trials
Aspecto:
Patient_preference
Limite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Curr Med Res Opin
Ano de publicação:
2012
Tipo de documento:
Article