Abstract | OBJECTIVES: METHODS: This is a post hoc analysis of three Phase 3 studies in adults with and without type 2 diabetes mellitus (T2DM) treated with lorcaserin 10 mg BID or placebo. NNT is reported for patients achieving ≥5% or ≥10% weight loss, achievement of either HbA1c <5.7% or FPG <100 mg/dL in patients with prediabetes, and reduction of HbA1c to <7% in patients with T2DM at Week 52. RESULTS: In the modified intention-to-treat (MITT) population, NNTs for ≥5% and ≥10% weight loss were 3.6 and 6.2 (without T2DM) and 4.3 and 7.5 (with T2DM); in Week 12 responders (≥5% weight loss at Week 12), NNTs were 1.7 and 2.6 (without T2DM) and 1.9 and 3.2 (with T2DM). In patients with prediabetes, NNTs to achieve HbA1c <5.7% were 9.9 (MITT) and 5.2 (Week 12 responders). In patients with T2DM, NNTs to achieve HbA1c <7% were 4.2 (MITT) and 2.3 (Week 12 responders). CONCLUSION: In addition to weight management, lorcaserin improved glycemic control in patients with prediabetes and facilitated targeted HbA1c reduction in patients with T2DM, especially for those who achieved ≥5% weight loss by Week 12. Assessment of treatment response at Week 12 is a valuable tool to achieve efficient use of healthcare resources. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifiers are NCT00395135, NCT00603291, and NCT00603902.
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Authors | Yehuda Handelsman, Randi Fain, Zhixiao Wang, Xuan Li, Ken Fujioka, William Shanahan |
Journal | Postgraduate medicine
(Postgrad Med)
Vol. 128
Issue 8
Pg. 740-746
(Nov 2016)
ISSN: 1941-9260 [Electronic] England |
PMID | 27659698
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Benzazepines
- Blood Glucose
- Hypoglycemic Agents
- Serotonin 5-HT2 Receptor Agonists
- lorcaserin
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Topics |
- Adolescent
- Adult
- Aged
- Benzazepines
(administration & dosage, therapeutic use)
- Blood Glucose
(drug effects)
- Body Mass Index
- Body Weight
(drug effects)
- Comorbidity
- Diabetes Mellitus, Type 2
(drug therapy)
- Double-Blind Method
- Drug Therapy, Combination
- Exercise
- Female
- Humans
- Hypoglycemic Agents
(administration & dosage)
- Male
- Middle Aged
- Obesity
(drug therapy)
- Prediabetic State
(drug therapy)
- Serotonin 5-HT2 Receptor Agonists
(administration & dosage, therapeutic use)
- Weight Loss
(drug effects)
- Young Adult
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