RESUMEN
AIM: To evaluate the efficacy and safety of the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide in African-American people with Type 2 diabetes. METHODS: Analyses were performed on patient-level data from individuals self-defined as African-American or non-African-American in seven phase III studies. Endpoints included change in HbA1c level, fasting plasma glucose level and body weight from baseline, proportion of patients reaching HbA1c target [< 53 mmol/mol (< 7.0%)], and incidence of hypoglycaemia and nausea. Analyses used data obtained after 26 weeks. Within-population comparisons of liraglutide were performed vs placebo for African-American and non-African-American patient groups. In addition, between-population comparisons with non-African-American patients were performed for each treatment. RESULTS: In African-American patients (n = 225), HbA1c was significantly reduced at 26 weeks with liraglutide 1.2 and 1.8 mg (-11 and -14 mmol/mol, respectively compared with placebo; P < 0.0001). There were also significant reductions in fasting plasma glucose (-2.4 and -3.1 mmol/l, respectively, compared with placebo; P < 0.0001). Statistically significant reductions in body weight were observed with 1.8 mg liraglutide (-2.1 kg compared with placebo; P = 0.0056), but not with 1.2 mg liraglutide (-0.26 kg; P = 0.7307). The P value for interaction between treatment and race was significant for body weight (P = 0.0355). The incidence of non-severe hypoglycaemia with liraglutide was low (11-15% of patients), and < 25% of patients receiving liraglutide experienced nausea. CONCLUSIONS: This meta-analysis suggests that liraglutide is well tolerated and efficacious for treatment of Type 2 diabetes in African-American patients, with an efficacy that was shown not to differ from that observed in non-African-American patients over 26 weeks.
Asunto(s)
Negro o Afroamericano , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Liraglutida/uso terapéutico , Glucemia/metabolismo , Ensayos Clínicos Fase III como Asunto , Diabetes Mellitus Tipo 2/metabolismo , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemia/inducido químicamente , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
The aim of the present analysis was to evaluate the efficacy of the glucagon-like peptide-1 receptor agonist liraglutide in Latino/Hispanic individuals with type 2 diabetes, in addition to comparing its treatment effects with those observed in non-Latino/Hispanic individuals. Analyses were performed on patient-level data from a subset of individuals self-defined as Latino/Hispanic from four phase III studies, the LEAD-3, LEAD-4, LEAD-6 and 1860-LIRA-DPP-4 trials. Endpoints included change in glycated haemoglobin (HbA1c) and body weight from baseline. In Latino/Hispanic patients (n = 505; 323 treated with liraglutide) after 26 weeks, mean HbA1c reductions were significantly greater with both liraglutide 1.2 and 1.8 mg versus comparator or placebo in the LEAD-3 and LEAD-4 studies, and with 1.8 mg liraglutide in the 1860-LIRA-DPP-4 trial. In LEAD-3 both doses led to significant differences in body weight change among Latino/Hispanic patients versus the comparator. With 1.8 mg liraglutide, difference in weight change was significant only in the 1860-LIRA-DPP-4 trial versus sitagliptin. For both endpoints Latino/Hispanic and non-Latino/Hispanic patients responded to liraglutide similarly. In summary, liraglutide is efficacious for treatment of type 2 diabetes in Latino/Hispanic patients, with a similar efficacy to that seen in non-Latino/Hispanic patients.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hispánicos o Latinos , Hipoglucemiantes/administración & dosificación , Liraglutida/administración & dosificación , Glucemia/metabolismo , Ensayos Clínicos Fase III como Asunto , Diabetes Mellitus Tipo 2/etnología , Método Doble Ciego , Esquema de Medicación , Péptido 1 Similar al Glucagón/análogos & derivados , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemiantes/efectos adversos , Liraglutida/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
BACKGROUND: Testosterone is an important anabolic hormone in humans and in vitro testosterone stimulates growth of lung and colon cancer cells. We tested the hypothesis that plasma testosterone associate with increased risk of cancer and with increased risk of early death after cancer. MATERIALS AND METHODS: Plasma testosterone was measured in 8771 20- to 94-year-old men and women who participated in a prospective study of the general population. Participants were included in 1981-1983 and followed for a median of 22 years (range: 0-30 years). RESULTS: During follow-up, 1140 men and 809 women developed cancer. For risk of early death after cancer, for men, after adjustment for age at diagnosis, tumour stage at diagnosis, and time since blood-sampling, the hazard ratio was 1.30 [95% confidence interval (CI) 1.03-1.65] for the 2nd quintile, 1.31 (1.02-1.67) for the 3rd quintile, 1.52 (1.19-1.93) for the 4th quintile, and 1.52 (1.20-1.91) for the 5th quintile, versus the 1st quintile. For women, corresponding hazard ratios were 1.09 (0.81-1.46), 1.17 (0.86-1.59), 1.03 (0.76-1.39), and 1.80 (1.32-2.46). For risk of cancer, multifactorially adjusted hazard ratios for risk of any cancer were 1.07 (95% CI 0.98-1.18) and 1.06 (0.93-1.22) for men and women, respectively, when testosterone doubled. For both men and women, a doubling of testosterone was not associated with risk of any cancer type. CONCLUSIONS: In this prospective study of 8771 men and women from the general population followed for >30 years, increased levels of testosterone were associated with a 30%-80% increased risk of early death after cancer, but unchanged risk of incident cancer.