WHAT ARE THE EFFECTS OF THIS DRUG?
↓ Weight is less than expected considering the constant calorie loss via sugar in the urine [200 kcal/day for a daily loss of 50 g of sugar (glucose)]. (1266) Weight loss generally occurs in the first 6 months of therapy and then weight remains about the same at 12 months of therapy. ↓ Weight (1266, 1272-1274)
↓ Weight, ↓ blood pressure, and ↑ hematocrit are due to removal of sugar via the urine (1267)
↓ Weight is likely due to removal of sugar via the urine (1268)
↓ Weight is about 68% to 90% fat due to loss of sugar via the urine (1266, 1269-1271)
↓ Weight at 12 weeks at doses from 1 to 25 mg compared to placebo (no drug) and sitagliptin 100 mg. (1283)
↓ Weight VERTIS trial 26 weeks given alone vs placebo, 5 mg/day −3.87 pounds, 15 mg /day −4.75 pounds. (1283).
↓ Weight loss in VERTIS MONO trial continued till week 52, the 5 mg/day showed loss of 7.1 pounds = 3.23 kg, and the 15 mg/day group a loss of 7.44 pounds = 3.38 kg = (1275, 1276)
↓ Weight VERTIS MET trial 5mg/day or 15 mg/day + at least 1,500 mg of metformin caused significant weight loss 5mg/day 3.64 pounds =1.67 kg; 15mg/day 3.52 pounds =1.60 kg, compared to placebo (1277)
↓ Weight VERTIS FACTORAL trial combo 5 mg/day + sitagliptin 100 mg: −5.5 pounds = 2.5 kg; 15 mg/day + sitagliptin 100 mg: -6.38 pounds = 2.9 kg compared to sitagliptin alone, which was not significant if compared to 5 mg/day and 15 mg/day ertugliflozin alone (sitagliptin 100 mg: −1.54 pounds = 0.7 kg; ertugliflozin 5 mg: −5.94 pounds = 2.7 kg; ertugliflozin 15 mg: −8.14 pounds = 3.7 kg). (1278) After the early phase of the study, weight leveled off for each group and remained about the same till week 52 at the end. (1278, 1279)
↓ Weight VERTIS SITA trial 5 mg/day or 15 mg/day with sitagliptin combo therapy compared to placebo (ertugliflozin 5 mg + sitagliptin 100 mg: -4.4 pounds = −2 kg; ertugliflozin 15 mg + sitagliptin 100 mg: -4.62 pounds = -2.1 kg. (1280) In the VERTIS SITA trial adding metformin for triple therapy ↓ weight also at 5mg/day - 4.4pounds = -2 kg; 15mg/day -3.74 pounds =-1.7 kg at 52 weeks (1281, 1282)
↓ Weight VERTIS SU trial greater weight reduction vs Amaryl (glimepiride) a weight gain drug (586)
* Warnings: ↑ Risks of serious UTI (urinary tract infections) ↑ Ketoacidosis risk (difficulty breathing, vomiting, abdominal pain, confusion, sleepiness), ↑ Risk of necrotizing fasciitis of the perineum (Fournier gangrene) is rare but potentially fatal.
Generic Name: Ertugliflozin
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