Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR variation assessment report (EMEA/H/C/002654, 2013)
Takeda Pharmaceutical Company Limited · 2013 · EMA EPAR variation assessment report · company profile →
Report summary
This EMA report re-evaluates metformin use in patients with moderate renal impairment, addressing inconsistencies in prescribing guidelines and the risk of lactic acidosis. It presents pharmacokinetic and efficacy data supporting metformin's use in these populations. The report synthesizes safety data from multiple studies, concluding that while lactic acidosis is rare and serious, its direct association with metformin is often unclear, with comorbidities being primary causes. Incidence rates and dose recommendations for metformin in chronic kidney disease are provided. The report details updated dose adjustments for various metformin-containing fixed-dose combinations (e.g., saxagliptin, sitagliptin, empagliflozin) in renally impaired patients, emphasizing that with appropriate dosing and monitoring, the benefit-risk balance for metformin remains favorable.
Key findings — cited to the page
| Pioglitazone maximum dose | 45 mg once daily | Pioglitazone/metformin · p.24 |
| Empagliflozin dose in GFR 45-60 ml/min | 10 mg | Empagliflozin/metformin · p.25 |
| Vildagliptin dose in moderate to severe renal impairment | 50 mg once daily | Vildagliptin/metformin · p.24 |
| Pioglitazone initial dose | 15 or 30 mg once daily | Pioglitazone/metformin · p.24 |
| Dapagliflozin recommended dose | 10 mg daily | Dapagliflozin/metformin · p.25 |
| Canagliflozin dose in GFR 45-60 ml/minute | 100 mg | Canagliflozin/metformin · p.25 |
| Saxagliptin dose in moderate to severe renal impairment | 2.5 mg once daily | Saxagliptin/metformin · p.24 |
| Sitagliptin dose in moderate to severe renal impairment | 50 mg once daily | Sitagliptin/metformin · p.24 |
| Linagliptin recommended dose in renal impairment | 5 mg daily | Linagliptin/metformin · p.24 |
| Alogliptin dose in moderate renal impairment (GFR 30-50 ml/min) | 12.5 mg once daily | Alogliptin/metformin · p.24 |
| Glibenclamide recommended dose in moderate renal impairment | 1.75 to 10.5 mg daily | Glibenclamide/metformin · p.24 |
| Recommended daily dose of metformin in moderate renal impairment stage 3a | 2000 mg/day | · p.27 |
Source: Takeda Pharmaceutical Company Limited ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →