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Metformin ER / working resource

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The boxed warning

Metformin ER, approved for type 2 diabetes, with the evidence and its limits for other uses in plain view. What should I know about the lactic acidosis warning?

In the 15-year follow-up of the Diabetes Prevention Program Outcomes Study, the cumulative incidences of diabetes at year 15 were 55% in the lifestyle group, 56% in the metformin group, and 62% in the placebo group.

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These are starting points for the Metformin ER library. Read the source's exact question, product, population and date. A source can be authoritative for one claim and irrelevant to another.

Record 01

Metformin hydrochloride extended-release tablets prescribing information ↗

Record 02

Drugs@FDA: Glucophage XR (metformin hydrochloride) application overview ↗

Record 03

FDA: understanding unapproved use of approved drugs (off label) ↗

Record 04

FDA: updates and press announcements on NDMA in metformin ↗

Record 05

NIDDK: the Diabetes Prevention Program ↗

Keep claims and sources together.

In the 15-year follow-up of the Diabetes Prevention Program Outcomes Study, the cumulative incidences of diabetes at year 15 were 55% in the lifestyle group, 56% in the metformin group, and 62% in the placebo group.

Supporting record ↗

A systematic review and meta-analysis of studies comparing metformin users with non-diabetics or diabetics on other therapies reported that diabetics taking metformin had significantly lower all-cause mortality than non-diabetics (hazard ratio 0.93, 95% CI 0.88-0.99), and noted that differences in baseline characteristics had the potential to bias findings.

Supporting record ↗

A review concluded that developments in the evidence, including replication attempts and clinical trials of metformin in individuals without type II diabetes, generally illustrate an emerging uncertainty in the anti-aging potential of metformin. Its conflict-of-interest statement lists consulting or advisory relationships between one author and Boehringer-Ingelheim and Novartis.

Supporting record ↗

The MASTERS randomized, double-blind trial gave healthy older adults 1,700 mg/day metformin (N = 46) or placebo (N = 48) throughout 14 weeks of supervised progressive resistance exercise training, and concluded that metformin negatively impacts the hypertrophic response to resistance training in healthy older individuals.

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The MA.32 randomized trial in patients with high-risk operable breast cancer without diabetes concluded that adding metformin versus placebo to standard breast cancer treatment did not significantly improve invasive disease-free survival.

Supporting record ↗

A secondary analysis of the randomized Diabetes Prevention Program and its Outcomes Study (metformin 850 mg twice daily) concluded that long-term use of metformin was associated with biochemical B12 deficiency and anemia and that routine testing of vitamin B12 levels in metformin-treated patients should be considered.

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An FDA patient page on off-label use says FDA has not determined that an approved drug is safe and effective for an unapproved use.

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