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Pharmacokinetic drug–drug interaction study of ranolazine and metformin in subjects with type 2 diabetes mellitus
Julia Zack, Jolene Berg, Axel Juan, Nicola Pannacciulli, Martine Allard, Mildred Gottwald, Heather Zhang, Yongwu Shao et al.. Clinical Pharmacology in Drug Development, 2015-01-22
Topic: Drug trials: efficacy and safety
Ranolazine and metformin may be frequently co‐administered in subjects with chronic angina and co‐morbid type 2 diabetes mellitus (T2DM). The potential for a drug–drug interaction was explored in two phase 1 clinical studies in subjects with T2DM to evaluate the pharmacokinetics and safety of metformin 1000 mg BID when administered with ranolazine 1000 mg BID ( Study 1 , N = 28) or ranolazine 500 mg BID ( Study 2 , N = 25) as compared to metformin alone. Co‐administration of ranolazine 1000 mg BID with metformin 1000 mg BID resulted in 1.53‐ and 1.79‐fold increases in steady‐state metformin C max and AUC tau , respectively; co‐administration of ranolazine 500 mg BID with metformin 1000 mg BID resulted in 1.22‐ and 1.37‐fold increases in steady‐state metformin C max and AUC tau , respectively. Co‐administration of ranolazine and metformin was well tolerated in these T2DM subjects, with no serious adverse events or drug‐related adverse events leading to discontinuation. The most common adverse events were nausea, diarrhea, and dizziness. These findings are consistent with a dose‐related interaction between ranolazine and metformin, and suggest that a dose adjustment of metformin may not be required with ranolazine 500 mg BID; whereas, the metformin dose should not exceed 1700 mg of total daily dose when using ranolazine 1000 mg BID.
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APA 7th
Zack, J., Berg, J., Juan, A., Pannacciulli, N., Allard, M., Gottwald, M., et al. (2015). Pharmacokinetic drug–drug interaction study of ranolazine and metformin in subjects with type 2 diabetes mellitus. Clinical Pharmacology in Drug Development. https://doi.org/10.1002/cpdd.174
Vancouver
Zack J, Berg J, Juan A, Pannacciulli N, Allard M, Gottwald M, et al. Pharmacokinetic drug–drug interaction study of ranolazine and metformin in subjects with type 2 diabetes mellitus. Clinical Pharmacology in Drug Development. 2015. doi:10.1002/cpdd.174.
BibTeX
@article{zack2015-2d3045db,
author = {Zack, Julia and Berg, Jolene and Juan, Axel and Pannacciulli, Nicola and Allard, Martine and Gottwald, Mildred and Zhang, Heather and Shao, Yongwu and others},
title = {{Pharmacokinetic drug–drug interaction study of ranolazine and metformin in subjects with type 2 diabetes mellitus}},
journal = {Clinical Pharmacology in Drug Development},
year = {2015},
doi = {10.1002/cpdd.174},
url = {https://doi.org/10.1002/cpdd.174}
}
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Key findings
- The potential for a drug–drug interaction was explored in two phase 1 clinical studies in subjects with T2DM to evaluate the pharmacokinetics and safety of metformin 1000 mg BID when administered with ranolazine 1000 mg BID ( Study 1 , N = 28) or ranolazine 500 mg BID ( Study 2 , N = 25) as compared to metformin alone.
- These findings are consistent with a dose‐related interaction between ranolazine and metformin, and suggest that a dose adjustment of metformin may not be required with ranolazine 500 mg BID; whereas, the metformin dose should not exceed 1700 mg of total daily dose when using ranolazine 1000 mg BID.
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Study details
- Study designclinical trial
- Participants28
- Evidence strengthLow
How this study scored 43/100
Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomized / blinded because the record does not state it. We have no data on journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record, institution's track record, multicenter collaboration and free to read, so those were left out: it earned 24 of the 56 points we could judge it on, which is 43 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Clinical Pharmacology in Drug Development) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 0 / 12 | Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2015 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 28 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomized / blinded | 0 / 2 | No randomization or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multicenter collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 1 / 2 | Not in PubMed, but has a DOI |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 24 / 56 | Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 24 of the 56 points we could judge it on is 43 out of 100. |
| Total | 43 / 100 | — |
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