{
 "query": "metformin / saxagliptin",
 "ingredient": "metformin / saxagliptin",
 "slug": "metformin-saxagliptin",
 "rxcui": "1043562",
 "brands": [
  "Kombiglyze"
 ],
 "names": [
  "metformin / saxagliptin"
 ],
 "components": [
  {
   "ingredient": "metformin",
   "slug": "metformin",
   "grade": "B",
   "total": 81,
   "scores": {
    "safety": "D",
    "evidence": "A",
    "regulatory": "B",
    "conflict": "A",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "03/03/1995",
   "first_approval": "19950303"
  },
  {
   "ingredient": "saxagliptin",
   "slug": "saxagliptin",
   "grade": "B",
   "total": 79,
   "scores": {
    "safety": "B",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "07/31/2009",
   "first_approval": "20090731"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19950303",
  "first_approval_fmt": "",
  "anda": 5,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "metformin / saxagliptin",
   "Kombiglyze"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 11683,
  "beneficiaries": 3648,
  "spend": 7417606.24,
  "by_brand": [
   {
    "brand": "Saxagliptin-Metformin ER",
    "claims": 9249,
    "per_claim": 632.85410639,
    "is_generic": false
   },
   {
    "brand": "Kombiglyze XR",
    "claims": 2434,
    "per_claim": 642.70279786,
    "is_generic": false
   }
  ],
  "per_claim": 634.905952238295
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 62,
   "letter": "D",
   "why": [
    "Graded by its riskiest ingredient, metformin (62)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-8)",
    "1,797 FDA reports naming it as the suspect drug per million Medicare fills, 0.6x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, saxagliptin (45)",
    "113 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 84,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, metformin (84)",
    "Recalls since 2016: 0 Class I, 19 Class II, 2 Class III across 94 generic makers (-7)",
    "3 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, metformin (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 90,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, metformin (90)",
    "Generic versions approved (94 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "This is a fixed combination of metformin and saxagliptin. Why both together, instead of only the one I need?",
  "In 2016 the FDA issued a safety communication about this drug (FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney ). Does that risk apply to me?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea, acute kidney injury. How would we recognize and handle those?",
  "Why this one over phenformin? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)",
  "In 2016 the FDA issued a safety communication about this drug (FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and a). Does that risk apply to me?",
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "The most-reported problems in FDA's adverse event data are cardiac failure congestive, cardiac failure, nausea, blood glucose increased. How would we recognize and handle those?",
  "Why this one over alogliptin, linagliptin, sitagliptin? What would make you pick one of those instead?"
 ]
}