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Optimal Use Recommendations for Second- and Third-Line Therapy for Patients With Type 2 Diabetes [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2013 Jul. (CADTH Optimal Use Report, No. 3.1D.)

4RECOMMENDATIONS

Recommendation 1

The Canadian Drug Expert Committee (CDEC) recommends that a sulfonylurea be added to metformin for most adults with type 2 diabetes inadequately controlled on metformin alone.

Reasons for Recommendation

  1. All of the drug classes demonstrated similar improvements in hemoglobin A1C. Sulfonylureas were the most cost-effective treatment option, with an incremental cost-utility ratio (ICUR) of $8,445 per quality-adjusted life-year (QALY) gained compared with metformin alone.
  2. There are considerably more long-term safety data for sulfonylureas compared to drugs from the newer classes of antihyperglycemic agents.

Of Note

  • Although there were 69 randomized controlled trials (RCTs) included in the systematic review, the evidence was limited by the lack of adequate data for clinically important outcomes such as diabetes-related complications and severe hypoglycemia.
    The Committee identified the values of safety, efficacy, and cost-effectiveness as being of particular importance in making this recommendation.

Recommendation 2

The Canadian Drug Expert Committee (CDEC) recommends that insulin NPH be added for most adults with type 2 diabetes inadequately controlled on metformin and a sulfonylurea.

Reasons for Recommendation

  1. Based on the results of a network meta-analysis of 24 RCTs in patients with type 2 diabetes mellitus and inadequate glycemic control on metformin and a sulfonylurea, statistically significant reductions in hemoglobin A1C of similar magnitude were found for all classes of antihyperglycemic drugs added to existing therapy, with the exception of alpha-glucosidase inhibitors and meglitinides. The addition of insulin NPH to metformin plus a sulfonylurea was associated with the most favourable cost-effectiveness estimate.
  2. There are considerably more long-term safety data for the use of insulin NPH compared with drugs from the newer classes of antihyperglycemic agents.

Of Note

  1. The evidence provided in the 40 RCTs that were included in the CADTH systematic review was limited by the lack of data for clinically important outcomes such as diabetes-related complications and severe hypoglycemia.
  2. Long-acting insulin analogues at prices similar to insulin NPH would also be an option for patients inadequately controlled on metformin and a sulfonylurea.
  3. Although there is more clinical experience with DPP-4 inhibitors and GLP-1 analogues since the original CADTH recommendations were published, the Committee concluded that there remains uncertainty regarding the long-term safety of these drug classes. The Committee noted that additional long-term follow-up data — including the results of ongoing trials designed to investigate the effects of DPP-4 inhibitors and GLP-1 analogues on cardiovascular end points – may help address this uncertainty in the future.

The Committee identified the values of safety, efficacy, and cost-effectiveness as being of particular importance in making this recommendation.

Recommendation 3

In circumstances where patients are unable to use insulin as a third-line option, the Canadian Drug Expert Committee (CDEC) recommends that a DPP-4 inhibitor may be added to metformin and sulfonylurea therapy.

Reason for Recommendation

  • DPP-4 inhibitors were the most cost-effective option when insulins were excluded from the cost-effectiveness analysis.

Of Note

  1. The Committee noted that there are few instances where patients with type 2 diabetes are unable to use insulin after adequate education and training. However, the Committee recognized that an alternative to insulin should be available to facilitate optimal glycemic control for such patients.
  2. The Committee noted that although DPP-4 inhibitors were the most cost-effective option when insulin is not an option, the addition of agents from this drug class to metformin and a sulfonylurea was associated with a relatively high incremental cost per QALY gained relative to metformin and a sulfonylurea alone ($113,254).

The Committee identified the values of efficacy and cost-effectiveness as of particular importance in making this recommendation.

Copyright © CADTH 2013.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Cover of Optimal Use Recommendations for Second- and Third-Line Therapy for Patients With Type 2 Diabetes
Optimal Use Recommendations for Second- and Third-Line Therapy for Patients With Type 2 Diabetes [Internet].
CADTH Optimal Use Report, No. 3.1D.

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