Sitagliptin. Agreed by Clinical Priorities Group

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1 New Medicine Report Document Status Sitagliptin Agreed by Clinical Priorities Group Traffic Light Decision Blue- Primary Care Prescriber s Rating Offers an advantage - The product has some value but does not fundamentally change present therapeutic practice. Date of Last Revision!4 th June 2010 Approved Name Sitagliptin Trade Name Januvia Manufacturer Merck Sharp & Dohme Legal Status EMEA Positive Opinion granted Jan 2007 Expected to be POM Indication Patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin when diet and exercise, plus metformin do not provide adequate control Patients with type 2 diabetes mellitus in whom the use of a PPARγ* agonist is appropriate, in combination with the PPARγ agonist, when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control Dosage Anticipated dosage 100mg once daily Cost Expected to be in the range 90p to 2.00 per day Possible Number of Suffolk 14,000 patients in the Suffolk PCT area are Patients likely to have type 2 diabetes, with a further 3,000 in the Waveney area Number Needed to Treat Treatment Alternatives Not calculated Metformin Sulphonylureas Rosiglitazone/pioglitazone Future Alternatives Vildagliptin expected towards end 2007 Possible Future Indications None known but would suggest they may seek licence for monotherapy at some point * PPARγ peroxisome proliferator activated receptor gamma agonist (glitazones) This is an NHS Suffolk document that has been adopted by the WSCCG.

2 Reviewer s Comments Sitagliptin is a new agent for the control of type 2 diabetes mellitus. Comparative data with established antidiabetic agents in the combination therapy setting are limited to one study (press release), which suggests that, after 52 weeks of therapy, the effect of sitagliptin on HbA 1c is not inferior to that of glipizide, when added to metformin. There are no comparative data for sitagliptin against established antidiabetic agents in the monotherapy setting. The long-term adverse event profile of sitagliptin is unknown. Limited data suggest the short-term adverse event profile of sitagliptin is similar to placebo. In combined therapy, sitagliptin had an improved adverse effect profile vs. glipizide, with respect to hypoglycaemia and weight gain. All data are in a limited format, and the clinical significance of the adverse event profile cannot be properly evaluated at present. Secondary measures suggest that sitagliptin improves beta-cell function (e.g. HOMA-β), which may lead to a hypothesis that it might delay or even reverse beta-cell loss. It should be noted that HOMA-β is a measure of beta-cell activity, not of beta-cell health or pathology, and large robust studies are required before this potential advantage can be used as a reason to prescribe sitagliptin in place of existing treatments. It is likely that metformin will remain first line choice of oral therapy in obese type 2 diabetes mellitus for the foreseeable future. Assessing the place of sitagliptin in relation to existing treatments for type 2 diabetes mellitus is difficult, due to limited data and the current lack of consensus regarding the preferred choice of agent to be added to metformin. Although it could potentially compete with sulphonylureas, due to both being predominantly insulin secretagogues, it is anticipated that sitagliptin will be priced more in line with, and so compete against, glitazones. The EMEA propose that sitagliptin is prescribed by physicians experienced in the treatment of type 2 diabetes mellitus. Submitted for comment to: Date Medical Information Department, MSD 9/2/2007 Dr T Lockington, The Ipswich Hospital 9/2/2007 Page 2 of 10

3 Evidence Reviewed Paper, Review, Abstract etc. Level of evidence Smith K. Cambridgeshire Joint Prescribing Group III Sitagliptin January 2007 Rosenstock J, Bragz R,Andryuk PJ et al Efficacy and I safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group study Clin Thera 2006;28(10): Charbonnel B, Karasik A, Liu J et al Efficacy and safety I of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone Diabetes Care 2006;29: Aschner P, Kipnes MS, Lunceford JK et al Effect of the I dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycaemic control in patients with type 2 diabetes Diabetes Care 2006;29: Merck Sharp & Dohme Personal Communication including abstracted bibliography Level of evidence adapted from Quick and Clean : authorative health technology assessment for local health care contracting Andrew Stevens, Duncan Collin-Jones & John Gabbay Health Trends Vol 27 No Review Sitagliptin is a new drug which is a dipeptidyl peptidase-4 inhibitor. It helps to improve glycaemic control in patients with type 2 diabetes mellitus by enhancing the levels of active incretin hormones. Incretin hormones, including glucagon-like peptide 1 (GLP 1) and glucose dependent insulinotropic peptide (GIP), are released by the intestine throughout the day and levels are increased in response to a meal. The incretins are part of an endogenous system involved in the regulation of glucose levels through the direct effect on the pancreatic β-cells via specific receptors. In addition they delay gastric emptying and increase satiety. The activity of both GLP 1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyses the incretin hormones to produce metabolites. Sitagliptin acts to help prevent the inactivation of incretin hormones by the enzyme DPP-4 by 80% over 24 hours thus increasing plasma concentrations of the active forms of GLP 1 and GIP leading to a lowering of postprandial and fasting glucose levels. Rosenstock notes that hyperglycaemia in type 2 diabetics is usually a consequence of three defects; impaired insulin action, decreased insulin secretion and increased hepatic glucose production. The latter defect is Page 3 of 10

4 caused in part by defective insulin secretion and excessive glucagon concentrations. Glitazones lower glucose concentrations by decreasing insulin resistance. Given the different action of sitagliptin (through the increase of insulin release and lowering of glucagon concentrations) it is suggested that sitagliptin and glitazones may be complementary in therapeutic use. Three phase III studies of sitagliptin have been published (see Evidence Reviewed section). All other data are only available from conference abstracts, presentations and data on file, precluding a fully informed analysis. Studies range in length from 18 to 52 weeks and as would be expected, current data relate to glycaemic control rather than hard diabetes related outcomes. The results from the trials are given in Appendix 1. When added to ongoing metformin or pioglitazone therapy, sitagliptin significantly improved HbA 1c vs. placebo after 24 weeks. Comparative 'add on' data vs. established antidiabetic agents are only available from one study, and suggest that sitagliptin is not inferior to glipizide in its effect on HbA 1c after 52 weeks when added to metformin. There are no comparative data for sitagliptin in the monotherapy setting. Adverse Effects etc. For full information please refer to the Summary of Product Characteristics. Limited data suggest the short-term adverse event profile of sitagliptin is similar to placebo. In the combined setting sitagliptin had an improved adverse effect profile vs. glipizide, with respect to hypoglycaemia and weight gain. The EMEA notes that the most common side effects: When taking sitagliptin on its own are: low blood sugar, headache, stuffy or runny nose and sore throat When taking it with metformin are: nausea and upper respiratory infections When taking it with pioglitazone are: low blood sugar, flatulence and foot swelling. However all data are in a limited format, and the clinical significance of the adverse event profiles cannot be properly evaluated at present. Economic Information In England and Wales 1.36 million people have been diagnosed with type 2 diabetes, this equates to about 2,500 per 100,000. (Ref: Prescribing Outlook, Sept 2006) In the Suffolk PCT area that equates to 14,000 patients with type 2 diabetes and in the Waveney area a further 3,000 patients. Page 4 of 10

5 Appendix 1 Trial Design & population Intervention Outcomes Raz I, Hanefeld M, Xu L, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia 2006;49: week, randomised, double blind, placebo controlled study in 521 type 2 diabetics (27-76 yrs old), mean baseline HbA1c = 8% Placebo Sitagliptin 100mg OD Sitagliptin 200mg OD Placebo subtracted change in HbA1c Sitagliptin 100mg -0.60% Sitagliptin 200mg -0.48% HbA1c <7% - Placebo 15.5% Sitagliptin 100mg 35.8% Sitagliptin 200mg 28.6% Metformin rescue therapy required in Placebo 17.3% Sitagliptin 100mg 8.8% Sitagliptin 200mg 11.7% Aschner P, Kipnes MS, Lunceford JK, et al. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycaemic control in patients with type 2 diabetes. Diabetes Care 2006;29: week, randomised, double blind, placebo controlled study in 741 type 2 diabetics (18-75 yrs old), mean baseline HbA1c = 8% Placebo Sitagliptin 100mg OD Sitagliptin 200mg OD Placebo subtracted change in HbA1c Sitagliptin 100mg -0.79% Sitagliptin 200mg -0.94% HbA1c <7% Placebo 17% Sitagliptin 100mg 41% Sitagliptin 200mg 45% Metformin rescue therapy required in Placebo 20.6% Sitagliptin 100mg 8.8% Sitagliptin 200mg 4.8% Charbonnel B, Karasik A, Liu J, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care 2006;29: week, randomised, double blind, placebo controlled study in 701 type 2 diabetics (19-78 yrs old) with inadequate glycaemic control despite 1500mg/day metformin, mean baseline HbA1c = 8% Placebo + metformin Sitagliptin 100mg OD + metformin Placebo subtracted change in HbA1c Sitagliptin -0.65% HbA1c <7% Placebo 18% Sitagliptin 47% Pioglitazone rescue therapy required in Placebo 13.5% Sitagliptin 4.5% Rosenstock J, Brazg R, Andryuk PJ, et al. Addition of sitagliptin to pioglitazone improved glycaemic control with neutral weight effect over 24 weeks in inadequately controlled type 2 diabetes. Abstract 556-P. Presented at the 66th Scientific Sessions of the American Diabetes Association, June 2006, Washington, DC 24 week, randomised, double blind, placebo controlled study in 353 type 2 diabetics (24-87 yrs old) on pioglitazone monotherapy, mean baseline HbA1c = 8% Placebo + pioglitazone Sitagliptin 100mg OD + pioglitazone Placebo subtracted change in HbA1c Sitagliptin -0.70% HbA1c <7% Placebo 23% Sitagliptin 45% Page 5 of 10

6 Merck & Co Press release. In new data at one year, Januvia, an investigational once-daily medicine for type 2 diabetes, demonstrated substantial glucose-lowering effect, with significant differences compared to glipizide (a sulfonylurea) in weight change and hypoglycaemia, 13 June Accessed from: press_releases/research_and_development/2006_0613.html 52 week, randomised, double blind, non-inferiority study in 1,172 type 2 diabetics inadequately controlled on metformin monotherapy, mean baseline HbA1c = 7.5% Glipizide (titrated up to a maximum dose of 20mg) + metformin Sitagliptin 100mg OD + metformin Change in HbA1c Glipizide -0.56% Sitagliptin -0.51% HbA1c <7% Glipizide 59% Sitagliptin 63% Sitagliptin non-inferior to glipizide SUFFOLK DRUG AND THERAPEUTICS COMMITTEE New Drug Bulletin Sitagliptin SUFFOLK DRUG AND THERAPEUTICS COMMITTEE RECOMMENDATION: Prescriber s Rating- Offers an Advantage Traffic Light decision Green Hospital initiated, GP prescribed Indication: Patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin when diet and exercise plus metformin do not provide adequate control Page 6 of 10

7 Patients with type 2 diabetes mellitus in whom the use of a PPARγ agonist is appropriate, in combination with the PPARγ agonist, when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control Dosage: Cost: 100mg once daily 1.19 per day Further Comments: Sitagliptin has a similar effect to other oral hypoglycaemic drugs, although no outcome data exist. The New England Journal of Medicine has queried whether further hypoglycaemic drugs are needed to combat the current epidemic of diabetes in the USA, and has commented on the potential for unwanted consequences of treatment with sitagliptin. The Committee noted a 52-week trial which showed a 0.26% reduction in HbA1c with sitagliptin + metformin, compared with a 0.14% reduction in HbA1c with glipizide + metformin; the sitagliptin + metformin group also showed a reduction in body weight and a lower rate of hypoglycaemia than the glipizide + metformin group (5% vs 30%). Local consultants commented variously that it is too soon to comment on the place in treatment of sitagliptin; that it might be of use in Type 2 diabetics intolerant of currently available agents; that more evidence is needed before widespread use can be recommended; and that it should be started in hospital. A formal assessment produced a Judgement Reserved grading because of the lack of outcome data, which exists for metformin, sulfonylureas and insulin. Sitagliptin carries a black triangle in common with all new drugs. All suspected adverse reactions should be reported to the CSM on a yellow card. *Suffolk D&T s Prescriber s Rating ranges from Grade 1: Bravo! The drug is a major therapeutic advance in an area where previously no treatment was available to Grade 7 Not acceptable - product without evident benefit over others but with potential or real disadvantages. Paul Berry Prescribing Medical Advisor May 2007 These notes are only intended to provide brief guidance. Please refer to the latest Summary of Product Characteristics (Data Sheet) for full prescribing details. Page 7 of 10

8 Grids used to assist the NHS Suffolk PCT Drug & Therapeutics Committee in reaching a decision about new medications For many years scientists have recognised two types of research: Primary: original studies, based on observation or experimentation on subjects. Secondary: reviews of published research, drawing together the findings of two or more primary studies. In biomedical science there is general agreement over a hierarchy: the higher up a methodology is ranked, the more robust and closer to objective truth it is assumed to be. The orthodox hierarchy looks something like this; Rank: Methodology Description 1 Systematic reviews and meta-analyses Systematic review: review of a bod methods to locate primary studies assess their quality. Meta-analysis: A statistical analysis integrates the results of several ind considered by the analyst to be "co level of re-analysing the original da pooling, quantitative synthesis. Both are sometimes called "overvie 2 Randomised controlled trials (finer distinctions may be drawn within this group based on statistical parameters like the confidence intervals) Individuals are randomly allocated group who receive a specific interv groups are identical for any signific followed up for specific end points. 3 Cohort studies Groups of people are selected on th to a particular agent and followed u 4 Case-control studies "Cases" with the condition are mat without, and a retrospective analys differences between the two group Page 8 of 10

9 5 Cross sectional surveys Survey or interview of a sample of at one point in time 6 Case reports. A report based on a single patient collected together into a short seri e 7 Expert opinion A consensus of experience from th 8 Anecdotal Something a bloke told you after a Adapted from Systematic reviews, What are they and why are they useful? ScHARR 2008 To Decide if a Medication Is To Be Used In Suffolk Criterion to be measured Tends to 2 poor Quality of evidence in the papers reviewed Magnitude of effect inferred from trials reviewed Low Are trial end-points surrogate markers or clinical outcomes? Clinical usefulness of trial end-points Known Side Effect Profile High Known Interactions High Concern re Possible Side Effects Not Yet Uncovered High Balance of Benefit To Harm (side effects toxicity interactions etc) Poor NNT High Comparison Of Effectiveness With Other Medicines In Use For The Same Poor Condition Severity of Condition to be Treated Trivial Novel drug or member of existing class Uptake (estimated proportion of people with this condition likely to be prescribed the medication under consideration maximum and minimum uptake) Prescriber s Rating Definitions Bravo! -The drug is a major therapeutic advance in an area where previously no treatment was available. A real advance - The product is an important therapeutic innovation but has certain limitations. Offers an advantage - The product has some value but does not fundamentally change present therapeutic practice. Page 9 of 10

10 Possibly Helpful - The product has minimal additional value, and should not change prescribing habits except in rare circumstances. Judgement reserved - The Committee postpones its judgement until better data and a more thorough evaluation of the drug are available. Nothing New - The product may be a new substance but is superfluous because it does not add to the clinical possibilities offered by previous products available. In most cases these are me-too products. Not acceptable - Product without evident benefit over others but with potential or real disadvantages. (With acknowledgement to Prescrire) To Decide Where A Medication Is To Be Used In Suffolk Skills of the prescriber Criterion Red Amber Experience Of The Condition Specific Specific Diagnosis Specific Specific Monitoring Progress Of Treatment Difficult Specific Therapy Patient Selection Difficult Specific Initiation Of Treatment Difficult Difficult Dose Titration Difficult Specific Monitoring Of Side Effects Complex Easy Method Of Administration Complex Normal Discontinuation Of Treatment Complex Complex References Jonsen A. Bentham in a box: Technology assessment and health care allocation. Law Med. Health Care. 1986;14: Suffolk Drug & Therapeutics Committee Responsibility for prescribing, Hospital Trust or GP Attached as Appendix 1 and Appendix 2 Page 10 of 10

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