Efficacy Arid Pharmacoeconomic Evaluation Of Adding Sitagliptin In Poorly Controlled Type2Diabetes With Oral Metformin

BACKGROUNDDiabetes mellitus is a kind of chronic noninfectious disease which is needed lifelongtreatment.If the blood glucose can not be controlled well, it would lead to many kinds ofacute or chronic complications, which may Seriously affect the patient’s quality of life, andIncrease the economic burden of the patients. To control the blood glucose well or close tothe ideal level, is the effective measure to prevent and reduce diabetes complications.Atpresent there are many kindsOf oral antidiabetic drug,such as sulfonylureas,metformin,α-glycosidaseinhibitors,TZD and Glinides，which work in different mechanism.The doctors need tochoose a reasonable strategy to treat diabetes mellitus by Pharmacoeconomics,which caneffectively control blood glucose,prevent the complication of diabetes,and reduce theeconomic burden of patients.Sitagliptin is a kind of new type of oral antidiabetic drug.Itcan reduce the blood glucose by Inhibiting activity of DPP-4enzyme, preventing thedegradation of GLP-1,and increased plasma concentrations of active forms of GLP-1.Itcan inhibite glucagon secretion, promote insulin secretion, and protect the islet beta cellfunction. In addition to this, it will not easy to cause hypoglycemia and can reduceweight.And now it is a new hot spot of diabetes treatment.OBJECTIVETo compare the effects and the safely of metformin plus sitagliptin and metforminplus Pioglitazone on the treatmen to patients with type2diabetes inadequately controlledon metformin monotherapy.And toevaluatethe cost-effectiveness analysis of metforminplus sitagliptin and metformin plus Pioglitazone by Pharmacoeconomics.METHODS1.Subjects:158patients with type2diabetes inadequately controlled on metforminmonotherapy，aged30to75，in accordance with the WHO diagnostic criteria fordiabetes,1999，wereincluded in thestudyinChanghai Hospitalfrom August,2011toAugust,2012．2. Research methods: The trial was conducted in a prospective，randomized，andcontrolled design, and carried12weeks．Accordingwiththe inclusions，thepatientswererandomly in to2groups. The control groupwas allocated to receive:1.5-2mg metforminas a once daily plus o Pioglitazone (Actos)30mgas a once daily, which can be up-titrated to pio45mg or down-titrated to15mg according to the blood glucose. The experimentalgroup was allocated to receive1.5-2mg metformin as a once daily plus100mg sitagliptin(JANUVIA) as a once daily. Made records of age，gender,bodyMass index(BMI)，Glycosylated hemoglobin(HbAlc)，fasting blood glucose(FBG)，posting，2hbloodglucose(PBG2h)before thetherapy．The main end points were HbA1C，FBG andPBG2h，the second end point were weight，adverse events and so on.Statistics the costof the2groups during treatment, and using cost-effectiveness analysis method andestablishing Markol model to perform a pharmacoeconomic analysis3. Statistical analysis：Using SPSS16.0statistics software to analyze and handledata．Measurement data expressed as mean±Standard deviation,count data expressed as apercentage，think that P<0.05represent the results have statistical significance.RESULTS1. Clinic therapeutic result1.1changes in blood glucoseIn the experimental group,FBG was reduced from9.1±0.8mmol/L to7.3±1.0mmol/L(p<0.05), PBG2h was reduced from13.5±2.1mmol/L to11.0±2.2mmol/L((p<0.05), HbA1C was reduced from8.1±0.6%to7.1±0.6%(p<0.05).In the control group,FBG was reduced from9.0±0.8mmol/L to7.1±1.0mmol/L(p<0.05), PBG2h was reduced from3.7±2.1mmol/L to10.6±1.7mmol/L(p<0.05), HbA1C was reduced from8.1±0.6%to6.8±0.7%(p<0.05).1.2Change in weight and blood lipid profileIn the experimental group, weight was reduced from72.9±8.7mmol/L to71.8±8.7kg(p<0.05), while in the control group the weight was increase from72.4±8.8kg to72.8±8.7kg.And the blood lipid profile (p<0.05) were significantly reduced in the2groups.2. Safety analysisIn both groups there were no serious adverse events and little adverse events.Theincidence rate of adverse event in both treatment groups were11.3％and6.9％．respectively.The incidence rate of hypoglycemia were1.39％and3.75％，respectively. Difference of incidence rate of hypoglycemia and i adverse events in the twogroups had not statistically significant(p＞0.05)．3Clinicaleconomic evaluations3.1CIinicaleffect Al the end of12weeks treatment, in the experimental group the effective rate inlowering FBG was77.8%, in lowering FBG2h was75%,and HbA1C was decreased by1.1±0.7%.In the control group the effective rate in lowering FBG was85%, in loweringFBG2h was82.5%,and HbA1C was decreased by1.3±0.7%.There was no statisticallysignificant in the2groups(p＞0.05).3.2Healthcare costThe cost of control group was2422.3±165.5yuan and of the experimental groupwas1928.7±62.3yuan. The cost of plus sitagliptin group is significant lower than the groupplus Pioglitazone(p＜0.05).3.3Cost-effectiveness analysisBoth treatments provided improvements in lowering blood glucose. In loweringFBG,the C/E of control group and experimental group was24.8and28.5respectively,andthe C/E was68.6.It means that FBG each fell by1%, the cost is about24.8yuan and28.5yuan, respectively. In lowering PBG2h,the C/E of control group and experimentalgroup was25.7and29.4respectively,and the C/E was65.8.It means that PBG2h eachfell by1%, the cost is about25.7yuan and29.4yuan, respectively. In Markov model,HbA1C was the measurement.The result shows that the expected cost in control group andexperimental group was1847.4yuan and2292.6yuan, and the C/E was1885.1and2047respectively.4. Sensitive analysisIf the cost of medication was decreased10%and the cost of the Medical check wasincrease5%,the cost effectivess and incremental cost effectiveness ratio were changedtogether.But the cost-effectivess of metformin plus sitagliptin group were better than thatof metformin plus Pioglitazone grouop．CONCLUSIONAdding sitagliptin or Pioglitazone to patients with type2diabetes who inadequatelycontrolled on metformin monotherapy can significanty control blood glucose.There are nodifferences in lower FBG, PBG and PBG2h in the two groups. Weight loss with metforminplus sitagliptin was significantly greater than with metformin plus Pioglitazone grouop. Noepisodes of major hypoglycaemia occurred.Incidence rate of hypoglycemia and i adverseevents is low in the two groups.The cost-effectivess of metformin plus sitagliptin group were better than that ofmetformin plus Pioglitazone grouop in FBG，PBG and HbA1C.