Progression to insulin therapy among patients with type 2 diabetes treated with sitagliptin or sulphonylurea plus metformin dual therapy.

AIM: To assess time to insulin initiation among patients with type 2 diabetes mellitus (T2DM) treated with sitagliptin versus sulphonylurea as add-on to metformin. METHODS: This retrospective cohort study used GE Centricity electronic medical records and included patients aged ≥18 years with continuous medical records and an initial prescription of sitagliptin or sulphonylurea (index date) with metformin for ≥90 days during 2006-2013. Sitagliptin and sulphonylurea users were matched 1 : 1 using propensity score matching, and differences in insulin initiation were assessed using Kaplan-Meier curves and Cox regression. We used conditional logistic regression to examine the likelihood of insulin use 1-6 years after the index date for each year. RESULTS: Propensity score matching produced 3864 matched pairs. Kaplan-Meier analysis showed that sitagliptin users had a lower risk of insulin initiation compared with sulphonylurea users (p = 0.003), with 26.6% of sitagliptin users initiating insulin versus 34.1% of sulphonylurea users over 6 years. This finding remained significant after adjusting for baseline characteristics (hazard ratio 0.76, 95% confidence interval 0.65-0.90). Conditional logistic regression analyses confirmed that sitagliptin users were less likely to initiate insulin compared with sulphonylurea users [odds ratios for years 1-6: 0.77, 0.79, 0.81, 0.57, 0.29 and 0.75, respectively (p < 0.05 for years 4 and 5)]. CONCLUSIONS: In this real-world matched cohort study, patients with T2DM treated with sitagliptin had a significantly lower risk of insulin initiation compared with patients treated with sulphonylurea, both as add-on to metformin.

Time to treatment initiation with oral antihyperglycaemic therapy in US patients with newly diagnosed type 2 diabetes.

AIM: To compare the time from initial diagnosis to initiation with oral antihyperglycaemic treatment in younger versus older patients with type 2 diabetes, and to evaluate factors associated with initiating treatment. METHODS: This was a retrospective US cohort study with a 2-year follow-up period after diagnosis of type 2 diabetes. Using the General Electric Healthcare's Clinical Data Services electronic medical record database, eligible patients included those aged ≥30 years at initial diagnosis of type 2 diabetes between January 2003 and December 2005. In the 2-year period following diagnosis, the time to the first prescription of an oral antihyperglycaemic agent was compared between younger (30-64 years) and older (≥65 years) patients. Factors associated with time to treatment with an oral antihyperglycaemic agent were examined using Cox proportional hazards regression. RESULTS: Of the 10 743 patients with newly diagnosed type 2 diabetes, 43% were ≥65 years old. The mean age at diagnosis was 73 years for older patients and 52 years for younger patients. Compared to younger patients, a greater proportion of older patients had a baseline haemoglobin A1c (HbA1c) value <7% (38 vs. 32%; p < 0.001). In the 2-year follow-up period, a significantly greater proportion of younger patients (59%) received oral antihyperglycaemic treatment compared to older patients (44%; p < 0.001). The median time between diagnosis and initiating treatment with an oral antihyperglycaemic agent was 350 days for younger patients and >2 years for older patients. After adjusting for covariates, older patients had a greater risk of not receiving treatment with oral antihyperglycaemic therapy than younger patients [adjusted hazard ratio = 0.82 (95% confidence interval: 0.75, 0.90)]. CONCLUSIONS: In patients with newly diagnosed type 2 diabetes, the time to initiation of oral antihyperglycaemic therapy was significantly longer in older patients (≥65 years old) than younger patients (<65 years).

The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial.

AIMS: To compare the incidence of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan. METHODS: Patients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA(1c) < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open-label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin 100 mg qd or to remain on their prestudy sulphonylurea. Patients completed daily diary cards to document information on hypoglycaemic symptoms and complications. The primary end-point was the overall incidence of symptomatic hypoglycaemia recorded during Ramadan. RESULTS: Of the 1066 patients randomised, 1021 (n = 507 for sitagliptin and n = 514 for sulphonylurea) returned at least one completed diary card and were included in the analysis. The proportion of patients who recorded one or more symptomatic hypoglycaemic events during Ramadan was lower in the sitagliptin group (6.7%) compared with the sulphonylurea group (13.2%). The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment (Mantel-Haenszel relative risk ratio [95% CI] = 0.51 [0.34, 0.75]; p < 0.001). There were no reported events that required medical assistance (i.e. visits to physician or emergency room or hospitalisations) or were considered severe (i.e. events that caused loss of consciousness, seizure, coma or physical injury) during Ramadan. CONCLUSIONS: In Muslim patients with type 2 diabetes who observed the fast during Ramadan, switching to a sitagliptin-based regimen decreased the risk of hypoglycaemia compared with remaining on a sulphonylurea-based regimen. The incidence of hypoglycaemia was lower with gliclazide relative to the other sulphonylurea agents and similar to that observed with sitagliptin.

Treatment intensification in patients with type 2 diabetes who failed metformin monotherapy.

AIM: To evaluate the time to and factors associated with treatment intensification in patients with type 2 diabetes who failed metformin monotherapy. METHODS: In a retrospective analysis using a large US electronic medical record database, eligible patients included those with type 2 diabetes and an HbA(1c) of ≥7.0% or at least two fasting blood glucose levels of ≥126 mg/dl while on metformin monotherapy for at least 6 months within the period of 1 January 1997 to 31 December 2008. Time to treatment intensification was calculated as the time between index date (date on which HbA(1c) ≥ 7% after metformin monotherapy for at least 6 months) and first prescription for additional antihyperglycaemic agent during follow-up period. All patients were required to have data for at least 12 months prior to and following the index date. A Cox proportional hazards model was employed to determine patient baseline characteristics associated with time to treatment intensification. RESULTS: Of the 12 566 patients identified, mean age at index date was 63 years and 51% were female. Mean index HbA(1c) was 8.0% overall, with 66, 19 and 15% of patients having an index HbA(1c) of 7 to <8%, 8 to <9% and ≥9%, respectively. Median time to treatment intensification was 14.0 months overall and 19.0, 8.7 and 4.5 months for patients with index HbA(1c) of 7 to <8%, 8 to <9% and ≥9%, respectively. Factors associated with treatment intensification included higher index HbA(1c) , younger age, higher Charlson co-morbidity index, metformin daily dose ≥ 1500 mg and later index date (all p < 0.05). CONCLUSIONS: In US clinical practice, median time to receive additional antihyperglycaemic medication is more than 1 year for patients with type 2 diabetes who failed metformin monotherapy.

Impact of concurrent macrovascular co-morbidities on healthcare utilization in patients with type 2 diabetes in Europe: a matched study.

AIM: To examine and to quantify the impact of concurrent macrovascular co-morbidities (MVC) on healthcare resource utilization among patients with type 2 diabetes mellitus (T2DM) in Europe. METHODS: This is a matched cohort study based on the Real-Life Effectiveness and Care Patterns of Diabetes Management study, a multicentre, observational study with retrospective medical chart reviews of T2DM patients in Spain, France, UK, Norway, Finland, Germany and Poland. Included patients were aged > or =30 years at time of diagnosis of T2DM who added a sulfonylurea or a PPARgamma agonist to failing metformin monotherapy (index date) and had concurrent MVC (cases). A control cohort with T2DM but without concurrent MVC was identified using 1:1 propensity score matching. Logit models were used to identify the relationship between concurrent MVC and the likelihood of emergency room admission, receiving medical/surgical procedures, and hospitalization during the study period after controlling for baseline demographics, clinical information and baseline treatment. Negative binomial models were used to predict the number of office visits and length of hospital stay per year attributable to the concurrent MVC. RESULTS: Relative to controls, patients with MVC were significantly more likely to have emergency department admissions [odds ratio (OR) 2.69; 95% CI: 1.56-4.65], receiving medical/surgical procedures (OR 2.57; 95% CI: 1.56-4.21) and hospitalizations (OR 2.58; 95% CI: 1.64-4.07) after controlling for other predictors. Similarly, MVC were associated with 1.49 additional office visits per year (p = 0.036) and 0.32 days of hospital stay per year (p = 0.023). CONCLUSIONS: Within a seven-country European sample, this study showed that T2DM patients with MVC were more likely to use healthcare resources compared with T2DM patients without MVC.

Validation and comparative evaluation of the osteoporosis self-assessment tool (OST) in a Caucasian population from Belgium.

BACKGROUND: Risk indices have been developed to identify women at risk of low bone mineral density (BMD) who should undergo BMD testing. AIM: To compare the performance of four risk indices in White ambulatory women in Belgium. DESIGN: Epidemiological cross-sectional study. METHODS: Records were analysed for 4035 postmenopausal White women without Paget's disease or advanced osteoarthritis, seen at an out-patient osteoporosis centre between January 1996 and September 1999. Osteoporosis risk index scores were compared to bone density T-scores. The ability of each risk index to identify women with low BMD (T-score < -2.0) or osteoporosis (T < -2.5) was evaluated. RESULTS: Using an Osteoporosis Self-Assessment Tool (OST) score <2 to recommend DXA referral, sensitivity ranged from 85% at the lumbar spine to 97% at the total hip to detect BMD T-scores of

On conducting burden-of-osteoporosis studies: a review of the core concepts and practical issues. A study carried out under the auspices of a WHO Collaborating Center.

Osteoporosis is a problem that is relevant to public health from the clinical, economic and social viewpoints. Except in a handful of industrialized countries, there is a considerable void in our knowledge of the magnitude of the problem. By exploring both the epidemiological and the economic impact of osteoporosis and the fractures associated with it in a particular country, studies of the 'burden of illness' (BOI) can fill that void. BOI analysis raises many questions at both the conceptual and the practical level. The purpose of this paper is to review the methodology underlying analyses of this type, to discuss its limitations and to provide a general format to improve their implementation in the field of osteoporosis. Investigators involved in BOI analysis should be very clear and explicit regarding the methods they adopt, so that studies in different countries can be interpreted and compared appropriately by interested parties.

Cost-effectiveness of pravastatin in secondary prevention of coronary artery disease.

This study analyzed the cost-effectiveness of pravastatin in secondary prevention of coronary artery disease (CAD). The projected risk model in 445 male patients with established CAD and moderately elevated serum low-density lipoprotein cholesterol used results data from 2 placebo-controlled plaque regression trials: Pravastatin Limitation of Atherosclerosis in the Coronary Arteries and Pravastatin, Lipids, and Atherosclerosis in the Carotids. Framingham Heart Study data were used to project the risk of mortality 10 years after myocardial infarction (MI) for incremental male patients in the placebo group who had MI. A Markov process was used to estimate life-years saved, and decision analysis was used to estimate cost. Depending on the patient-risk profile, the midrange estimated cost per life-year saved with pravastatin in secondary prevention of CAD varied from $7,124 to $12,665, which is favorable compared with other widely accepted medical interventions.