Dataset Information

Analysis of the Adherence and Safety of Second Oral Glucose-Lowering Therapy in Routine Practice From the Mediterranean Area: A Retrospective Cohort Study.

ABSTRACT: The aims of our study was compare adherence measured by the medical possession ratio (MPR), time until discontinuation and describe adverse events after adding a DPP-4i, SGLT-2i, or sulfonylureas (SU) to metformin in a primary care population with insufficient glycemic control. We used routinely-collected health data from the SIDIAP database. The included subjects were matched by propensity score. The follow-up period was up to 24 months or premature discontinuation. The primary outcomes were the percentage of subjects with good adherence, treatment discontinuation and adverse events among treatment groups. The proportion of patients with good adherence (MPR> 0.8) after the addition of DPP-4i, SGLT-2i or SU was 53.6%, 68.7%, and 43.0%, respectively. SGLT-2i users were 1.7 times more likely to achieve good adherence compared with DPP-4i users (odds ratio [OR]:1.72, 98% confidence interval [CI]:1.51, 1.96), and 2.8 times more likely compared with SU users (OR: 0.35, 98% CI: 0.07, 0.29). The discontinuation hazard ratios were 1.43 (98%CI: 1.26; 1.62) and 1.60 (98%CI: 1.42; 1.81) times higher among SGLT-2i and SU users than DPP-4i users during the follow-up period. No differences were observed for adverse events among the treatment groups. In conclusion, in our real-world setting, the combination of SGLT-2i with metformin was associated with better adherence. The mean time until discontinuation was longer in the SGLT-2i group in comparison with the DPP-4i or SU groups.

SUBMITTER: Vlacho B

PROVIDER: S-EPMC8318034 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionResearch has shown that glycemic control is associated with lower rates of microvascular and long-term cardiovascular complications. In the analyses reported here, we examined treatment failure on oral glucose-lowering agents (GLAs), defined as having sustained hemoglobin A1c (HbA1c) ≥ 7%.MethodsThis study utilized the IBM® MarketScan® Claims and Laboratory Data from 1 January 2012 through 30 June 2018. Adults with type 2 diabetes (T2D) were classified based upon the maximum number of classes of GLAs prescribed per day during the time period from 1 July 2012 through 31 December 2012. Patients were followed for 5.5 years in order to examine time to failure on oral GLAs, defined based upon receipt of ≥ 2 consecutive HbA1c results ≥ 7%. Multivariable analyses employing a Cox proportional hazards model were used to examine time to failure overall and based upon the number of index classes of oral GLAs prescribed. For patients who had sustained HbA1c above the threshold, multivariable analyses examined the duration of time that HbA1c remained above the threshold (i.e, glycemic burden) and whether or not an additional oral or injectable class of GLA was added to the patient treatment regimen (i.e., clinical inertia).ResultsA total of 4156 patients were included in the study, of whom 16% were identified with sustained HbA1c ≥ 7% after 365 days (1 year) and 36% after 730 days (2 years), with half of all patients having sustained HbA1c above target after 1102 days (3 years). There was a statistically significant difference in time to having sustained HbA1c above target based upon index classes of therapy, with patients treated with more GLAs being quicker to have HbA1c above target (P < 0.0001). Among those patients who were found to have sustained HbA1c ≥ 7%, the average number of days in the post-period that HbA1c remained above target was 1026 (2.8 years). Only 36% of patients with sustained HbA1c above target added a GLA to their treatment regimen and, for patients who did add such a therapy, the average duration from identification of HbA1c above target until treatment intensification was 401 days (1.1 years). Multivariable analyses revealed that, among those with sustained HbA1c ≥ 7%, treatment with more classes of oral GLAs was associated with a significantly higher glycemic burden and significantly lower odds of clinical inertia.ConclusionThese results indicate that for many patients treated with oral GLAs, glycemic control is not consistently achieved. For patients with above-target HbA1c , the results indicate a relatively large glycemic burden and clinical inertia towards treatment intensification. The findings illustrate some limitations associated with treatment of T2D with oral GLAs.

Project description:IntroductionSystematic patient education has been reported to improve adherence to treatment, leading to better clinical outcomes. This cluster randomized real-world study investigated the effect of a systematic education program and telephone support on self-reported adherence to oral glucose-lowering treatment in patients with type 2 diabetes mellitus (T2DM).MethodsCenters were randomized (1:1) to provide either standard-of-care (control group) or standard-of-care along with the education program and telephone support (empowerment group). Adherence to treatment and satisfaction with treatment were assessed using the four-item Morisky Medication Adherence Scale (MMAS-4) and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The study population included 457 patients (258/199 male/female) with T2DM and non-optimal glycemic control, on oral antidiabetic treatment (age 62.7 [11.4]; disease duration 8.5 [6.5] years).ResultsMMAS-4 high adherence rates for the control and empowerment groups were increased by 3.8% and 16.8% at 4 months (Breslow-Day test p = 0.04) and by 8.5% and 18.8% at 8 months of follow-up, respectively (Breslow-Day test p = 0.09), compared to baseline. Intense physical activity was increased in both control and empowerment groups by 2.3% and 13.9% at 4 months (Breslow-Day test p = 0.082) and by 4.0% and 22.5% at 8 months of follow-up (Breslow-Day test p < 0.001). Baseline mean (SD) HbA1c was significantly lower in the control group compared with the empowerment group [7.7% versus 8.0%, p = 0.001] and decreased in both groups at 4 months by 0.7% and 0.9%, respectively. The change from baseline in the mean DTSQ status score at 4 months was greater in the empowerment group, and the effect was sustained at 8 months (control group: 29.1, 30.5, and 30.9; empowerment group: 25.0, 28.7, and 29.4 at baseline, 4 and 8 months, respectively, p < 0.001).ConclusionSystematic education combined with telephone support delivered by physicians might be associated with improvement in treatment adherence and treatment satisfaction in patients with T2DM.FundingMSD, Greece.

Project description:Background and objectivesIntermediate hyperglycemia in the first half of pregnancy, defined as a fasting plasma glucose level between 5.1- 6.9 mM, increases the risk of gestational diabetes mellitus, but clinical evidence for further management is lacking. We aim to evaluate the effectiveness of an early oral glucose tolerance test (OGTT) followed by the identification of intermediate hyperglycemia on pregnancy outcomes in real world setting.Subjects and methodsA retrospective cohort study was conducted at the Obstetrics and Gynecology Hospital, Shanghai, China, between 2013 and 2017. Women with intermediate hyperglycemia at the first prenatal visit were identified and underwent an immediate (within one week) or a routine OGTT (24-28 gw) according to their wishes and received nutrition and exercise advice. Women diagnosed of gestational diabetes (GDM) were managed by standard interventions. Primary outcome was larger for gestational age (LGA). Secondary outcomes were primary cesarean delivery, preterm birth, shoulder dystocia or forceps delivery, preeclampsia, neonatal hypoglycemia, hyperbilirubinemia, and low Apgar score. Logistic regressions with or without a further propensity score-matched analysis were performed.ResultsAmong 42406 women involved, 1104 (2.6%) with intermediate hyperglycemia at the first prenatal visit were identified, of whom 176 (15.9%) underwent an early OGTT and 741 (67.1%) received a routine OGTT. Logistic regression showed that an early OGTT was not significantly associated with an altered risk of LGA (adjusted OR 1.13, 95% CI 0.73-1.75) but was related to an increased odds for neonatal hyperbilirubinemia (adjusted OR 2.89; 95% CI 1.55-5.37). No significant associations were observed for other secondary outcomes. These trends remained consistent in propensity score-matched models.ConclusionsOur data from a real-world setting did not support that an early OGTT among women with intermediate hyperglycemia at the first prenatal visit improved pregnancy outcomes.

Dataset Information

Analysis of the Adherence and Safety of Second Oral Glucose-Lowering Therapy in Routine Practice From the Mediterranean Area: A Retrospective Cohort Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets