Dataset Information

Incidence of hypoglycaemia in patients with type-2 diabetes taking multiple glucose lowering therapies during Ramadan: the PROFAST Ramadan Study.

ABSTRACT:

Objective

To assess the incidence of hypoglycemia in people with type-2 diabetes mellitus (T2DM) on three or more anti-diabetic medications during Ramadan.

Study design methods

We have studied people with T2DM on three or more glucose-lowering drugs during Ramadan of H1438 (May-June 2017). The dose of each drug was adjusted according to a pre-specified protocol. The incidence of symptomatic or blood glucose confirmed hypoglycemia was recorded during the study.

Results

We enrolled 228 people with T2DM; 181 completed the study, and data on hypoglycaemia was available in 172 subjects. There were 115 males and 66 females, (mean age?±?SD) 53.6?±?9.7 years, diabetes duration 10?±?6 yrs. The incidence of hypoglycaemia was 16.3% (28/172). Univariable logistic regression analysis showed that the risk of hypoglycaemia was increased in Arab subjects compared to Qatari; in those with longer duration of diabetes; and in those on four or more anti-diabetic medications compared to those on three anti-diabetic medications.

Conclusion

Despite the tailored advice, there is a high incidence of hypoglycemia in people with T2DM taking multiple glucose lowering therapies whilst fasting during Ramadan. Guidelines should address the increased complexity in anti-diabetic medications in patients who fast during Ramadan. Healthcare providers should individualize the modifications in anti-diabetic medications during Ramadan.

SUBMITTER: Elhadd T

PROVIDER: S-EPMC6405393 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Incidence of hypoglycaemia in patients with type-2 diabetes taking multiple glucose lowering therapies during Ramadan: the PROFAST Ramadan Study.

Elhadd Tarik T Dabbous Zeinab Z Bashir Mohammed M Elzouki Abdulnasir A Ghadban Wissam W Baagar Khaled K Benjamin Silas S Hassanien Mohamed M Saeed Abazar A M AAM Dukhan Khaled K Malik Rayaz A RA Abou-Samra Abdul-Badie AB

Journal of diabetes and metabolic disorders 20181119 2

<h4>Objective</h4>To assess the incidence of hypoglycemia in people with type-2 diabetes mellitus (T2DM) on three or more anti-diabetic medications during Ramadan.<h4>Study design methods</h4>We have studied people with T2DM on three or more glucose-lowering drugs during Ramadan of H1438 (May-June 2017). The dose of each drug was adjusted according to a pre-specified protocol. The incidence of symptomatic or blood glucose confirmed hypoglycemia was recorded during the study.<h4>Results</h4>We en ...[more]

PMID: 30918866

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Project description:BackgroundEpidemiologic studies have shown a relationship between glycated hemoglobin levels and cardiovascular events in patients with type 2 diabetes. We investigated whether intensive therapy to target normal glycated hemoglobin levels would reduce cardiovascular events in patients with type 2 diabetes who had either established cardiovascular disease or additional cardiovascular risk factors.MethodsIn this randomized study, 10,251 patients (mean age, 62.2 years) with a median glycated hemoglobin level of 8.1% were assigned to receive intensive therapy (targeting a glycated hemoglobin level below 6.0%) or standard therapy (targeting a level from 7.0 to 7.9%). Of these patients, 38% were women, and 35% had had a previous cardiovascular event. The primary outcome was a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up.ResultsAt 1 year, stable median glycated hemoglobin levels of 6.4% and 7.5% were achieved in the intensive-therapy group and the standard-therapy group, respectively. During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P<0.001).ConclusionsAs compared with standard therapy, the use of intensive therapy to target normal glycated hemoglobin levels for 3.5 years increased mortality and did not significantly reduce major cardiovascular events. These findings identify a previously unrecognized harm of intensive glucose lowering in high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)

Project description:IntroductionMetformin is an established first-line treatment for patients with type 2 diabetes mellitus (T2DM), but treatment intensification with other oral antidiabetes drugs (OADs) is usually required over time. Effectiveness of diabetes control with vildagliptin and vildagliptin/metformin was a 1-year, large observational study of 45,868 patients with T2DM across 27 countries which assessed effectiveness and safety of vildagliptin as add-on therapy to other OADs versus other comparator OAD combinations. Here, we present the data from Germany.MethodsPatients inadequately controlled with monotherapy were eligible only after the add-on treatment was finalized. Patients were assigned to either vildagliptin or comparator OADs [sulfonylureas, thiazolidinediones, glinides, α-glucosidase inhibitors or metformin, excluding dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon-like peptide-1 mimetic/analogues]. The primary efficacy endpoint was the proportion of patients achieving a glycosylated hemoglobin (HbA1c) reduction of >0.3% without peripheral edema, hypoglycemia, discontinuation due to a gastrointestinal event or weight gain ≥5%. One secondary efficacy endpoint was the proportion of patients achieving HbA1c <7% without hypoglycemia and weight gain. Change in HbA1c from baseline to study endpoint and safety were assessed.ResultsOf 8,887 patients enrolled in Germany, 6,679 received vildagliptin and 1,695 received other OADs. The mean ± SD baseline age, HbA1c, and T2DM duration were 62.8 ± 11.0 years, 7.7 ± 1.2%, and 5.8 ± 4.9 years, respectively. The proportion of patients achieving the primary (34.5% vs. 30.5%, p < 0.01) and secondary (25.4% vs. 21.7%, p = 0.01) endpoints was higher with vildagliptin than comparator OADs. Vildagliptin showed a numerically greater reduction in HbA1c (0.7%) from baseline vs. comparator OADs (0.6%). The overall incidence of adverse events was similar.ConclusionIn real life, treatment with vildagliptin is associated with a higher proportion of patients reaching target HbA1c without hypoglycemia and weight gain compared with other OADs in Germany.

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Project description:Introduction: The Glulisine in Combination with Insulin Glargine in an Intensified Insulin Regimen (GINGER) study compared insulin glargine plus insulin glulisine with premixed insulin in the treatment of patients with Type 2 diabetes mellitus (T2DM). This was a post-hoc analysis of hypoglycaemia rates in subgroups from the GINGER study. Methods: This analysis compared the once-daily glargine plus mealtime glulisine group (n=153, four injections/day) with the overall twice-daily premixed insulin group (n=157, two injections/day), which consisted of two subgroups receiving either neutral protamine Hagedorn (NPH) plus regular insulin (n=93) or biphasic insulin aspart 70/30 (n=63). Observed and predicted hypoglycaemia rates relative to endpoint HbA1c for both the total population and those patients who experienced ?1 episodes of any hypoglycaemia were estimated. Results: The overall hypoglycaemic event rate (episodes per patient-year) for patients receiving glargine plus glulisine was numerically but not significantly lower (-24.5 %) compared with the overall premixed insulin group (14.0±24.2 versus 18.5±36.9; p=0.12) and significantly lower (-43.3 %) compared with the biphasic insulin aspart 70/30 subgroup (24.7±48.5; p=0.02). In patients with ?1 episode of hypoglycaemia during treatment, the overall hypoglycaemic event rate was significantly lower (-26.5 %) in patients receiving glargine plus glulisine versus overall premixed insulin (18.5±26.3 versus 25.1±41.1; p=0.044) and significantly lower (-40.7 %) than in patients receiving biphasic insulin aspart 70/30 (31.1±52.7; p=0.009). Glargine/glulisine treatment maintained a more consistent and numerically lower hypoglycaemia rate at all achieved HbA1c endpoints compared with premixed insulin treatment. Conclusion: This post-hoc analysis of the GINGER study showed that the frequency of hypoglycaemia in T2DM patients was lowered to a greater extent by insulin glargine plus insulin glulisine in a comparison with premixed biphasic insulin aspart 70/30 than was previously shown in a comparison with overall premixed insulin. Trial Identifier: NCT00174668.

Dataset Information

Incidence of hypoglycaemia in patients with type-2 diabetes taking multiple glucose lowering therapies during Ramadan: the PROFAST Ramadan Study.

Objective

Study design methods

Results

Conclusion

Publications

Incidence of hypoglycaemia in patients with type-2 diabetes taking multiple glucose lowering therapies during Ramadan: the PROFAST Ramadan Study.

Similar Datasets

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