Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt – results from the GUARD study

Objective: The GUARD study evaluated the effectiveness, safety, and tolerability of vildagliptin treatment with or without metformin in patients with type 2 diabetes mellitus (T2DM) in real-life settings. Here we present the results of the GUARD study for the patient subset from Egypt.

Research design and methods: This was a 24?±?6 weeks, prospective, non-interventional study that enrolled adult patients with T2DM receiving vildagliptin or vildagliptin?+?metformin combination therapy as per local prescribing information.

Main outcome measures: The primary effectiveness endpoint was change in HbA1c levels from baseline to week 24?±?6 endpoint. Safety was assessed by reporting of adverse events and serious adverse events (SAEs).

Results: Of 2786 patients enrolled from Egypt, 655 received vildagliptin and 2131 received vildagliptin?+?metformin. Overall, at baseline, mean (± standard deviation [SD]) age was 49.5?±?9.49 years, BMI was 31.5?±?4.85?kg/m², HbA1c was 8.4?±?0.86%, and duration of T2DM was 2.3?±?3.78 years. At week 24, significant reductions in mean (±SD) HbA1c were observed in the vildagliptin (?1.47?±?0.79%) and vildagliptin?+?metformin (?1.62?±?0.82%) groups (both p?Conclusion: In a real-world setting, vildagliptin, with or without metformin, resulted in significant reductions in HbA1c and was well tolerated in patients with T2DM from Egypt. Limitations of the study include non-randomization and the open-label, observational nature of the study.     

Efficacy and tolerability of initial combination therapy with nateglinide and metformin in treatment-naïve patients with type 2 diabetes

OBJECTIVE: To assess the efficacy and tolerability of the combination of nateglinide (120 mg, ac) and metformin (500 mg, tid) as initial treatment in drug-na?ve patients with type 2 diabetes mellitus (T2DM). Research design and methods: This study reports data from the treatment-na?ve (TN) subgroup of patients in a previously published, randomized, multicenter, placebo-controlled, 24- week trial that compared nateglinide, metformin, and the combination therapy (CT) in 701 patients with T2DM with baseline HbA(1c) between 6.8% and 11.0%. Of the 401 TN patients, 104, 104, 89, and 104 patients received nateglinide (120 mg, ac), metformin (500 mg, tid), CT, and placebo, respectively. The baseline characteristics of each group were similar, with mean age, BMI, duration of diabetes, HbA(1c), and fasting plasma glucose (FPG) levels of approximately 58 years, 30 kg/m(2), 4 Gastrointestinal side effects occurred in 27% of years, 8.2%, and 10.2 mmol/L, respectively. RESULTS: In patients receiving initial CT, HbA(1c) decreased substantially (Delta = -1.6 +/- 0.1%, p < 0.0001 vs. baseline or placebo) from a mean baseline of 8.2 +/- 0.1%, an effect significantly greater than the 0.8% reduction observed with both monotherapies (p < 0.001); whereas, in placebo-treated patients, HbA(1c) increased modestly (Delta = +0.3 +/- 0.1%, p < 0.05) from an identical baseline value. Seventy percent of CT-treated patients achieved a target HbA(1c) of < 7.0%. Both fasting plasma glucose (FPG) and the 2-hour postprandial glucose excursion (PPGE) after a liquid meal challenge decreased by 2.3 mmol/L in patients receiving CT, while the changes from baseline values in FPG and PPGE were +0.2 +/- 0.3 mmol/L and -0.5 +/- 0.2 mmol/L, respectively, in placebo-treated patients. The incremental 30-minute post-load insulin levels increased by 88 +/- 32 pmol/L (p = 0.006) in patients receiving CT and did not change significantly in placebo-treated patients. patients receiving CT (vs. 27.9% in the metformin monotherapy, and 14.4% in the placebo groups). Confirmed hypoglycemia (glucose 相似文献   

Efficacy and tolerability of initial combination therapy with nateglinide and metformin in treatment-naïve patients with type 2 diabetes

SUMMARY

Objective: To assess the efficacy and tolerability of the combination of nateglinide (120?mg, ac) and metformin (500?mg, tid) as initial treatment in drug-naïve patients with type 2 diabetes mellitus (T2DM).

Research design and methods: This study reports data from the treatment-naïve (TN) subgroup of patients in a previously published, randomized, multicenter, placebo-controlled, 24-week trial that compared nateglinide, metformin, and the combination therapy (CT) in 701 patients with T2DM with baseline HbA_1c between 6.8% and 11.0%. Of the 401 TN patients, 104, 104, 89, and 104 patients received nateglinide (120?mg, ac), metformin (500?mg, tid), CT, and placebo, respectively. The baseline characteristics of each group were similar, with mean age, BMI, duration of diabetes, HbA_1c, and fasting plasma glucose (FPG) levels of approximately 58 years, 30?kg/m², 4 years, 8.2%, and 10.2?mmol/L, respectively.

Results: In patients receiving initial CT, HbA_1c decreased substantially (? = –1.6 ± 0.1%, p < 0.0001 vs. baseline or placebo) from a mean baseline of 8.2 ± 0.1%, an effect significantly greater than the 0.8% reduction observed with both monotherapies (?p < 0.001); whereas, in placebo-treated patients, HbA_1c increased modestly (? = +0.3 ± 0.1%, p < 0.05) from an identical baseline value. Seventy percent of CT-treated patients achieved a target HbA_1c of < 7.0%. Both fasting plasma glucose (FPG) and the 2-hour postprandial glucose excursion (PPGE) after a liquid meal challenge decreased by 2.3?mmol/L in patients receiving CT, while the changes from baseline values in FPG and PPGE were +0.2 ± 0.3?mmol/L and –0.5 ± 0.2?mmol/L, respectively, in placebo-treated patients. The incremental 30-minute post-load insulin levels increased by 88 ± 32?pmol/L (?p = 0.006) in patients receiving CT and did not change significantly in placebo-treated patients. Gastrointestinal side effects occurred in 27% of patients receiving CT (vs. 27.9% in the metformin monotherapy, and 14.4% in the placebo groups). Confirmed hypoglycemia (glucose ≤ 2.8?mmol/L) occurred in 3.4% of patients receiving CT.

Conclusions: Initial CT with the rapid-acting insulinotropic agent, nateglinide, and metformin, an agent with insulin-sensitizing effects in the liver and periphery, is a safe and effective means of achieving glycemic targets in TN patients with T2DM.     

Rationale,design and organisation of an efficacy and safety study of oxypurinol added to standard therapy in patients with NYHA class III – IV congestive heart failure

Oxypurinol, the active metabolite of allopurinol and a potent xanthine oxidase inhibitor (XOI), is under evaluation as a novel agent for the treatment of congestive heart failure (HF). Several lines of evidence provide the rationale for the hypothesis that XOIs will improve clinical outcomes in patients with HF. First, XOIs have unique positive inotropic effects, improving myocardial contraction and performance while simultaneously improving myocardial energy metabolism. Second, XOIs ameliorate endothelial dysfunction in humans with HF. Finally, XO activity is upregulated in the heart and vasculature of subjects with HF, which may in turn contribute to oxidative stress and/or increased uric acid levels. Together these findings form the rationale for the Controlled Efficacy and Safety Study of Oxypurinol Added to Standard Therapy in Patients with New York Heart Association (NYHA) class III – IV Congestive Heart Failure (OPT-CHF) trial (Food and Drug Adminstration IND 65,125), a Phase II – III prospective, randomised, double-blind, placebo-controlled trial, which will include patients with stable symptomatic HF in NYHA class III – IV congestive HF who are deemed clinically stable on a standard and appropriately maximised heart failure therapy regimen. The efficacy end point for OPT-CHF is a composite that incorporates measures of patient outcome and well-being.     

Biologics in pediatric psoriasis – efficacy and safety

Introduction: Childhood psoriasis is a special situation that is a management challenge for the treating dermatologist. As is the situation with traditional systemic agents, which are commonly used in managing severe psoriasis in children, the biologics are being increasingly used in the recalcitrant disease despite limited data on long term safety.

Areas covered: We performed an extensive literature search to collect evidence-based data on the use of biologics in pediatric psoriasis. The relevant literature published from 2000 to September 2017 was obtained from PubMed, using the MeSH words ‘biologics’, ‘biologic response modifiers’ and ‘treatment of pediatric/childhood psoriasis’. All clinical trials, randomized double-blind or single-blind controlled trials, open-label studies, retrospective studies, reviews, case reports and letters concerning the use of biologics in pediatric psoriasis were screened. Articles covering the use of biologics in pediatric psoriasis were screened and reference lists in the selected articles were scrutinized to identify other relevant articles that had not been found in the initial search. Articles without relevant information about biologics in general (e.g. its mechanism of action, pharmacokinetics and adverse effects) and its use in psoriasis in particular were excluded. We screened 427 articles and finally selected 41 relevant articles.

Expert opinion: The available literature on the use of biologics such as anti-tumor necrosis factor (TNF)–α agents, and anti-IL-12/23 agents like ustekinumab suggests that these are effective and safe in managing severe pediatric psoriasis although there is an urgent need to generate more safety data. Dermatologists must be careful about the potential adverse effects of the biologics before administering them to children with psoriasis. It is likely that with rapidly evolving scenario of biologics in psoriasis, these will prove to be very useful molecules particularly in managing severe and recalcitrant psoriasis in pediatric age group.     

Effects of pioglitazone and vildagliptin on coagulation cascade in diabetes mellitus – targeting thrombogenesis

Introduction: Type 2 diabetes mellitus (T2DM) is intricately allied with an increased risk of atherothrombotic disease. Thrombosis is the cause of mortality in 80% of patients with diabetes mellitus. Endothelial abnormalities lead to elevated inflammatory and coagulation biomarkers as seen in diabetes. Progression of atherothrombotic disease in diabetes has been linked with elevated levels of various coagulation factors including fibrinogen, plasminogen activator inhibitor-1, and von Willebrand factor.

Areas covered: We review the existing evidence and most recent data elucidating the various inflammatory and coagulation biomarkers that are elevated in T2DM leading to thrombosis as well as the anti-inflammatory, anticoagulant and antithrombotic mechanisms of pioglitazone and vildagliptin in addition to their effect on glucose metabolism that may halt the progression of atherothrombotic disease.

Expert opinion: The review highlights the pleiotropic effects of pioglitazone and vildagliptin on metabolic, inflammatory and coagulation processes that have the potential to influence cardiovascular disease progression at various points in the disease process, including hemostatic disturbances, inflammation, plaque rupture and atherogenesis in T2DM. Finally, the paper suggests a possible decline in T2DM-associated cardiovascular comorbidities once the antithrombotic potential of pioglitazone and vildagliptin is established through clinical investigation.     

Adverse drug reactions associated with the use of liraglutide in patients with type 2 diabetes – focus on pancreatitis and pancreas cancer

Introduction: The glucagon-like peptide-1 (GLP-1) receptor agonist, liraglutide, is a widely used drug for the treatment of type 2 diabetes. Liraglutide is one of several incretin-based agents that have been suggested to be associated with pancreatitis and pancreas cancer. The suspicion accelerated after publication of an autopsy study claiming increased incidences of several pathological changes in pancreata from patients with diabetes treated with incretin-based drugs.

Areas covered: The aim of the present review is to give an overview of the pharmacology of liraglutide and provide a review of adverse reactions associated with liraglutide with a focus on the risk of pancreatitis and pancreas cancer.

Expert opinion: When comprehensively reviewing the available literature, no clear and significant associations between liraglutide and pancreatitis and/or pancreas cancer seem evident. However, a recently published analysis suggests a trend toward a slightly elevated risk of pancreatitis with GLP-1 receptor agonists (including liraglutide), which may become statistical significant as more data become available. Well-established side effects are of gastrointestinal origin, typical mild-to-moderate and of transient character. The risk of hypoglycemia associated with liraglutide treatment is low.     

Effect of saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes

ABSTRACT

Objective: To evaluate the efficacy and safety of once-daily saxagliptin monotherapy in treatment-naïve patients with type 2 diabetes (T2D) and inadequate glycemic control.

Research design and methods: This study included a main treatment cohort (MTC) with 401 patients (HbA_1c?≥?7% and ≤10%) randomized and treated with oral saxagliptin 2.5, 5, or 10?mg once daily or placebo for 24 weeks and a separate open-label cohort (OLC) with 66 patients (HbA_1c?>?10% and ≤12%) who received saxagliptin 10?mg once daily for 24 weeks. Primary endpoint was HbA_1c change from baseline to week 24. Secondary endpoints included change from baseline to week 24?in fasting plasma glucose (FPG), proportion of patients achieving HbA_1c?<?7%, and changes in postprandial glucose area-under-the-curve (PPG-AUC). Efficacy analyses for continuous variables were performed using an ANCOVA model with last-observation-carried-forward methodology.

Results: In the MTC, saxagliptin demonstrated statistically significant decreases in adjusted mean HbA_1c changes from baseline (mean, 7.9%) to week 24 (?0.43%, ?0.46%, ?0.54%) for saxagliptin 2.5, 5, and 10?mg, respectively, vs. +0.19% for placebo (all p?<?0.0001). Adjusted mean FPG was significantly reduced from baseline (?15, ?9, ?17?mg/dL) for saxagliptin 2.5, 5, and 10?mg, respectively, vs. +6?mg/dL for placebo (p?=?0.0002, p?=?0.0074, p?<?0.0001, respectively). More saxagliptin-treated patients achieved HbA_1c?<?7% at week 24 (35% [p?=?NS], 38% [p?=?0.0443], 41% [p?=?0.0133]) for saxagliptin 2.5, 5, and 10?mg, respectively, than placebo (24%). PPG-AUC was reduced for saxagliptin 2.5, 5, and 10?mg (?6868, ?6896, ?8084?mg·min/dL, respectively) vs. placebo (?647?mg·min/dL) with statistical significance demonstrated for saxagliptin 5?mg (p?=?0.0002) and 10?mg (p?<?0.0001). HbA_1c, FPG, and PPG-AUC reductions were also observed in the OLC at 24 weeks. In the MTC, adverse event frequency was similar across all study arms. No cases of confirmed hypoglycemia (symptoms, with fingerstick glucose ≤50?mg/dL) were observed in either cohort. Saxagliptin was not associated with weight gain. Study limitations included the lack of a control group for the OLC and the use of prespecified rescue criteria, which limited the exposure time during which patients could remain on their originally randomized medication without the introduction of additional antihyperglycemic rescue treatment.

Conclusions: Once-daily saxagliptin monotherapy for 24 weeks was generally well tolerated and demonstrated clinically meaningful reductions in key parameters of glycemic control vs. placebo.

Trial Registration: Clinical Trials NCT00121641     

Initial combination therapy with vildagliptin plus metformin in drug-naïve patients with T2DM: a 24-week real-life study from Asia

Aims: To assess the effectiveness and safety of vildagliptin/metformin initial combination therapy in drug-naïve patients with type 2 diabetes mellitus (T2DM).

Methods: INITIAL was a 24-week prospective, observational study in T2DM patients with glycated hemoglobin (HbA1c)?≥?7.5%, and prescribed vildagliptin/metformin as initial combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. Key secondary endpoints were HbA1c change from baseline to week 12, proportion of patients achieving HbA1c ≤7.0%, change in body weight at 12 and 24 weeks, change in HbA1c by sub-groups (baseline HbA1c, age, body mass index [BMI], dosage strength, co-morbidities) from baseline to week 24, and safety.

Results: A total of 532 patients were enrolled. The mean age, HbA1c, and BMI were 49.6?±?11.27 years, 9.3?±?1.57%, and 26.7?±?4.50?kg/m², respectively. Cardiovascular risk factors present at baseline were dyslipidemia (30.1%), hypertension (29.7%), and obesity (20.9%). The mean reductions in HbA1c from baseline to week 12 (?1.6?±?1.59%) and 24 (?1.9?±?1.70%) were statistically significant (p?Conclusions: Overall, in a relatively young drug-naïve T2DM Asian study population with high baseline HbA1c and often associated with cardiovascular risk factors, vildagliptin/metformin combination therapy was associated with significant and clinically relevant HbA1c reduction from baseline. This effect was seen at week 12, was maintained over 24 weeks, and was accompanied by good tolerability.     

Plasma thromboxane B2 and 6-keto-prostaglandin-F1α in patients with type 2 diabetes mellitus

Objective To investigate the changes of plasma thrombexane B2 (TXB2) and 6-keto-prostaglan-din-F1α (6-keto-PGF1α) in patients with type 2 diabetic mellitus and their roles in the pathogenesis of diabetic macroangiopathy. Methods Plasma levels of TXB2 and 6-keto-PGF1α were measured with RIA in 60 cases of type 2 diabetic patients(43 patients with and 17 without diabetic macroangiopathy), with 31 cases of controls. Results Plasma levels of TXB2 in type 2 diabetic patients were significantly higher than those in controls. However, plasma levels of 6-keto-PGF1α in type 2 diabetic patients were significantly lower than those in controls. Changes of both indexes were more significant in type 2 diabetic patients with macroangiopathy than those without macroangiopathy. Plasma levels of TXB2 showed negative correlation with 6-keto-PGF 1α. Conclusion TXB2 and 6-keto-PGF 1 α may play important roles in the pathogenesis of diabetic macroangiopathy. Determination of TXB2 and 6-keto-PGF1α levels in type 2 diabetic patients may be useful for early detection of diabetic macroangiopathy.     

Impact of genetic polymorphisms of leptin and TNF-α on rosiglitazone response in Chinese patients with type 2 diabetes

Background  Leptin and tumor necrosis factor-α (TNF-α) play important role in homeostasis and insulin resistance in the treatment of Type 2 diabetes (T2DM). The aims of the present study were to investigate the association between leptin G-2548A and TNF-α G-308A polymorphisms and rosiglitazone response in T2DM patients. Materials  245 patients with T2D and 122 health volunteers were enrolled to identify leptin G-2548A and TNF-α G-308A genotypes by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) assay. Forty-two T2D patients with different leptin G-2548A and TNF-α G-308A genotypes received orally rosiglitazone as a single-agent therapy (4 mg day⁻¹ p.o.) for 12 weeks. Serum triglyceride (TG), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), fasting serum insulin (FINs), glycated hemoglobin (HbAlc), postprandial serum insulin (PINS), homeostasis model assessment for insulin resistance (HOMA-IR), low-density lipoprotein-cholesterol (LDL-c), and high-density lipoprotein-cholesterol (HDL-c) were determined before and after rosiglitazone treatment. Results  A significant association between the variation of G-2548A allele with body mass index (BMI), serum leptin levels and FPG was observed in T2DM patients. Moreover, patients with G allele of leptin G-2548A had lower BMI and serum leptin concertration as well as bigger FPG than that in AA genotypes (P < 0.05). Moreover, we found an enhanced rosiglitazone effect in patients with AA genotype of leptin G-2548A on FINS and PINS compared with GG+GA genotype (P < 0.05). Finally, our results showed an attenuated rosiglitazone effect in patients with GA+AA genotype of TNF-α G-308A on FINS compared with GG genotype (P < 0.05). Conclusions  These data suggest there were not significantly differences in the frequencies of leptin G-2548A and TNF-α G-308A between patients with T2DM and health control. TNF-α G-308A polymorphism might be associated with the therapeutic efficacy of rosiglitazone in T2DM patients. This project was supported by the National Natural Science Foundation of China grant, No 30572230, and the Supported Program for New Century Excellent Talents in University sponsored by Ministry of Education of China, No. NCET-04-0749. Yang-Gen Lin and Jing-Wu these authors have contributed equally.     

Plasma thromboxane B2 and 6-keto-prostaglandin-F1α in patients with type 2 diabetes mellitus

Objective To investigate the changes of plasma thrombexane B2 (TXB2) and 6-keto-prostaglan-din-F1α (6-keto-PGF1α) in patients with type 2 diabetic mellitus and their roles in the pathogenesis of diabetic macroangiopathy. Methods Plasma levels of TXB2 and 6-keto-PGF1α were measured with RIA in 60 cases of type 2 diabetic patients(43 patients with and 17 without diabetic macroangiopathy), with 31 cases of controls. Results Plasma levels of TXB2 in type 2 diabetic patients were significantly higher than those in controls. However, plasma levels of 6-keto-PGF1α in type 2 diabetic patients were significantly lower than those in controls. Changes of both indexes were more significant in type 2 diabetic patients with macroangiopathy than those without macroangiopathy. Plasma levels of TXB2 showed negative correlation with 6-keto-PGF 1α. Conclusion TXB2 and 6-keto-PGF 1 α may play important roles in the pathogenesis of diabetic macroangiopathy. Determination of TXB2 and 6-keto-PGF1α levels in type 2 diabetic patients may be useful for early detection of diabetic macroangiopathy.     

Plasma thromboxane B2 and 6-keto-prostaglandin-F1α in patients with type 2 diabetes mellitus

Objective To investigate the changes of plasma thrombexane B2 (TXB2) and 6-keto-prostaglan-din-F1α (6-keto-PGF1α) in patients with type 2 diabetic mellitus and their roles in the pathogenesis of diabetic macroangiopathy. Methods Plasma levels of TXB2 and 6-keto-PGF1α were measured with RIA in 60 cases of type 2 diabetic patients(43 patients with and 17 without diabetic macroangiopathy), with 31 cases of controls. Results Plasma levels of TXB2 in type 2 diabetic patients were significantly higher than those in controls. However, plasma levels of 6-keto-PGF1α in type 2 diabetic patients were significantly lower than those in controls. Changes of both indexes were more significant in type 2 diabetic patients with macroangiopathy than those without macroangiopathy. Plasma levels of TXB2 showed negative correlation with 6-keto-PGF 1α. Conclusion TXB2 and 6-keto-PGF 1 α may play important roles in the pathogenesis of diabetic macroangiopathy. Determination of TXB2 and 6-keto-PGF1α levels in type 2 diabetic patients may be useful for early detection of diabetic macroangiopathy.     

Plasma thromboxane B2 and 6-keto-prostaglandin-F1α in patients with type 2 diabetes mellitus

Objective To investigate the changes of plasma thrombexane B2 (TXB2) and 6-keto-prostaglan-din-F1α (6-keto-PGF1α) in patients with type 2 diabetic mellitus and their roles in the pathogenesis of diabetic macroangiopathy. Methods Plasma levels of TXB2 and 6-keto-PGF1α were measured with RIA in 60 cases of type 2 diabetic patients(43 patients with and 17 without diabetic macroangiopathy), with 31 cases of controls. Results Plasma levels of TXB2 in type 2 diabetic patients were significantly higher than those in controls. However, plasma levels of 6-keto-PGF1α in type 2 diabetic patients were significantly lower than those in controls. Changes of both indexes were more significant in type 2 diabetic patients with macroangiopathy than those without macroangiopathy. Plasma levels of TXB2 showed negative correlation with 6-keto-PGF 1α. Conclusion TXB2 and 6-keto-PGF 1 α may play important roles in the pathogenesis of diabetic macroangiopathy. Determination of TXB2 and 6-keto-PGF1α levels in type 2 diabetic patients may be useful for early detection of diabetic macroangiopathy.     

Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial

Abstract Objective: Glycaemic control in patients with type 2 diabetes (T2DM) is often not achieved or not sustained using monotherapy such as metformin, necessitating the addition of other antihyperglycaemic agents. Linagliptin, a dipeptidyl peptidase-4 inhibitor, is licensed for 5?mg once-daily dosing. As metformin is administered twice daily, a fixed-dose combination of these compounds would require twice-daily administration of linagliptin. This study evaluated whether 2.5?mg twice-daily dosing of linagliptin has comparable efficacy and safety to 5?mg once-daily dosing when given in addition to metformin twice daily in patients with inadequate glycaemic control. Methods: A total of 491 T2DM patients with glycated haemoglobin (HbA1c) 7.0-10.0% were randomised (5:5:1) to double-blind treatment with linagliptin 2.5?mg twice daily, 5?mg once daily or placebo, respectively, in addition to continuing metformin twice daily (≥1500?mg/day or maximally tolerated dose). The primary endpoint was change from baseline in HbA1c after 12 weeks. ClinicalTrials.gov, NCT01012037. Results: Mean baseline HbA1c for all patients was 7.97%. After 12 weeks, linagliptin 2.5?mg twice daily and 5?mg once daily both significantly reduced HbA1c (placebo-adjusted changes from baseline -0.74% (95% CI -0.97, -0.52) and -0.80% (95% CI -1.02, -0.58), respectively, both p?相似文献   

Cross-sectional analysis of adult diabetes type 1 and type 2 patients with diabetic micro­vascular complications from a German retrospective observational study

ABSTRACT

Objective: To obtain epidemiological data on the prevalence of predefined stages of diabetic microvascular complications from a representative cross-section of patients with existing microvascular complications of type 1 or type 2 diabetes in Germany.

Research design and methods: A cross-sectional, retrospective study of medical records of 705 type 1 and 1910 type 2 adult diabetic patients with a diagnosis of retinopathy and/or peripheral neuropathy and/or nephropathy before 2002 and treated in 2002 in Germany.

Results: Of 376 patients with type 1 diabetes having retinopathy, 59.3% had mild or moderate non-proliferative retinopathy without macular oedema, 27.1% had macular oedema, and 13.6% had severe retinopathy without macular oedema. In 862 patients with type 2 diabetes, the distribution of retinopathy/maculopathy classes was 56.8%, 35.5%, and 7.7%, respectively. Of 381 type 1 diabetes patients with observed peripheral neuropathy, 81.4% had sensorimotor neuropathy, 8.9% had diabetic foot conditions, and 9.7% had lower extremity amputa­tions because of diabetes. In 1005 patients with type 2 diabetes, the distribution of neuropathy classes was 78.2%, 12.1%, and 9.7%, respectively. The proportions of patients with renal insufficiency in type 1 and type 2 diabetes groups were 15.3% versus 13.5%, respectively.

Conclusions: The study suggests that there are considerable proportions of patients with progressive stages of microvascular complications related to type 1 and type 2 diabetes in Germany. This underlines the importance of improvement of optimal quality of care and frequent screening for preventing late diabetic microvascular complications and the necessity of effective intervention strategies to tackle this major public health problem.