The prognostic value of multiple electrode aggregometry and light transmittance aggregometry in stable cardiovascular patients with type 2 diabetes mellitus.
Thromb Res. 2019 Jun 04;180:47-54
Authors: Tsantes AΕ, Taichert M, Kyriakou E, Katogiannis K, Lytras T, Gialeraki A, Tzoumakidou E, Kokoris S, Douramani P, Kypraiou A, Poulis A, Katsadiotis G, Kalantzis D, Kottaridi C, Kopterides P, Bonovas S, Ikonomidis I
AIM: Limited data are available regarding the clinical relevance of platelet function measurements in stable patients with coronary artery disease (CAD). Our aim is to evaluate the agreement between multiple electrode aggregometry (MEA) and light transmittance aggregometry (LTA) in detecting clopidogrel low responders and their prognostic value in CAD patients with type 2 diabetes mellitus (T2DM) on dual platelet inhibition.
METHODS: LTA and MEA were performed in 122 stable cardiovascular patients with T2DM. The upper quartile of patients according to maximum LTA (LTAmax) and MEA measurements were defined as clopidogrel low responders. Agreement between the two methods was evaluated by kappa statistics. We assessed the potential correlation between antiplatelet response and clinical outcome and the optimal cutoff value according to ROC analysis to predict the occurrence of major adverse cardiovascular events (MACE), during 1-year follow-up period.
RESULTS: Cohen's kappa coefficients (0.214) indicated fair agreement (70.2%) between LTA and MEA. A total of 25 MACE occurred in 108 patients (23.1%). Patients with MACE had higher LTAmax than those without (57.1 ± 16.5 vs 49.3 ± 18.3, respectively, p = 0.023). MEA measurements were similar between patients with and without MACE (30.1 ± 15.4 vs 30.6 ± 20.8, respectively; p = 0.84). Multiple logistic regression showed LTAmax response as an independent predictor of death from cardiovascular causes (Odds Ratio, adjusted:0.2;0.05-0.81). ROC analysis indicated that LTAmax cutoff of 62.5% best predicted death (AUC = 0.67, sensitivity = 78%, specificity = 61.5%).
CONCLUSIONS: The assessment of platelet responsiveness remains highly test-specific. Our results support the prognostic role of LTA, but not MEA testing, for death risk evaluation in stable cardiovascular T2DM patients.
PMID: 31202191 [PubMed - as supplied by publisher]
Acetyl-L-carnitine for the treatment of diabetic peripheral neuropathy.
Cochrane Database Syst Rev. 2019 Jun 15;6:CD011265
Authors: Rolim LC, da Silva EM, Flumignan RL, Abreu MM, Dib SA
BACKGROUND: Diabetic peripheral neuropathy (DPN) is a common and severe complication that affects 50% of people with diabetes. Painful DPN is reported to occur in 16% to 24% of people with diabetes. A complete and comprehensive management strategy for the prevention and treatment of DPN, whether painful or not, has not yet been defined.Research into treatment for DPN has been characterised by a series of failed clinical trials, with few noteworthy advances. Strategies that support peripheral nerve regeneration and restore neurological function in people with painful or painless DPN are needed. The amino acid acetyl-L-carnitine (ALC) plays a role in the transfer of long-chain fatty acids into mitochondria for β-oxidation. ALC supplementation also induces neuroprotective and neurotrophic effects in the peripheral nervous system. Therefore, ALC supplementation targets several mechanisms relevant to potential nerve repair and regeneration, and could have clinical therapeutic potential. There is a need for a systematic review of the evidence from clinical trials.
OBJECTIVES: To assess the effects of ALC for the treatment of DPN.
SEARCH METHODS: On 2 July 2018, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform. We checked references, searched citations, and contacted study authors to identify additional studies.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs of ALC compared with placebo, other therapy, or no intervention in the treatment of DPN. Participants could be of any sex and age, and have type 1 or type 2 diabetes mellitus, of any severity, with painful or painless DPN. We accepted any definition of minimum criteria for DPN, in accordance with the Toronto Consensus. We imposed no language restriction.Pain was the primary outcome, measured as the proportion of participants with at least 30% (moderate) or 50% (substantial) decrease in pain over baseline, or as the score on a visual analogue scale (VAS) or Likert scale for pain.
DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methods.
MAIN RESULTS: We included four studies with 907 participants, which were reported in three publications. Three trials studied ALC versus placebo (675 participants); in one trial the dose of ALC was 2000 mg/day, and in the other two trials, it was 1500 mg/day or 3000 mg/day. The fourth trial studied ALC 1500 mg/day versus methylcobalamin 1.5 mg/day (232 participants). The risk of bias was high in both trials of different ALC doses and low in the other two trials.No included trial measured the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. ALC reduced pain more than placebo, measured on a 0- to 100-mm VAS (MD -9.16, 95% CI -16.76 to -1.57; three studies; 540 participants; P = 0.02; I² = 56%; random-effects; very low-certainty evidence; a higher score indicating more pain). At doses of 1500 mg/day or less, the VAS score after ALC treatment was little different from placebo (MD -0.05, 95% CI -10.00 to 9.89; two studies; 159 participants; P = 0.99; I² = 0%), but at doses greater than 1500 mg/day, ALC reduced pain more than placebo (MD -14.93, 95% CI -19.16 to -10.70; three studies; 381 participants; P < 0.00001; I² = 0%). This subgroup analysis should be viewed with caution as the evidence was even less certain than the overall analysis, which was already of very low certainty.Two placebo-controlled studies reported that vibration perception improved after 12 months. We graded this evidence as very low certainty, due to inconsistency and a high risk of bias, as the trial authors did not provide any numerical data. The placebo-controlled studies did not measure functional impairment and disability scores. No study used validated symptom scales. One study performed sensory testing, but the evidence was very uncertain.The fourth included study compared ALC with methylcobalamin, but did not report effects on pain. There was a reduction from baseline to 24 weeks in functional impairment and disability, based on the change in mean Neuropathy Disability Score (NDS; scale from zero to 10), but there was no important difference between the ALC group (mean score 1.66 ± 1.90) and the methylcobalamin group (mean score 1.35 ± 1.65) groups (P = 0.23; low-certainty evidence).One placebo-controlled study reported that six of 147 participants in the ALC > 1500 mg/day group (4.1%) and two of 147 participants in the placebo group (1.4%) discontinued treatment because of adverse events (headache, facial paraesthesia, and gastrointestinal disorders) (P = 0.17). The other two placebo-controlled studies reported no dropouts due to adverse events, and more pain, paraesthesia, and hyperaesthesias in the placebo group than the 3000 mg/day ALC group, but provided no numerical data. The overall certainty of adverse event evidence for the comparison of ALC versus placebo was low.The study comparing ALC with methylcobalamin reported that 34/117 participants (29.1%) experienced adverse events in the ALC group versus 33/115 (28.7%) in the methylcobalamin group (P = 0.95). Nine participants discontinued treatment due to adverse events (ALC: 4 participants, methylcobalamin: 5 participants), which were most commonly gastrointestinal symptoms. The certainty of the adverse event evidence for ALC versus methylcobalamin was low.Two studies were funded by the manufacturer of ALC and the other two studies had at least one co-author who was a consultant for an ALC manufacturer.
AUTHORS' CONCLUSIONS: We are very uncertain whether ALC causes a reduction in pain after 6 to 12 months' treatment in people with DPN, when compared with placebo, as the evidence is sparse and of low certainty. Data on functional and sensory impairment and symptoms are lacking, or of very low certainty. The evidence on adverse events is too uncertain to make any judgements on safety.
PMID: 31201734 [PubMed - as supplied by publisher]
Remogliflozin Etabonate: First Global Approval.
Drugs. 2019 Jun 14;:
Authors: Markham A
Remogliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor, which is to be administered as remogliflozin etabonate (Remo™, Remozen™), the prodrug for remogliflozin, recently received its first approval as a treatment for type 2 diabetes mellitus (T2DM) in India. This article summarizes the milestones in the development of remogliflozin etabonate leading to this first approval for T2DM.
PMID: 31201711 [PubMed - as supplied by publisher]
Impact of different dietary approaches on blood lipid control in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis.
Eur J Epidemiol. 2019 Jun 14;:
Authors: Neuenschwander M, Hoffmann G, Schwingshackl L, Schlesinger S
The aim of this study was to assess the effects of different dietary approaches on low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglyceride (TG) levels in patients with type 2 diabetes (T2D) by applying network meta-analysis (NMA). Systematic electronic and hand searches were conducted until January 2018. Randomized controlled trials (RCTs) with an intervention period of ≥ 12 weeks, focussing on adults with T2D, and comparing dietary approaches regarding LDL, HDL or TGs, were included. For each outcome measure, random effects NMA was performed in order to determine the effect of each dietary approach compared to every other dietary intervention. Mean differences (MDs) and 95% confidence intervals (95% CIs) were calculated, and for the ranking, the surface under the cumulative ranking curves (SUCRA) was determined. Additionally, the credibility of evidence was evaluated. 52 RCTs (44 for LDL, 48 for HDL and 52 for TGs) comparing nine dietary approaches (low fat, vegetarian, Mediterranean, high protein, moderate carbohydrate, low carbohydrate, control, low glycaemic index/glycaemic load and Palaeolithic diet) enrolling 5360 T2D patients were included. The vegetarian diet most effectively reduced LDL levels [MD (95% CI): - 0.33 (- 0.55, - 0.12) mmol/L; compared to the control diet]. The Mediterranean diet beneficially raised HDL [MD (95% CI): 0.09 (0.04, 0.15) mmol/L] and decreased TG levels [MD (95% CI): - 0.41 (- 0.72, - 0.10) mmol/L] compared to the control diet. The Mediterranean diet was the most effective dietary approach to manage diabetic dyslipidaemia altogether (SUCRA: 79%). The overall findings are mainly limited by low credibility of evidence.
PMID: 31201670 [PubMed - as supplied by publisher]
Marriage and diabetes.
J Pak Med Assoc. 2019 Jun;69(6):911-912
Authors: Jawad F, Kalra S
This communication shares the challenges and concerns associated with marriage in persons living with diabetes. It classifies the challenges as psychosocial and biomedical, and lists counselling tips to tackle these. It dispels the various myths associated with marriage, andsuggests proactive steps to improve societal attitudes and practices.
PMID: 31201405 [PubMed - in process]