scholarly journals Treatment withα-Lipoic Acid over 16 Weeks in Type 2 Diabetic Patients with Symptomatic Polyneuropathy Who Responded to Initial 4-Week High-Dose Loading

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Hector Garcia-Alcala ◽  
Celia Isabel Santos Vichido ◽  
Silverio Islas Macedo ◽  
Christelle Nathalie Genestier-Tamborero ◽  
Marissa Minutti-Palacios ◽  
...  
Keyword(s):  
Lipoic Acid ◽  
Phase 1 ◽  
Treated Group ◽  
Diabetic Patients ◽  
High Dose ◽  
Phase 2 ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic

Effective treatment of diabetic sensorimotor polyneuropathy remains a challenge. To assess the efficacy and safety ofα-lipoic acid (ALA) over 20 weeks, we conducted a multicenter randomized withdrawal open-label study, in which 45 patients with type 2 diabetes and symptomatic polyneuropathy were initially treated with ALA (600 mg tid) for 4 weeks (phase 1). Subsequently, responders were randomized to receive ALA (600 mg qd;n=16) or to ALA withdrawal (n=17) for 16 weeks (phase 2). During phase 1, the Total Symptom Score (TSS) decreased from 8.9 ± 1.8 points to 3.46 ± 2.0 points. During phase 2, TSS improved from 3.7 ± 1.9 points to 2.5 ± 2.5 points in the ALA treated group (p<0.05) and remained unchanged in the ALA withdrawal group. The use of analgesic rescue medication was higher in the ALA withdrawal group than ALA treated group (p<0.05). In conclusion, in type 2 diabetic patients with symptomatic polyneuropathy who responded to initial 4-week high-dose (600 mg tid) administration of ALA, subsequent treatment with ALA (600 mg qd) over 16 weeks improved neuropathic symptoms, whereas ALA withdrawal was associated with a higher use of rescue analgesic drugs. This trial is registered with ClinicalTrials.gov Identifier:NCT02439879.

scholarly journals Does High-Dose Metformin Cause Lactic Acidosis in Type 2 Diabetic Patients after CABG Surgery? A Double Blind Randomized Clinical Trial

2011 ◽  
Vol 6 (1) ◽  
pp. hi.2011.e8 ◽  
Author(s):  
Afshin Gholipour Baradari ◽  
Mohammad Reza Habibi ◽  
Hadi Darvishi Khezri ◽  
Mohsen Aarabi ◽  
Mohammad Khademloo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lactic Acidosis ◽  
Randomized Clinical Trial ◽  
Diabetic Patients ◽  
High Dose ◽  
Type 2 Diabetic Patients ◽  
Double Blind ◽  
Cabg Surgery ◽  
Type 2 Diabetic

scholarly journals Preventing microalbuminuria with benazepril, valsartan, and benazepril–valsartan combination therapy in diabetic patients with high-normal albuminuria: A prospective, randomized, open-label, blinded endpoint (PROBE) study

PLoS Medicine ◽  
2021 ◽  
Vol 18 (7) ◽  
pp. e1003691
Author(s):  
Piero Ruggenenti ◽  
Monica Cortinovis ◽  
Aneliya Parvanova ◽  
Matias Trillini ◽  
Ilian P. Iliev ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Angiotensin Receptor Blockers ◽  
Combined Therapy ◽  
Accelerated Failure Time Model ◽  
Diabetic Patients ◽  
Open Label ◽  
Type 2 Diabetic Patients ◽  
Link Type ◽  
Type 2 Diabetic

Background Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) prevent microalbuminuria in normoalbuminuric type 2 diabetic patients. We assessed whether combined therapy with the 2 medications may prevent microalbuminuria better than ACE inhibitor or ARB monotherapy. Methods and findings VARIETY was a prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether, at similar blood pressure (BP) control, combined therapy with benazepril (10 mg/day) and valsartan (160 mg/day) would prevent microalbuminuria more effectively than benazepril (20 mg/day) or valsartan (320 mg/day) monotherapy in 612 type 2 diabetic patients with high-normal albuminuria included between July 2007 and April 2013 by the Istituto di Ricerche Farmacologiche Mario Negri IRCCS and 8 diabetology or nephrology units in Italy. Time to progression to microalbuminuria was the primary outcome. Analyses were intention to treat. Baseline characteristics were similar among groups. During a median [interquartile range, IQR] follow-up of 66 [42 to 83] months, 53 patients (27.0%) on combination therapy, 57 (28.1%) on benazepril, and 64 (31.8%) on valsartan reached microalbuminuria. Using an accelerated failure time model, the estimated acceleration factors were 1.410 (95% CI: 0.806 to 2.467, P = 0.229) for benazepril compared to combination therapy, 0.799 (95% CI: 0.422 to 1.514, P = 0.492) for benazepril compared to valsartan, and 1.665 (95% CI: 1.007 to 2.746, P = 0.047) for valsartan compared to combination therapy. Between-group differences in estimated acceleration factors were nonsignificant after adjustment for predefined confounders. BP control was similar across groups. All treatments were safe and tolerated well, with a slight excess of hyperkalemia and hypotension in the combination therapy group. The main study limitation was the lower than expected albuminuria at inclusion. Conclusions Risk/benefit profile of study treatments was similar. Dual renin–angiotensin system (RAS) blockade is not recommended as compared to benazepril or valsartan monotherapy for prevention of microalbuminuria in normoalbuminuric type 2 diabetic patients. Trial registration EudraCT 2006-005954-62; ClinicalTrials.gov NCT00503152.

scholarly journals Long-term vitamin D and high-dose n-3 fatty acids’ supplementation improve markers of cardiometabolic risk in type 2 diabetic patients with CHD — CORRIGENDUM

2019 ◽  
Vol 122 (6) ◽  
pp. 719-719
Author(s):  
Hamid Reza Talari ◽  
Vahid Najafi ◽  
Fariba Raygan ◽  
Naghmeh Mirhosseini ◽  
Vahidreza Ostadmohammadi ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Vitamin D ◽  
Cardiometabolic Risk ◽  
Diabetic Patients ◽  
High Dose ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic
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