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INTRODUCTION: Our trial (ClinicalTrials.gov Identifier: NCT04246619) evaluates the efficacy of two generic medications, pregabalin and duloxetine, for treating pain in PDPN patients. METHODS: The patients were randomised either into the pregabalin (99) or the duloxetine (102) arm. Pain was evaluated using the DN-4 questionnaire, and visual analogue scales (VASs, 0-100 mm) were used to measure the average pain intensity (API), worst pain intensity (WPI) in the last 24 h and current pain intensity (CPI). RESULTS: The proportion of patients with a clinically significant improvement in the API at Week 12 was 88.3% [CI 81.7%, 94.8%] in the pregabalin arm and 86.9% [CI 76.7%, 97.1%] in the duloxetine arm. After 12 weeks, the CPI, API, and WPI decreased by -35.3 [-40.5, -30.0], -37.0 [-41.4, -32.6], and -41.6 [-46.6, -36.5] in the pregabalin arm, and by -35.0 [-39.2, -30.7], -36.9 [-41.5, -32.3], and -40.0 [-44.8, -35.2] in the duloxetine arm (all in mm, all p < 0.001). CONCLUSION: Our results demonstrate that pregabalin and duloxetine are effective medications for treating pain in PDPN in more than 86% of all randomised patients.
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AIMS: To compare the effectiveness of different titration algorithms for insulin glargine U100 used in everyday practice to achieve glycaemic targets in patients with type 2 diabetes mellitus (T2DM). METHODS: A total of 526 patients (278 in Slovenia, 248 in Croatia) with T2DM (agedâ¯≥â¯18â¯years) and treated with insulin glargine prior to inclusion were enrolled. Patients self-titrated insulin glargine according to physicians' guidance. RESULTS: Among the 524 patients included in the final analysis, the titration algorithm from the LANMET study was used most commonly (nâ¯=â¯368, 70.5% patients), followed by the Treat-To-Target (TTT) algorithm (nâ¯=â¯117, 22.4%). At the end of the study (6â¯months), 179 (34.3%) patients reached HbA1câ¯≤â¯7%. There was no significant difference in the proportion of patients who reached their target HbA1c between the different algorithms at 6â¯months (35.6% using LANMET, 30.7% with TTT, and 32.4% with other algorithms; pâ¯=â¯0.611). HbA1c levels were more significantly reduced in patients using the TTT algorithm compared to LANMET (-2.31%, vs. -1.57%; pâ¯<â¯0.05). The proportion of patients with reported symptomatic hypoglycaemia did not differ significantly between the algorithms. CONCLUSIONS: Continuous titration of insulin glargine U100 is a safe and efficient option for T2DM management, regardless of the titration algorithm applied.
