| Title |
Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, double-blind, noninferiority comparative study with pregabalin
|
|---|---|
| Published in |
Journal of Pain Research, September 2018
|
| DOI | 10.2147/jpr.s170646 |
| Pubmed ID | |
| Authors |
Hiroyuki Enomoto, Hitoshi Yasuda, Atsushi Nishiyori, Shinji Fujikoshi, Masashi Furukawa, Mitsuhiro Ishida, Masashi Takahashi, Toshinaga Tsuji, Aki Yoshikawa, Levent Alev |
| Abstract |
Duloxetine and pregabalin are recommended as first-line treatments for diabetic peripheral neuropathic pain (DPNP). However, studies have not reported a direct comparison between duloxetine and pregabalin. We conducted a postmarketing, randomized, double-blind study to assess the noninferiority of duloxetine compared with pregabalin after 12 weeks of treatment in adult patients with DPNP in Japan (NCT02417935). Patients (N = 303) with distal symmetrical DPNP were randomized to and were administered duloxetine (40-60 mg/day) or pregabalin (300-600 mg/day). The primary endpoint was the change from baseline in weekly mean of the 24-hour average pain score (numeric rating scale [NRS]). Noninferiority of duloxetine compared with pregabalin was assessed with the primary endpoint at week 12. Secondary measures, including night pain and worst pain, Brief Pain Inventory-Severity and Interference rating short form (BPI-SF), Clinical Global Impression of Improvement (CGI-I), Patient Global Impression of Improvement (PGI-I), and Neuropathic Pain Symptom Inventory (NPSI), health outcome measures (EuroQol 5-Dimension index and VAS), and safety were also assessed. For the 24-hour NRS average pain score, the difference between the duloxetine and pregabalin groups was 0.072 (95% CI: - 0.295, 0.439), and the upper bound of the 95% CI (0.439) did not exceed the predefined noninferiority margin (0.51), at the end of the study period. For secondary outcome measures (night pain, worst pain, BPI-SF, CGI-I, PGI-I, NPSI) and health outcome measures, both the duloxetine and pregabalin treatment groups showed an improvement from baseline with no significant between-group difference. Duloxetine and pregabalin were well tolerated and the safety profiles were consistent with previously reported results. This study demonstrated the noninferior efficacy of duloxetine compared with pregabalin in the treatment of adult patients with DPNP. The safety analyses showed an acceptable tolerability based on safety profiles of duloxetine and pregabalin. |
Mendeley readers
The data shown below were compiled from readership statistics for 45 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 45 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 6 | 13% |
| Researcher | 6 | 13% |
| Student > Master | 4 | 9% |
| Student > Ph. D. Student | 3 | 7% |
| Student > Bachelor | 3 | 7% |
| Other | 9 | 20% |
| Unknown | 14 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 13 | 29% |
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 11% |
| Engineering | 4 | 9% |
| Computer Science | 1 | 2% |
| Chemical Engineering | 1 | 2% |
| Other | 2 | 4% |
| Unknown | 19 | 42% |
Attention Score in Context
This research output has an Altmetric Attention Score of 4. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 21 June 2019.
All research outputs
#7,327,980
of 23,103,436 outputs
Outputs from Journal of Pain Research
#733
of 1,773 outputs
Outputs of similar age
#127,719
of 335,776 outputs
Outputs of similar age from Journal of Pain Research
#34
of 79 outputs
Altmetric has tracked 23,103,436 research outputs across all sources so far. This one has received more attention than most of these and is in the 67th percentile.
So far Altmetric has tracked 1,773 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 14.0. This one has gotten more attention than average, scoring higher than 57% of its peers.
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We're also able to compare this research output to 79 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 56% of its contemporaries.