Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study
Abstract Introduction The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerabilit...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-06-01
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| Series: | Pain and Therapy |
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| Online Access: | https://doi.org/10.1007/s40122-023-00531-z |
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| author | Carlo L. M. Trevisan Andrea Carraro Gemma L. A. Baldari the Study 18I-Fsg08 Investigators |
| author_facet | Carlo L. M. Trevisan Andrea Carraro Gemma L. A. Baldari the Study 18I-Fsg08 Investigators |
| author_sort | Carlo L. M. Trevisan |
| collection | DOAJ |
| description | Abstract Introduction The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain. Methods A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner’s clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator’s satisfaction with the treatment was also assessed. Subjects initially took 1–2 capsules of the study treatment and then one or two soft capsules every 4–6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period. Results A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated. Conclusions The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects’ overall satisfaction with treatment more than 90%. Trial registration EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018. |
| first_indexed | 2024-03-12T13:13:26Z |
| format | Article |
| id | doaj.art-6a8a0a67bc2143abac633025acee7111 |
| institution | Directory Open Access Journal |
| issn | 2193-8237 2193-651X |
| language | English |
| last_indexed | 2024-03-12T13:13:26Z |
| publishDate | 2023-06-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Pain and Therapy |
| spelling | doaj.art-6a8a0a67bc2143abac633025acee71112023-08-27T11:08:30ZengAdis, Springer HealthcarePain and Therapy2193-82372193-651X2023-06-011251149116310.1007/s40122-023-00531-zTreatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional StudyCarlo L. M. Trevisan0Andrea Carraro1Gemma L. A. Baldari2the Study 18I-Fsg08 InvestigatorsOrthopedic Department, Ospedale Bolognini Seriate ASST Bergamo EstAzienda Sociosanitaria Ligure n. 3 (ASL3)Azienda Sociosanitaria Ligure n. 3 (ASL3)Abstract Introduction The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain. Methods A prospective, open-label, phase IV clinical study in adult outpatients at hospital clinic departments/general practitioner’s clinics at eight sites in Italy. The primary efficacy variable was the degree of satisfaction with treatment at 72 ± 7 h after initiation of treatment, assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS) and described by classic descriptive statistics. Secondary objectives were to evaluate the analgesic effect after the first administration and over time; the time to and satisfaction with the onset of pain relief, amount of and duration of pain relief; pain intensity differences over time; and safety and tolerability. The investigator’s satisfaction with the treatment was also assessed. Subjects initially took 1–2 capsules of the study treatment and then one or two soft capsules every 4–6 h according to their needs. Not more than six soft capsules were to be taken in any 24-h period. Results A total of 182 subjects (mean age, 56.2 years; 54.4% female) took ≥ 1 dose of DHEP capsule and were included in the full analysis set. The most common musculoskeletal conditions were arthralgia (39.0%) and low back pain (23.1%). All subjects completed the study, and 165/182 (90.7%, 95% CI 0.86, 0.95) were satisfied or very satisfied with the treatment at 72 ± 7 h after the first dose (primary efficacy variable). Similar percentages were recorded for treatment satisfaction concerning other efficacy parameters. The onset of the analgesic effect was rapid, with complete pain relief reached after a mean of 49.45 min. Investigators rated their overall treatment satisfaction as 92.9%. Treatment was well tolerated. Conclusions The low-dose (12.5 or 25 mg) oral diclofenac epolamine soft capsules formulation exerted rapid, effective, and safe analgesic activity in patients with mild-to-moderate musculoskeletal pain, with subjects’ overall satisfaction with treatment more than 90%. Trial registration EudraCT Number: 2018-004886-15 (Study 18I-Fsg08). Registered 04/09/2018.https://doi.org/10.1007/s40122-023-00531-zDiclofenac epolamineMusculoskeletal painOpen-labelPatient-reported outcome measuresPhase IVSoft capsules |
| spellingShingle | Carlo L. M. Trevisan Andrea Carraro Gemma L. A. Baldari the Study 18I-Fsg08 Investigators Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study Pain and Therapy Diclofenac epolamine Musculoskeletal pain Open-label Patient-reported outcome measures Phase IV Soft capsules |
| title | Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study |
| title_full | Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study |
| title_fullStr | Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study |
| title_full_unstemmed | Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study |
| title_short | Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study |
| title_sort | treatment satisfaction efficacy and tolerability of low dose diclofenac epolamine soft capsules in acute mild or moderate musculoskeletal pain a prospective open label single arm interventional study |
| topic | Diclofenac epolamine Musculoskeletal pain Open-label Patient-reported outcome measures Phase IV Soft capsules |
| url | https://doi.org/10.1007/s40122-023-00531-z |
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