Patients’ experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data

Abstract

Objective

Describe and characterize treatment patterns, satisfaction, improvement in pain and functional impairment (health-related quality of life [HRQoL]) in users of over the counter (OTC) Voltaren gel diclofenac (VGD) 2.32% and 1.16% in a real-world setting.

Methods

This observational real-world German study had prospective and retrospective components. The prospective data were collected from electronic surveys completed by adults who purchased VGD to treat their musculoskeletal pain at baseline and 4 and 12 weeks after baseline. Retrospective data were from a 12-month (March 2019 to February 2020) abstraction from dispensing software platforms used in select German pharmacies.

Results

Surveys from 467 participants (mean age 60.8 years) were analyzed. Average pain severity at baseline was 6.0 on an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain), improving by 0.8 and 1.2 points at Weeks 4 and 12, respectively. Performance of functional activities (daily/physical/social activities and errands/chores) improved and the proportion of participants with at least moderate interference decreased at both follow-up timepoints. Retrospective analyses indicated that majority of patients receiving VGD (n = 95,085) were ≥65 years old (67.9%), had one dispensed tube (70.8%) and did not switch to another topical treatment (including other NSAIDs) (77.3%), and were co-prescribed at least one cardiovascular medication (74.3%).

Conclusions

This study provides the first real-world insights into OTC VGD use in Germany. The participants using VGD reported a decrease in pain severity and an improvement of HRQoL while under treatment, as well as resulting satisfaction with treatment. Patients infrequently switched to alternate topical therapies/NSAIDs.

Keywords:

• Real-world
• Germany
• topical diclofenac
• NSAIDs
• pain relief
• patient survey
• health-related quality of life

Transparency

 

Declaration of funding

The study and medical writing were funded by Haleon (formerly GSK Consumer Healthcare).

Declaration of financial/other relationships

Christian Maihöfner has received honorarium payments for advising on study methodology. Anke de Haas, Vidhu Sethi, Gilbert Shanga and Kate Fabrikant are employees of Haleon (formerly GSK Consumer Healthcare). Teresa Wilcox was an employ of PPD, Part for Thermo Fisher Scientific, during the conduct of the study. Emese Csoke was an employee of GSK Consumer Healthcare during conduct of the study. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

CM, KF, VS, GS, and EC contributed to the conception and design of the study and interpretation of data; drafting the article or revising it critically for important intellectual content; and final approval of the version to be submitted. AdH contributed to the interpretation of data; drafting the article or revising it critically for important intellectual content; and final approval of the version to be submitted. TKW contributed to the conception and design of the study, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, final approval of the version to be submitted.

Acknowledgements

The authors thank the following Haleon contributors: Anela Lihic Haveric and Denise Pohlhaus for contributing to study design, Roberto Bazzanella and Simon Arnold for helping in to define the research area, Daniela Deutsch for contributing to the interpretation of data, Vishal Rampartaap as project lead, and Farzana Sufi for editorial inputs; Laura Sayegh and Mary Kay Margolis (PPD, part of Thermo Fisher Scientific) for medical writing, editorial assistance, and their contributions to the design, analysis, and interpretation of the data; Chester Wong, Adrian Jackson and Maria Olimpia Perulan-Escanilla (Clarivate Plc, formerly Patient Connect Limited) for performing data analysis of the secondary database, consumer enrollment and their contributions for hosting the consumer survey; Erica Zaiser (Evidera, part of Thermo Fisher Scientific) for cognitive interviews.