Startseite Medizin Real-world evidence evaluation on consumer experience and prescription journey of diclofenac gel in Sweden
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Real-world evidence evaluation on consumer experience and prescription journey of diclofenac gel in Sweden

  • Deepika Nair EMAIL logo , Jan-Rickard Norrefalk , Emese Csoke , Teresa K. Wilcox und Gilbert Shanga
Veröffentlicht/Copyright: 20. August 2024
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Scandinavian Journal of Pain
Aus der Zeitschrift Scandinavian Journal of Pain Band 24 Heft 1

Abstract

Objectives

The aim of this study was to understand profiles of topical Voltaren gel diclofenac (VGD) 2.32 and 1.16% consumers through analyzing prescription patterns and to characterize treatment satisfaction, functional impairment, and pain relief after over-the-counter (OTC) VGD use in Sweden under real-world conditions.

Methods

This observational, real-world study conducted in Sweden had retrospective and prospective segments. The retrospective secondary data segment utilized 12-month diclofenac gel prescription data from the Swedish eHealth Agency (E-hälsomyndigheten). The prospective segment included electronic surveys completed at baseline and weeks 4 and 12 by adult consumers who purchased OTC VGD to treat their pain.

Results

Secondary data analyses (n = 12,145) showed that 56.7% of patients receiving diclofenac gel were females ≥70 years old. Most patients did not switch pain treatments; the mean time between diclofenac gel refills was about 2.5 months. From the surveys (n = 264), VGD provided pain relief, indicated by improvement in 11-point pain numeric rating scale scores. Average pain severity at baseline was 5.8 – improving by a mean of 1.3 and 1.9 points at weeks 4 and 12, respectively. The majority of consumers reported improvement in daily functioning (i.e., health-related quality of life [HRQoL]), and most were at least somewhat satisfied with VGD treatment results.

Conclusions

This real-world study provides important insights into the prescription patterns of diclofenac gel and the consumer experience with OTC VGD in Sweden. Patients rarely switched to other topical nonsteroidal anti-inflammatory drugs, and VGD consumers reported pain relief and improved HRQoL compared to baseline – resulting in treatment satisfaction.

Keywords: real-world evidence; topical diclofenac; NSAIDs; pain management; patient survey; patient satisfaction

1 Introduction

Musculoskeletal pain – which affects bones, muscles, ligaments, tendons, and nerves – is a common complaint by people of all ages [1]. Prevalence estimates vary widely according to definition and methodology, but an estimated one in five adults in Europe experiences long-standing non-malignant pain [2,3,4,5,6]. Musculoskeletal pain is frequently associated with reduced function, activity, and health-related quality of life (HRQoL) [7], and it constitutes a public health concern that predominantly affects working-aged and older people [8,9]. Thus, the prevalence is expected to increase as the population ages and as older adults live increasingly active lives – with expectations of having a functional lifestyle and robust quality of life [9]. Adequate management of musculoskeletal pain is essential to achieve these expectations, and it is an important healthcare goal.

Topically administered nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as oral drugs in treating pain amenable to topical treatment [10,11] but without some of the oral drug-associated systemic (e.g., gastrointestinal [GI] and cardiovascular [CV complications] [12,13]). Although topical analgesics are frequently used and generally available over the counter (OTC), little is known about their real-world use or the characteristics of their consumers. Consequently, this observational study was conducted in Sweden to better understand the real-world use of topical Voltaren gel diclofenac (VGD) – one of the most widely used topical NSAIDs [14]. Topical VGD (Haleon) is available OTC under the brand names Voltaren 11.6 mg/g gel (1.16%) and Voltaren 23.2 mg/g gel (2.23%) and by prescription for musculoskeletal pain treatment in Sweden [15]. Two data sources were used for this study: prescription information on topical diclofenac gel collected by the Swedish eHealth Agency (E-hälsomyndigheten) and surveys completed by consumers who purchased OTC VGD.

By analyzing topical diclofenac gel drug prescription data and survey responses from OTC VGD consumers, we produced novel insights and a deeper understanding of usage patterns and consumers’ experiences under real-world conditions.

2 Methods

The study population included adults ≥18 years old and comprised two segments: (1) secondary data analysis of sales of prescribed topical diclofenac gel (all brands) in Sweden and (2) a prospective survey of Swedish consumers of OTC VGD. “Patient” terminology is used for the retrospective segment, and “consumers” is used for the prospective segment. This study was conducted under the same protocols as Maihöfner et al., and followed similar design methods [16].

2.1 Secondary analysis of prescription diclofenac gel

The Swedish eHealth Agency collects data on prescriptions filled at all Swedish pharmacies, with a national e-Prescription repository that provides comprehensive population data. Drug prescriptions were identified based on the level-7 anatomical therapeutic chemical classification between March 1, 2019, and February 29, 2020. Age data were grouped in 5-year intervals and stratified by sex.

This analysis primarily aimed to evaluate diclofenac gel prescription patterns. Secondary analysis objectives included describing the frequency of prescriptions for medications of interest dispensed concurrently with diclofenac gel. Treatment switches were defined as a change to a different topical treatment. Gap between refills was evaluated for patients with two or more prescriptions and was calculated by subtracting the estimated supply duration from the number of days between refills. Analyses were limited to patients collecting their first prescription within 3 and 6 months. The decision to treat their condition with VGD, and usage according to the product label, was at the consumer’s discretion.

2.2 Consumer survey of pain severity, pain-related functional impairment, and satisfaction with VGD treatment

The survey aimed to characterize consumer satisfaction with treatment, functional impairment, and pain severity at baseline (within 5 days of purchase), at 4 weeks (primary outcome) and 12 weeks (secondary outcome) after VGD purchase.

Consumers were identified through online pharmacies and sent a study leaflet in their purchase package. The leaflet contained a QR code and URL to access the study website. Each participant could complete the study surveys only once.

The baseline survey included 16 questions covering demographics, treated condition, comorbidities, strength of VGD, other pain treatments (i.e., previous NSAIDs use, other treatments), and patient-reported outcomes (PROs). The PROs included pain severity, pain continuity, and pain-related functional impairment in the previous week on social activities, physical activities, daily activities, and ability to perform errands/chores. The week 4/week 12 follow-up survey included 11 questions, the PROs from the baseline survey, plus items on satisfaction with treatment results and improvement of functional impairment.

Pain was evaluated using a numeric rating scale (NRS), with anchors of 0 (no pain) and 10 (worst possible pain) [17]. Pain on the NRS was classified as mild (1–3), moderate (4–6), or severe (7–10) [18,19,20]. The HRQoL impairment items (were adapted from the brief pain inventory [21] and pain disability index [22]. Functional impairment, functional improvement, and satisfaction with treatment results were assessed using Likert-type questions (Table 1).

Table 1

Pain-related functional impairment and select satisfaction follow-up survey items

Concept Timepoint Question Likert scale response options
Degree of pain interference (functional impairment) in the past seven days Baseline • During the past 7 days, how much did pain interfere with your daily activities? (This includes activities like eating, dressing, activities related to personal hygiene, and sleep) Not at all
Week 4 • During the past 7 days, how much did pain interfere with your ability to perform errands and chores around and outside your home? (This includes activities like preparing meals, gardening, driving, and cleaning) Somewhat
Week 12 • During the past 7 days, how much did pain interfere with physical activities? (This includes activities like going to the gym, running, jogging, and swimming) Moderately
• During the past 7 days, how much did pain interfere with your social activities? (This includes activities like parties, going to the theater, concerts, dining out, and activities with family and friends) Quite a bit
Extremely
Degree of functional improvement compared to baseline Week 4 • Mark the one response that best describes your ability to participate in your daily activities now, compared with how it was before using Voltaren gel (this includes activities like eating, dressing, activities related to personal hygiene, and sleep). Very much better
• Mark the one response that best describes your ability to perform errands and chores around and outside your home now, compared with how it was before using Voltaren gel (this includes activities like preparing meals, gardening, driving, and cleaning). Much better
Week 12 • Mark the one response that best describes your ability to participate in physical activities now, compared with how it was before using Voltaren gel (this includes activities like going to the gym, running, jogging, and swimming). A little better
• Mark the one response that best describes your ability to participate in your social activities now, compared with how it was before using Voltaren gel (this includes things like parties, going to the theater, concerts, dining out, and activities with family and friends). No change
Much worse
Very much worse
Satisfaction with treatment results Week 4 • How satisfied are you with the result you experienced with the Voltaren gel you bought 4 weeks/12 weeks ago? Extremely satisfied
Somewhat satisfied
Neither satisfied nor dissatisfied
Week 12 Somewhat dissatisfied
Extremely dissatisfied

This represents the exact wording of the survey questions; however, VGD is used in the main text for Voltaren gel.

2.3 Statistical methods

Secondary data analysis was conducted with Python-SQL; the consumer survey analyses were conducted with SAS v.9.4 (SAS Institute, Cary, NC, USA). All analyses were descriptive. Subgroup analyses, including by age (≥65 vs <65 years old), were performed. No imputation was performed for missing data.

3 Results

3.1 Secondary data analysis of prescription topical diclofenac gel

A total of 15,652 records (14,569 patients) were received from the Swedish eHealth Agency. Incomplete records from patients <18 years old, or without prescription activity within 12 months were excluded; the final analysis population included 12,145 adults who had at least one prescription of any topical diclofenac gel during the study period (Figure 1). Nearly three-quarters of the patients (73.9%) were female; the mean age was 73.2 (standard deviation [SD] 17.1 years), and 67.3% were >65 years old. Over half of the patients (56.7%) were females ≥70 years old. In all 5-year interval age groups ≥25 years old, more females were prescribed topical diclofenac gel (Figure S1, Supplementary Material).

Figure 1 Patient selection flowchart from the Swedish eHealth Agency Database.
Figure 1

Patient selection flowchart from the Swedish eHealth Agency Database.

A total of 9,655 patients (79.5%) had one topical diclofenac gel prescription, 12.3% had two prescriptions, and 8.1% had more than two prescriptions. Among patients with at least two prescriptions, the mean interval between refills was 76.9 days for those who filled their prescription within 3 months and 69.1 days if their prescription was filled within 6 months. Two-thirds of patients had a gap of <3 months between prescriptions (Figure 2).

Figure 2 Proportion of patients by gap duration between diclofenac gel prescription fills.
Figure 2

Proportion of patients by gap duration between diclofenac gel prescription fills.

More than 95% of patients did not switch from topical diclofenac gel to a different topical treatment.

During the study period, 49.0% of patients who were prescribed diclofenac gel also filled a prescription for CV disease, and 30.0% filled a prescription for a GI condition; 19.3% filled prescriptions for both CV and GI conditions. Few patients (9.1%) also filled prescriptions for oral NSAIDs within 7 days.

3.2 Consumer survey of pain severity, functional impairment, and satisfaction with treatment

Overall, 279 consumers consented to participate in the survey, 264 (94.6%) of which completed the baseline survey. Week 4 and week 12 follow-up surveys were completed by 255 (91.4%) and 253 (90.7%) consumers, respectively (Figure S2, Supplementary Material).

3.2.1 Baseline characteristics

Among the 264 baseline survey completers, 55.3% were women; the mean age was 53.4 (SD 16.1), and 28.8% were ≥65 years old. Further, 31.4% reported CV disease, and 6.1% reported a GI condition.

3.2.2 Baseline pain prevalence and severity

The majority of OTC VGD consumers (99.6%) experienced acute physical pain within the week prior to baseline survey. Treatment of local muscle and joint injuries was the most reported reason for VGD purchase (68.6%) (Table 1). The mean (SD) worst pain NRS score within a week from baseline was 5.8 (2.0) – indicating moderate pain. Severe pain in the previous week was reported by 38.7% of consumers.

3.2.3 Baseline pain management

Nearly all consumers (94.7%) purchased VGD 2.32% strength, and 61.7% used VGD in the previous year. The most common reason for re-purchase was the perceived efficacy of VGD (74.2%). Less than half (43.9%) purchased a different pain treatment product within the month before study participation (paracetamol 41.4%; ibuprofen 26.7%; naproxen 7.8%; and other topical diclofenac 7.8%).

3.2.4 Pain relief at weeks 4 and 12

Consumers reported pain relief across the 12 weeks, with mean (SD) NRS score changes from the baseline of −1.3 (2.1) at week 4 and −1.9 (2.5) at week 12. The proportions of consumers with no pain and mild-to-severe pain at each survey timepoint are presented in Figure 3a. The proportion of consumers with severe pain at baseline (38.7%) was halved by week 12 (18.1%). Among consumers with pain at baseline, half moved to a better pain category by week 12. Figure 3b shows the proportions of consumers reporting a change to a better pain category.

Figure 3 NRS pain scores. (a) NRS pain severity was reported by consumers at baseline, week 4, and week 12. (b) Consumers who changed to a better pain category after baseline.
Figure 3

NRS pain scores. (a) NRS pain severity was reported by consumers at baseline, week 4, and week 12. (b) Consumers who changed to a better pain category after baseline.

3.2.5 Baseline functional impairment

Consumers stated that pain limited their activities “quite a bit” across the HRQoL parameters of social activities, physical and daily activities, and ability to perform errands/chores. An impact on social activities was reported by 20.1% of the consumers, compared to that on physical activities (51.9%), daily activities (41.7%), and errands/chores (32.6%).

3.2.6 Improvement in functional impairment at weeks 4 and 12

The proportion of consumers reporting “quite a bit” of pain interference with daily activities decreased, from 41.7% at baseline to 25.6% at week 4 and 18.1% at week 12. This improvement in pain interference was also noted regarding errands/chores (32.6% at baseline to 20.9% at week 4 and 14.5% at week 12), physical activities (51.9% at baseline to 35.8% at week 4 and 22.2% at week 12), and social activities (20.1% at baseline to 10.6% at week 4 and 7.7% at week 12). Most consumers reported improvement in their ability to participate in all four functional activity domains at weeks 4 and 12 compared to baseline (Figure 4). Consumers who reported “quite a bit” of interference at baseline also reported improved participation in daily activities, physical activities, errands/chores, and social activities at week 4 (91.6, 82.2, 91.7, and 78.8%, respectively) and week 12 (87.4, 84.0, 93.9, and 74.5%, respectively).

Figure 4 Improvement in functional impairment at week 4 and week 12.
Figure 4

Improvement in functional impairment at week 4 and week 12.

3.2.7 Treatment satisfaction at weeks 4 and 12

At week 4, 78.3% of consumers were “somewhat” or “extremely” satisfied with VGD treatment results, increasing to 87.1% at week 12. “Ease of use” (72.9 and 82.4% at weeks 4 and 12, respectively), “ability to carry on with daily activities” (67.3 and 67.6%, respectively), “no need of assistance/being in control” (52.7 and 73.6%, respectively), and “no need for a doctor appointment” (38.7 and 50.9%, respectively) contributed to this satisfaction. Social independence (e.g., do not need to ask for help) was reported by 89.4% at week 4 and 91.2% at week 12.

Among consumers who reported “quite a bit” of functional impairment on daily activities, errands and chores, physical activities, or social activities at baseline, 81.3, 83.3, 79.3, and 86.5%, respectively, were somewhat or extremely satisfied with VGD at week 4, and 89.5, 90.2, 87.8, and 90.2%, respectively, at week 12.

3.2.8 Use of VGD among older adults

Among the 76 consumers of at least 65 years old who completed the baseline survey, 73.7% were repeat purchasers of VGD, which was higher than the rate for the full study sample. Over half (59.2%) were informed by their physician that they had underlying CV disease, and 6.6% reported underlying GI disorders. Survey results stratified by consumer age are presented in Table 2.

Table 2

VGD consumer survey results by age cohort

Study population
Overall consumers, N = 2641 Consumers 18–64 years old, N = 188 Consumers ≥65 years old, N = 76
Total in study sample, n (%)1 264 (100) 188 (71.2) 76 (28.8)
Comorbidities reported
 CV disease, n (%)2 83 (31.4) 38 (20.2) 45 (59.2)
 GI disorders, n (%)3 16 (6.1) 11 (5.9) 5 (6.6)
Purchased VGD
 2.32% strength, n (%) 250 (94.7) 176 (93.6) 74 (97.4)
 1.16% strength, n (%) 14 (5.3) 12 (6.4) 2 (2.6)
Repeat VGD consumers, n (%) 163 (61.7) 107 (56.9) 56 (73.7)
Purchased VGD to
 Treat local pain of mild to moderate intensity associated with muscle/joint injuries (e.g., sports injuries), n (%) 181 (68.6) 138 (73.4) 43 (56.6)
 Treatment of other types of pain, n (%) 83 (31.4) 50 (26.6) 33 (43.4)
  Treatment of other body pains (not specific to arthritis), n (%) 49 (18.6) 27 (14.4) 22 (28.9)
  Treatment of muscle pain in the back, n (%) 19 (7.2) 14 (7.4) 5 (6.6)
  Other pain, arthritis (not knee or finger joints), n (%) 6 (2.3) 3 (1.6) 3 (3.9)
  Other, inflammation (not specific to arthritis), n (%) 5 (1.9) 3 (1.6) 2 (2.6)
  Other pain, osteoarthritis of the knee and finger joints, n (%) 3 (1.1) 2 (1.1) 1 (1.3)
  Response not interpretable, n (%) 1 (0.4) 1 (0.5) 0
Used other pain treatment products besides VGD in four weeks prior to baseline, n (%) 116 (43.9) 76 (40.4) 40 (52.6)
Described pain as
 Persistent, n (%) 84 (31.8) 50 (26.6) 34 (44.7)
 Transient, n (%) 151 (57.2) 115 (61.2) 36 (47.4)
 Inconsistent, n (%) 29 (11.0) 23 (12.2) 6 (7.9)
Worst pain (on the NRS) in the seven days prior to
 Baseline, mean (SD) 5.8 (2.0) 5.8 (2.0) 5.8 (2.0)
 Week 4, mean (SD) 4.5 (2.2) 4.3 (2.2) 4.9 (2.0)
 Week 12, mean (SD) 3.8 (2.5) 3.7 (2.5) 4.2 (2.4)
Improvement in pain score ≥1 at
 Week 4, n (%) 153 (58.0) 111 (61.7) 42 (56.8)
 Week 12, n (%) 169 (64.0) 124 (70.9) 45 (61.6)
Consumers selecting mild to moderate pain on the NRS at
 Baseline, n (%) 161 (61.0) 115 (61.2) 46 (60.5)
 Week 4, n (%) 195 (73.9) 139 (77.2) 56 (75.7)
 Week 12, n (%) 184 (69.7) 130 (74.3) 54 (74.0)
Consumers reporting at least “Quite a bit” of pain interference with daily activities at
 Baseline, n (%) 110 (41.7) 80 (42.6) 30 (39.5)
 Week 4, n (%) 65 (24.2) 40 (22.2) 25 (33.8)
 Week 12, n (%) 45 (17.0) 32 (18.3) 13 (17.8)
Consumers reporting at least “Quite a bit” of pain interference with errands and chores at
 Baseline, n (%) 86 (32.6) 65 (34.6) 21 (27.6)
 Week 4, n (%) 53 (20.0) 31 (17.2) 22 (29.7)
 Week 12, n (%) 36 (13.6) 26 (14.9) 10 (13.7)
Consumers reporting at least “Quite a bit” of pain interference with physical activities
 Baseline, n (%) 137 (51.9) 100 (53.2) 37 (48.7)
 Week 4, n (%) 91 (34.5) 60 (33.3) 31 (41.9)
 Week 12, n (%) 55 (20.8) 35 (20.0) 20 (27.4)
Consumers reporting at least “quite a bit” of pain interference with social activities at
 Baseline, n (%) 53 (20.0) 37 (19.7) 16 (21.1)
 Week 4, n (%) 27 (10.2) 20 (11.1) 7 (9.5)
 Week 12, n (%) 19 (7.2) 10 (5.7) 9 (12.3)
Improvement from baseline in the ability to participate in daily activities at
 Week 4 (N = 254 for overall; 180 for 18–64 years old; 74 for ≥65 years old), n (%) 222 (87.4) 153 (85.0) 69 (93.2)
 Week 12 (N = 248 for overall; 175 for 18–64 years old; 73 for ≥65 years old), n (%) 220 (88.7) 157 (89.7) 63 (86.3)
Improvement from baseline in the ability to perform errands and chores at
 Week 4 (N = 254 for overall; 180 for 18–64 years old; 74 for ≥65 years old), n (%) 200 (78.7) 138 (76.7) 62 (83.8)
 Week 12 (N = 248 for overall; 175 for 18–64 years; 73 for ≥65 years old), n (%) 213 (85.9) 151 (86.3) 62 (84.9)
Improvement from baseline in the ability to participate in physical activities at
 Week 4 (N = 254 for overall; 180 for 18–64 years old; 74 for ≥65 years old), n (%) 202 (79.5) 141 (78.3) 61 (82.4)
 Week 12 (N = 248 for overall; 175 for 18–64 years old; 73 for ≥65 years old), n (%) 207 (83.5) 148 (84.6) 59 (80.8)
Improvement from baseline in the ability to participate in social activities at
 Week 4 (N = 254 for overall; 180 for 18–64 years old; 74 for ≥65 years), n (%) 149 (58.7) 102 (56.7) 47 (63.5)
 Week 12 (N = 248 for overall; 175 for 18–64 years; 73 for ≥65 years old), n (%) 171 (69.0) 124 (70.9) 47 (64.4)

Abbreviations: CV, cardiovascular; GI, gastrointestinal; NRS, numeric rating scale; SD, standard deviation; VGD, Voltaren (diclofenac) gel.

1Denominator for all rows, unless otherwise stated.

2Includes heart problems (such as a previous heart attack) and/or high blood pressure.

3Includes stomach or intestinal ulcers, bleeding from the stomach, or blood in stools.

4 Discussion

Topical NSAIDs are safe and effective for pain relief [13,23,24]. A systemic review [13] reported that topical diclofenac is effective for treating acute musculoskeletal pain, with some studies reporting better effectiveness than other topical NSAIDs [13,25]. There is the perception that acute pain will resolve on its own; however, if not managed, it can persist. The current study aimed to provide an evaluation of real-world use of topical diclofenac gel in Sweden, from use, to assessing consumers’ perspectives on pain management, HRQoL, and satisfaction.

The retrospective results showed that topical diclofenac was prescribed more to females, which aligns with previous reports [26,27]. Furthermore, the proportion of females in the retrospective sample was higher than that among OTC VGD users in the survey sample, and OTC VGD users were, on average, nearly 20 years younger than prescription users. Notably, more than two-thirds of patients prescribed topical diclofenac were ≥65 years old. While this is the largest age group in Sweden, it is also possible that older people are preferentially prescribed topical diclofenac due to GI risk factors and the markedly better GI safety of diclofenac [28]. Physicians were co-prescribing it with CV drugs (49.0%), GI drugs (30.0%), or both (19.3%). Similarly, in the survey, consumers with CV and GI conditions used OTC VGD. This may indicate that those with contraindications for oral NSAIDs rely on topical treatment.

Medication side effects can lead to poor compliance. Our results suggested that patients generally adhered to their prescriptions. This aligns with previous findings that patients are more compliant with medications administered non-invasively [29]. Further, there is a connection between adherence and treatment satisfaction [29,30]. Retrospective analysis indicated that most patients did not switch from diclofenac gel treatment, suggesting sufficient pain relief and patient satisfaction.

The survey asked consumers to evaluate their satisfaction with treatment results, it showed that most consumers were satisfied over 12 weeks of follow-up. The mean worst pain in the week prior to baseline was 5.8 on the NRS, (moderate pain), which decreased by two points to 3.8 at week 12. A one-point change has been established as the minimal clinical important difference (MCID) in chronic musculoskeletal pain intensity [31,32], and a change of 1.4 points has been established for acute pain [33]. Consumers in this study exceeded both MCID cut points.

While consumer satisfaction is strongly affected by treatment efficacy, it may also be influenced by other factors. This survey revealed that consumers prioritized practicality of OTC VGD use. This aligns with a study on patients’ and physicians’ perceptions of factors that contributed to greater satisfaction, which showed that patients prioritize efficacy, comfort, and ease of application [34].

Consumers also experienced substantial improvements in functional status after OTC VGD treatment, including the ability to participate in social, physical, and daily activities, and errands/chores at weeks 4 and 12. Improvement in these HRQoL domains may have influenced their satisfaction [33].

Among older people, topical NSAIDs provide a first step toward musculoskeletal pain management, as they are effective in short-term pain relief while avoiding systemic exposure. As part of a comprehensive treatment, pain-related functional impairment should be assessed – particularly since musculoskeletal pain relief enables older adults to maintain a high HRQoL [35]. In line with this, older consumers reported less pain with OTC VGD treatment and improvements in the ability to participate in life activities. This demonstrates that VGD is a valuable treatment option, especially in vulnerable populations.

Although similar results regarding patterns of use, characteristics of consumers, and HRQoL have been previously reported among German patients [16], our study provides novel insights regarding the prescribing and patient experience in the Swedish population. The secondary analysis data source was prescription diclofenac gel data from a national repository covering 100% of the Swedish population, rather than pharmacy-specific dispensing database in the German study. Furthermore, the indication for VGD is different in Sweden compared to other European countries, making the enrolled population different in both publications. Therefore, our results provide crucial information for Swedish decision-makers, healthcare providers, and patients, and may contribute to improving patient care and safety.

4.1 Limitations and strengths

The secondary data study segment assessed prescribing topical diclofenac under real-world conditions. The analysis was limited by the data available in dispensing records.

Recruitment for the prospective surveys targeted purchasers of OTC VGD via an online pharmacy. Age, familiarity with technology, and economic factors may have affected participation; however, the mean age of the consumers in this study was 53.4. Online pharmacies did not offer downstream visibility of consumers; therefore, assessing the geographical distribution of consumers was not possible. However, the data from the Swedish eHealth Agency cover 100% of the country’s population. It is possible that consumers who were not satisfied with VGD withdrew early; however, attrition was low, and therefore, this likely did not affect the results. The survey did not capture the cause of pain, it is thus possible that the pain may have naturally improved. As data collection occurred during the COVID-19 pandemic when social interactions were disrupted, lower interference with social activity was expected [36]. Lastly, due to the nature of the study’s design and objectives, a control group was not utilized and, therefore, comparisons related to the effectiveness of VGD were not possible.

Although there were limitations, this study had several strengths. The real-world setting results help better understand the profiles and patterns of use for patients who filled a topical diclofenac prescription. They also provided an understanding of consumers’ perspectives on how VGD helps to improve daily activities and HRQoL. Beyond confirming that pain severity improved following VGD use, these findings highlight the novel point of view on the Swedish consumer experience.

5 Conclusions

While musculoskeletal pain relief is vital, treatment effects beyond pain relief play a key role in self-care. Secondary data analysis results from this study suggest that topical diclofenac gel is prescribed for pain relief; patients adhere to their treatment; and diclofenac gel is commonly prescribed for patients with CV and/or GI issues and is predominantly prescribed to older adults and females. The prospective survey revealed that OTC VGD is an effective pain treatment, supported by the high rate of repeat consumers, improved pain scores, reduced pain-related functional impairment, improved HRQoL, and high rate of treatment satisfaction.

# The content of this manuscript has not been previously published and is not currently under consideration for publication elsewhere. Part of this work has been presented at The Congress of the European Pain Federation EFIC 2022 (prospective analysis) and The World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (retrospective analysis).

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Acknowledgments

The authors thank the following Haleon contributors: Anela Lihic Haveric (Safety Science Director) and Kate Fabrikant (Medical Director) for contributing to study design, Roberto Bazzanella (Medical Director), and Simon Arnold (Medical Lead) for helping to define the research area, Vishal Rampartaap (Principal Medical Scientist) as for project management and Farzana Sufi (Clinical Development Director) and Vidhu Sethi (Principal Medical Scientist) 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.

  1. Research ethics: The prospective study was approved by the Swedish Ethical Review Authority (2020-02100) and performed according to the declaration of Helsinki under the European Pharmaceutical Market Research Association (EphMRA) code of conduct, thus ensuring compliance with Health Insurance Portability and Accountability Act (HIPAA) and all European data protection requirements. The need for ethical approval for the secondary data analysis was waived by the Swedish Ethical Review Authority because of the retrospective nature of the study.

  2. Informed consent: Informed consent was sought from all participants included in the prospective study; the secondary data study relied on the data controller for obtaining consent.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. Deepika Nair, Gilbert Shanga, Emese Csoke, and Jan-Rickard Norrefalk: 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. Teresa K. Wilcox: 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.

  4. Competing interests: Jan-Rickard Norrefalk has received honorarium payments for advising on study methodology. Deepika Nair and Gilbert Shanga are employees of Haleon (formerly GSK Consumer Healthcare). Teresa Wilcox was an employee of PPD, Part for Thermo Fisher Scientific, during the conduct of the study. Emese Csoke was an employee of GSK Consumer Healthcare during the conduct of the study.

  5. Research funding: The study and medical writing were funded by Haleon (formerly GSK Consumer Healthcare), the manufacturer of VGD.

  6. Data availability: Anonymized individual participant data and study documents can be requested for further research from www.haleon.com/studyregister.

  7. Artificial intelligence/Machine learning tools: Not applicable.

  8. Supplementary Material: This article contains supplementary material (followed by the link to the article online).

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Received: 2023-12-14
Revised: 2024-03-13
Accepted: 2024-04-08
Published Online: 2024-08-20

© 2024 the author(s), published by De Gruyter

This work is licensed under the Creative Commons Attribution 4.0 International License.

Artikel in diesem Heft

  1. Editorial Comment
  2. From pain to relief: Exploring the consistency of exercise-induced hypoalgesia
  3. Christmas greetings 2024 from the Editor-in-Chief
  4. Original Articles
  5. The Scandinavian Society for the Study of Pain 2022 Postgraduate Course and Annual Scientific (SASP 2022) Meeting 12th to 14th October at Rigshospitalet, Copenhagen
  6. Comparison of ultrasound-guided continuous erector spinae plane block versus continuous paravertebral block for postoperative analgesia in patients undergoing proximal femur surgeries
  7. Clinical Pain Researches
  8. The effect of tourniquet use on postoperative opioid consumption after ankle fracture surgery – a retrospective cohort study
  9. Changes in pain, daily occupations, lifestyle, and health following an occupational therapy lifestyle intervention: a secondary analysis from a feasibility study in patients with chronic high-impact pain
  10. Tonic cuff pressure pain sensitivity in chronic pain patients and its relation to self-reported physical activity
  11. Reliability, construct validity, and factorial structure of a Swedish version of the medical outcomes study social support survey (MOS-SSS) in patients with chronic pain
  12. Hurdles and potentials when implementing internet-delivered Acceptance and commitment therapy for chronic pain: a retrospective appraisal using the Quality implementation framework
  13. Exploring the outcome “days with bothersome pain” and its association with pain intensity, disability, and quality of life
  14. Fatigue and cognitive fatigability in patients with chronic pain
  15. The Swedish version of the pain self-efficacy questionnaire short form, PSEQ-2SV: Cultural adaptation and psychometric evaluation in a population of patients with musculoskeletal disorders
  16. Pain coping and catastrophizing in youth with and without cerebral palsy
  17. Neuropathic pain after surgery – A clinical validation study and assessment of accuracy measures of the 5-item NeuPPS scale
  18. Translation, contextual adaptation, and reliability of the Danish Concept of Pain Inventory (COPI-Adult (DK)) – A self-reported outcome measure
  19. Cosmetic surgery and associated chronic postsurgical pain: A cross-sectional study from Norway
  20. The association of hemodynamic parameters and clinical demographic variables with acute postoperative pain in female oncological breast surgery patients: A retrospective cohort study
  21. Healthcare professionals’ experiences of interdisciplinary collaboration in pain centres – A qualitative study
  22. Effects of deep brain stimulation and verbal suggestions on pain in Parkinson’s disease
  23. Painful differences between different pain scale assessments: The outcome of assessed pain is a matter of the choices of scale and statistics
  24. Prevalence and characteristics of fibromyalgia according to three fibromyalgia diagnostic criteria: A secondary analysis study
  25. Sex moderates the association between quantitative sensory testing and acute and chronic pain after total knee/hip arthroplasty
  26. Tramadol-paracetamol for postoperative pain after spine surgery – A randomized, double-blind, placebo-controlled study
  27. Cancer-related pain experienced in daily life is difficult to communicate and to manage – for patients and for professionals
  28. Making sense of pain in inflammatory bowel disease (IBD): A qualitative study
  29. Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication
  30. Does pain influence cognitive performance in patients with mild traumatic brain injury?
  31. Hypocapnia in women with fibromyalgia
  32. Application of ultrasound-guided thoracic paravertebral block or intercostal nerve block for acute herpes zoster and prevention of post-herpetic neuralgia: A case–control retrospective trial
  33. Translation and examination of construct validity of the Danish version of the Tampa Scale for Kinesiophobia
  34. A positive scratch collapse test in anterior cutaneous nerve entrapment syndrome indicates its neuropathic character
  35. ADHD-pain: Characteristics of chronic pain and association with muscular dysregulation in adults with ADHD
  36. The relationship between changes in pain intensity and functional disability in persistent disabling low back pain during a course of cognitive functional therapy
  37. Intrathecal pain treatment for severe pain in patients with terminal cancer: A retrospective analysis of treatment-related complications and side effects
  38. Psychometric evaluation of the Danish version of the Pain Self-Efficacy Questionnaire in patients with subacute and chronic low back pain
  39. Dimensionality, reliability, and validity of the Finnish version of the pain catastrophizing scale in chronic low back pain
  40. To speak or not to speak? A secondary data analysis to further explore the context-insensitive avoidance scale
  41. Pain catastrophizing levels differentiate between common diseases with pain: HIV, fibromyalgia, complex regional pain syndrome, and breast cancer survivors
  42. Prevalence of substance use disorder diagnoses in patients with chronic pain receiving reimbursed opioids: An epidemiological study of four Norwegian health registries
  43. Pain perception while listening to thrash heavy metal vs relaxing music at a heavy metal festival – the CoPainHell study – a factorial randomized non-blinded crossover trial
  44. Observational Studies
  45. Cutaneous nerve biopsy in patients with symptoms of small fiber neuropathy: a retrospective study
  46. The incidence of post cholecystectomy pain (PCP) syndrome at 12 months following laparoscopic cholecystectomy: a prospective evaluation in 200 patients
  47. Associations between psychological flexibility and daily functioning in endometriosis-related pain
  48. Relationship between perfectionism, overactivity, pain severity, and pain interference in individuals with chronic pain: A cross-lagged panel model analysis
  49. Access to psychological treatment for chronic cancer-related pain in Sweden
  50. Validation of the Danish version of the knowledge and attitudes survey regarding pain
  51. Associations between cognitive test scores and pain tolerance: The Tromsø study
  52. Healthcare experiences of fibromyalgia patients and their associations with satisfaction and pain relief. A patient survey
  53. Video interpretation in a medical spine clinic: A descriptive study of a diverse population and intervention
  54. Role of history of traumatic life experiences in current psychosomatic manifestations
  55. Social determinants of health in adults with whiplash associated disorders
  56. Which patients with chronic low back pain respond favorably to multidisciplinary rehabilitation? A secondary analysis of a randomized controlled trial
  57. A preliminary examination of the effects of childhood abuse and resilience on pain and physical functioning in patients with knee osteoarthritis
  58. Differences in risk factors for flare-ups in patients with lumbar radicular pain may depend on the definition of flare
  59. Real-world evidence evaluation on consumer experience and prescription journey of diclofenac gel in Sweden
  60. Patient characteristics in relation to opioid exposure in a chronic non-cancer pain population
  61. Topical Reviews
  62. Bridging the translational gap: adenosine as a modulator of neuropathic pain in preclinical models and humans
  63. What do we know about Indigenous Peoples with low back pain around the world? A topical review
  64. The “future” pain clinician: Competencies needed to provide psychologically informed care
  65. Systematic Reviews
  66. Pain management for persistent pain post radiotherapy in head and neck cancers: systematic review
  67. High-frequency, high-intensity transcutaneous electrical nerve stimulation compared with opioids for pain relief after gynecological surgery: a systematic review and meta-analysis
  68. Reliability and measurement error of exercise-induced hypoalgesia in pain-free adults and adults with musculoskeletal pain: A systematic review
  69. Noninvasive transcranial brain stimulation in central post-stroke pain: A systematic review
  70. Short Communications
  71. Are we missing the opioid consumption in low- and middle-income countries?
  72. Association between self-reported pain severity and characteristics of United States adults (age ≥50 years) who used opioids
  73. Could generative artificial intelligence replace fieldwork in pain research?
  74. Skin conductance algesimeter is unreliable during sudden perioperative temperature increases
  75. Original Experimental
  76. Confirmatory study of the usefulness of quantum molecular resonance and microdissectomy for the treatment of lumbar radiculopathy in a prospective cohort at 6 months follow-up
  77. Pain catastrophizing in the elderly: An experimental pain study
  78. Improving general practice management of patients with chronic musculoskeletal pain: Interdisciplinarity, coherence, and concerns
  79. Concurrent validity of dynamic bedside quantitative sensory testing paradigms in breast cancer survivors with persistent pain
  80. Transcranial direct current stimulation is more effective than pregabalin in controlling nociceptive and anxiety-like behaviors in a rat fibromyalgia-like model
  81. Paradox pain sensitivity using cuff pressure or algometer testing in patients with hemophilia
  82. Physical activity with person-centered guidance supported by a digital platform or with telephone follow-up for persons with chronic widespread pain: Health economic considerations along a randomized controlled trial
  83. Measuring pain intensity through physical interaction in an experimental model of cold-induced pain: A method comparison study
  84. Pharmacological treatment of pain in Swedish nursing homes: Prevalence and associations with cognitive impairment and depressive mood
  85. Neck and shoulder pain and inflammatory biomarkers in plasma among forklift truck operators – A case–control study
  86. The effect of social exclusion on pain perception and heart rate variability in healthy controls and somatoform pain patients
  87. Revisiting opioid toxicity: Cellular effects of six commonly used opioids
  88. Letter to the Editor
  89. Post cholecystectomy pain syndrome: Letter to Editor
  90. Response to the Letter by Prof Bordoni
  91. Response – Reliability and measurement error of exercise-induced hypoalgesia
  92. Is the skin conductance algesimeter index influenced by temperature?
  93. Skin conductance algesimeter is unreliable during sudden perioperative temperature increase
  94. Corrigendum
  95. Corrigendum to “Chronic post-thoracotomy pain after lung cancer surgery: a prospective study of preoperative risk factors”
  96. Obituary
  97. A Significant Voice in Pain Research Björn Gerdle in Memoriam (1953–2024)
https://doi.org/10.1515/sjpain-2023-0147
Schlagwörter für diesen Artikel
real-world evidence; topical diclofenac; NSAIDs; pain management; patient survey; patient satisfaction
Creative Commons
BY 4.0

Artikel in diesem Heft

  1. Editorial Comment
  2. From pain to relief: Exploring the consistency of exercise-induced hypoalgesia
  3. Christmas greetings 2024 from the Editor-in-Chief
  4. Original Articles
  5. The Scandinavian Society for the Study of Pain 2022 Postgraduate Course and Annual Scientific (SASP 2022) Meeting 12th to 14th October at Rigshospitalet, Copenhagen
  6. Comparison of ultrasound-guided continuous erector spinae plane block versus continuous paravertebral block for postoperative analgesia in patients undergoing proximal femur surgeries
  7. Clinical Pain Researches
  8. The effect of tourniquet use on postoperative opioid consumption after ankle fracture surgery – a retrospective cohort study
  9. Changes in pain, daily occupations, lifestyle, and health following an occupational therapy lifestyle intervention: a secondary analysis from a feasibility study in patients with chronic high-impact pain
  10. Tonic cuff pressure pain sensitivity in chronic pain patients and its relation to self-reported physical activity
  11. Reliability, construct validity, and factorial structure of a Swedish version of the medical outcomes study social support survey (MOS-SSS) in patients with chronic pain
  12. Hurdles and potentials when implementing internet-delivered Acceptance and commitment therapy for chronic pain: a retrospective appraisal using the Quality implementation framework
  13. Exploring the outcome “days with bothersome pain” and its association with pain intensity, disability, and quality of life
  14. Fatigue and cognitive fatigability in patients with chronic pain
  15. The Swedish version of the pain self-efficacy questionnaire short form, PSEQ-2SV: Cultural adaptation and psychometric evaluation in a population of patients with musculoskeletal disorders
  16. Pain coping and catastrophizing in youth with and without cerebral palsy
  17. Neuropathic pain after surgery – A clinical validation study and assessment of accuracy measures of the 5-item NeuPPS scale
  18. Translation, contextual adaptation, and reliability of the Danish Concept of Pain Inventory (COPI-Adult (DK)) – A self-reported outcome measure
  19. Cosmetic surgery and associated chronic postsurgical pain: A cross-sectional study from Norway
  20. The association of hemodynamic parameters and clinical demographic variables with acute postoperative pain in female oncological breast surgery patients: A retrospective cohort study
  21. Healthcare professionals’ experiences of interdisciplinary collaboration in pain centres – A qualitative study
  22. Effects of deep brain stimulation and verbal suggestions on pain in Parkinson’s disease
  23. Painful differences between different pain scale assessments: The outcome of assessed pain is a matter of the choices of scale and statistics
  24. Prevalence and characteristics of fibromyalgia according to three fibromyalgia diagnostic criteria: A secondary analysis study
  25. Sex moderates the association between quantitative sensory testing and acute and chronic pain after total knee/hip arthroplasty
  26. Tramadol-paracetamol for postoperative pain after spine surgery – A randomized, double-blind, placebo-controlled study
  27. Cancer-related pain experienced in daily life is difficult to communicate and to manage – for patients and for professionals
  28. Making sense of pain in inflammatory bowel disease (IBD): A qualitative study
  29. Patient-reported pain, satisfaction, adverse effects, and deviations from ambulatory surgery pain medication
  30. Does pain influence cognitive performance in patients with mild traumatic brain injury?
  31. Hypocapnia in women with fibromyalgia
  32. Application of ultrasound-guided thoracic paravertebral block or intercostal nerve block for acute herpes zoster and prevention of post-herpetic neuralgia: A case–control retrospective trial
  33. Translation and examination of construct validity of the Danish version of the Tampa Scale for Kinesiophobia
  34. A positive scratch collapse test in anterior cutaneous nerve entrapment syndrome indicates its neuropathic character
  35. ADHD-pain: Characteristics of chronic pain and association with muscular dysregulation in adults with ADHD
  36. The relationship between changes in pain intensity and functional disability in persistent disabling low back pain during a course of cognitive functional therapy
  37. Intrathecal pain treatment for severe pain in patients with terminal cancer: A retrospective analysis of treatment-related complications and side effects
  38. Psychometric evaluation of the Danish version of the Pain Self-Efficacy Questionnaire in patients with subacute and chronic low back pain
  39. Dimensionality, reliability, and validity of the Finnish version of the pain catastrophizing scale in chronic low back pain
  40. To speak or not to speak? A secondary data analysis to further explore the context-insensitive avoidance scale
  41. Pain catastrophizing levels differentiate between common diseases with pain: HIV, fibromyalgia, complex regional pain syndrome, and breast cancer survivors
  42. Prevalence of substance use disorder diagnoses in patients with chronic pain receiving reimbursed opioids: An epidemiological study of four Norwegian health registries
  43. Pain perception while listening to thrash heavy metal vs relaxing music at a heavy metal festival – the CoPainHell study – a factorial randomized non-blinded crossover trial
  44. Observational Studies
  45. Cutaneous nerve biopsy in patients with symptoms of small fiber neuropathy: a retrospective study
  46. The incidence of post cholecystectomy pain (PCP) syndrome at 12 months following laparoscopic cholecystectomy: a prospective evaluation in 200 patients
  47. Associations between psychological flexibility and daily functioning in endometriosis-related pain
  48. Relationship between perfectionism, overactivity, pain severity, and pain interference in individuals with chronic pain: A cross-lagged panel model analysis
  49. Access to psychological treatment for chronic cancer-related pain in Sweden
  50. Validation of the Danish version of the knowledge and attitudes survey regarding pain
  51. Associations between cognitive test scores and pain tolerance: The Tromsø study
  52. Healthcare experiences of fibromyalgia patients and their associations with satisfaction and pain relief. A patient survey
  53. Video interpretation in a medical spine clinic: A descriptive study of a diverse population and intervention
  54. Role of history of traumatic life experiences in current psychosomatic manifestations
  55. Social determinants of health in adults with whiplash associated disorders
  56. Which patients with chronic low back pain respond favorably to multidisciplinary rehabilitation? A secondary analysis of a randomized controlled trial
  57. A preliminary examination of the effects of childhood abuse and resilience on pain and physical functioning in patients with knee osteoarthritis
  58. Differences in risk factors for flare-ups in patients with lumbar radicular pain may depend on the definition of flare
  59. Real-world evidence evaluation on consumer experience and prescription journey of diclofenac gel in Sweden
  60. Patient characteristics in relation to opioid exposure in a chronic non-cancer pain population
  61. Topical Reviews
  62. Bridging the translational gap: adenosine as a modulator of neuropathic pain in preclinical models and humans
  63. What do we know about Indigenous Peoples with low back pain around the world? A topical review
  64. The “future” pain clinician: Competencies needed to provide psychologically informed care
  65. Systematic Reviews
  66. Pain management for persistent pain post radiotherapy in head and neck cancers: systematic review
  67. High-frequency, high-intensity transcutaneous electrical nerve stimulation compared with opioids for pain relief after gynecological surgery: a systematic review and meta-analysis
  68. Reliability and measurement error of exercise-induced hypoalgesia in pain-free adults and adults with musculoskeletal pain: A systematic review
  69. Noninvasive transcranial brain stimulation in central post-stroke pain: A systematic review
  70. Short Communications
  71. Are we missing the opioid consumption in low- and middle-income countries?
  72. Association between self-reported pain severity and characteristics of United States adults (age ≥50 years) who used opioids
  73. Could generative artificial intelligence replace fieldwork in pain research?
  74. Skin conductance algesimeter is unreliable during sudden perioperative temperature increases
  75. Original Experimental
  76. Confirmatory study of the usefulness of quantum molecular resonance and microdissectomy for the treatment of lumbar radiculopathy in a prospective cohort at 6 months follow-up
  77. Pain catastrophizing in the elderly: An experimental pain study
  78. Improving general practice management of patients with chronic musculoskeletal pain: Interdisciplinarity, coherence, and concerns
  79. Concurrent validity of dynamic bedside quantitative sensory testing paradigms in breast cancer survivors with persistent pain
  80. Transcranial direct current stimulation is more effective than pregabalin in controlling nociceptive and anxiety-like behaviors in a rat fibromyalgia-like model
  81. Paradox pain sensitivity using cuff pressure or algometer testing in patients with hemophilia
  82. Physical activity with person-centered guidance supported by a digital platform or with telephone follow-up for persons with chronic widespread pain: Health economic considerations along a randomized controlled trial
  83. Measuring pain intensity through physical interaction in an experimental model of cold-induced pain: A method comparison study
  84. Pharmacological treatment of pain in Swedish nursing homes: Prevalence and associations with cognitive impairment and depressive mood
  85. Neck and shoulder pain and inflammatory biomarkers in plasma among forklift truck operators – A case–control study
  86. The effect of social exclusion on pain perception and heart rate variability in healthy controls and somatoform pain patients
  87. Revisiting opioid toxicity: Cellular effects of six commonly used opioids
  88. Letter to the Editor
  89. Post cholecystectomy pain syndrome: Letter to Editor
  90. Response to the Letter by Prof Bordoni
  91. Response – Reliability and measurement error of exercise-induced hypoalgesia
  92. Is the skin conductance algesimeter index influenced by temperature?
  93. Skin conductance algesimeter is unreliable during sudden perioperative temperature increase
  94. Corrigendum
  95. Corrigendum to “Chronic post-thoracotomy pain after lung cancer surgery: a prospective study of preoperative risk factors”
  96. Obituary
  97. A Significant Voice in Pain Research Björn Gerdle in Memoriam (1953–2024)
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