Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities

Figures & data

Table 1 Patient characteristics

Characteristic	Study population (n = 947)
Mean (SD) age, years	61.7 (10.1)
Range	35–90
Women, %	64.2
Race, %
White	82.5
Black	11.0
Asian	1.0
Other	5.6
Mean (SD) BMI, kg/m^2	31.5 (6.7)
Range	17.5–62.0
Missing, n	8

Adapted with permission from Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Adapted from Phys Sportsmed. Volume 39;31–38. Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. © 2011 with permission from JTE Multimedia.²³

Abbreviations: BMI, body mass index; SD, standard deviation.

Figure 1 Patient disposition.

Notes:^aStudy completion for each patient was decided by the investigator. For some patients, the final visit was too early to be included in the 12-month efficacy analysis.
Abbreviations: DSG, diclofenac sodium 1% gel; PBO, placebo.

Table 2 Total and most frequent adverse events stratified by age

AE, n (%)	Patients < 65 years (n = 575)	Patients ≥ 65 years (n = 372)
Any AE	392 (68.2)	250 (67.2)
Gastrointestinal AE	54 (9.4)	25 (6.7)
Cardiovascular AE	19 (3.3)	12 (3.2)
Application-site dermatitis	50 (8.7)	49 (13.2)
TEAEs reported in ≥3% of either age group
Headache	110 (19.1)	57 (15.3)
Arthralgia	77 (13.4)	55 (14.8)
Back pain	64 (11.1)	47 (12.6)
Nasopharyngitis	46 (8.0)	21 (5.6)
Upper respiratory tract infection	43 (7.5)	11 (3.0)
Pain in extremity	33 (5.7)	26 (7.0)
Pain	27 (4.7)	8 (2.2)
Influenza	27 (4.7)	7 (1.9)
Sinusitis	26 (4.5)	9 (2.4)
Toothache	18 (3.1)	4 (1.1)
Sinus congestion	18 (3.1)	1 (0.3)
Myalgia	17 (3.0)	9 (2.4)
Neck pain	10 (1.7)	13 (3.5)

Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event.

Table 3 Total and most frequent adverse events stratified by comorbidity

AE, n (%)	With HTN (n = 438)	Without HTN (n = 509)	With T2DM (n = 100)	Without T2DM (n = 847)	With C/CVD (n = 97)	Without C/CVD (n = 850)
Any AE	287 (65.5)	355 (69.7)	64 (64.0)	587 (68.2)	60 (61.9)	582 (68.5)
Gastrointestinal AE	39 (8.9)	40 (7.9)	7 (7.0)	72 (8.5)	12 (12.4)	67 (7.9)
Cardiovascular AE	22 (5.0)	9 (1.8)	8 (8.0)	23 (2.7)	6 (6.2)	25 (2.9)
Application-site dermatitis	36 (8.2)	63 (12.4)	10 (10.0)	89 (10.5)	8 (8.2)	91 (10.7)
TEAEs reported in ≥3% of any comorbidity group
Headache	73 (16.7)	94 (18.5)	18 (18.0)	149 (17.6)	6 (6.2)	161 (18.9)
Arthralgia	70 (16.0)	62 (12.2)	7 (7.0)	125 (14.8)	14 (14.4)	118 (13.9)
Back pain	52 (11.9)	59 (11.6)	12 (12.0)	99 (11.7)	7 (7.2)	104 (12.2)
Nasopharyngitis	32 (7.3)	35 (6.9)	5 (5.0)	62 (7.3)	8 (8.2)	59 (6.9)
Pain in extremity	31 (7.1)	28 (5.5)	6 (6.0)	53 (6.3)	4 (4.1)	55 (6.5)
Upper respiratory tract infection	18 (4.1)	36 (7.1)	3 (3.0)	51 (6.0)	5 (5.2)	49 (5.8)
Pain	16 (3.7)	19 (3.7)	2 (2.0)	33 (3.9)	2 (2.1)	33 (3.9)
Sinusitis	15 (3.4)	20 (3.9)	3 (3.0)	32 (3.8)	3 (3.1)	32 (3.8)
Neck pain	13 (3.0)	10 (2.0)	1 (1.0)	22 (2.6)	5 (5.2)	18 (2.1)
Rash	13 (3.0)	6 (1.2)	3 (3.0)	16 (1.9)	3 (3.1)	16 (1.9)
Sinus congestion	12 (2.7)	7 (1.4)	5 (5.0)	14 (1.7)	1 (1.0)	18 (2.1)
Contusion	11 (2.5)	8 (1.6)	4 (4.0)	15 (1.8)	5 (5.2)	14 (1.6)
Pharyngolaryngeal pain	10 (2.3)	8 (1.6)	1 (1.0)	17 (2.0)	3 (3.1)	15 (1.8)
Influenza	8 (1.8)	26 (5.1)	0	34 (4.0)	4 (4.1)	30 (3.5)
Edema, peripheral	6 (1.4)	8 (1.6)	5 (5.0)	9 (1.1)	3 (3.1)	11 (1.3)
Pneumonia	5 (1.1)	4 (0.8)	2 (2.0)	7 (0.8)	3 (3.1)	6 (0.7)
Myalgia	4 (0.9)	22 (4.3)	1 (1.0)	25 (3.0)	3 (3.1)	23 (2.7)
Diabetes mellitus	1 (0.2)	2 (0.4)	3 (3.0)	0	1 (1.0)	2 (0.2)
Localized infection	1 (0.2)	4 (0.8)	0	5 (0.6)	3 (3.1)	2 (0.2)

Abbreviations: AE, adverse event; C/CVD, cerebrovascular or cardiovascular disease; HTN, hypertension; T2DM, type 2 diabetes mellitus; TEAE, treatment-emergent adverse event.

Table 4 Total and most frequent adverse events stratified by multiple comorbidities*

AE, n (%)	With MultiCom (n = 15)	Without MultiCom (n = 932)
Any AE	8 (53.3)	634 (68.0)
Gastrointestinal AE	0	79 (8.5)
Cardiovascular AE	2 (13.3)	29 (3.1)
Application-site dermatitis	0	99 (10.6)
TEAEs reported in ≥3% of either group
Headache	1 (6.7)	166 (17.8)
Arthralgia	3 (20.0)	129 (13.8)
Back pain	0	111 (11.9)
Nasopharyngitis	0	67 (7.2)
Pain in extremity	0	59 (6.3)
Upper respiratory tract infection	0	54 (5.8)
Pain	0	35 (3.8)
Sinusitis	2 (13.3)	33 (3.5)
Neck pain	1 (6.7)	22 (2.4)
Hypertension	1 (6.7)	10 (1.1)
Influenza	0	34 (3.6)
Edema, peripheral	1 (6.7)	13 (1.4)
Pneumonia	1 (6.7)	8 (0.9)
Application-site erythema	1 (6.7)	8 (0.9)
Myalgia	1 (6.7)	25 (2.7)
Dyspnea	1 (6.7)	6 (0.6)
Pruritus	1 (6.7)	5 (0.5)
Cough	1 (6.7)	11 (1.2)
Atrial fibrillation	1 (6.7)	1 (0.1)
Dental caries	1 (6.7)	2 (0.2)
Muscle spasms	1 (6.7)	7 (0.8)
Pharyngitis streptococcal	1 (6.7)	1 (0.1)
Application-site papules	1 (6.7)	1 (0.1)
Diabetes mellitus	1 (6.7)	2 (0.2)
Epistaxis	1 (6.7)	0
Ligament disorder	1 (6.7)	0

Note:

* Hypertension and type 2 diabetes mellitus and cerebrovascular or cardiovascular disease.

Abbreviations: AE, adverse event; MultiCom, multiple comorbidities; TEAE, treatment-emergent adverse event.

PenistonJHGoldMSAlwineLKAn open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritisPhys Sportsmed201139313822030938

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