Limits...
Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors.

Álvarez E, Olivares JM, Carrasco JL, López-Gómez V, Rejas J - Ann Gen Psychiatry (2015)

Bottom Line: Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs.Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777.The effect of pregabalin was independent of patient gender.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Hospital de la Santa Creu i San Pau, Universitat Autónoma de Barcelona, CiberSam, Carrer Sant Quintí, 89, 08026 Barcelona, Spain.

ABSTRACT

Background: This study is done to compare the effect of adjunctive therapy with pregabalin versus usual care (UC) on health-care costs and clinical and patients consequences in generalized anxiety disorder (GAD) subjects with partial response (PR) to a previous selective serotonin reuptake inhibitor (SSRI) course in medical practice in Spain.

Methods: Post hoc analysis of patients with PR to SSRI monotherapy enrolled in a prospective 6-month naturalistic study was done. PR was defined as a Clinical Global Impression (CGI) scale score ≥3 and insufficient response with persistence of anxiety symptoms ≥16 in the Hamilton Anxiety Rating Scale (HAM-A). Two groups were analyzed: 1) adjunctive therapy (AT) with pregabalin (150-600 mg/day) to existing therapy and 2) UC (switching to a different SSRI or adding another anxiolytic different than pregabalin). Costs included GAD-related health-care resources utilization. Consequences were a combination of psychiatrist-based measurements [HAM-A, CGI, and Montgomery-Asberg Depression Rating Scale (MADRS)] and patient-reported outcomes [Medical Outcomes Study Sleep (MOS-sleep) scale, disability (World Health Organization Disability Assessment Schedule II (WHO-DAS II) and quality-of-life (Euro Qol-5D (EQ-5D)]. Changes in both health-care costs and scale scores were compared separately at end-of-trial visit by a general linear model with covariates.

Results: Four hundred eighty-six newly prescribed pregabalin and 239 UC GAD patients [mean (SD) HAM-A 26.7 (6.9) and CGI 4.1 (0.5)] were analyzed. Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs. UC in HAM-A [-14.9 (-15.6; -14.2) vs. -11.2 (-12.2; -10.2), p < 0.001] and MADRS [-11.6 (-12.2; -10.9) vs. -7.8 (-8.7; -6.8), p < 0.001]. Changes in all patient-reported outcomes favored significantly patients receiving pregabalin, including quality-of-life gain; 26.4 (24.7; 28.1) vs. 19.4 (17.1; 21.6) in the EQ-VAS, p < 0.001. Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777. The effect of sex on costs and consequences were negligible.

Conclusion: In medical practice, GAD patients with PR to SSRI experienced greater consequence improvements with adjunctive therapy with pregabalin versus UC, without increasing health-care cost. The effect of pregabalin was independent of patient gender.

No MeSH data available.


Related in: MedlinePlus

Adjusted mean reduction in patient disability reported WHO-DAS II components after 6 months of study in pregabalin and usual care groups. *p < 0.05; **p < 0.01; ***p < 0.001 between groups adjusted by age, sex, and baseline values.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4308936&req=5

Fig3: Adjusted mean reduction in patient disability reported WHO-DAS II components after 6 months of study in pregabalin and usual care groups. *p < 0.05; **p < 0.01; ***p < 0.001 between groups adjusted by age, sex, and baseline values.

Mentions: As shown in Table 2, adjusted significant changes between visits were observed in all patient-reported outcomes. The detected improvements in sleep problems measured by the MOS-sleep scale (Table 2) and WHO-DAS II disability scale (Figure 3) favored differentially to patients in the group receiving pregabalin. Mean reduction (±95% CI) in general index sleep problems of the MOS-sleep scale was 26.4 (24.7, 28.1) in the pregabalin group and 19.6 (17.3, 22.0) in the UC group (p < 0.001). All items of the MOS-sleep scale reflected reductions that significantly favored the pregabalin group, except the snoring item and the optimal sleep score that accounted for non-significant lower reductions in patients treated with pregabalin (Table 2).Table 2


Clinical and economic outcomes of adjunctive therapy with pregabalin or usual care in generalized anxiety disorder patients with partial response to selective serotonin reuptake inhibitors.

Álvarez E, Olivares JM, Carrasco JL, López-Gómez V, Rejas J - Ann Gen Psychiatry (2015)

Adjusted mean reduction in patient disability reported WHO-DAS II components after 6 months of study in pregabalin and usual care groups. *p < 0.05; **p < 0.01; ***p < 0.001 between groups adjusted by age, sex, and baseline values.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4308936&req=5

Fig3: Adjusted mean reduction in patient disability reported WHO-DAS II components after 6 months of study in pregabalin and usual care groups. *p < 0.05; **p < 0.01; ***p < 0.001 between groups adjusted by age, sex, and baseline values.
Mentions: As shown in Table 2, adjusted significant changes between visits were observed in all patient-reported outcomes. The detected improvements in sleep problems measured by the MOS-sleep scale (Table 2) and WHO-DAS II disability scale (Figure 3) favored differentially to patients in the group receiving pregabalin. Mean reduction (±95% CI) in general index sleep problems of the MOS-sleep scale was 26.4 (24.7, 28.1) in the pregabalin group and 19.6 (17.3, 22.0) in the UC group (p < 0.001). All items of the MOS-sleep scale reflected reductions that significantly favored the pregabalin group, except the snoring item and the optimal sleep score that accounted for non-significant lower reductions in patients treated with pregabalin (Table 2).Table 2

Bottom Line: Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs.Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777.The effect of pregabalin was independent of patient gender.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Hospital de la Santa Creu i San Pau, Universitat Autónoma de Barcelona, CiberSam, Carrer Sant Quintí, 89, 08026 Barcelona, Spain.

ABSTRACT

Background: This study is done to compare the effect of adjunctive therapy with pregabalin versus usual care (UC) on health-care costs and clinical and patients consequences in generalized anxiety disorder (GAD) subjects with partial response (PR) to a previous selective serotonin reuptake inhibitor (SSRI) course in medical practice in Spain.

Methods: Post hoc analysis of patients with PR to SSRI monotherapy enrolled in a prospective 6-month naturalistic study was done. PR was defined as a Clinical Global Impression (CGI) scale score ≥3 and insufficient response with persistence of anxiety symptoms ≥16 in the Hamilton Anxiety Rating Scale (HAM-A). Two groups were analyzed: 1) adjunctive therapy (AT) with pregabalin (150-600 mg/day) to existing therapy and 2) UC (switching to a different SSRI or adding another anxiolytic different than pregabalin). Costs included GAD-related health-care resources utilization. Consequences were a combination of psychiatrist-based measurements [HAM-A, CGI, and Montgomery-Asberg Depression Rating Scale (MADRS)] and patient-reported outcomes [Medical Outcomes Study Sleep (MOS-sleep) scale, disability (World Health Organization Disability Assessment Schedule II (WHO-DAS II) and quality-of-life (Euro Qol-5D (EQ-5D)]. Changes in both health-care costs and scale scores were compared separately at end-of-trial visit by a general linear model with covariates.

Results: Four hundred eighty-six newly prescribed pregabalin and 239 UC GAD patients [mean (SD) HAM-A 26.7 (6.9) and CGI 4.1 (0.5)] were analyzed. Adding pregabalin was associated with significantly higher mean (95% CI) score reductions vs. UC in HAM-A [-14.9 (-15.6; -14.2) vs. -11.2 (-12.2; -10.2), p < 0.001] and MADRS [-11.6 (-12.2; -10.9) vs. -7.8 (-8.7; -6.8), p < 0.001]. Changes in all patient-reported outcomes favored significantly patients receiving pregabalin, including quality-of-life gain; 26.4 (24.7; 28.1) vs. 19.4 (17.1; 21.6) in the EQ-VAS, p < 0.001. Health-care costs were significantly reduced in both cohorts yielding similar 6-month costs; €1,565 (1,426; 1,703) pregabalin and €1,406 (1,200; 1,611) UC, p = 0.777. The effect of sex on costs and consequences were negligible.

Conclusion: In medical practice, GAD patients with PR to SSRI experienced greater consequence improvements with adjunctive therapy with pregabalin versus UC, without increasing health-care cost. The effect of pregabalin was independent of patient gender.

No MeSH data available.


Related in: MedlinePlus