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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

Mean (95% confidence interval) reduction in clinical variables (HAM-A, MADRS, CGI-I) after 6 months of study in pregabalin and usual care groups.
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Fig1: Mean (95% confidence interval) reduction in clinical variables (HAM-A, MADRS, CGI-I) after 6 months of study in pregabalin and usual care groups.

Mentions: Adding pregabalin was associated with significantly higher benefit in anxiety and depression outcomes, as reflected by mean (95% CI) reduction vs. UC in HAM-A [−15.2 (−16.0; −14.4) vs. −10.7 (−11.8; −9.5), p < 0.001] and MADRS [−11.8 (−12.5; −11.1) vs. −7.3 (−8.3; −6.3), p < 0.001] (Figure 1). No significant differences between sexes were observed in the reduction of these variables. Similarly, the change in CGI-I scale presented significant differences between groups: −1.7 in pregabalin vs. −1.2 in UC (p < 0.005). Figure 2 shows in detail the specific changes in the 14 anxiety-related items included in the HAM-A. Reductions in all items favored the pregabalin group with statistically significant differences for anxious mood (p < 0.05), tension (p < 0.05), fears (p < 0.05), intellectual (p < 0.001), somatic (sensory) (p < 0.01), gastrointestinal (p < 0.05), and autonomic symptoms (p < 0.05).Figure 1


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)

Mean (95% confidence interval) reduction in clinical variables (HAM-A, MADRS, CGI-I) after 6 months of study in pregabalin and usual care groups.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig1: Mean (95% confidence interval) reduction in clinical variables (HAM-A, MADRS, CGI-I) after 6 months of study in pregabalin and usual care groups.
Mentions: Adding pregabalin was associated with significantly higher benefit in anxiety and depression outcomes, as reflected by mean (95% CI) reduction vs. UC in HAM-A [−15.2 (−16.0; −14.4) vs. −10.7 (−11.8; −9.5), p < 0.001] and MADRS [−11.8 (−12.5; −11.1) vs. −7.3 (−8.3; −6.3), p < 0.001] (Figure 1). No significant differences between sexes were observed in the reduction of these variables. Similarly, the change in CGI-I scale presented significant differences between groups: −1.7 in pregabalin vs. −1.2 in UC (p < 0.005). Figure 2 shows in detail the specific changes in the 14 anxiety-related items included in the HAM-A. Reductions in all items favored the pregabalin group with statistically significant differences for anxious mood (p < 0.05), tension (p < 0.05), fears (p < 0.05), intellectual (p < 0.001), somatic (sensory) (p < 0.01), gastrointestinal (p < 0.05), and autonomic symptoms (p < 0.05).Figure 1

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