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Modeling the longitudinal latent effect of pregabalin on self-reported changes in sleep disturbances in outpatients with generalized anxiety disorder managed in routine clinical practice.

Ruiz MA, Álvarez E, Carrasco JL, Olivares JM, Pérez M, Rejas J - Drug Des Devel Ther (2015)

Bottom Line: Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: -15.9 (-15.2; -16.6) vs -14.5 (-13.5; -15.5), P=0.027, in Hamilton Anxiety Scale; and -29.7 (-28.1; -31.3) vs -24.0 (-21.6; -26.4), P<0.001, in MOS-S.The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =-3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms.A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement.

View Article: PubMed Central - PubMed

Affiliation: Department of Methodology, School of Psychology, Universidad Autónoma de Madrid, Madrid, Spain.

ABSTRACT

Background: Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD) being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC) therapies on changes in sleep in outpatients with GAD under routine clinical practice.

Methods: Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale) and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S]) were estimated by a conditional latent curve model applying structural equation modeling.

Results: A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: -15.9 (-15.2; -16.6) vs -14.5 (-13.5; -15.5), P=0.027, in Hamilton Anxiety Scale; and -29.7 (-28.1; -31.3) vs -24.0 (-21.6; -26.4), P<0.001, in MOS-S. The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =-3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms. A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement.

Conclusion: A substantial proportion of the incremental improvements in anxiety-related sleep disturbances with pregabalin vs UC were explained by its direct effect, not mediated by improvements in anxiety symptoms.

No MeSH data available.


Related in: MedlinePlus

Estimated effect of pregabalin treatment on slope and intercept of MOS-S over time, with the presence of anxiety measures as covariates.Notes: Boxes represent observed variables, and circles unobserved error variables. Straight lines represent regression effects, and the values above them, raw estimated regression weights. Curved lines represent covariances, and values above their estimate. Values above exogenous variables represent means and variances, and values above endogenous variables represent means. Estimated mean values for the random slope (α) and intercept (β) have been labeled.Abbreviations: Anxiety0, anxiety score at baseline; Anxiety3, anxiety score at month 3; Anxiety6, anxiety score at month 6; MOS-S, Medical Outcomes Study-Sleep Scale; Sleep0, sleep score at baseline; Sleep3, sleep score at month 3; Sleep6, sleep score at month 6.
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f3-dddt-9-4329: Estimated effect of pregabalin treatment on slope and intercept of MOS-S over time, with the presence of anxiety measures as covariates.Notes: Boxes represent observed variables, and circles unobserved error variables. Straight lines represent regression effects, and the values above them, raw estimated regression weights. Curved lines represent covariances, and values above their estimate. Values above exogenous variables represent means and variances, and values above endogenous variables represent means. Estimated mean values for the random slope (α) and intercept (β) have been labeled.Abbreviations: Anxiety0, anxiety score at baseline; Anxiety3, anxiety score at month 3; Anxiety6, anxiety score at month 6; MOS-S, Medical Outcomes Study-Sleep Scale; Sleep0, sleep score at baseline; Sleep3, sleep score at month 3; Sleep6, sleep score at month 6.

Mentions: Lastly, we obtained the estimated change in slope (and intercept) after discounting the effect of anxiety changes over time using the restricted model with covariates (Figure 3). The mean slope for the MOS-S trajectory for the UC group after adjusting for anxiety reduction was µβ =−7.598 (SE =1.233, P<0.001), while the mean intercept for this group was µα =15.970 (SE =1.102, P<0.001). The estimated change in the random slope of MOS-S change over time due to pregabalin treatment, as compared with UC, was γβ =−3.990 (SE =0.863, P<0.001), and the estimated impact on the random intercept was γα =3.973 (SE =0.794, P<0.001), both of which were significant. The effect of anxiety values on MOS-S values was always significant and ranged from 1.297 (SE =0.032) at month 3 to 1.529 (SE =0.039) at month 6.


Modeling the longitudinal latent effect of pregabalin on self-reported changes in sleep disturbances in outpatients with generalized anxiety disorder managed in routine clinical practice.

Ruiz MA, Álvarez E, Carrasco JL, Olivares JM, Pérez M, Rejas J - Drug Des Devel Ther (2015)

Estimated effect of pregabalin treatment on slope and intercept of MOS-S over time, with the presence of anxiety measures as covariates.Notes: Boxes represent observed variables, and circles unobserved error variables. Straight lines represent regression effects, and the values above them, raw estimated regression weights. Curved lines represent covariances, and values above their estimate. Values above exogenous variables represent means and variances, and values above endogenous variables represent means. Estimated mean values for the random slope (α) and intercept (β) have been labeled.Abbreviations: Anxiety0, anxiety score at baseline; Anxiety3, anxiety score at month 3; Anxiety6, anxiety score at month 6; MOS-S, Medical Outcomes Study-Sleep Scale; Sleep0, sleep score at baseline; Sleep3, sleep score at month 3; Sleep6, sleep score at month 6.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4532214&req=5

f3-dddt-9-4329: Estimated effect of pregabalin treatment on slope and intercept of MOS-S over time, with the presence of anxiety measures as covariates.Notes: Boxes represent observed variables, and circles unobserved error variables. Straight lines represent regression effects, and the values above them, raw estimated regression weights. Curved lines represent covariances, and values above their estimate. Values above exogenous variables represent means and variances, and values above endogenous variables represent means. Estimated mean values for the random slope (α) and intercept (β) have been labeled.Abbreviations: Anxiety0, anxiety score at baseline; Anxiety3, anxiety score at month 3; Anxiety6, anxiety score at month 6; MOS-S, Medical Outcomes Study-Sleep Scale; Sleep0, sleep score at baseline; Sleep3, sleep score at month 3; Sleep6, sleep score at month 6.
Mentions: Lastly, we obtained the estimated change in slope (and intercept) after discounting the effect of anxiety changes over time using the restricted model with covariates (Figure 3). The mean slope for the MOS-S trajectory for the UC group after adjusting for anxiety reduction was µβ =−7.598 (SE =1.233, P<0.001), while the mean intercept for this group was µα =15.970 (SE =1.102, P<0.001). The estimated change in the random slope of MOS-S change over time due to pregabalin treatment, as compared with UC, was γβ =−3.990 (SE =0.863, P<0.001), and the estimated impact on the random intercept was γα =3.973 (SE =0.794, P<0.001), both of which were significant. The effect of anxiety values on MOS-S values was always significant and ranged from 1.297 (SE =0.032) at month 3 to 1.529 (SE =0.039) at month 6.

Bottom Line: Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: -15.9 (-15.2; -16.6) vs -14.5 (-13.5; -15.5), P=0.027, in Hamilton Anxiety Scale; and -29.7 (-28.1; -31.3) vs -24.0 (-21.6; -26.4), P<0.001, in MOS-S.The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =-3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms.A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement.

View Article: PubMed Central - PubMed

Affiliation: Department of Methodology, School of Psychology, Universidad Autónoma de Madrid, Madrid, Spain.

ABSTRACT

Background: Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD) being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC) therapies on changes in sleep in outpatients with GAD under routine clinical practice.

Methods: Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale) and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S]) were estimated by a conditional latent curve model applying structural equation modeling.

Results: A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: -15.9 (-15.2; -16.6) vs -14.5 (-13.5; -15.5), P=0.027, in Hamilton Anxiety Scale; and -29.7 (-28.1; -31.3) vs -24.0 (-21.6; -26.4), P<0.001, in MOS-S. The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =-3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms. A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement.

Conclusion: A substantial proportion of the incremental improvements in anxiety-related sleep disturbances with pregabalin vs UC were explained by its direct effect, not mediated by improvements in anxiety symptoms.

No MeSH data available.


Related in: MedlinePlus