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Efficacy and tolerability of controlled-release paroxetine in the treatment of panic disorder.
J Clin Psychiatry. 2005 Jan; 66(1):34-40.JC

Abstract

OBJECTIVE

To assess the efficacy and tolerability of controlled-release paroxetine (paroxetine CR) in the treatment of adults with panic disorder.

METHOD

Paroxetine CR (25-75 mg/day; N = 444) was compared with placebo (N = 445) in patients with DSM-IV panic disorder with or without agoraphobia in 3 identical, double-blind, placebo-controlled, 10-week clinical trials that were pooled for analysis.

RESULTS

Paroxetine CR was statistically superior to placebo in the primary outcome measure, percentage of patients who were free of panic attacks in the 2 weeks prior to endpoint. Of the total population that completed or prematurely terminated treatment, 63% and 53% of paroxetine CR-and placebo-treated patients, respectively, were panic-free during the final 2 weeks (p < .005; odds ratio [OR] = 1.63; 95% CI = 1.21 to 2.19). For week 10 completers (72% of total), 73% and 60% of paroxetine CR- and placebo-treated patients, respectively, were panic-free at week 10 (p < .005; OR = 2.11; 95% CI = 1.45 to 3.07). Paroxetine CR was also statistically superior to placebo on the global improvement and severity items of the Clinical Global Impressions scale and in reducing anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety total score and total fear and avoidance on the Marks-Sheehan Phobia Scale. Adverse events leading to study withdrawal were minimal and occurred in 11% of the paroxetine CR group and 6% of the placebo group. Most of the treatment-emergent adverse events were rated as mild to moderate in severity and occurred early in the study. There were no unexpected adverse events, and serious adverse events were uncommon (10 [2.3%] of the 444 patients treated with paroxetine CR vs. 8 [1.8%] of the 445 patients treated with placebo).

CONCLUSION

Paroxetine CR is an effective and well-tolerated treatment for panic disorder. Paroxetine CR is associated with low rates of treatment-emergent anxiety as well as low dropout rates from adverse events.

Authors+Show Affiliations

Institute for Research in Psychiatry, Department of Psychiatry, University of South Florida, Tampa, FL 33613-4788, USA. dsheehan@hsc.usf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15669886

Citation

Sheehan, David V., et al. "Efficacy and Tolerability of Controlled-release Paroxetine in the Treatment of Panic Disorder." The Journal of Clinical Psychiatry, vol. 66, no. 1, 2005, pp. 34-40.
Sheehan DV, Burnham DB, Iyengar MK, et al. Efficacy and tolerability of controlled-release paroxetine in the treatment of panic disorder. J Clin Psychiatry. 2005;66(1):34-40.
Sheehan, D. V., Burnham, D. B., Iyengar, M. K., & Perera, P. (2005). Efficacy and tolerability of controlled-release paroxetine in the treatment of panic disorder. The Journal of Clinical Psychiatry, 66(1), 34-40.
Sheehan DV, et al. Efficacy and Tolerability of Controlled-release Paroxetine in the Treatment of Panic Disorder. J Clin Psychiatry. 2005;66(1):34-40. PubMed PMID: 15669886.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of controlled-release paroxetine in the treatment of panic disorder. AU - Sheehan,David V, AU - Burnham,Daniel B, AU - Iyengar,Malini K, AU - Perera,Philip, AU - ,, PY - 2005/1/27/pubmed PY - 2005/2/25/medline PY - 2005/1/27/entrez SP - 34 EP - 40 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 66 IS - 1 N2 - OBJECTIVE: To assess the efficacy and tolerability of controlled-release paroxetine (paroxetine CR) in the treatment of adults with panic disorder. METHOD: Paroxetine CR (25-75 mg/day; N = 444) was compared with placebo (N = 445) in patients with DSM-IV panic disorder with or without agoraphobia in 3 identical, double-blind, placebo-controlled, 10-week clinical trials that were pooled for analysis. RESULTS: Paroxetine CR was statistically superior to placebo in the primary outcome measure, percentage of patients who were free of panic attacks in the 2 weeks prior to endpoint. Of the total population that completed or prematurely terminated treatment, 63% and 53% of paroxetine CR-and placebo-treated patients, respectively, were panic-free during the final 2 weeks (p < .005; odds ratio [OR] = 1.63; 95% CI = 1.21 to 2.19). For week 10 completers (72% of total), 73% and 60% of paroxetine CR- and placebo-treated patients, respectively, were panic-free at week 10 (p < .005; OR = 2.11; 95% CI = 1.45 to 3.07). Paroxetine CR was also statistically superior to placebo on the global improvement and severity items of the Clinical Global Impressions scale and in reducing anxiety symptoms as measured by the Hamilton Rating Scale for Anxiety total score and total fear and avoidance on the Marks-Sheehan Phobia Scale. Adverse events leading to study withdrawal were minimal and occurred in 11% of the paroxetine CR group and 6% of the placebo group. Most of the treatment-emergent adverse events were rated as mild to moderate in severity and occurred early in the study. There were no unexpected adverse events, and serious adverse events were uncommon (10 [2.3%] of the 444 patients treated with paroxetine CR vs. 8 [1.8%] of the 445 patients treated with placebo). CONCLUSION: Paroxetine CR is an effective and well-tolerated treatment for panic disorder. Paroxetine CR is associated with low rates of treatment-emergent anxiety as well as low dropout rates from adverse events. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/15669886/Efficacy_and_tolerability_of_controlled_release_paroxetine_in_the_treatment_of_panic_disorder_ L2 - http://www.psychiatrist.com/jcp/article/pages/2005/v66n01/v66n0105.aspx DB - PRIME DP - Unbound Medicine ER -