Long-term efficacy of pregabalin in generalized anxiety disorder. Int Clin Psychopharmacol

Pfizer Global Research and Development, Ann Arbor, Missouri, USA.
International Clinical Psychopharmacology (Impact Factor: 2.46). 01/2008; 23(1):18-28. DOI: 10.1097/YIC.0b013e3282f0f0d7
Source: PubMed


A multicenter, randomized, placebo-controlled, double-blind study was conducted to evaluate the efficacy of pregabalin in preventing relapse of generalized anxiety disorder (GAD) after response to short-term treatment. Outpatients (n=624) with GAD for > or =1 year received open-label pregabalin (450 mg/day) for 8 weeks and, if a clinical response was observed, were randomized to receive either pregabalin (450 mg/day; n=168) or placebo (n=170) for 24 weeks. The primary efficacy parameter was time to relapse. Among responders to open-label acute treatment with pregabalin, time to relapse of GAD was significantly longer for patients treated with pregabalin compared with placebo (P<0.0001). Fifty per cent of the placebo group had relapsed by day 23, and at study endpoint, 65% had relapsed. In the pregabalin group, only 42% had relapsed by study end. Total attrition during double-blind treatment was somewhat higher on pregabalin compared with placebo (21.4 vs. 15.3%); attrition owing to adverse events (AEs) was also somewhat higher on pregabalin (6.0 vs. 2.4%). AEs were relatively low in the double-blind phase; only three AEs occurred with an incidence of more than 5% on pregabalin and placebo, respectively: infection (14.9 vs. 11.2%), headache (10.1 vs. 11.2%), and somnolence (6.0 vs. 0%). No safety concerns were identified with long-term treatment. The study indicates that pregabalin is an effective treatment for the prevention of relapse in patients with GAD.

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Available from: Atul C. Pande, Feb 27, 2015
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    • "Various anticonvulsant drugs, such as Carbamazepine or Valproate, have been used in the treatment of mood and anxiety disorders (Lipper et al., 1986; Tondo et al., 1989) as they have been found to be effective mood stabilizers in patients with bipolar disorder (Yatham et al., 2002) and are also beneficial in the treatment of anxiety disorders (Kinrys et al., 2003). Pregabalin, a gamma-aminobutyric acid analog, has been shown to have an acute anxiolytic effect in patients with generalized anxiety disorder (Pande et al., 2003; Pohl et al., 2005; Strawn and Geracioti, 2007) as well as being effective in long-term relapse prevention in patients with generalized anxiety disorder (Feltner et al., 2008). While its efficacy is comparable to benzodiazepines (Pande et al., 2003; Rickels et al., 2005), it is a well-tolerated drug with less cognitive and psychomotor side effects as well as less risk for dependence (Pande et al., 2003; Pohl et al., 2005), although latest data indicate that it does provide some potential for abuse Contents lists available at ScienceDirect journal homepage: "
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    ABSTRACT: Abstract Symptoms of anxiety are common in patients with depression. In this retrospective case series we investigated the effect of Pregabalin as an add-on medication in unipolar depressed patients with high levels of anxiety. The therapeutic effect of Pregabalin showed a fast onset and was comparable to the anxiolytic effect of benzodiazepines.
    Psychiatry Research 01/2014; 215(1-1):246 - 248. DOI:10.1016/j.psychres.2013.10.007 · 2.47 Impact Factor
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    • "The randomized double-blind placebo-controlled evidence base supporting the use of pregabalin in GAD has steadily expanded, and currently comprises six short term (4–6 week) fixed-dose studies;62–67 two short-term (8-week) flexible-dose studies, one in elderly patients,68 the other in younger patients;69 a single long-term (6-month) fixed dose relapse prevention study;70 and a short-term (8-week) flexible-dose study in patients who had not responded to previous treatment with either an SSRI or SNRI antidepressant (Table 1).71 "
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    ABSTRACT: A PREVIOUS REVIEW SUMMARIZED WHAT WAS THEN KNOWN ABOUT THE POTENTIAL ROLE OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH GENERALIZED ANXIETY DISORDER (GAD): this review provides an update on its pharmacological properties and presumed mechanism of action, the liability for abuse, and efficacy and tolerability in patients with GAD. Pregabalin has a similar molecular structure to the inhibitory neurotransmitter gamma amino butyric acid (GABA) but its mechanism of action does not appear to be mediated through effects on GABA. Instead, its anxiolytic effects may arise through high-affinity binding to the alpha-2-delta sub-unit of the P/Q type voltage-gated calcium channel in "over-excited" presynaptic neurons, thereby reducing the release of excitatory neurotransmitters such as glutamate. The findings of randomized controlled trials and meta-analyses together indicate that pregabalin is efficacious in both acute treatment and relapse prevention in GAD, with some evidence of an early onset of effect, and broad efficacy in reducing the severity of psychological and physical symptoms of anxiety. It also has efficacy as an augmenting agent after non-response to antidepressant treatment in GAD. Continuing vigilance is needed in assessing its potential abuse liability but the tolerability profile of pregabalin may confer some advantages over other pharmacological treatments in the short term for treatment in patients with GAD.
    Neuropsychiatric Disease and Treatment 06/2013; 9:883-92. DOI:10.2147/NDT.S36453 · 1.74 Impact Factor
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    • "Pregabalin treatment attenuated the ratings of anxious, irritable, and frustrated following 2.5 days of tobacco abstinence. These selective effects of pregabalin are consistent with its antianxiety properties which have been demonstrated in randomized clinical trials (Feltner et al. 2008; Montgomery et al. 2008; Montgomery et al. 2006). Consistent with its effects on tobacco withdrawal, pregabalin attenuated alcohol withdrawal symptoms in clinical studies (Di Nicola et al. 2010; Martinotti et al. 2010). "
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    ABSTRACT: In preclinical and clinical studies, medications enhancing the GABA neurotransmission attenuate nicotine reward. Pregabalin, a GABA analogue, presumably interacts with brain glutamate and GABA neurotransmission. The goal of this study was to determine pregabalin's effects on smoking behavior, nicotine withdrawal, craving for cigarettes, and cognitive performance. Twenty-four smokers participated in an outpatient double-blind, placebo-controlled, crossover study. Subjects had a 4-day treatment period with either pregabalin (300 mg/day) or placebo and following a washout period were then crossed over for 4 days to the other treatment. In each treatment period, starting at midnight of day 1, participants were asked to stop smoking until the experimental session on day 4. During the experimental session measures of ad lib smoking behavior, tobacco withdrawal, craving for cigarettes, and cognitive performance were obtained. Pregabalin treatment, compared to placebo, did not reduce the smoking behavior during the first 3 days of treatment or during ad lib smoking period. Pregabalin treatment attenuated some tobacco withdrawal symptoms including ratings of anxious, irritable, and frustrated in abstinent smokers. Pregabalin treatment also attenuated the subjective ratings of "liking" in response to smoking. Under pregabalin treatment, smokers made more errors in a sustained attention task. These findings provide limited support for pregabalin as a treatment for nicotine addiction.
    Psychopharmacology 09/2011; 220(3):611-7. DOI:10.1007/s00213-011-2507-x · 3.88 Impact Factor
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