51 research outputs found

    The relationship between sales of SSRI, TCA and suicide rates in the Nordic countries

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    <p>Abstract</p> <p>Background</p> <p>In the period 1990-2006, strong and almost equivalent increases in sales figures of selective serotonin re-uptake inhibitors (SSRIs) were observed in all Nordic countries. The sales figures of tricyclic antidepressants (TCAs) dropped in Norway and Sweden in the nineties. After 2000, sales figures of TCAs have been almost constant in all Nordic countries. The potentially toxic effect of TCAs in overdose was an important reason for replacing TCAs with SSRIs when treating depression. We studied whether the rapid increase in sales of SSRIs and the corresponding decline in TCAs in the period 1990-98 were associated with a decline in suicide rates.</p> <p>Methods</p> <p>Aggregated suicide rates for the period 1975-2006 in four Nordic countries (Denmark, Finland, Norway and Sweden) were obtained from the national causes-of-death registries. The sales figures of antidepressants were provided from the wholesale registers in each of the Nordic countries. Data were analysed using Fisher's exact test and Pearson's correlation coefficient.</p> <p>Results</p> <p>There was no statistical association (P = 1.0) between the increase of sales figures of SSRIs and the decline in suicide rates. There was no statistical association (P = 1.0) between the decrease in the sale figures of TCAs and change in suicide rates either.</p> <p>Conclusions</p> <p>We found no evidence for the rapid increase in use of SSRIs and the corresponding decline in sales of TCAs being associated with a decline in the suicide rates in the Nordic countries in the period 1990-98. We did not find any inverse relationship between the increase in sales of SSRIs and declining suicide rates in four Nordic countries.</p

    Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis

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    Background Naltrexone is an opioid antagonist used in many different conditions, both licensed and unlicensed. It is used at widely varying doses from 3 - 250 mg. The aim of this review was to evaluate the safety of oral naltrexone by examining the risk of serious adverse events (SAEs) in randomised controlled trials (RCTs) of naltrexone compared to placebo. Methods A systematic search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, other databases and clinical trials registries was undertaken up to March 2018. Parallel placebo-controlled RCTs longer than 4 weeks published after 1/1/2001, of oral naltrexone at any dose were selected. Any condition and age group were included, excluding only studies for opioid or ex-opioid users, due to possible opioid/opioid antagonist interactions. The systematic review used the guidance of the Cochrane Handbook throughout. Numerical data was independently extracted by two people and cross-checked. Risk of bias was assessed with the Cochrane Risk of Bias Tool. Meta-analyses were performed using Stata 15 and R, using random and fixed effects models throughout. Results Eighty-nine RCTs with 11194 participants were found, studying alcohol use disorders, various psychiatric disorders, impulse control disorders, other addictions, obesity, Crohn’s disease, fibromyalgia and cancers. Twenty-six studies (4,960 participants) recorded SAEs occurring by arm of study. There was no evidence of increased risk of SAEs for naltrexone compared to placebo, relative risk (RR) 0.84 (95% CI: 0.66 to 1.06). Sensitivity analyses pooling risk differences supported this conclusion (RD = -0.01 (-0.02, 0.00)) and subgroup analyses showed that results were consistent across different doses and disease groups. The quality of evidence for this outcome was judged high using the GRADE criteria. Conclusions Naltrexone does not appear to increase the risk of SAEs over placebo. These findings confirm the safety of naltrexone when used in licensed indications and encourage investments to undertake efficacy studies in unlicensed indications
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