March 24, 2023

In this episode, I discuss the side effects of escitalopram (Lexapro, Cipralex).

All right so we’re now discussing adverse events or side effects so adverse drug reaction overview adverse events information with isitalopram was collected from 715 patients with major depressive disorder who were exposed to esotelopram and from not 592 patients who were exposed to placebo in a double-blind placebo-controlled trial during clinical trials all

Treatment groups were comparable with respect to gender age and race the mean age of patients was 41 years old the range was 18 to 76 of these patients approximately sixty six percent were female and thirty four percent were male the adverse event information for issa teleprom in patients with obsessive disorder was collected from two studies uh with double-blind

Placebo-controlled treatment over the period of 24 weeks in the first study a total of 227 patients were exposed to isotelopram and 114 to placebo in a 24-week double-blind placebo-controlled fixed dose trial with assessment at 12 and 24 weeks so right here they’re just explaining how the trials were conducted for ocd and for major depression we’re not actually

Into the side effects yet okay so adverse events observed in control trials adverse events associated with the discontinuation of treatment but from a short-term eight-week placebo-controlled phase three studies in patients suffering from major depressive disorder the incidence of discontinuation was 17.3 percent so 124 of 750 patients discontinued the medication

This continuation due to adverse events was more common in the active treatment group so five point nine percent isotelepram and five point four percent in the citalopram group and only two 2.2 percent in the placebo group the more people stop taking the medication um than the placebo due to side effects which is to be expected the events that were associated

With discontinuation of visa teleprom in one percent or more of patients at a rate of at least twice of that of placebo so these are the main things that were causing people to discontinue taking cetalopram so nausea is 1.5 versus 0.2 percent and ejaculation failure during the first 12 weeks of treatment in the 24-week placebo control trial discontinuation

Of treatment due to adverse events was reported for nine percent and 11 of the 227 ocd patients who were treated with 10 milligrams per day or 20 milligrams per day of visa teleprem respectively compared to five percent of the 114 patients receiving placebo so all patients who discontinued treatment due to adverse events in the isa teleprem group did so in the

First 12 weeks eight percent of patients receiving placebo discontinued treatment due to adverse events in the first in the 24-week total period adverse events that were associated with discontinuation of at least one percent of patients treated with esotelopram for which the rate was higher than placebo were nausea insomnia and erectile dysfunction so so

Far for the two studies with a major depressive disorder study and the obsessive-compulsive disorder study the main reasons people stopped taking the medication were nausea ejaculation failure erectile dysfunction insomnia and nausea most frequent adverse events adverse events that occurred in the isa teleprem treated patients in the course of the short-term

Placebo-controlled trials with an incidence greater or equal to 10 percent were headache and nausea the incidence of headache was higher in the placebo group which suggests that this is a non-specific symptom related to underlying condition or treatment administration the point prevalence of nausea increased during the first week and then decreased to approach

Placebo levels at the end of the studies okay so now we have a table with all the listed side effects and again these are from these studies that we discussed above and it shows the percentage of patients that experience these side effects on isa talapram compared to on placebo let’s just go through this chart here and look at just we’ll forget about placebo

But we’ll just look at the percentages of the group that we’re taking the medication so heart palpitations 1.4 percent vertigo 1.4 percent now with gastrointestinal disorders so nausea 15.2 percent diarrhea 8.4 percent dry mouth 6.6 constipation 3.5 um dyspepsia or upset stomach 3.1 then we have abnormal pain in the abnormal upper abdominal pain and stomach

Discomfort around 1.1 1.5 so continuing to move down we have fatigue about five percent hyrexia about one percent now infections and infestations so nasopharyngitis under five percent influenza four point three percent sinusitis two percent gastroenteritis and herpes simplex both under two percent um an increase in weight was 1.8 very close to placebo so hard

To really justify that um decreased appetite 2.4 percent increased appetite 1.7 percent um arthralgia or joint pain one point four percent pain in the extremity one point four percent dizziness six point three percent dominance four point 4.1 sedation 2.4 migraine 1.5 we have tremors 1.5 percent lethargy and sinus headaches both one percent insomnia eight

Point two percent that’s significant anxiety two point two percent decreased libido two point one percent which is much higher than placebo inability to have an orgasm 1.8 percent again much higher than placebo abnormal dreams 1.3 percent um hyperhidrosis so sweating 3.4 night sweats 1.7 percent rash one percent hot flush 2.2 percent this reproduction system

And breast disorder uh yeah so sexual side effects ejaculation delayed 3.6 notice here placebo we’re all zero percent so um these are significant ejaculation ejaculation failure 2.7 erectile dysfunction 2.7 percent ejaculation disorder 1.3 percent the following events had a higher incidence of in the placebo group compared to the isotelopram group vomiting

Abdominal pain flatulence upper respiratory tract infections bronchitis back pain neck pain and headache adverse reactions observed with isitalopram are in general mild and transient i’ll say that again adverse events observed with east teleprom are in general mild and transient they are most frequent during the first and or second week of treatment and usually

Decrease in intensity and frequency with continued treatment and do not generally lead to a cessation of therapy so typically your body gets used to the medication the side effects do go away in a clinical trial involving patients with major depressive disorder that compared fixed doses of isotelopram 10 or 20 milligrams a day with placebo the most common adverse

Events that occurred in patients treated with placebo or sorry treated with esotelopram are shown in table two so the most common adverse events that occurred in patients treated with isotelopram are shown here so diarrhea 10 for 10 milligrams a day 14 for 20 milligrams a day nausea 22 for 10 milligrams a day 13.6 percent for 20 milligrams a day insomnia about

11 percent for each dry mouth 11 and about 10 percent dizziness about 10 percent ejaculation failure so nobody taking 10 milligrams a day had ejaculation failure but 7.3 percent taking 20 milligrams did nasopharyngitis 5 on 10 7 on 20 constipation two point five percent on ten five point six percent on twenty dyspepsia six percent on ten four percent on twenty and

Bare no landriel pain six percent on 10 1.6 on 20. male and female sexual dysfunction with ssris while sexual dysfunction is often part of depression and other psychiatric disorders there is increasing evidence that treatment with selective serotonin reuptake inhibitors ssris may induce sexual side effects this is a difficult area to study because patients may

Not spontaneously report symptoms of this nature and therefore it is thought that sexual side effects with ssris may be underestimated so table three here shows the major sexual side effects so decreased libido two percent inability to have an orgasm one point eight percent now males only ejaculation delayed three point six percent ejaculation failure two point

Seven percent ejacu sorry erectile dysfunction two point seven percent and ejaculation disorder one point three percent they also have tables here um going through the studies for the obsessive compulsive disorder trial we just went through the side effects for the major depressive trial i don’t think there’s much use in going through the tables for both so if

You would like to go through these numbers pause the video now take a look at the numbers again obsessive compulsive disorder pause the video now take a look at the numbers it should be similar to that of the major depressive disorder group adverse reactions during treatment for up to 44 weeks the treatment emergent adverse event incidence profile of isa telepram

Is a longer term study in patients with major depressive disorder consisting of a 36-week placebo-controlled relapse observation phase in responders of a preceding eight-week acute treatment phase was similar to that observed in short-term studies so even when the medication is used for longer term the percentages of side effects still seem to be the same in those shorter trials

Transcribed from video
Side Effects of Escitalopram (Lexapro) By Drug Talk