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Desvenlafaxine Drug Assessment Pristiq® in Major Depressive Report Disorder in Adults @DTB Navarre.Es More Cost for Less

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Desvenlafaxine Drug Assessment Pristiq® in Major Depressive Report Disorder in Adults @DTB Navarre.Es More Cost for Less 03 2015 DESVENLAFAXINE DRUG ASSESSMENT Pristiq® in major depressive REPORT www.dtb.navarra.es disorder in adults @DTB_Navarre.es More cost for less... ABSTRACT Desvenlafaxine is an active me- tabolite of venlafaxine. Indications1 In the study against escitalopram4 flexible Treatment of major depressive disorder doses of desvenlafaxine were used (100 and In three placebo-controlled 200 mg daily) in postmenopausal women. No trials, the results on the reduc- 1 Mechanism of action advantage of desvenlafaxine over escitalopram tion in HAM-D17 score were not This is an active metabolite of venlafaxine, that was found. consistent. inhibits the reuptake of serotonine and nora- There is only one long-term study16 that eva- dernaline. Its bioavailability reaches up to 80% luated relapse prevention. Patients responding The most common adverse while elimination occurs without alteration after 8 weeks of treatment with desvenlafaxine effects are of gastrointestinal through the urine (45%) and metabolism by 50 mg daily and with a stable response up to origin or sleep disorders. There glucurono conjugation (19%). week 20 were randomized either to placebo or are no available long-term safe- desvenlafaxine 50 mg daily for 6 months. The ty data. Dosage and administration1 endpoint was time to relapse (defined as HAM- The recommended dose is 50 mg daily. The ta- D17 score ≥16), treatment withdrawal due to In the only head-to-head trial blets are swallowed wholly, with liquid with or unsatisfactory response, hospital admission carried out in post-menopause without food and at the same time. The increa- due to depression, suicide attempt or suicide. women, desvenlafaxine at high se in doses should be gradual and up to a maxi- Time to relapse was significantly lower in the doses did not show superiority mum of 200 mg daily and at intervals of at least case of placebo compared to desvenlafaxine versus escitalopram. 7 days. In cases of severe renal failure or termi- (p<0.001). The estimated probability of relapse nal renal disease the initial dose should be 50 at the end of treatment was greater in placebo The pharmaceutical company mg on alternate days. Dose reductions should group (30.3%) compared to the desvenlafaxine withdrew the application for also be gradual, during at least one or two wee- group (14.3%). marketing authorisation after an ks, given the risk of withdrawal symptoms. For initial evaluation by the EMA´s treatment lasting over 6 weeks, withdrawal Safety CHMP that concluded that des- should be carried out over at least a 2-week Adverse reactions1,17 venlafaxine was less effective period. If symptoms appear after discontinuing In general, these are mild or moderate, dose- than venlafaxine and did not pre- treatment or dose reduction, then restoring the dependent and more frequent in the first week.1 sent any advantages with regard previous dose should be considered. A pooled analysis17 of placebo-controlled stu- to safety. dies showed that the most frequent adverse Clinical efficacy reactions were nausea, vomiting, constipation, There are no studies including reference com- loss of appetite, dry mouth, hyperhidrosis, parators (SSRI, venlafaxine) in the general po- headache, dizziness, insomnia, fatigue, erectile CLASSIFICATION pulation. Only three randomised, double-blind, dysfunction, and tremor. Nausea was the most placebo-controlled, 8-week duration trials6,7,8 frequent adverse effect reported, 31.9% (des- IMPORTANT employed the recommended dose. One of them venlafaxine) vs 10.5% (placebo). THERAPEUTIC included a branch with duloxetine (60 mg daily). Drop outs due to adverse effects were asso- 4 INNOVATION The primary endpoint was change in the HAM- ciated with the dose administered, 4.1% (100 D17 score at week 8 compared to baseline mg daily) and 17.7% (400 mg daily). The pro- MODEST THERAPEUTIC (maximum score, 54 points; severe depression portion of drop outs in the placebo group was INNOVATION = 19-22 points). A 50% reduction in the HAM- 3.9%.17 3 D17 scale score was considered to be clinically Other adverse effects included increase in SOME ADDED relevant.9 A total of 1,097 patients were inclu- blood pressure, heart rate, cholesterol and VALUE IN SPECIFIC ded, and two thirds were women between 38 triglycerides, sexual function alterations and 2 SITUATIONS and 46 years of age. The average score at the orthostatic hypotension (more frequent in pa- 1 onset of the study was similar: 24, 23 and 23, tients > 65 years). NO THERAPEUTIC respectively (SD=3). The doses used were 50 INNOVATION 1 1 and 100 mg daily (see table below). Contraindications It was only in the case of the Boyer et al stu- Hypersensitivity to the main substance, some INSUFFICIENT dy that statistically significant differences of the excipients or to venlafaxine. EVIDENCE were found at both doses. The other two trials 0 showed statistically significant differences, one Warnings and precautions1 with the daily 50 mg dose and the other at 100 Use with precaution in patients with a history The qualification assigned to the drug was mg daily dose, but in both cases the clinical re- of mania or bipolar disorder; hypertension and agreed by the Drug Assessment Commit- levance was only modest (1.9 and 1.8). heart disorders (which may also require blood tees of Andalusia, Basque Country, Catalonia Studies with desvenlafaxine at higher doses pressure control); history of seizures; narrow Institute of Health, Aragon and Navarre. The current report is based on the available infor- (up to 400 mg daily) did not show any thera- angled glaucoma, acute glaucoma or elevated mation and is susceptible to be updated ac- peutic advantage compared to lower doses intraocular pressure; patients treated with anti- cording to the latest evidence. Let us remind the reader about the importance of notifying whereas more patients dropped out treatment coagulants or drugs affecting platelet function the Pharmacovigilance Centre when there due to adverse effects. and patients with known bleeding diathesis. are suspicions of adverse reactions to drugs. BOYER ET AL6 LIEBOWITZ ET AL7 TOURIAN ET AL8 DSV 50 DSV 100 PBO DSV 50 DSV 100 PBO DSV 50 DSV 100 PBO Baseline HAM- D17 24 24 24 23 23 23 23 23 24 Change HAM-D17 -13.2 -13.7 -10.7 -11.5 -11.0 -9.53 -9.8 -10.5 -8.7 DSV / PBO -2.5 -3.0 -- -1.9 -1.5 -- -1.1 -1.8 -- CI 95% (-0.9 to -4.1) (-1.4 to -4.7) -- (-0.3 to -3.5) (-0.1 to 3.1) -- (-0.6 to 2.7) (-0.2 to -3.4) -- p value 0.002 <0.001 -- 0.018 0.065 -- 0.198 0.028 -- Daily cost OF treatment (E) Desvenlafaxine (50 mg 28 comp.) 0.83 Sertraline (100 mg 30 comp.) 0.39 Venlafaxine (75 mg 30 caps.) 0.32 Escitalopram (10 mg 28 comp.) 0.31 Paroxetine (20 mg 28 comp.) 0.22 Citalopram (20 mg 28 comp.) 0.18 Fluoxetine (20 mg 28 caps.) 0.09 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 Withdrawal symptoms are frequent and initiated at least 7 days after discontinuing cal interventions. The SNRIs are an adequa- self-limited on treatment interruption or treatment with desvenlafaxine. Precaution te alternative in patients who do not respond after switching another antidepressant for is advised when using concomitantly drugs to SSRIs. The reference comparators would desvenlafaxine (including switching venla- such as SSRIs, triptans, other NSRIs, lithium, be SSRIs (fluoxetine, paroxetine, citalopram faxine to desvenlafaxine). sibutramine, tramadol or St. John’s wort and sertraline) and venlafaxine en case a Some cases of suicidal ideation and beha- (Hypericum perforatum) or any other drug change in therapeutic class is necessary.23 viour have been reported during treatment affecting the serotonin metabolism (MAII, The majority of the available studies pre- or soon after withdrawal. It is necessary to linezolid or tryptophan supplements). sent methodological limitations such as monitor high-risk patients and physicians Precaution should be taken in case of short duration, use of unauthorised doses should be consulted when self destructive combining desvenlafaxine with drugs or and exclusion of specific patients, which thoughts appear. substances with central action like alcohol makes an assessment of its efficacy difficult. or sedatives. The EMA carried out a preliminary as- Use in especial situations1 The concomitant use of desvenlafaxine sessment of desvenlafaxine and concluded Elderly patients: no dose adjustments are with drugs metabolised via CYP2D6 can in- that it was less effective than venlafaxine required. Dose increase should be made with crease the plasma concentrations of these and also presented no safety advantages. precaution given the risk of orthostatic hypo- drugs and those drugs that are substrates The pharmaceutical company decided to tension. Pediatric patients: not recommen- of CYP3A4 can lead to a lower exposure to withdraw the application for authorisation ded in patients under 18 years of age. Renal these drugs. at the EMA and applied for authorisation at impairment: a 50 mg daily dose is recom- a national level in Spain. mended on alternate days in cases of severe EMA Risk Management Plan1 Desvenlafaxine has not proven more effec- renal failure or terminal renal failure. Liver Desvenlafaxine has been authorised through tive than either the recommended SSRIs or impairment: dose adjustment is not neces- a national procedure (not centralised) and venlafaxine in the general population and its sary. Pregnancy: do not prescribe unless thus there is no existing EMA risk manage- long-term safety profile is still unknown. It is absolutely necessary. Breastfeeding: it is ment plan. recommended to continue using those anti- excreted in breast milk. Either breastfeeding depressants with is greater experience and or drug treatment should be discontinued.
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