Effects of desvenlafaxine on blood pressure in @entity1 treated for XXXX : a pooled analysis.

@entity1 @entity308 @entity101
OBJECTIVE: To evaluate the effect of the serotonin-norepinephrine re-uptake inhibitor desvenlafaxine on blood pressure and incidence of new onset @entity101 in pooled short-term studies and in two longer-term, randomized withdrawal studies. RESEARCH DESIGN AND METHODS: Data from @entity1 randomly assigned to desvenlafaxine 10   mg to 400   mg/day or placebo in 11 short-term (8-12 weeks), fixed-dose, double-blind, placebo-controlled studies of @entity308 ( @entity308 ) were pooled for analysis; two desvenlafaxine randomized withdrawal studies (36 and 46 weeks) were analyzed separately. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov , NCT00072774, NCT00073762, NCT00277823, NCT00300378, NCT00384033, NCT00798707, NCT00863798, NCT01121484, NCT00824291, NCT01432457, NCT00075257, NCT00887224. MAIN OUTCOME MEASURES: Outcomes included change from baseline in supine systolic blood pressure (SSBP) and supine diastolic blood pressure (SDBP), assessed using a mixed model repeated measures (MMRM) analysis, and incidence of @entity101 (defined as three consecutive second SDBP measures >= 90   mm Hg AND increase of >= 10   mm Hg from baseline and/or SSBP >= 140   mm Hg AND increase of >= 10   mm Hg), analyzed using Cochran Mantel Hanzael tests. Potential predictors of change in SSBP and SDBP at LOCF were examined by including predictor variables in a regression model. RESULTS: In the pooled, short-term studies, mean changes from baseline over time in SSBP and SDBP were statistically significant compared with placebo for the desvenlafaxine doses of 10   mg/day or greater for SSBP (p    <=   0.0004; MMRM) and 25   mg/day or greater for SDBP (p    <=   0.0449; MMRM). The proportion of @entity1 with new onset @entity101 differed significantly from placebo for the 50, 200, and 400   mg/day doses (1.9%, 2.4%, 4.8%, respectively, vs 0.8%; all p    <=   0.0244). Predictors of change in BP included baseline SDBP, baseline SSBP, dose, body mass index, gender, age, race, and history of @entity101 . LIMITATIONS: Data were pooled from studies which differed somewhat in study design and @entity1 demographics. None of the studies were originally designed to examine treatment effects on BP. Study entry criteria limit generalization of these results to medically stable @entity1 with a primary diagnosis of @entity308 . CONCLUSIONS: Short-term desvenlafaxine treatment was associated with small but statistically significant increases in SSBP and SDBP.
