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Query: UMLS:C0012833 (
dizziness
)
9,689
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
Nine hundred and twenty-two hypertensive patients were included in a substudy to the hypertension optimal (HOT) study which aimed to investigate the impact on quality of life of lowering the pressure and of intensified therapy. Patients were randomised to three diastolic BPs (DBPs) levels, i.e. < or = 90 mmHg, < or = 85 mmHg and < or = 80 mmHg. Seven hundred and eighty one patients completed both baseline and follow-up questionnaires after 6 months (intention to treat,
ITT
, population), while 610 patients were included in a per protocol (PP) analysis. The lower the DBP achieved, the greater the improvement in well-being (p < 0.05). The increase in well-being from baseline to 6 months was significant in target groups < or = 80 mmHg (p < 0.01) and < or = 85 mmHg (p < 0.05). Cardiac symptoms and
dizziness
improved in all groups but the sex life score deteriorated in the < or = 80 and < or = 85 mmHg groups in male patients. Headaches were reduced in all groups (p < 0.001), while swollen ankles (p < 0.001), and dry cough in the < or = 80 mmHg group (p < 0.001) increased. Despite a slight increase in subjective symptoms, more intensive antihypertensive therapy was still associated with improvements in patients' well-being.
...
PMID:[What is the effect of lowering the arterial blood pressure on the quality of life? An auxiliary study to the HOT (Hypertension Optimal Treatment) trial]. 1048 69
Enfuvirtide is a novel antiretroviral that blocks HIV-1 cell fusion and viral entry. This Phase II, controlled, open-label, randomized, multicentre dose-ranging trial explored the safety, antiviral activity and pharmacokinetics of enfuvirtide, administered by subcutaneous (s.c.) injection, in 71 HIV-1-infected, protease inhibitor-experienced, non-nucleoside reverse transcriptase inhibitor (NNRTI)-naive adults for 48 weeks. Study participants were randomized to receive enfuvirtide at a deliverable dose of 45, 67.5 or 90 mg twice daily; the 45 mg twice daily dose required 2 injections/day, while the higher doses required 4 injections/day. A background oral antiretroviral (ARV) regimen of abacavir (300 mg twice daily), amprenavir (1200 mg twice daily), ritonavir (200 mg twice daily) and efavirenz (600 mg once daily) was provided with enfuvirtide. A control group received the background ARV regimen alone. All potential participants underwent an HIV genotype at screen to ensure a homogenous population and to exclude patients with evidence of genotypic resistance to NNRTIs. Overall, the tolerability of the combination of abacavir, amprenavir, ritonavir, efavirenz and enfuvirtide was generally comparable to control through 48 weeks. No enfuvirtide dose-dependent adverse events (AEs) were observed across treatment groups. Injection site reactions (ISRs) occurred at least once in 68.5% of the enfuvirtide-treated population, and most ISRs were mild to moderate in severity, with no apparent dose relationship. Excluding ISRs, the most common treatment-emergent AEs were nausea, diarrhoea,
dizziness
and fatigue; with no clinically significant differences in the incidence of AEs observed between the control and enfuvirtide groups. Each treatment group benefited from ARV therapy, with a trend of increasing antiviral and immunological activity associated with increasing enfuvirtide dose. At 48 weeks, the median HIV-1 RNA change from baseline for the
ITT
population was -2.24 log10 copies/ml for the combined enfuvirtide groups compared with -1.87 log10 copies/ml for the control group. In addition, 54.9% of patients in the enfuvirtide group achieved HIV-1 RNA < or = 400 copies/ml versus 36.8% of patients in the control group. These results indicate that enfuvirtide has a favourable safety profile and is a promising new antiviral agent for HIV-infected patients who have been on previously failing ARV regimens.
...
PMID:A controlled Phase II trial assessing three doses of enfuvirtide (T-20) in combination with abacavir, amprenavir, ritonavir and efavirenz in non-nucleoside reverse transcriptase inhibitor-naive HIV-infected adults. 1451 96
The objective of this paper is to evaluate the efficacy of gepirone immediate-release (gepirone-IR) for relapse prevention in outpatients with MDD who had responded to initial gepirone-IR therapy. Patients with MDD and a HAM-D(25) score > or = 20 were treated with open-label gepirone-IR 20 to 90 mg/day for 6 weeks. Responders with a HAM-D(17) total score < or = 12 or with a > or = 50% reduction in total HAM-D(17) score and at least a "much improved" or "very much improved" CGI improvement score, were randomized to gepirone-IR or placebo for six additional weeks. Time to relapse was defined in six ways [(1) return to > or = 75% of baseline HAM-D(17) total score; (2) CGI improvement score of "no change" or "minimally worse," "much worse" or "very much worse" than baseline (> or = 4); and four more definitions combining the HAM-D(17) or CGI criteria with discontinuation, or discontinuation due to lack of efficacy] and analyzed for the
ITT
population using the LOCF method. Of 134 patients in the open-label phase, 70 were responders. In the double-blind phase, the relapse rate was significantly lower with gepirone-IR than with placebo (P < or = 0.05) for four of the six definitions of relapse. Discontinuations of gepirone-IR due to adverse events were observed for 26.9% of patients in the open-label phase, and four patients (6%) during the double-blind phase. The most frequent adverse events with gepirone-IR were
dizziness
, nausea, headache, and somnolence, and with placebo were headache and paresthesia. A relapse-prevention study of longer duration is needed to confirm these preliminary results. Gepirone-IR was significantly more effective than placebo for relapse prevention and demonstrated acceptable tolerability in outpatient responders with MDD.
...
PMID:Sustained efficacy of gepirone-IR in major depressive disorder: a double-blind placebo substitution trial. 1500 31