Outlook: Clinical Trials

Michele Reed, PharmD
Published Online: Thursday, August 19, 2010
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Lorcaserin Demonstrates Efficacy in Weight Management
Recent clinical trial data showed that treatment with lorcaserin resulted in significant weight loss and improved maintenance of weight loss compared with placebo.1 In this double-blind, clinical study, 3182 obese or overweight patients (mean body mass index of 36.2 kg/m2) were randomized to receive either lorcaserin 10 mg or placebo twice daily during the 52-week treatment period. At the conclusion of 52 weeks, patients receiving placebo continued on placebo and patients receiving lorcaserin either continued lorcaserin treatment or were switched to placebo. All patients in the study also received nutritional and exercise counseling. The primary outcomes of the study were weight loss at 52 weeks as well as weight loss maintenance at 2 years.

At the end of 52 weeks, 883 (55.4%) patients in the lorcaserin group and 716 (45.1%) patients in the placebo group remained in the trial. After 1 year of treatment, patients in the lorcaserin group lost an average of 5.8 ± 0.2 kg compared with 2.2 ± 0.1 kg in the placebo group (P <.001). Additionally, 47.5% of patients receiving lorcaserin lost ≥5% of their body weight compared with 20.3% of patients in the placebo group (P <.001). Among patients who lost ≥5% of their body weight and continued lorcaserin treatment, 67.9% maintained their weight loss during year 2 compared with 50.3% of patients receiving placebo (P <.001). There was no reported increase in the risk of cardiac valvulopathy, as assessed by echocardiography, associated with the use of lorcaserin. Serious adverse-event rates did not differ significantly between treatment arms, and headache, dizziness, and nausea were frequently reported in the lorcaserin group. The new drug application for lorcaserin is currently under review with the FDA.


Long-Term Fluoxetine Monotherapy Versus Lithium Monotherapy in Bipolar II Major Depressive Episodes
Findings from a recent clinical trial showed that long-term fluoxetine monotherapy may be superior to lithium monotherapy in the prevention of relapse of bipolar II major depressive episodes.2 A randomized clinical trial included 81 patients ≥18 years of age who recovered from a bipolar II major depressive episode after receiving open-label fluoxetine monotherapy. After the initial 12-week, open-label fluoxetine treatment period, patients who scored ≤8 on the Hamilton Depression Rating Scale were randomized to receive fluoxetine 10-40 mg/day, lithium 300-1200 mg/day, or placebo for 50 weeks of double-blind treatment. The primary outcome of the study was time to relapse or recurrence of a major depressive episode.

Patients in the fluoxetine group showed the longest mean time to relapse at 249.9 days (95% confidence interval [CI], 186.8-312.9) compared with 156.4 days (95% CI, 92.3-220.6) and 186.9 days (95% CI, 113.0-260.7) for the lithium and placebo groups, respectively [P = .03]. Additionally, the hazard of relapse in the lithium group was 2.5 times greater than that in the fluoxetine group. There were no serious adverse events reported in the trial. The most frequent adverse events (>10%) across all treatment groups were headache, polyuria, polydipsia, tremor, weight gain, agitation, and minor depressive symptoms.


Citalopram Safe and Effective in the Management of Hot Flashes
The results of a phase 3, placebo-controlled trial of citalopram showed that 3 doses of citalopram were effective in the management of hot flashes.3 A total of 254 postmenopausal women with at least 14 bothersome hot flashes per week were evaluated in this randomized, double-blind trial. After recording hot flashes for 7 days prior to treatment initiation, the women were randomized to either titration of citalopram target doses of 10, 20, or 30 mg per day, or placebo. The primary outcome of the study was change in hot flash score from baseline to week 6.

Citalopram significantly reduced mean hot flash scores across all 3 doses compared with placebo (-2.0, -7.0, -7.7, and -10.7 for placebo, 10, 20, and 30 mg of citalopram, respectively [P≤.002]). Citalopram 20 mg also showed significant improvement in the secondary outcome of the Hot Flash Related Daily Interference Scale.


Glucosamine and Pain-Related Disability in Chronic LBP and Degenerative OA
The results of a double-blind, randomized study of 250 patients showed that oral glucosamine, when compared with placebo, did not reduce pain-related disability in chronic low back pain (LBP) and degenerative lumbar osteoarthritis (OA).4 Study subjects older than 25 years of age with chronic LBP for longer than 6 months and degenerative lumbar OA were randomized to receive 1500 mg of oral glucosamine or placebo for a period of 6 months. The primary outcome of the study was pain-related disability as measured by the Roland Morris Disability Questionnaire (RMDQ).

After 6 months of treatment, the mean RMDQ score was the same between the glucosamine and placebo groups (5.0; 95% confidence interval [CI], 4.2-5.8). At 1 year following study initiation (6 months postintervention), the mean RMDQ score for glucosamine was 4.8 (95% CI, 3.9-5.6) compared with 5.5 (95% CI, 4.7-6.4) for placebo. Mild adverse events were reported in both study groups.


Dr. Reed received her Doctor of Pharmacy degree from the University of the Sciences in Philadelphia and currently works as a medical editor in the greater Philadelphia area.

References

1. Smith SR, Weissman NJ, Anderson CM, et al. Multicenter, placebo-controlled trial of lorcaserin for weight management. N Engl J Med. 2010;363(3):245-256.
 
2. Amsterdam JD, Shults J. Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study. Am J Psychiatry. 2010;167(7):792-800.
 
3. Barton DL, LaVasseur BI, Sloan JA, et al. Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. J Clin Oncol.2010;28(20):3278-3283.
 
4. Wilkens P, Scheel IB, Grundnes O, Hellum C, Storheim K. Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial. JAMA. 2010;304(1):45-52.




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