Effects of olanzapine long-acting injection on levels of functioning among acutely ill patients with schizophrenia

Abstract

Objective:

To assess the effects of olanzapine long-acting injection (olanzapine-LAI) on levels of functioning in acutely ill patients with schizophrenia.     

Real-world use patterns of olanzapine long-acting injection in the United States: comparison to the recommended dosing strategy

Abstract

Objective:

Recommended doses for olanzapine long-acting injection (olanzapine LAI) are 150?mg/2 weeks, 210?mg/2 weeks, 300?mg/2 or 4 weeks, and 405?mg/4 weeks. This analysis evaluated the dosing and interval patterns to compare the actual dosing patterns with the recommended dosing strategy.     

Comparison of metabolic effects of ziprasidone versus olanzapine treatment in patients with first-episode schizophrenia

Objective

The objective of the study was to compare metabolic effects of ziprasidone versus olanzapine treatment in patients with first-episode schizophrenia.

Methods

In this 6-week, multicenter, open-label trial, 260 patients were randomly assigned to receive ziprasidone or olanzapine treatment (130 per group). Primary metabolic measures were changes in weight and body mass index (BMI). Secondary metabolic measures were changes in glucose, insulin, lipids, and blood pressure. Efficacy and safety were also measured additionally.

Results

A total number of 230 patients completed the study. The mean daily dosages were 138.2(28.6) mg for ziprasidone and 19.0(2.3) mg for olanzapine. After 6-week treatment, there were significant between-group differences in change scores on weight [4.22(3.49) kg versus ?0.84(2.04) kg, p < 0.001] and BMI [1.59(1.37) versus ?0.30(0.74), p < 0.001]. In addition, there were significant between-group differences in change scores on fasting plasma glucose, insulin, homeostasis model assessment 2-insulin resistance, low-density lipoprotein, total cholesterol, and triglycerides (p < 0.001); all the changes were clinically in favor of ziprasidone treatment. Both medications were effective in improving schizophrenia symptoms, but the decreases in Positive and Negative Syndrome Scale total scores of the olanzapine group were significantly greater than that of the ziprasidone group (p < 0.05). Compared with olanzapine, ziprasidone also induced more prolonging of corrected QT interval and extrapyramidal side effects (p < 0.05). Both medications were well tolerated, and no serious adverse events were observed in either group.

Conclusions

Compared with olanzapine, ziprasidone treatment was associated with less adverse effects on glucose and lipid metabolism in patients with first-episode schizophrenia.     

Acute back pain: benefits and risks of current treatments

Abstract

Objective:

To review the efficacy and safety of current treatments for acute low back pain.     

The effect of ethinylestradiol-containing contraceptives on the serum concentration of olanzapine and N-desmethyl olanzapine

AIM

To investigate the potential interaction between olanzapine, a CYP1A2 substrate, and ethinylestradiol-containing contraceptives (ECC).

METHODS

The study was carried out at a routine therapeutic drug monitoring service. To identify patients who were co-administered ECC or other contraceptives, a questionnaire was sent to the physician who ordered serum monitoring of olanzapine for women aged 18–40 years during an 18 month period. The physicians were asked to provide information about contraceptive use and smoking habits. When questionnaires were returned by the physicians, the respective serum concentration data were included in the analysis. Patients were stratified into users of ECC, progestogen-based contraceptives (PBC) or no contraceptives. Dose-adjusted serum concentrations of olanzapine and the metabolite N-desmethyl olanzapine were compared between the subgroups.

RESULTS

A total of 149 patients were included in the study (10 ECC users and 10 PBC users). In users of ECC, we found no differences in serum concentrations of olanzapine, but significantly lower concentrations of the CYP1A2-mediated metabolite N-desmethyl olanzapine compared with users of PBC (P = 0.019) and non-contraceptive users (P = 0.012).

CONCLUSION

The present study confirms that ECC exhibit CYP1A2-inhibitory properties in terms of significantly lower exposure of N-desmethyl olanzapine. However, the inhibition does not provide clinically relevant changes in serum concentrations of olanzapine.     

Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized,placebo-controlled study in patients with acute low back pain

Abstract

Objective:

Combinations of oral analgesics may offer several potential benefits compared with an individual agent. The objective of this study was to investigate the efficacy and safety of an extended-release, twice-daily fixed combination of 75?mg tramadol/650?mg paracetamol (DDS-06C) in the treatment of moderate-to-severe pain, using acute low back pain as a model.     

Semiological evaluation of pain according to its origin: a prospective,observational, and national study of current French medical practice

Abstract

Objective:

To determine how the origin of acute pain influences its semiological characteristics, and to evaluate the efficacy and safety of two Level 2 analgesic combinations in general practice.     

Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension

Abstract

Objective:

To assess the long-term safety and antihypertensive efficacy of aliskiren/valsartan 300/320?mg combination.     

Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients inadequately controlled with amlodipine monotherapy

Abstract

Objective:

The antihypertensive efficacy of amlodipine/valsartan combination has not been evaluated in Asian patients as previous large-scale studies enrolled very few patients. This multicentre, randomised, double-blind study assessed the efficacy and safety of a single-pill combination of amlodipine/valsartan versus amlodipine in Asian hypertensive patients.     

Diclofenac epolamine medicated plaster in the treatment of minor soft tissue injuries: a multicenter randomized controlled trial

Abstract

Objective:

To investigate the efficacy and safety of a topical plaster containing diclofenac epolamine (DHEP) 1.3% in the treatment of patients with acute minor soft tissue injuries in China.     

Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability

Abstract

Objective:

Short-term clinical trials have demonstrated the efficacy and safety of pregabalin in the treatment of generalized anxiety disorder (GAD). This study examined long-term safety and tolerability of pregabalin in patients with GAD, social anxiety disorder (SAD), or panic disorder (PD).     

Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain

Abstract

Objective:

This multicenter, double-blind, placebo-controlled study using a randomized withdrawal design evaluated the efficacy and safety of once-daily OROS hydromorphone ER in the treatment of opioid-tolerant patients with chronic moderate-to-severe low back pain (LBP).     

Efficacy and tolerability of rosiglitazone and pioglitazone in drug-naïve Japanese patients with type 2 diabetes mellitus: a double-blind, 28 weeks’ treatment,comparative study

Abstract

Objective:

A 28-week, randomized, placebo-controlled study was performed to evaluate efficacy and tolerability of rosiglitazone in Japanese type 2 diabetes patients.     

Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes

Abstract

Objective:

The BENIFICIARY (BENIcar safety and efFICacy evaluatIon: An open-label, single-ARm, titration study in patients with hypertension and tYpe 2 diabetes) study was conducted to evaluate the efficacy and safety of olmesartan medoxomil (OM) plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.     

Long-term safety and efficacy of ambrisentan in Japanese adults with pulmonary arterial hypertension

Abstract

Objective:

To investigate the safety and efficacy of long-term administration of ambrisentan in Japanese adults with pulmonary arterial hypertension (PAH).     

Efficacy,safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension

Abstract

Objective:

To investigate the efficacy, safety, and pharmacokinetics of ambrisentan in Japanese adults with pulmonary arterial hypertension (PAH).     

Short- and long-term efficacy and safety of duloxetine in women with predominant stress urinary incontinence

Abstract

Objective:

To evaluate short- and long-term safety and efficacy of duloxetine in women with predominant stress urinary incontinence (SUI).     

Long-term safety,tolerability, and efficacy of fesoterodine treatment in men and women with overactive bladder symptoms

Abstract

Objective:

To evaluate long-term safety, tolerability, and efficacy of fesoterodine for men and women with overactive bladder (OAB) symptoms.     

Safety and efficacy outcomes of long-term treatment up to 4 years with 5% lidocaine medicated plaster in patients with post-herpetic neuralgia

Abstract

Objective:

Prospective evaluation of the long-term efficacy and safety of the 5% lidocaine medicated plaster in patients with post-herpetic neuralgia (PHN).     

Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe,chronic malignant tumor-related pain

Abstract

Objective:

This phase 3 study evaluated the efficacy and safety of tapentadol extended release (ER) compared with oxycodone controlled release (CR) for the management of moderate to severe, chronic malignant tumor-related cancer pain.