Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study

Abstract

Objective:

To examine the efficacy and tolerability of rosuvastatin 5?mg at daily and non-daily dosing regimens.     

A multicenter randomized double-masked comparative study of different preparations of alendronate in osteoporosis – monthly (four weeks) intravenous versus once weekly oral administrations

Abstract

Objective:

The aim of this study was to evaluate the efficacy and safety of intravenous alendronate (ALN) 900?µg every 4 weeks compared to oral ALN 35?mg once weekly.     

Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia

Abstract

Objective:

To examine the effects of abruptly withdrawing milnacipran during the 2-week discontinuation phase of a study in which FM patients had received 12 weeks of stable-dose treatment with milnacipran at 100?mg/day.     

Medication dosing patterns associated with duloxetine and pregabalin among patients with fibromyalgia

Abstract

Objective:

To examine medication dosing patterns of duloxetine and pregabalin among patients with fibromyalgia.     

Dosing patterns of three tumor necrosis factor blockers among patients with rheumatoid arthritis in a large United States managed care population

Abstract

Objective:

To describe dosing patterns of etanercept, adalimumab, and infliximab in rheumatoid arthritis (RA) patients in US managed care.     

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.     

Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy

Abstract

Objective:

To assess the long-term safety and efficacy of a fenofibrate/pravastatin 160/40?mg fixed-dose combination in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40?mg monotherapy.     

Efficacy and tolerability of the single-pill combination of aliskiren 300 mg/amlodipine 10 mg in hypertensive patients not controlled by olmesartan 40 mg/amlodipine 10 mg

Abstract

Objective:

We aimed to investigate whether the single pill combination (SPC) of aliskiren 300?mg and amlodipine 10?mg (ALIS 300/AMLO 10) improves blood pressure (BP) reduction in hypertensive patients not adequately controlled by the SPC olmesartan 40?mg and amlodipine 10?mg (OLM 40/AMLO 10).     

Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting

Abstract

Objective:

Assess comparative efficacy of liposome bupivacaine administered at doses ≤266?mg and bupivacaine HCl administered at doses ≤200?mg for postsurgical analgesia.     

Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder

Abstract

Objective:

To assess the onset of efficacy of fesoterodine 4?mg versus placebo in subjects with overactive bladder (OAB) symptoms     

Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine,valsartan, and hydrochlorothiazide for moderate to severe hypertension

Abstract

Objective:

To compare the antihypertensive efficacy and safety of once-daily triple therapy with amlodipine (Aml) 10?mg, valsartan (Val) 320?mg, and hydrochlorothiazide (HCTZ) 25?mg versus dual-therapy combinations of these components in patients with moderate to severe hypertension.     

Association between the brain-derived neurotrophic factor Val66Met polymorphism and therapeutic response to olanzapine in schizophrenia patients

Rationale

Brain-derived neurotrophic factor (BDNF) is a neurotrophin that plays a major role in neurogenesis and neuroplasticity, and in the modulation of several neurotransmitter systems including the dopaminergic system. There are mixed reports about the association between the BDNF Val66Met polymorphism, schizophrenia, and treatment response to antipsychotic drugs.

Objectives

The present study evaluated the association of the BDNF Val66Met polymorphism with treatment response to atypical antipsychotic olanzapine in schizophrenia and the possible predictive value of the BDNF Val66Met genotype status in treatment response to antipsychotic medication.

Methods

The study included 590 ethnically homogenous Caucasian patients with schizophrenia (diagnosed using the SCID), 40.2?±?12.0 years old, treated with olanzapine monotherapy (10–20 mg/day), or with other antipsychotics such as risperidone (3–6 mg/day), clozapine (100–500 mg/day), haloperidol (3–115 mg/day), fluphenazine (4–25 mg/day), and quetiapine (50–800 mg/day). Patients were subdivided into responders and non-responders according to a 50 % reduction in the Positive and Negative Syndrome Scale (PANSS) total and subscale scores after 8 weeks of treatment.

Results

The results, corrected for possible effects of gender and age, showed a significant association between the BDNF Val66Met polymorphism and treatment response to olanzapine in patients. The Val/Val genotype was observed more frequently in treatment responders to olanzapine, and this genotype was associated with an improvement in clinical symptoms.

Conclusions

Our results suggest that BDNF Val66Met variants might influence the response to 8 weeks of monotherapy with olanzapine, in a relatively large sample of patients with schizophrenia.     

Weight loss dynamics during combined fluoxetine and olanzapine treatment

Background

Fluoxetine and olanzapine combination therapy is rapidly becoming an effective strategy for managing symptoms of treatment-resistant depression. Determining drug-drug interactions, drug metabolism and pharmacokinetics is of particular interest for revealing potential liabilities associated with drug augmentation in special patient populations. In the current studies, we chronically administered fluoxetine and olanzapine in non-stressed rats to extend our previous findings regarding body weight dynamics.

Results

Chronic fluoxetine (10 mg/kg) and olanzapine (5 mg/kg and 0.5 mg/kg) treatment decreased weight gain irrespective of olanzapine dosing. At the 10 mg/kg and 5 mg/kg dose, respectively, fluoxetine and olanzapine also significantly reduced food and water consumption. This pharmacodynamic event-related effect, however, was not observed at the 10 mg/kg and 0.5 mg/kg dosing paradigm suggesting differences in tolerability rates as a function of olanzapine dose. The decrease in weight gain was not associated with apparent changes in glucose metabolism as vehicle- and drug-treated rats showed undistinguishable serum glucose levels. The combination of fluoxetine and olanzapine in rats yielded drug plasma concentrations that fell within an expected therapeutic range for these drugs in psychiatric patients.

Conclusions

These data suggest that fluoxetine and olanzapine treatment decreases weight gain in rats; a pharmacodynamic event-related effect that differs considerably from what is observed in the clinical condition. The possibility of mismatched models regarding body weight changes during drug augmentation therapy should be seriously considered.     

Post hoc analysis of the Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term risk (CRUCIAL) trial

Abstract

Objective:

A proactive, multifactorial intervention strategy incorporating single-pill amlodipine/atorvastatin (SPAA) (5–10/10?mg up-titrated to 5–10/20?mg, where approved) is more effective than physician’s usual care (UC) for reducing calculated 10 year coronary heart disease (CHD) risk, in patients with hypertension and additional risk factors (CRUCIAL trial: Curr Med Res Opin 2011;27:821--33). As SPAA combinations containing atorvastatin 20?mg are not approved in some countries, this post hoc analysis investigated the efficacy and safety of a proactive intervention strategy incorporating low-dose SPAA (5/10 or 10/10?mg) only (low-dose PI) versus UC.     

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.     

Begin with the Real-world Patients of Non-goal-achieved Hypercholesterolemia in Taiwan through the Ezetimibe/Simvastatin Tablet – The BRAVO Study

Abstract

Objective:

To assess the efficacy, safety, and tolerability of a combination of 10?mg ezetimibe and 20?mg simvastatin in Taiwanese patients with hypercholesterolemia.     

Safety and efficacy of olanzapine monotherapy and olanzapine with a mood stabilizer in 18-week treatment of manic/mixed episodes for Japanese patients with bipolar I disorder

Abstract

Objective:

To assess the safety and efficacy of 18-week olanzapine monotherapy in Japanese patients with bipolar mania, following a 6-week, placebo- and haloperidol-controlled double-blind study (acute study). For those who discontinued the acute study due to lack of efficacy, safety and efficacy was assessed with a combination therapy of olanzapine and a mood stabilizer.     

Comparison of quetiapine and risperidone in Chinese Han patients with schizophrenia: results of a single-blind,randomized study

Abstract

Objective:

To evaluate the efficacy and safety of 750?mg/day quetiapine fumarate (Seroquel) in the treatment of Chinese Han patients with schizophrenia.     

Estimation of the impact of noncompliance on pharmacokinetics: an analysis of the influence of dosing regimens

AIMS

To determine whether, for oxybutynin and risperidone, drug exposure is better with less frequent dosing regimens than with regimens that require more frequent dosing.

METHODS

Pharmacokinetic models of oxybutynin (5 mg twice-daily and 10 mg once-daily) and risperidone (2 mg once-daily orally and 25 mg fortnightly intramuscular injection) were developed. Simulations of multiple doses were performed by use of stochastic models of dose-taking compliance and clinic visit attendance.

RESULTS

At therapeutic concentrations and with typical patterns of noncompliance, intramuscular injections of risperidone resulted in a 41% (SD 12%) greater pharmacokinetic coverage than the oral dose, 76% (SD 10%) vs. 35% (SD 7%). No discernable differences were evident between once- and twice-daily formulations of oxybutynin, 29.2% (SD 10%) vs. 29.0% (SD 13%).

CONCLUSIONS

For equivalent doses for each drug, the longer acting preparation of risperidone, but not oxybutynin, is pharmacokinetically more forgiving of noncompliance than the shorter acting counterparts. Further analysis is required to confirm whether these observations are valid clinically.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT

• Patient compliance is better with formulations that require less frequent dosing than with formulations that require more frequent dosing.
• Intramuscular risperidone and long-acting oxybutynin are two examples of medicines reformulated for less frequent dosing.
• However, it is not clear whether better compliance with less frequent dosing regimens translates to improved therapeutic outcome.

WHAT THIS STUDY ADDS

• At equivalent daily doses and typical patterns of compliance, fortnightly intramuscular depot administrations of risperidone provide better pharmacokinetic coverage than once-daily oral dosing.
• Once-daily dosing of oxybutynin is no better at maintaining pharmacokinetic exposure than twice-daily dosing at half strength.
• The use of simulated compliance data as input to pharmacokinetic models is useful to assess the impact of noncompliance on internal drug exposure.