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Obesity and pharmacology

Obesity: new pharmacological advances

Credit: e-Magine Art/Flickr
New drugs will also assistant many bariatric patients manage weight regain post-surgery

New advances in pharmacology will help patients to achieve clinically significant weight loss, claimed Dr Donna H Ryan, Pennington Biomedical Research Center, Baton Rouge, LA.

In her presentation, ‘What’s up and coming? Will it make a Difference?’ at the Minimally Invasive Surgery Symposium, in Red Rock, Nevada, Ryan said obesity pharmacotherapy has changed in the past 12 months and her talked concentrated on the two most recent FDA approved drugs, Belviq (lorcaserin hydrochloride) and Qsymia (a combination of the drugs phentermine and topiramate in extended release formulation).

Dr Donna Ryan

Before the approvals of Belviq and Qsymia in June and July 2012, respectively, there were only two drugs approved; one for short-term use (phentermine) and one for long-term use (Orlistat).

Qsymia

Qsymia was assessed by the CONQUER randomised, double-blind, placebo controlled study, which included 93 centers in the US. The study recruited 2,487 patients aged 18–70 years who had at least two obesity-related comorbidities and were overweight or obese (BMI 27–45), although no lower BMI limit was set for patients diagnosed with diabetes at enrollment.

The 56 week study was design to assess the efficacy and safety of two doses of a once daily, controlled-release phentermine plus topiramate combination for weight reduction in adults who were overweight or obese, and had weight related comorbidities.

A total of 994 patients were randomised to the placebo group, 994 patients were randomised to receive 15mg phentermine/92mg topiramate dosage and the remaining 498 patients to receive 7.5mg phentermine/46mg topiramate dosage.

At 12 months, both doses of the phentermine plus topiramate combination showed greater efficacy than placebo for each primary outcome measure, and after 56 weeks of treatment patients treated with PHEN/TOP ER achieved weight loss of 9.8% (7.5mg phentermine/46mg) and 12.4% (15mg phentermine/92mg topiramate dosage) compared with baseline (and greater than placebo (1.6%).

Comorbidities

Both does of phentermine plus topiramate also resulted in reductions in systolic and diastolic blood pressure compared with placebo and more patients had their antihypertensive drugs withdrawn in the phentermine 7.5mg topiramate/46mg group (11%) and phentermine 15mg/topiramate 92mg group versus placebo.

Diabetic pateints (n=388) also reported greater reductions in glycated haemoglobin with both doses of phentermine plus topiramate than with placebo. Patients with pre-diabetes had greater reductions in fasting blood glucose and insulin with both doses of phentermine plus topiramate than with placebo. Fewer patients on active medication progressed to type 2 diabetes.

SEQUEL

Six hundred and seventy five patients were also included in SEQUEL, a 52 week extension study (227=placebo, 295=15mg phentermine/92mg topiramate dosage and 153= 7.5mg phentermine/46mg topiramate).

Overall, 84.0% of subjects completed the study, with similar completion rates among treatment groups. At week 108, PHEN/TPM ER was associated with significant, sustained weight loss (intent-to-treat with last observation carried forward; p<0.0001 compared with placebo) and that weight loss had been sustained for over two years at between 10-12% reduction in baseline body weight.

Significantly more PHEN/TPM ER–treated subjects at each dose achieved ≥5%, ≥10%, ≥15%, and ≥20% weight loss compared with placebo (p< 0.001). At two years, there was a 9.3% weight loss from baseline in the 7.5mg topiramate/46mg group and 10.5% in the 15mg/topiramate 92mg group.

Belviq

Belviq was assessed in a double-blind clinical trial, which randomly assigned 3,182 obese or overweight adults (mean BMI36.2) to receive lorcaserin at a dose of 10mg (n=1,595), or placebo (n=1,587), twice daily for 52 weeks. All patients also underwent diet and exercise counselling.

After 12 months, 47.5% of patients in the lorcaserin group and 20.3% in the placebo group had lost 5% or more of their body weight (p<0.001). The lorcaserin group also reported a marked reduction in systolic and diastolic blood pressure, fasting glucose, fasting insulin and haemoglobin levels, compared with placebo.

At one year, 55.4% of patients (883 of 1595) receiving lorcaserin and 45.1% of patients (716 of 1587) receiving placebo remained in the trial; 1,553 patients continued into year two.

Among the patients who received lorcaserin during the first year and who had lost 5% or more of their baseline weight at one year, the loss was maintained in more patients who continued to receive lorcaserin during the second year (67.9%) than in patients who received placebo during the second year (50.3%, p<0.001). Among 2,472 patients evaluated at 12 months and 1127 evaluated at after 24 months, the rate of cardiac valvulopathy was not increased with the use of lorcaserin. Among the most frequent adverse events reported with lorcaserin were headache, dizziness, and nausea. The rates of serious adverse events in the two groups were similar.

“These new drugs will also assist many bariatric patients manage weight regain post-surgery,” concluded Ryan. “Weight loss medications will become an important part of treatment in the fight against obesity.”

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