What is the evidence for requiring lifestyle management prior to or in conjunction with phentermine (Phentermine) and topiramate (Topiramate) therapy for weight loss?

From the Guidelines

Lifestyle management is a crucial component of weight loss treatment with phentermine and topiramate, and it is strongly recommended to be used in conjunction with the medication. The FDA approval of phentermine and topiramate emphasizes the importance of using the medication as an adjunct to a reduced-calorie diet and increased physical activity 1. The standard recommendation includes a 500-1000 calorie deficit diet and at least 150 minutes of moderate physical activity per week. This combined approach is supported by the understanding that sustainable weight management requires addressing both energy intake and expenditure.

Key Points to Consider

• Lifestyle modifications help address underlying behaviors that contribute to weight gain, while the medication enhances these efforts through appetite suppression (phentermine component) and reduced food cravings (topiramate component) 1.
• Without lifestyle changes, patients may not develop the long-term habits necessary to maintain weight loss after medication discontinuation, potentially leading to weight regain.
• The medication's side effects and contraindications make it unsuitable as a standalone treatment for many patients, highlighting the need for a comprehensive approach that includes lifestyle management 1.
• Clinical guidelines and the medication's FDA approval emphasize the importance of using the medication in conjunction with lifestyle changes, suggesting that lifestyle management is not just a recommendation, but a necessary component of effective weight loss treatment.

Recommendations for Practice

• Healthcare providers should emphasize the importance of lifestyle management to patients prescribed phentermine and topiramate for weight loss.
• Patients should be encouraged to adopt a reduced-calorie diet and increase physical activity to at least 150 minutes of moderate exercise per week.
• Regular monitoring and follow-up appointments should be scheduled to assess patient progress and provide ongoing support and guidance.

From the FDA Drug Label

Phentermine Hydrochloride, USP 15 mg and 30 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors

The evidence suggests that lifestyle management, including exercise, behavioral modification, and caloric restriction, is required prior to or in conjunction with phentermine medication for weight loss.

• Key components of lifestyle management include:
  • Exercise
  • Behavioral modification
  • Caloric restriction 2

From the Research

Requirement of Lifestyle Management

The requirement of lifestyle management either prior to or in conjunction with the medication (phentermine and topiramate) for weight loss is emphasized in several studies.

• The FDA approval of phentermine and topiramate extended-release (phentermine/topiramate ER) for chronic weight management in obese adults and overweight adults with weight-related co-morbidities is contingent upon its use in conjunction with a reduced-calorie diet and increased physical activity 3.
• Lifestyle modification is considered the cornerstone of weight reduction, and pharmacotherapy, such as phentermine-topiramate ER, may be used as an adjunct to lifestyle modification 4.
• The US Food and Drug Administration (FDA) recently approved the combination of phentermine and extended release topiramate (phentermine/topiramate ER) for the treatment of obesity in conjunction with a lifestyle intervention 5.

Efficacy of Phentermine and Topiramate with Lifestyle Management

The efficacy of phentermine and topiramate in conjunction with lifestyle management has been demonstrated in several studies.

• A 56-week phase 3 trial found that the combination of phentermine and topiramate, with office-based lifestyle interventions, resulted in significant weight loss and improvement in metabolic risk factors 6.
• A 52-week extension study found that controlled-release phentermine/topiramate (PHEN/TPM CR), as an adjunct to lifestyle modification, resulted in significant, sustained weight loss and improvement in cardiovascular and metabolic variables 7.

Importance of Lifestyle Management

Lifestyle management is crucial for achieving and maintaining weight loss with phentermine and topiramate.

• The studies suggest that lifestyle modification, including a reduced-calorie diet and increased physical activity, is essential for achieving significant weight loss and improving metabolic risk factors 3, 4, 5, 6, 7.
• The combination of phentermine and topiramate with lifestyle management may provide a well-tolerated and effective option for the sustained treatment of obesity complicated by cardiometabolic disease 7.