Tags

Type your tag names separated by a space and hit enter

Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss.
J Manag Care Pharm. 2013 Oct; 19(8):642-54.JM

Abstract

BACKGROUND

Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities.

OBJECTIVE

To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result.

METHODS

A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website.

RESULTS

5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate.

CONCLUSIONS

Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed.

Authors+Show Affiliations

Blue Cross Blue Shield of Michigan/University of Michigan Health Systems, 600 E. Lafayette, Mail Code 512C, Detroit, MI 48226., USA E-mail: ekelly@bcbsm.com.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

24074010

Citation

Kelly, Elizabeth M., et al. "Formulary Management of 2 New Agents: Lorcaserin and Phentermine/topiramate for Weight Loss." Journal of Managed Care Pharmacy : JMCP, vol. 19, no. 8, 2013, pp. 642-54.
Kelly EM, Tungol AA, Wesolowicz LA. Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss. J Manag Care Pharm. 2013;19(8):642-54.
Kelly, E. M., Tungol, A. A., & Wesolowicz, L. A. (2013). Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss. Journal of Managed Care Pharmacy : JMCP, 19(8), 642-54.
Kelly EM, Tungol AA, Wesolowicz LA. Formulary Management of 2 New Agents: Lorcaserin and Phentermine/topiramate for Weight Loss. J Manag Care Pharm. 2013;19(8):642-54. PubMed PMID: 24074010.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulary management of 2 new agents: lorcaserin and phentermine/topiramate for weight loss. AU - Kelly,Elizabeth M, AU - Tungol,Alexandra A, AU - Wesolowicz,Laurie A, PY - 2013/10/1/entrez PY - 2013/10/1/pubmed PY - 2014/5/3/medline SP - 642 EP - 54 JF - Journal of managed care pharmacy : JMCP JO - J Manag Care Pharm VL - 19 IS - 8 N2 - BACKGROUND: Obesity may lead to the development of multiple chronic disease states, including hypertension, dyslipidemia, and type 2 diabetes mellitus. Over a half billion adults worldwide are affected by obesity, and more than two-thirds of adults are either obese or overweight in the United States. Diet and exercise have been the mainstays of treatment in this population; however, once failed, noninvasive, long-term effective treatment modality is lacking, and medications may potentially fill the void. Lorcaserin and phentermine/topiramate were approved by the FDA in June 2012 and July 2012, respectively, as adjuncts to diet and exercise for chronic weight management of obese (body mass index [BMI] ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) individuals with comorbidities. OBJECTIVE: To review the phase 3 trials of lorcaserin and phentermine/topiramate and provide managed care considerations that may be taken into account as a result. METHODS: A MEDLINE review was performed for articles published and available through September 17, 2012, using keywords "lorcaserin" or "phentermine/topiramate" with an emphasis on phase 3 trials. The literature search was limited to randomized controlled trials in humans published in the English language. Additional information on lorcaserin from its FDA review was obtained from the FDA website. RESULTS: 5 pivotal phase 3 trials were identified: 3 for lorcaserin and 2 for phentermine/topiramate. Both agents demonstrated a statistically significant higher proportion of individuals who lost ≥ 5% of body weight, as well as higher mean weight loss when compared with placebo. Safety concerns for lorcaserin include cardiac valvulopathy and increased risk of psychiatric, cognitive, and serotonergic adverse effects. Teratogenicity and increased heart rate are major safety concerns regarding phentermine/topiramate. CONCLUSIONS: Health care decision makers have many factors to consider when developing strategies to fight obesity. Despite a great need for new therapies to treat obesity, medications used for weight loss have significant side-effect profiles and contraindications that may limit therapy. An appropriate utilization management strategy is needed. SN - 1944-706X UR - https://www.unboundmedicine.com/medline/citation/24074010/Formulary_management_of_2_new_agents:_lorcaserin_and_phentermine/topiramate_for_weight_loss_ L2 - https://dx.doi.org/10.18553/jmcp.2013.19.8.642 DB - PRIME DP - Unbound Medicine ER -