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Clinical Trial
. 2023 Jul 1;14(7):e00598.
doi: 10.14309/ctg.0000000000000598.

Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide

Satish S C Rao  1 , Adam P Laitman  2 , Philip B Miner Jr  3
Affiliations
Clinical Trial

Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide

Satish S C Rao et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Chronic idiopathic constipation (CIC) is a common condition that affects some patient groups more often. Demographic/clinical characteristics can differ in presentation and therapeutic response. The impact of these characteristics on plecanatide efficacy/safety was examined.

Methods: Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed. Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender. Endpoints included durable overall complete spontaneous bowel movement (CSBM) responder rate, weekly CSBMs and spontaneous bowel movements (SBMs), and adverse events.

Results: Overall (N = 2,639; 3 mg of plecanatide [n = 877]; 6 mg of plecanatide [n = 877]; and placebo [n = 885]), CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001); as well, for 3 mg: 65 years or older ( P = 0.03), non-White individuals ( P < 0.001), and BMI ≥30 kg/m 2 ( P = 0.02). Improvement from baseline in weekly CSBM and SBM frequency occurred in all subgroups for both plecanatide doses vs placebo ( P ≤ 0.02) at week 12, except those aged 65 years or older for 6 mg of plecanatide. The most common adverse event was diarrhea (3 mg [4.9%]; 6 mg [5.4%]; and placebo [1.3%]).

Discussion: Pooled data from identically designed CIC trials strengthened the ability to identify meaningful subgroup comparisons regarding plecanatide efficacy and safety.

Trial registration: ClinicalTrials.gov NCT01982240.

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Conflict of interest statement

Guarantor of the article: Satish S.C. Rao, MD, PhD.

Specific author contributions: S.S.C.R., A.P.L., and P.B.M.: participated in the research of the article, had access to the data, and participated in the preparation of the article. All authors read and approved the final version of the manuscript.

Financial support: The trials were supported by Synergy Pharmaceuticals, and the post hoc analyses were supported by Salix Pharmaceuticals.

Potential competing interests: S.S.C.R. has served on advisory boards for Medtronic, Takeda Pharmaceuticals, and Salix Pharmaceuticals. A.P.L. is an employee of Salix Pharmaceuticals. P.B.M. reports having nothing to disclose.

IRB approval statement: Approvals were obtained for 1 trial (NCT01982240) from a centralized IRB (Schulman Associates IRB) and 4 site IRBs (Chesapeake IRB; NorthShore University HealthSystem IRB; University of Oklahoma Health Sciences Center IRB; and Western IRB). Approvals were obtained for 1 trial (NCT02122471) from a centralized IRB (Copernicus Group) and 1 site IRB (University of Oklahoma Health Sciences Center IRB).

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Percentage of patients with durable overall CSBM response for total population and by subgroup. *P ≤ 0.001 vs placebo. †P = 0.03 vs placebo. ‡P = 0.04 vs placebo. §P = 0.004 vs placebo. ¶P = 0.02 vs placebo. BMI, body mass index; CSBM, complete spontaneous bowel movement.
Figure 2.
Figure 2.
Change from baseline in (a) weekly CSBMs and (b) weekly SBMs in overall population and subgroups at week 12. *P ≤ 0.001 vs placebo. †P ≤ 0.01 vs placebo. ‡P = 0.02 vs placebo. BMI, body mass index; CSBM, complete spontaneous bowel movement; LSM, least squares mean; SBM, spontaneous bowel movement.
See this image and copyright information in PMC

References

    1. Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: Systematic review and meta-analysis. Am J Gastroenterol 2011;106(9):1582–91; quiz 1, 92. - PubMed
    1. Palsson OS, Whitehead W, Törnblom H, et al. Prevalence of Rome IV functional bowel disorders among adults in the United States, Canada, and the United Kingdom. Gastroenterology 2020;158(5):1262–73.e3. - PubMed
    1. Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide prevalence and burden of functional gastrointestinal disorders, results of Rome Foundation Global Study. Gastroenterology 2021;160(1):99–114.e3. - PubMed
    1. Nag A, Martin SA, Mladsi D, et al. The humanistic and economic burden of chronic idiopathic constipation in the USA: A systematic literature review. Clin Exp Gastroenterol 2020;13:13255–265. - PMC - PubMed
    1. Heidelbaugh JJ, Stelwagon M, Miller SA, et al. The spectrum of constipation-predominant irritable bowel syndrome and chronic idiopathic constipation: US survey assessing symptoms, care seeking, and disease burden. Am J Gastroenterol 2015;110(4):580–7. - PMC - PubMed

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