Заказ звонка
* Представьтесь:
* Ваш телефон:
Сообщение:
* - поля, обязательные для заполнения
Заказать звонок

Does age or ethnicity influence the safety of the drugs used to treat chronic constipation?

Are there subgroups of patients based on demographics (age, racial or ethnic groups, and gender), other medications, or co-morbidities, including Irritable Bowel Syndrome, for which one symptomatic treatment is more effective or associated with fewer adverse events?

I. Summary of findings

We did not find any studies published as full text articles specifically designed to examine the general or comparative efficacy of docusate calcium, docusate sodium, lactulose, lubiprostone, PEG 3350, psyllium, or tegaserod for chronic constipation or constipation associated with IBS in subpopulations.

Only one study, published as an abstract only, examined differences in the general efficacy of lubiprostone for chronic constipation based on sex.

Two RCTs support the general efficacy of tegaserod for the treatment of IBS-C in women. However, there is insufficient evidence available to determine whether any difference in efficacy between men and women existed.

Only two published abstracts examined the general efficacy of lubiprostone in elderly patients.

 

II. Detailed assessment

Sex

Chronic constipation

 We did not find any studies published as full text articles specifically designed to examine the general or comparative efficacy of docusate calcium, docusate sodium, lactulose, lubiprostone, PEG 3350, psyllium, or tegaserod for chronic constipation in men versus women. The available direct evidence is limited to one pooled data analysis comparing lubiprostone and placebo.28

This published abstract compared the efficacy of lubiprostone and placebo for treating chronic constipation in men versus women.28 Data were combined from three clinical trials. Men and women both responded favorably to lubiprostone experiencing approximately twice as many spontaneous bowel movements (SBMs) per week as placebo patients. Response rates were similar in males and females treated with lubiprostone (5.69–6.05 SBMs/week vs. 4.99–5.75 SBMs/week). No differences in harms were reported. This study was published as an abstract only; the information presented is insufficient to critically appraise the underlying methods of this study and draw firm conclusions.

Multiple studies enrolled primarily females as study participants.31, 33 37, 38 42 For example, in two RCTs on tegaserod 90%37 and 86%38 of patients were female. In general, effect sizes of treatment responses in such populations did not appear to be substantially different from those in populations with higher proportions of male participants. However, no firm conclusions about any differences in efficacy and safety between men and women can be drawn based on such assessments.

Constipation associated with IBS

We did not find any studies published as full text articles specifically designed to examine the general efficacy of docusate calcium, docusate sodium, lactulose, lubiprostone, PEG 3350, psyllium, or tegaserod for IBS-C in men versus women.

Two RCTs assessed the efficacy of tegaserod for IBS-C in female patients.50, 51 Both studies provide evidence that tegaserod provides a rapid and sustained improvement in IBS-C symptoms in female patients. Tegaserod has never had FDA approval for the treatment of IBS-C in males, and evidence on the general efficacy of tegaserod in men is sparse. Only three studies enrolled males and females with IBS-C (males comprised 12%–17% of patients). From these studies it remains unclear, however, whether any differences in efficacy between men and women existed.

We did not find any studies specifically designed to examine the comparative e     fficacy of docusate calcium, docusate sodium, lactulose, lubiprostone, PEG 3350, psyllium, or tegaserod for chronic constipation in men versus women.

 

Age

Chronic constipation

We did not find any studies published as full text articles specifically designed to examine the general efficacy of docusate calcium, docusate sodium, lactulose, lubiprostone, PEG 3350, psyllium, or tegaserod for chronic constipation in elderly populations. The available evidence is limited to two pooled data analyses comparing lubiprostone and placebo.26, 27

Two published abstracts examined the efficacy of lubiprostone in patients > 65 years.26, 27 In each study, data were pooled from three RCTs to provide an adequate pool of elderly subjects for analysis. Lubiprostone was well tolerated by elderly subjects in both studies. With regard to long-term efficacy, in the first pooled analysis, improvements in assessments of constipation severity, abdominal bloating, and abdominal discomfort, were all statistically significant at all post baseline time points from week 1 to week 48 in both elderly and non-elderly subgroups (P < 0.0001).27 In the second study, mean changes from baseline in SBM rates were significantly improved among lubiprostone elderly subjects compared to their placebo counterpoarts during weeks 1,2, and 4 (P ≤ 0.0286).26 However, because these studies were published as abstracts only, the available information is insufficient to critically appraise the underlying methods and draw firm conclusions.

We did not find any studies specifically designed to examine the comparative efficacy of docusate calcium, docusate sodium, lactulose, lubiprostone, PEG 3350, psyllium, or tegaserod.

Constipation associated with IBS

We did not find any evidence on differences of efficacy and harms of constipation drugs based on age.

 

Race or Ethnicity

We did not find any evidence on differences of efficacy and harms of constipation drugs for the treatment of chronic constipation or constipation associated with IBS based on race or ethnicity.

 

Co-morbidities

We did not find any evidence on differences of efficacy and harms of constipation drugs for the treatment of chronic constipation or constipation associated with IBS based on co-morbidities.