- |||||||||| colesevelam / Generic mfg.
Preclinical, Journal: The novel phosphate and bile acid sequestrant polymer SAR442357 delays disease progression in a rat model of diabetic nephropathy. (Pubmed Central) - May 1, 2021
In comparison, colesevelam, a BAS with poor phosphate binding properties, did not prevent DKD progression, whereas losartan, an angiotensin II receptor blocker that is widely used to treat DKD, showed no effect on hyperglycemia...Significance Statement A new non-absorbed polymeric sequestrant with optimum phosphate and bile salt sequestration properties was developed as a treatment option for DKD. The new polymeric sequestrant offered combined pharmacological benefits including glucose regulation, lipid lowering and attenuation of DKD progression in a single therapeutic agent.
- |||||||||| colesevelam / Generic mfg.
Trial completion date, Trial primary completion date: SINBAD: Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea (clinicaltrials.gov) - Apr 25, 2021
P4, N=170, Recruiting,
The new polymeric sequestrant offered combined pharmacological benefits including glucose regulation, lipid lowering and attenuation of DKD progression in a single therapeutic agent. Trial completion date: Mar 2021 --> Dec 2021 | Trial primary completion date: Sep 2020 --> Jun 2021
- |||||||||| colesevelam / Generic mfg.
Journal: Colesevelam in the management of type 2 diabetes. (Pubmed Central) - Mar 6, 2021
Expert opinion suggests possible indications where colesevelam may add value as a glucose lowering agent. It also highlights the limitations of the drug, and precautions that must be observed while using it.
- |||||||||| colesevelam / Generic mfg.
[VIRTUAL] FAMILIAL HYPERCHOLESTEROLEMIA CAUSING ACUTE CORONARY SYNDROME IN PREGNANCY (eAbstract site) - Feb 17, 2021 - Abstract #ACC2021ACC_5594;
She was started on dual antiplatelet therapy (DAPT) with aspirin and prasugrel, which is preferred over ticagrelor in pregnancy...She started colesevelam as a lipid-lowering agent, metoprolol, and a low-fat diet... This case illustrates the management of ACS due to familial hypercholesterolemia in pregnancy with consideration of DAPT selection and peripartum management and appropriate lipid-lowering therapy.
- |||||||||| Nexletol (bempedoic acid) / Esperion Therap, Otsuka
[VIRTUAL] REMARKABLE EFFICACY OF BEMPEDOIC ACID IN HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH) (eAbstract site) - Feb 17, 2021 - Abstract #ACC2021ACC_4007;
In this patient with HeFH who was previously quite responsive to statins and had a less than expected response to PCSK9i, bempedoic acid led to a substantial reduction of LDL-C. Our findings suggest that patients who are quite responsive to statins (including many individuals of Asian/Pacific Islander descent) may also be very responsive to bempedoic acid, a medication that works in the same cholesterol synthetic pathway as statins.
- |||||||||| Praluent (alirocumab) / Sanofi, Regeneron, Repatha (evolocumab) / Amgen, Astellas
Trial completion date, Trial primary completion date: PERI-DYS: Prospective German Very High Cardiovascular Risk Patients Dyslipidemia Treatment Indication Registry (clinicaltrials.gov) - Feb 2, 2021
P=N/A, N=2000, Recruiting,
Our findings suggest that patients who are quite responsive to statins (including many individuals of Asian/Pacific Islander descent) may also be very responsive to bempedoic acid, a medication that works in the same cholesterol synthetic pathway as statins. Trial completion date: Feb 2021 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2023
- |||||||||| metformin / Generic mfg.
Clinical, Journal, Real-World Evidence: Real-world Effectiveness of treatments for type 2 diabetes, hypercholesterolemia, and hypertension in Canadian routine care - Results from the CardioVascular and metabolic treatment in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry, 12-months results. (Pubmed Central) - Jan 16, 2021
Management of additional risk factors such as elevated lipoprotein(a) and statin intolerance is also described. In a real-world Canadian setting, MetER, C, AZI, AZI/CHL, and TXC show improvement of the cardiometabolic profile of T2D, HCh, and HTN patients.
- |||||||||| lenalidomide / Generic mfg., colesevelam / Generic mfg.
Trial completion date, Trial primary completion date: A Study of Colesevelam for Lenalidomide-Associated Diarrhea (clinicaltrials.gov) - Jan 11, 2021
P2, N=25, Recruiting,
In a real-world Canadian setting, MetER, C, AZI, AZI/CHL, and TXC show improvement of the cardiometabolic profile of T2D, HCh, and HTN patients. Trial completion date: Jun 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2023
- |||||||||| colesevelam / Generic mfg.
Trial completion date, Trial primary completion date: A Study of Colesevelam in Fecal Incontinence (clinicaltrials.gov) - Dec 10, 2020
P3, N=60, Recruiting,
Trial completion date: Jun 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Jun 2023 Trial completion date: Oct 2020 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Jun 2022
- |||||||||| Triglide (fenofibrate) / Vectura, Shionogi, Jakafi oral (ruxolitinib) / Novartis, Incyte
[VIRTUAL] SEVERE HYPERTRIGLYCHERIDEMIA IN A PATIENT WITH GRAFT DISEASE AGAINST HOST IN TREATMENT WITH RUXOLITINIBE, SIROLIMUS AND CORTICOIDE () - Nov 26, 2020 - Abstract #HEMO2020HEMO_485;
Cyclosporine was suspended due to renal failure and later replaced by Sirolimus...On 06/27, Sirolimus and Ruxolitinib were suspended and Ezetimibe, Fenofibrate and Atorvastatin started...In cases of moderate to severe hypertriglyceridemia, the use of omega-3 and fibrates may be considered, as well as second-line treatments include niacin, Ezetimibe or Colesevelam...The interactions between immunosuppressive medications and lipid-lowering drugs used to treat side effects from previous treatment need to be regularly monitored, as changes are clinically important. In case of association of corticosteroids Sirolimus and Ruxolitinib, strict control of the lipid profile must be implemented in view of the cases described.
- |||||||||| colesevelam / Generic mfg.
Trial completion date, Trial primary completion date, Combination therapy: Effects of Fish Oil and Colesevelam (STAIR7007) (clinicaltrials.gov) - Nov 10, 2020
P=N/A, N=13, Active, not recruiting,
In case of association of corticosteroids Sirolimus and Ruxolitinib, strict control of the lipid profile must be implemented in view of the cases described. Trial completion date: Apr 2020 --> Jul 2021 | Trial primary completion date: Apr 2020 --> Apr 2021
- |||||||||| metformin / Generic mfg., colesevelam / Generic mfg.
Trial completion, Monotherapy: WELKid DM: Colesevelam for Children With Type 2 Diabetes (clinicaltrials.gov) - Jul 16, 2020
P4, N=230, Completed,
Enrolling by invitation --> Completed Active, not recruiting --> Completed
- |||||||||| colesevelam (IW-3718) / Ironwood Pharma, colesevelam / Generic mfg.
Journal: Integrative roles of microRNAs in lipid metabolism and dyslipidemia. (Pubmed Central) - Jun 10, 2020
miRNAs are not just fine-tuners of lipid metabolism, but critical regulatory factors in lipid homeostasis and health. Loss of these miRNA regulatory modules very likely contributes to the underlying metabolic defects observed in lipid disorders.
- |||||||||| metformin / Generic mfg., colesevelam / Generic mfg.
Trial completion date, Trial primary completion date, Monotherapy: WELKid DM: Colesevelam for Children With Type 2 Diabetes (clinicaltrials.gov) - May 26, 2020
P4, N=230, Active, not recruiting,
Loss of these miRNA regulatory modules very likely contributes to the underlying metabolic defects observed in lipid disorders. Trial completion date: Mar 2020 --> Jun 2020 | Trial primary completion date: Mar 2019 --> Nov 2019
- |||||||||| simvastatin / Generic mfg., Triglide (fenofibrate) / Vectura, Shionogi, Nexletol (bempedoic acid) / Esperion Therap, Otsuka
Journal: Bempedoic acid (Nexletol) for lowering LDL-cholesterol. (Pubmed Central) - May 19, 2020
Trial completion date: Mar 2020 --> Jun 2020 | Trial primary completion date: Mar 2019 --> Nov 2019 No abstract available
- |||||||||| colesevelam (IW-3718) / Ironwood Pharma, Welchol (colesevelam) / Daiichi Sankyo, cholestyramine / Generic mfg.
Bile Acid Sequestration Synergistically Accelerates Glucagon Receptor-Stimulated Body Weight Loss in Diet-Induced Obese Mice (ENDOExpo) - Feb 7, 2020 - Abstract #ENDO2020ENDO_1666;
Together these studies suggest BARS may enhance the anti-obesity effect of GCGR agonism, beneficially regulate feeding behaviors, and prevent GCGR-stimulated glucose dysregulation in DIO mice. Furthermore, these studies argue that GCGR agonsim combined with BARS treatment may represent a novel therapeutic approach for obesity and obesity-associated glucose intolerance.
- |||||||||| colesevelam / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Effects of Fish Oil and Colesevelam (STAIR7007) (clinicaltrials.gov) - Jan 31, 2020
P=N/A, N=13, Active, not recruiting,
Furthermore, these studies argue that GCGR agonsim combined with BARS treatment may represent a novel therapeutic approach for obesity and obesity-associated glucose intolerance. Recruiting --> Active, not recruiting | Trial completion date: Dec 2019 --> Apr 2020 | Trial primary completion date: Mar 2019 --> Apr 2020
- |||||||||| colesevelam / Generic mfg.
Trial completion, Enrollment change: CLASS-ACT: Colesevelam, Lipids And Sugars, South Asian Canadian Trial (clinicaltrials.gov) - Jan 23, 2020
P=N/A, N=90, Completed,
Colesevelam at 36 mg/mL in combination with 100 µM DCA, GCDCA and TDCA ameliorated the delay in gastric emptying and slowed intestinal transit induced by the bile acids. Recruiting --> Completed | N=250 --> 90
- |||||||||| lenalidomide / Generic mfg., colesevelam / Generic mfg.
Trial completion date, Trial primary completion date: A Study of Colesevelam for Lenalidomide-Associated Diarrhea (clinicaltrials.gov) - Jan 9, 2020
P2, N=25, Recruiting,
Recruiting --> Completed | N=250 --> 90 Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
- |||||||||| budesonide / Generic mfg., Nerlynx (neratinib) / Puma, Knight Therap, Welchol (colesevelam) / Daiichi Sankyo
Preclinical, Journal: Targeting neratinib-induced diarrhea with budesonide and colesevelam in a rat model. (Pubmed Central) - Jan 2, 2020
Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Jun 2021 Both budesonide and colesevelam show potential as effective interventions against neratinib-induced diarrhea.
- |||||||||| Review, Journal: Drugs for type 2 diabetes. (Pubmed Central) - Dec 22, 2019
Kinetics, Isotherm and Thermodynamics of bile acid adsorption. No abstract available
- |||||||||| colesevelam / Generic mfg.
Trial primary completion date: A Study of Colesevelam in Fecal Incontinence (clinicaltrials.gov) - Nov 26, 2019
P3, N=60, Recruiting,
No abstract available Trial primary completion date: Oct 2019 --> Oct 2020
- |||||||||| Welchol (colesevelam) / Daiichi Sankyo
Preclinical, Journal: Preclinical discovery and development of colesevelam for the treatment of type 2 diabetes. (Pubmed Central) - Oct 8, 2019
Nonetheless, colesevelam offers a clinically relevant combination of HbA1c- and LDL-lowering that in selected patients could be relevant as add-on treatment to other glucose-lowering drugs and a statin. Potential patients include those with renal impairment, and patients that are close to reaching their lipid and glycemic treatment goals but need further LDL and HbA1c reductions.
- |||||||||| Cycloset (bromocriptine) / Roche
Review, Journal: Adenosine monophosphate-activated protein kinase-based classification of diabetes pharmacotherapy. (Pubmed Central) - Sep 4, 2019
...Metformin and glitazones are pure stimulators of AMPK...Glycemic efficacy of alpha-glucosidase inhibitors, sodium glucose co-transporter-2 inhibitor, colesevelam, and bromocriptine may also involve AMPK activation, which warrants further evaluation...Hence, AMPK-based classification of antidiabetes medications provides a holistic unifying understanding of pharmacotherapy in diabetes. This classification is flexible with a scope for inclusion of promising agents of future.
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