A cross over bioequivalence study of losartan H 50/12.5 mg tablet compared to Hyzaar 50/12.5 mg tablet manufactured by Merck in 24 healthy volunteers under fasting condition

Start Date30 Jun 2022

Sponsor / Collaborator

Alborz Darou Pharmaceutical Co.

100 Clinical Results associated with Alborz Darou Pharmaceutical Co.

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Literatures (Medical) associated with Alborz Darou Pharmaceutical Co.

01 Aug 2023·Hepatology international

Polypill protects MAFLD patients from cardiovascular events and mortality: a prospective trial.

Article

Author: Poustchi, Hossein ; Sharafkhah, Maryam ; Nateghi Baygi, Alireza ; Malekzadeh, Reza ; Ramandi, Alireza ; Delavari, Alireza ; Merat, Shahin ; Mohammadi, Zahra ; George, Jacob ; Radmard, Amir Reza ; Jafari, Elham

BACKGROUNDMetabolic dysfunction-associated fatty liver disease (MAFLD) is a novel term that distinguishes patients at risk of adverse clinical outcomes with higher accuracy than those with non-alcoholic fatty liver disease (NAFLD). Cardiovascular mortality is the leading cause of death in MAFLD. The current literature lacks large-scale prospective studies that address preventive approaches for cardiovascular health in MAFLD. We investigated whether MAFLD patients benefit from a fixed-dose combination therapy (Aspirin, hydrochlorothiazide, atorvastatin, valsartan), known as a Polypill.METHODSAnalysis was performed (stratified based on MAFLD status) of a clinical trial that included 1596 individuals randomly allocated to an intervention (polypill) or a control (usual care) group. Patients were followed up for five years for any adverse drug reaction, major cardiovascular events, and mortality. Univariable and multivariable survival analyses were performed, and the interaction level was assessed by R programming.RESULTSPatients who consumed the polypill had significantly lower hazard ratios of major cardiovascular events incidence (HR 0.56, 95% CI 0.41-0.78) and cardiovascular mortality (HR 0.41, 95% CI 0.2-0.86) compared to the control group. Polypill showed significantly better results in lowering cardiovascular events in MAFLD patients than in the general population. (p-value for interaction: 0.028). Moreover, comparing those patients who had high adherence to the Polypill, with the control group, further enhanced the results.CONCLUSIONSMajor cardiovascular events are prevented in MAFLD patients who consume the Polypill. MAFLD patients benefit from the Polypill more than the general population.

01 Jun 2022·European Heart JournalQ1 · MEDICINE

Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver trial

Q1 · MEDICINE

Article

Author: Shiravi Khuzani, Abolfazl ; Nateghi Baygi, Alireza ; Jafari, Elham ; Poustchi, Hossein ; Marshall, Tom ; Merat, Shahin ; Malekzadeh, Reza ; Khoshnia, Masoud ; Sharafkhah, Maryam ; Cheng, Kar Keung ; Radmard, Amir Reza

AbstractAimsIndividuals with non-alcoholic steatohepatitis or elevated liver enzymes have increased cardiovascular mortality but are often excluded from prevention trials. We investigated the effectiveness of fixed-dose combination therapy for the prevention of major cardiovascular events (MCVE) among individuals with and without presumed non-alcoholic steatohepatitis (pNASH).Methods and resultsTwo thousand four hundred participants over 50 were randomized into the intervention and control groups. Consent was obtained post-randomization. Consenting participants in the intervention group were given a pill containing aspirin, atorvastatin, hydrochlorothiazide, and valsartan (polypill). Participants were followed for 5 years. Presumed non-alcoholic steatohepatitis was diagnosed by ultrasonography and elevated liver enzymes. The primary outcome was MCVE. ClinicalTrials.gov: NCT01245608. Among the originally randomized population, 138 of 1249 in the intervention group (11.0%) and 137 of 1017 controls (13.5%) had MCVE during the 5-year follow-up [unadjusted risk ratio (RR) 0.83, 95% confidence interval (CI) 0.66–1.03]. Of the 1508 participants who consented to additional measurements and treatment, 63 of 787 (8.0%) intervention group participants and 86 of 721 (11.9%) controls had MCVE (adjusted RR 0.61, 95% CI 0.44–0.83). Although the adjusted relative risk of MCVE in participants with pNASH (0.35, 95% CI 0.17–0.74) was under half that for participants without pNASH (0.73, 95% CI 0.49–1.00), the difference did not reach statistical significance. There was no change in liver enzymes in participants taking polypill but among those with pNASH, there was a significant decrease after 60 months of follow-up (intragroup −12.0 IU/L, 95% CI −14.2 to −9.6).ConclusionAmong patients consenting to receive fixed-dose combination therapy, polypill is safe and effective for the prevention of MCVE, even among participants with fatty liver and increased liver enzymes.

01 Aug 2015·Archives of Iranian medicineQ4 · MEDICINE

PolyPill for Prevention of Cardiovascular Disease in an Urban Iranian Population with Special Focus on Nonalcoholic Steatohepatitis: A Pragmatic Randomized Controlled Trial within a Cohort (PolyIran - Liver) - Study Protocol.

Q4 · MEDICINE

Article

Author: Jafari, Elham ; Khoshnia, Masoud ; Merat, Shahin ; Shiravi Khuzani, Abolfazl ; Malekzadeh, Reza ; Marshall, Tom ; Hemming, Karla ; Poustchi, Hossein ; Nateghi, Alireza ; Radmard, Amir-Reza

BACKGROUNDCardiovascular disease (CVD) is among the most common causes of mortality in all populations. Nonalcoholic steatohepatitis is a common finding in patients with CVD. Prevention of CVD in individual patients typically requires periodic clinical evaluation, as well as diagnosis and management of risk factors such as hypertension and hyperlipidemia. However, this is resource consuming and hard to implement, especially in developing countries. We designed a study to investigate the effects of a simpler strategy: a fixed-dose combination pill consisting of aspirin, valsartan, atorvastatin and hydrochlorthiazide (PolyPill) in an unselected group of persons aged over 50 years.DESIGNThe PolyIran-Liver study was performed in Gonbad city as an open label pragmatic randomized controlled trial nested within the Golestan Cohort Study. We randomly selected 2,400 cohort study participants aged above 50 years, randomly assigned them to intervention or usual care and invited them to participate in an additional measurement study (if they met the eligibility criteria) to measure liver related outcomes. Those agreeing and randomized to the intervention arm were offered a daily single dose of PolyPill. We will follow participants for 5 years. The primary outcome is major cardiovascular events, secondary outcomes include all-cause mortality and liver related outcomes: liver stiffness and liver enzyme levels. Cardiovascular outcomes and mortality will be determined from the cohort study and liver-related outcomes in those consenting to follow up. Analysis will be by allocated group.TRIAL STATUSBetween October and December 2011, 1,320 intervention and 1,080 control participants were invited to participate in the additional measurement study. For all these participants, the major cardiovascular events will be determined using blind assessment of outcomes through the cohort study. In the intervention and control arms, 875 (66%) and 721 (67%) respectively, met the eligibility criteria and agreed to participate in the additional measurement study. Liver related outcomes will be measured in these participants. Of the 1,320 participants randomized to the intervention, 787 (60%) accepted the PolyPill.CONCLUSIONThe PolyIran-liver urban study will provide us with important information on the effectiveness of PolyPill on major cardiovascular events, all-cause mortality and liver related outcomes. (ClinicalTrials.gov ID: NCT01245608).

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